Ph+ ALLNCT05603156
A Study of Olverembatinib Combined With Inotuzumab Ozogamicin in the Treatment ph+ ALL With MRD Persistent Positive
A study testing the usage of Olverembatinib combined with Inotuzumab Ozogamicin in people with Ph+ ALL and Bone Marrow Transplant, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Hematopoietic stem cell transplantation (HSCT) is the effective and even the only cure treatment option for ph+ acute lymphocyte leukemia (ph+ALL). However, the outcome has been insufficient and relapse remains the major cause of treatment failure and poor survival, especially for patients with persistent minimal… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ph+ ALL, Bone Marrow Transplant, Minimal Residual Disease
- What is being tested?
- the usage of Olverembatinib combined with Inotuzumab Ozogamicin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteChina
- Study dates
- 30 Oct 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Acute lymphoblastic leukemia with positive Ph chromosome or BCR / ABL fusion gene ; cD22 expression on the surface of leukemia cells ; hematological complete remission but with MRD persistent positive ( BCR-ABL1 level ≥ 10-4 ), after at least 3 times of intensive chemotherapy, in which classical chemotherapy combined with any first or second generation of tyrosine kinase inhibitors targeting BCR-ABL1.
- Be ≥ 18 years of age on the day of enrollment.
- Understand the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent.
- Necessary to meet the criteria of important organ function : renal function and liver function are as follows : AST, ALT and ALP below the normal 2 times the upper limit, total bilirubin below the normal upper limit 1.5 times ; creatinine clearance rate greater than 50ML / min ; pancreatic function : serum amylase is not higher than the normal upper limit 1.5 times, serum lipase is not higher than the normal upper limit 1.5 times ; normal heart function : ejection fraction ( EF ) > 60 %, pulmonary artery systolic pressure ≤ 50mmHg.
- Has documented nefative results for human immunodeficiency virus antibody (HIV-Ab), hepatitis C virus antibody (HCV-Ab) , as well as undetectable HCV RNA, or undetectable HBV DNA.
- ECOG-PS 0-2.
- Informed consent must be signed before the start of the trial. Informed consent must be signed by the patient himself or his direct family members who are 18 years old and above ; considering the patient 's condition, if the patient 's signature is not conducive to the treatment of the disease, the informed consent is signed by the legal guardian or the patient 's immediate family.
Who cannot join
- Diagnosed as mixed lineage leukemia.
- Documented as CNS leukemia or extramedullary infiltration.
- Patients with other malignant tumors ; the patients were assessed as having comorbidities that seriously endanger the patient 's life or affect the patient 's completion of the study.
- Used to use the third generation of TKIs, including Olverembatinib.
- Patients received any other kind of anti-leukemia antibody therapy two weeks before enrollment.
- Patients received radiotherapy or chemotherapy (except induction chemotherapy ) or any other research treatment within two weeks before enrollment, with the following exceptions :Designed to reduce circulating leukemia lymphocytes count or remission : Steroids, hydroxyurea or vincristine;Maintenance therapy : thiopurine, methotrexate, vincristine, thioguanine and / or tyrosine kinase inhibitors.
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- Patients with severe allergies to InO components and excipients ( Grade ≥ 3 ).
- History of clinically significant liver disease, such as hepatic veno - occlusive disease ( VOD ) or sinusoidal obstruction syndrome ( SOS ) ; such as cirrhosis, decompensated liver disease, acute or chronic hepatitis.
- Active heart disease, defined as one or more of the following : with any history of heart or vascular disease ; have uncontrolled or symptomatic angina history ; myocardial infarction less than 6 months before enrollment ; a history of arrhythmia requiring drug treatment or severe clinical symptoms ; uncontrolled or symptomatic congestive heart failure ( > NYHA grade 2 ) ; ejection fraction is below the lower limit of the normal range. Cardiac ultrasound pulmonary artery systolic pressure > 50mmHg ; or pulmonary hypertension - related clinical symptoms.
- Severe cardiovascular disease, including myocardial infarction, unstable angina, severe arrhythmia, congestive heart failure, etc. during previous TKI treatment.
- A history of auto- or allo-HSCT.
- Dysfunction of blood coagulation.
- Positive serological response to known HIV or active hepatitis C virus.
- Patients with mental illness or other conditions that do not meet the requirements of research treatment and monitoring.
- Unable or unwilling to sign consent form.
- Pregnant or lactating women.
- Patients with other special conditions assessed as unqualified by the researchers.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences
Tianjin, Tianjin Municipality, 300041
About this study
Official title: A Prospective, Single-arm, Multi-center Study of Olverembatinib Combined With Inotuzumab Ozogamicin in the Treatment ph+ ALL With MRD Persistent Positive
Hematopoietic stem cell transplantation (HSCT) is the effective and even the only cure treatment option for ph+ acute lymphocyte leukemia (ph+ALL). However, the outcome has been insufficient and relapse remains the major cause of treatment failure and poor survival, especially for patients with persistent minimal residual disease (MRD). It is believed that clearance of MRD pre-HSCT could significantly reduce the incidence of relapse post-HSCT. Olverembatinib has been documented as a promising third generation of TKIs. Meanwhile, Inotuzumab ozogamicin (InO) , an antibody-drug conjugate approved in the US and the European Union, has been applied in relapsed/refractory acute lymphoblastic leukemia (R/R ALL) and achieved good treatment outcome. This prospective, single arm and multicenter study is to investigate the efficacy and safety of combination of Olverembatinib and Ino for MRD clearance before bridging to HSCT.
- Conditions
- Ph+ ALL, Bone Marrow Transplant, Minimal Residual Disease
- Being tested
- the usage of Olverembatinib combined with Inotuzumab Ozogamicin
- Keywords
- ph+ALL, HSCT, MRD persistent positive, Inotuzumab, tyrosine kinase inhibitor
- Medical subject headings
- Neoplasm, Residual
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
the usage of Olverembatinib combined with Inotuzumab OzogamicinDrug
patients in this arm will accept a 28 days treatment regimen: Olverembatinib 40mg QOD (d1 to d28 )and Inotuzumab Ozogamicin 1.2mg/m2 (divided into 2 days, d1 and d8, 0.6mg/m2, respectively).
| Study group | Role | What they receive |
|---|---|---|
| treatment arm | Experimental | patients enrolled treated with the combination of Olverembatinib and Inotuzumab to clear the persistent MRD. Receives: Drug: the usage of Olverembatinib combined with Inotuzumab Ozogamicin |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRD clearance rate
The ratio of patients achieved MRD remission. The MRD remission was defined as the fusion gene BCR-ABL quantification in bone marrow samples was lower than the detection limit of RT-PCR ( < 0.01 %, the residual number of leukemia cells detected in our hospital was 0.0032 % ) ; at the same time, flow cytometry ( FACS ) was used to monitor the MRD of the cells, and the proportion of abnormal cells < 0.1 % was MRD-
Measured: 2 weeks after the treatment with Olverembatinib and Inotuzumab Ozogamicin
Secondary outcomes (3)
One year OS after HSCT
For patients achived MRD remission, HSCT will be performed. The one year overall survival after HSCT will be the seconday outcom.
Measured: One year after HSCT
One year RFS after HSCT
For patients achived MRD remission, HSCT will be performed. The one year relaspe free survival after HSCT will be the seconday outcom.
Measured: One year after HSCT
One year NRM after HSCT
For patients achived MRD remission, HSCT will be performed. The one year non-relaspe mortality after HSCT will be the seconday outcom.
Measured: One year after HSCT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2022
- Study start30 Oct 2022 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ph+ ALLStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 46 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05603156
- Sponsor's protocol ID
- IIT2022033
- Status last verified
- Oct 2022
- First submitted
- 24 Oct 2022
- Last updated
- 2 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multi-center Study of Olverembatinib Combined With Inotuzumab Ozogamicin in the Treatment ph+ ALL With MRD Persistent Positive
- ClinicalTrials.gov ID
- NCT05603156
- Acronym / sponsor ID
- IIT2022033
- Conditions
- Ph+ ALL, Bone Marrow Transplant, Minimal Residual Disease
- Keywords
- ph+ALL, HSCT, MRD persistent positive, Inotuzumab, tyrosine kinase inhibitor
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 46 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 30 Oct 2022 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 2 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hematopoietic stem cell transplantation (HSCT) is the effective and even the only cure treatment option for ph+ acute lymphocyte leukemia (ph+ALL). However, the outcome has been insufficient and relapse remains the major cause of treatment failure and poor survival, especially for patients with persistent minimal residual disease (MRD). It is believed that clearance of MRD pre-HSCT could significantly reduce the incidence of relapse post-HSCT. Olverembatinib has been documented as a promising third generation of TKIs. Meanwhile, Inotuzumab ozogamicin (InO) , an antibody-drug conjugate approved in the US and the European Union, has been applied in relapsed/refractory acute lymphoblastic leukemia (R/R ALL) and achieved good treatment outcome. This prospective, single arm and multicenter study is to investigate the efficacy and safety of combination of Olverembatinib and Ino for MRD clearance before bridging to HSCT.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| treatment arm | Experimental | Drug: the usage of Olverembatinib combined with Inotuzumab Ozogamicinpatients enrolled treated with the combination of Olverembatinib and Inotuzumab to clear the persistent MRD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Acute lymphoblastic leukemia with positive Ph chromosome or BCR / ABL fusion gene ; cD22 expression on the surface of leukemia cells ; hematological complete remission but with MRD persistent positive ( BCR-ABL1 level ≥ 10-4 ), after at least 3 times of intensive chemotherapy, in which classical chemotherapy combined with any first or second generation of tyrosine kinase inhibitors targeting BCR-ABL1.
- Be ≥ 18 years of age on the day of enrollment.
- Understand the study procedures, alternative treatment available, and risks involved with the study, and voluntarily agree to participate by giving written informed consent.
- Necessary to meet the criteria of important organ function : renal function and liver function are as follows : AST, ALT and ALP below the normal 2 times the upper limit, total bilirubin below the normal upper limit 1.5 times ; creatinine clearance rate greater than 50ML / min ; pancreatic function : serum amylase is not higher than the normal upper limit 1.5 times, serum lipase is not higher than the normal upper limit 1.5 times ; normal heart function : ejection fraction ( EF ) > 60 %, pulmonary artery systolic pressure ≤ 50mmHg.
- Has documented nefative results for human immunodeficiency virus antibody (HIV-Ab), hepatitis C virus antibody (HCV-Ab) , as well as undetectable HCV RNA, or undetectable HBV DNA.
Key exclusion criteria (17 listed)
- Diagnosed as mixed lineage leukemia.
- Documented as CNS leukemia or extramedullary infiltration.
- Patients with other malignant tumors ; the patients were assessed as having comorbidities that seriously endanger the patient 's life or affect the patient 's completion of the study.
- Used to use the third generation of TKIs, including Olverembatinib.
- Patients received any other kind of anti-leukemia antibody therapy two weeks before enrollment.
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 |
|---|---|---|
| the usage of Olverembatinib combined with Inotuzumab Ozogamicinpatients in this arm will accept a 28 days treatment regimen: Olverembatinib 40mg QOD (d1 to d28 )and Inotuzumab Ozogamicin 1.2mg/m2 (divided into 2 days, d1 and d8, 0.6mg/m2, respectively). | Drug | treatment arm |
Primary outcome
MRD clearance rate
Time frame: 2 weeks after the treatment with Olverembatinib and Inotuzumab Ozogamicin
The ratio of patients achieved MRD remission. The MRD remission was defined as the fusion gene BCR-ABL quantification in bone marrow samples was lower than the detection limit of RT-PCR ( < 0.01 %, the residual number of leukemia cells detected in our hospital was 0.0032 % ) ; at the same time, flow cytometry ( FACS ) was used to monitor the MRD of the cells, and the proportion of abnormal cells < 0.1 % was MRD-
3 secondary outcomes
One year OS after HSCT
Time frame: One year after HSCT
One year RFS after HSCT
Time frame: One year after HSCT
One year NRM after HSCT
Time frame: One year after HSCT
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing the usage of Olverembatinib combined with Inotuzumab Ozogamicin in people with Ph+ ALL and Bone Marrow Transplant, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
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 7 inclusion and 17 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: status not confirmed, as of the sponsor's last update on 2 Nov 2022. 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 China. 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?
Results are not available in the source record.
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?
MRD clearance rate (time frame: 2 weeks after the treatment with Olverembatinib and Inotuzumab Ozogamicin). 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 2 Nov 2022.