Hematologic MalignancyNCT04307134
Besponsa Post Marketing Surveillance Study
An observational study of Hematologic Malignancy, run by Pfizer at 1 site in South Korea.
Trial summary
Besponsa is approved for the treatment of R/R B-cell ALL in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with besponsa after marketing in Korea, with regard to the… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hematologic Malignancy
- What is being tested?
- Inotuzumab ozogamicin
- How many people
- 108 participants
- Where
- 1 siteSouth Korea
- Study dates
- 9 Jul 2020to 24 Dec 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).
Who may be able to join
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Who cannot join
- Patients meeting any of the following criteria will not be included in the study:
- Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information.
- Patients to whom BESPONSA® is contraindicated as per the local labeling.
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Korean Post Marketing Surveillance Study to Observe Safety and Effectiveness of BESPONSA (REGISTERED)
Besponsa is approved for the treatment of R/R B-cell ALL in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with besponsa after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of besponsa will be observed.
Read the detailed description
Before the approval of BESPONSA® in Korea, this non-interventional study is designated as a Post-Marketing Surveillance (PMS) Study and is a commitment to Ministry of Food and Drug Safety (MFDS), as a part of Risk Management Plan (RMP) which is required by MFDS. The safety and effectiveness information of BESPONSA® will be gathered in the setting of routine practice in Korea during the initial 6 years after the approval.
- Conditions
- Hematologic Malignancy
- Being tested
- Inotuzumab ozogamicin
- Keywords
- Refractory and relapsed B-cell ALL
- Medical subject headings
- Hematologic Neoplasms, Burkitt Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inotuzumab ozogamicinDrug
R/R ALL who treated with Inotuzumab ozogamicin
| Study group | Role | What they receive |
|---|---|---|
| R/R ALL | Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL) Receives: Drug: Inotuzumab ozogamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. AEs included both SAEs and all non-SAEs. An SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or was an important medical event.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With Adverse Drug Reactions (ADRs) and Serious ADRs (SADRs)
An ADR was any untoward medical occurrence attributed to medicinal product in participant who had received that product. SADR was an ADR that resulted in any of the following: death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; or was an important medical event.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With Unexpected AEs and SAEs
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. An SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that: resulted in death; is life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or was an important medical event. An AE was considered expected if the reported event and its specificity or severity were consistent with as pre-specified in the protocol, other than these all AEs were unexpected.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With Unexpected ADRs and SADRs
An ADR was any untoward medical occurrence attributed to medicinal product in participant who had received that product. SADR was an ADR that resulted in any of the following: death; was life-threatening; required inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; or was important medical event. In this outcome measure, number of participants with unexpected ADRs and SADRs are reported. An ADR was considered expected if the reported event and its specificity or severity were consistent with as pre-specified in the protocol, other than these all ADRs were unexpected.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of AEs According to Severity
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. AEs' severity was graded using common terminology criteria for AEs (CTCAE) version 4.0; grade 1= mild AE; grade 2= moderate AE; grade 3= severe AE; grade 4= life-threatening AE and grade 5= death.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of AEs According to Action Taken
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per action taken for AEs (withdrawn [temporarily or permanently or delayed]; dose reduced; dose increased; dose not changed; unknown, and not applicable) in this outcome measure. Not applicable per protocol referred to situations if participant died or if the treatment was completed prior to the reaction/event or if drug was not administered.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of AEs According to SAEs' Category
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per SAEs category (resulted in death; is life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect and is an important medical event) in this outcome measure. One SAE could have more than 1 outcome/characteristic and have been counted in more than one category.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of AEs According to Their Outcomes
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per their outcomes (recovered, recovered with sequelae, recovering, not recovered, and unknown) in this outcome measure.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of AEs Based on Causality of AEs to the Study Drug
AE: any untoward medical occurrence in participant administered medicinal product. Number of AEs per causality of AE to study drug (certain, probable/likely, possible, unlikely, conditional/unclassified, and not-assessable/unclassifiable) were reported. Certain: couldn't be explained by other drugs, had clinically reasonable reaction on cessation of drug and pharmacological/phenomenological reaction to drug re-administration. Probable/likely: couldn't be explained by other drugs, had clinically reasonable reaction on drug cessation. Possible: could also be explained by other drugs, lacked information/unclear information on drug discontinuation. Unlikely: not likely to have causal relationship from drug administration, could also be explained by other drugs. Conditional/unclassified: needed more data to make appropriate assessment/additional of data being reviewed. Not-assessable: lacked sufficient information/conflicting information hampering accurate causality assessment.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of AEs Based on Other Causality of AEs
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of AEs were classified as per other causality of AE to the study drug (disease under the study, other disease, concomitant treatment drug or non-drug, and others) in this outcome measure.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With AEs Classified According to Their Age at Baseline
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of age (less than [<] 65 years and more than or equal to [>=] 65 years) in this outcome measure.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With AEs Classified According to Their Sex at Baseline
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of sex (female and male) in this outcome measure.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With AEs Classified According to Their Diagnosis at Baseline
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of diagnosis (Philadelphia [+] B-cell Acute Lymphoblastic Leukemia [ALL], Philadelphia [-] B-cell ALL, and unknown) in this outcome measure.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With AEs Classified According to Their Disease Status at Baseline
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Refractory Disease: failure to achieve complete response (CR) at the end of induction. Relapsed disease: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, absolute neutrophil count (ANC) > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. Number of participants with AEs were classified according to their baseline demographic characteristics of disease status (refractory, first relapsed, second relapsed and third or more relapsed) in this outcome measure.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With AEs Classified According to Their Renal Disorder Status at Baseline
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of renal disorder status (yes or no) in this outcome measure.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With AEs Classified According to Their Hepatic Disorder Status at Baseline
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of hepatic disorder status (yes or no) in this outcome measure.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With AEs Classified According to Their Allergic History Status at Baseline
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of allergic history (yes or no) in this outcome measure.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With AEs Classified According to Their Veno-occlusive Liver Disease/ Sinusoidal Obstruction Syndrome (VOD /SOS) Status at Baseline
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. VOD also known as SOS is a potentially life-threatening condition in which the small veins in the liver are blocked. This obstruction impairs blood flow through the liver and can lead to liver damage and failure. Number of participants with AEs were classified according to their baseline demographic characteristics of VOD/SOS (yes or no) in this outcome measure.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With AEs Classified According to Their Previous Systemic Therapy Status at Baseline
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of previous systemic therapy status (yes, no, and unknown) in this outcome measure.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With AEs Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of previous hematopoietic cell transplant status (yes, no, and unknown) in this outcome measure.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Number of Participants With AEs Classified According to Usage of Concomitant Medication Throughout the Study
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to the use of concomitant medications (yes and no) in this outcome measure.
Measured: From first dose of study intervention (Day 1) up to the end of study (maximum up to 311 days)
Number of Elderly Participants With ADRs
An ADR was any untoward medical occurrence attributed to a medicinal product in a participant who had received that product. In this outcome measure, number of elderly participants (>=65 years) with ADRs at baseline were reported.
Measured: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
Secondary outcomes (12)
Number of Participants With Best Overall Response (BOR)
BOR was defined as the best response recorded from the start of treatment until disease progression (PD) or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. Ineffectiveness was defined as BOR of refractory disease, PD, or relapsed disease. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. Refractory Disease: failure to achieve CR at the end of induction. Relapsed disease: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR.
Measured: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Age at Baseline
BOR was defined as the best response recorded from the start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of age (<65 years and >=65 years) in this outcome measure.
Measured: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Sex at Baseline
BOR was defined as the best response recorded from the start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of sex (female and male) in this outcome measure.
Measured: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Diagnosis at Baseline
BOR was defined as the best response recorded from the start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of diagnosis (Philadelphia [+] B-cell ALL, Philadelphia [-] B-cell ALL and unknown) in this outcome measure.
Measured: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Disease Status at Baseline
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. Refractory Disease: failure to achieve CR at the end of induction. Relapsed disease: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR. The number of participants with effective BOR were classified according to their baseline demographic characteristic of disease status (refractory, first relapsed, second relapsed and third or more relapsed) in this outcome measure.
Measured: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Renal Disorder at Baseline
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of renal disorder (yes and no) in this outcome measure.
Measured: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Hepatic Disorder at Baseline
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of hepatic disorder (yes and no) in this outcome measure.
Measured: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Allergic History at Baseline
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of allergic history (yes and no) in this outcome measure.
Measured: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their VOD/SOS Status at Baseline
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. VOD also known as SOS is a potentially life-threatening condition in which the small veins in the liver are blocked. This obstruction impairs blood flow through the liver and can lead to liver damage and failure. The number of participants with effective BOR were classified according to their baseline demographic characteristic of VOD/SOS (yes and no) in this outcome measure.
Measured: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Previous Systemic Therapy Status at Baseline
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of previous systemic therapy (yes, no and unknown) in this outcome measure.
Measured: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC >1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to their baseline demographic characteristic of previous hematopoietic cell transplant (yes, no and unknown) in this outcome measure.
Measured: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Usage of Concomitant Medication Throughout the Study
BOR: best response recorded from start of treatment until PD or recurrence. Effectiveness was defined as a BOR of CR or CR with incomplete hematologic recovery. PD: Increase of at least 25% in the absolute number of circulating or bone marrow blasts or development of extramedullary disease. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, ANC > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. CR with incomplete hematologic recovery: met all criteria for CR except platelet count and/or ANC. The number of participants with effective BOR were classified according to usage of concomitant medication (yes and no) in this outcome measure.
Measured: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2020
- Study start9 Jul 2020
- Primary completion24 Dec 2024
- Study completion24 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 108 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04307134
- Sponsor's protocol ID
- B1931027
- Other IDs
- NCT04307134
- Status last verified
- Dec 2025
- First submitted
- 20 Feb 2020
- Last updated
- 31 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korean Post Marketing Surveillance Study to Observe Safety and Effectiveness of BESPONSA (REGISTERED)
- ClinicalTrials.gov ID
- NCT04307134
- Acronym / sponsor ID
- B1931027
- Conditions
- Hematologic Malignancy
- Keywords
- Refractory and relapsed B-cell ALL
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 108 participants (actual)
- Lead sponsor
- PfizerIndustry (pharma, biotech, devices)
- Study start
- 9 Jul 2020 (actual)
- Primary completion
- 24 Dec 2024 (actual)
- Study completion
- 24 Dec 2024 (actual)
- First posted
- 13 Mar 2020 (actual)
- Results
- Posted 31 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Besponsa is approved for the treatment of R/R B-cell ALL in Korea. In accordance with the Standards for Re-examination of New Drug, it is required to conduct a PMS. Post marketing surveillance is required to determine any problems or questions associated with besponsa after marketing in Korea, with regard to the following clauses under conditions of general clinical practice. Therefore, through this study, effectiveness and safety of besponsa will be observed.
Detailed description
Before the approval of BESPONSA® in Korea, this non-interventional study is designated as a Post-Marketing Surveillance (PMS) Study and is a commitment to Ministry of Food and Drug Safety (MFDS), as a part of Risk Management Plan (RMP) which is required by MFDS. The safety and effectiveness information of BESPONSA® will be gathered in the setting of routine practice in Korea during the initial 6 years after the approval.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| R/R ALL | – | Drug: Inotuzumab ozogamicinPatients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL) |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).
Key inclusion criteria (3 listed)
- Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Patients diagnosed as relapsed or refractory B-cell precursor lymphoblastic leukemia (ALL).
- Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study.
Key exclusion criteria (4 listed)
- Any patients who does not agree that Pfizer and companies working with Pfizer use his/her information.
- Patients to whom BESPONSA® is contraindicated as per the local labeling.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inotuzumab ozogamicinR/R ALL who treated with Inotuzumab ozogamicin | Drug | R/R ALL |
Primary outcome
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. AEs included both SAEs and all non-SAEs. An SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that: resulted in death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or was an important medical event.
Number of Participants With Adverse Drug Reactions (ADRs) and Serious ADRs (SADRs)
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An ADR was any untoward medical occurrence attributed to medicinal product in participant who had received that product. SADR was an ADR that resulted in any of the following: death; was life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; or was an important medical event.
Number of Participants With Unexpected AEs and SAEs
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. An SAE was any untoward medical occurrence in a participant administered a medicinal or nutritional product at any dose that: resulted in death; is life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect or was an important medical event. An AE was considered expected if the reported event and its specificity or severity were consistent with as pre-specified in the protocol, other than these all AEs were unexpected.
Number of Participants With Unexpected ADRs and SADRs
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An ADR was any untoward medical occurrence attributed to medicinal product in participant who had received that product. SADR was an ADR that resulted in any of the following: death; was life-threatening; required inpatient hospitalization/prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect; or was important medical event. In this outcome measure, number of participants with unexpected ADRs and SADRs are reported. An ADR was considered expected if the reported event and its specificity or severity were consistent with as pre-specified in the protocol, other than these all ADRs were unexpected.
Number of AEs According to Severity
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. AEs' severity was graded using common terminology criteria for AEs (CTCAE) version 4.0; grade 1= mild AE; grade 2= moderate AE; grade 3= severe AE; grade 4= life-threatening AE and grade 5= death.
Number of AEs According to Action Taken
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per action taken for AEs (withdrawn [temporarily or permanently or delayed]; dose reduced; dose increased; dose not changed; unknown, and not applicable) in this outcome measure. Not applicable per protocol referred to situations if participant died or if the treatment was completed prior to the reaction/event or if drug was not administered.
Number of AEs According to SAEs' Category
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per SAEs category (resulted in death; is life-threatening; required inpatient hospitalization or prolongation of hospitalization; resulted in persistent or significant disability/incapacity; resulted in congenital anomaly/birth defect and is an important medical event) in this outcome measure. One SAE could have more than 1 outcome/characteristic and have been counted in more than one category.
Number of AEs According to Their Outcomes
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of AEs were classified as per their outcomes (recovered, recovered with sequelae, recovering, not recovered, and unknown) in this outcome measure.
Number of AEs Based on Causality of AEs to the Study Drug
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
AE: any untoward medical occurrence in participant administered medicinal product. Number of AEs per causality of AE to study drug (certain, probable/likely, possible, unlikely, conditional/unclassified, and not-assessable/unclassifiable) were reported. Certain: couldn't be explained by other drugs, had clinically reasonable reaction on cessation of drug and pharmacological/phenomenological reaction to drug re-administration. Probable/likely: couldn't be explained by other drugs, had clinically reasonable reaction on drug cessation. Possible: could also be explained by other drugs, lacked information/unclear information on drug discontinuation. Unlikely: not likely to have causal relationship from drug administration, could also be explained by other drugs. Conditional/unclassified: needed more data to make appropriate assessment/additional of data being reviewed. Not-assessable: lacked sufficient information/conflicting information hampering accurate causality assessment.
Number of AEs Based on Other Causality of AEs
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of AEs were classified as per other causality of AE to the study drug (disease under the study, other disease, concomitant treatment drug or non-drug, and others) in this outcome measure.
Number of Participants With AEs Classified According to Their Age at Baseline
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of age (less than [<] 65 years and more than or equal to [>=] 65 years) in this outcome measure.
Number of Participants With AEs Classified According to Their Sex at Baseline
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of sex (female and male) in this outcome measure.
Number of Participants With AEs Classified According to Their Diagnosis at Baseline
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of diagnosis (Philadelphia [+] B-cell Acute Lymphoblastic Leukemia [ALL], Philadelphia [-] B-cell ALL, and unknown) in this outcome measure.
Number of Participants With AEs Classified According to Their Disease Status at Baseline
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily had a causal relationship with the product treatment or usage. Refractory Disease: failure to achieve complete response (CR) at the end of induction. Relapsed disease: Reappearance of blasts in the blood or bone marrow (>5%) or in any extramedullary site after a CR. CR: No circulating blasts or extramedullary disease, trilineage hematopoiesis and < 5% blasts, absolute neutrophil count (ANC) > 1000/microliter, platelets >100000/microliter and no recurrence for 4 weeks. Number of participants with AEs were classified according to their baseline demographic characteristics of disease status (refractory, first relapsed, second relapsed and third or more relapsed) in this outcome measure.
Number of Participants With AEs Classified According to Their Renal Disorder Status at Baseline
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of renal disorder status (yes or no) in this outcome measure.
Number of Participants With AEs Classified According to Their Hepatic Disorder Status at Baseline
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of hepatic disorder status (yes or no) in this outcome measure.
Number of Participants With AEs Classified According to Their Allergic History Status at Baseline
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of allergic history (yes or no) in this outcome measure.
Number of Participants With AEs Classified According to Their Veno-occlusive Liver Disease/ Sinusoidal Obstruction Syndrome (VOD /SOS) Status at Baseline
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. VOD also known as SOS is a potentially life-threatening condition in which the small veins in the liver are blocked. This obstruction impairs blood flow through the liver and can lead to liver damage and failure. Number of participants with AEs were classified according to their baseline demographic characteristics of VOD/SOS (yes or no) in this outcome measure.
Number of Participants With AEs Classified According to Their Previous Systemic Therapy Status at Baseline
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of previous systemic therapy status (yes, no, and unknown) in this outcome measure.
Number of Participants With AEs Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to their baseline demographic characteristics of previous hematopoietic cell transplant status (yes, no, and unknown) in this outcome measure.
Number of Participants With AEs Classified According to Usage of Concomitant Medication Throughout the Study
Time frame: From first dose of study intervention (Day 1) up to the end of study (maximum up to 311 days)
An AE was any untoward medical occurrence in a participant administered a medicinal product. The event need not necessarily have a causal relationship with the product treatment or usage. Number of participants with AEs were classified according to the use of concomitant medications (yes and no) in this outcome measure.
Number of Elderly Participants With ADRs
Time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)
An ADR was any untoward medical occurrence attributed to a medicinal product in a participant who had received that product. In this outcome measure, number of elderly participants (>=65 years) with ADRs at baseline were reported.
12 secondary outcomes
Number of Participants With Best Overall Response (BOR)
Time frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Age at Baseline
Time frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Sex at Baseline
Time frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Diagnosis at Baseline
Time frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Disease Status at Baseline
Time frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Renal Disorder at Baseline
Time frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Hepatic Disorder at Baseline
Time frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Allergic History at Baseline
Time frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their VOD/SOS Status at Baseline
Time frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Previous Systemic Therapy Status at Baseline
Time frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Their Previous Hematopoietic Cell Transplant Status at Baseline
Time frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Number of Participants With Effective BOR Classified According to Usage of Concomitant Medication Throughout the Study
Time frame: From first dose of study intervention (Day 1) until disease progression or recurrence (maximum up to 311 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- To obtain contact information for a study center near you, click here.Link provided by the sponsor.
- Individual participant dataSharing planned: No. Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pfizer CT.gov Call Center study director
Pfizer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hematologic Malignancy, run by Pfizer at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: From first dose of study intervention (Day 1) up to 28 days post last dose of study intervention (maximum up to 311 days)). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Dec 2025.