B-Cell Non Hodgkin LymphomaPhase 2/3NCT02910063
Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL
A Phase 2/3 study testing Blinatumomab in people with B-Cell Non Hodgkin Lymphoma, run by Amgen at 31 sites in 8 countries.
Trial summary
This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with Relapsed/Refractory (R/R) aggressive B-NHL not achieving CMR after 2 cycles of standard platinum-based chemotherapy regimens administered as S1. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- B-Cell Non Hodgkin Lymphoma
- What is being tested?
- Blinatumomab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 31 sitesin 8 countries
- Study dates
- 23 Jan 2017to 12 Mar 2020
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven aggressive B-cell Non-Hodgkin Lymphoma (B-NHL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), follicular lymphoma Grade 3B, PMBCL, T-cell rich B-cell lymphoma, or DLBCL that represents transformation of indolent non-Hodgkin's Lymphoma (NHL), (including follicular, marginal zone, and lymphoplasmacytoid lymphoma) excluding chronic lymphocytic leukemia or Hodgkin Lymphoma. The following histologies are not eligible:
- Lymphoblastic lymphoma
- Burkitt lymphoma
- Mantle cell lymphoma Any histologies not specifically mentioned must be discussed with medical monitor.
- Refractory (no prior CR/CMR) or relapsed (prior CMR) following front line treatment of standard multiagent chemotherapy containing an anthracycline AND an approved anti-CD20 agent. For subjects with refractory disease and who have received radiotherapy, PET positivity should be demonstrated no less than 6 weeks after the last dose of radiotherapy
- Biopsy proven confirmation of relapsed disease.
Show all 18Show fewer
- Received a minimum of 2 cycles of standard of care platinum-based chemotherapy in the S1 setting and had a response of progressive metabolic disease (PMD), no metabolic response (NMR), partial metabolic response (PMR) as centrally assessed by PET-/ CT scan or received at least 1 cycle of S1 chemotherapy and had evidence of PMD as centrally assessed. A pre-salvage scan is required to be submitted to the central reader if a subject had only 1 cycle of pre-salvage chemotherapy.
- Radiographically measurable disease with a demarcated nodal lesion at least 1.5 cm in its largest dimension or a target extranodal lesion at least 1.0 cm in its largest dimension
- Eastern Cooperative Oncology Group performance status less than or equal to 2
- Intention to proceed to high dose chemotherapy (HDT) and autologous hematopoietic stem cell transplant (HSCT)
- Laboratory parameters:
- Hematology:
- Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L
- Platelets ≥ 75 x 10^9/L
- Chemistry:
- Creatinine clearance ≥ 50 mL/min
- Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) < 3X upper limit of normal (ULN)
- Total bilirubin (TBL) < 2x ULN (unless Gilbert's disease or if liver involvement with lymphoma)
Who cannot join
- CMR following S1 chemotherapy
- Treatment within 30 days prior to randomization with another investigational device or drug study (ies).
- Prior anti-CD19-directed therapies
- Prior HDT with autologous HSCT
- Prior allogeneic HSCT
- Clinically relevant central nervous system (CNS) pathology such as epilepsy, paresis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis
Show all 19Show fewer
- Evidence of CNS involvement by NHL
- Known infection with human immunodeficiency virus or chronic infection with hepatitis B virus (hepatitis B surface antigen positive) or hepatitis C virus (anti hepatitis C virus positive)
- History of malignancy other than B-NHL within the past 3 years with the exception of:
- Malignancy treated with curative intent and with no known active disease present for ≥ 3 years before enrollment
- Adequately treated non-melanoma skin cancer or lentigo maligna
- Adequately treated cervical carcinoma in situ
- Adequately treated breast ductal carcinoma in situ
- Prostatic intraepithelial neoplasia without evidence of prostate cancer
- Adequately treated urothelial papillary non-invasive carcinoma or carcinoma in situ
- Known sensitivity to immunoglobulins or any of the components to be administered during dosing.
- Subject likely to not be available to complete all protocol-required study visits or procedures, and/or to comply with all required procedures.
- History or evidence of any other clinically significant disorder, condition or disease (with the exception of those outlined above) that would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
- Female subjects who are pregnant or breastfeeding or planning to become pregnant or breastfeed, or of childbearing potential unwilling to use an effective method of contraception while receiving, and for an additional 48 hours after the last dose of blinatumomab.
Trial locations and contacts
31 sites in 8 countries.
31 sites in 8 countries
Italy7 sites
Research Site
Bergamo, 24127
Research Site
Florence, 50134
Research Site
Genova, 16132
Research Site
Palermo, 90146
Research Site
Pisa, 56100
Research Site
Roma, 00161
Research Site
Udine, 33100
Spain7 sites
Research Site
Barcelona, Catalonia, 08025
Research Site
Córdoba, Andalusia, 14004
Research Site
Madrid, 28034
Research Site
Madrid, 28041
Research Site
Murcia, 30008
Research Site
Santiago de Compostela, Galicia, 15706
Research Site
Valladolid, Castille and León, 47012
Australia5 sites
Research Site
Herston, Queensland, 4029
Research Site
Melbourne, Victoria, 3004
Research Site
Murdoch, Western Australia, 6150
Research Site
Parkville, Victoria, 3052
Research Site
St Leonards, New South Wales, 2065
United States4 sites
Research Site
Baltimore, Maryland, 21201
Research Site
Duarte, California, 91010
Research Site
Greenville, South Carolina, 29607
Research Site
Oklahoma City, Oklahoma, 73104
Belgium3 sites
Research Site
Brussels, 1200
Research Site
Ghent, 9000
Research Site
Leuven, 3000
United Kingdom3 sites
Research Site
Bristol, BS2 8ED
Research Site
Nottingham, NG5 1PB
Research Site
Sheffield, S10 2JF
About this study
Official title: A Phase 2/3 Multi-center Study to Evaluate the Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma
This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with Relapsed/Refractory (R/R) aggressive B-NHL not achieving CMR after 2 cycles of standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to Investigator's Choice chemotherapy.
In March 2019, decision made to not proceed with phase 3.
Read the detailed description
This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with R/R aggressive B-NHL not achieving CMR after standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to IC chemotherapy.The phase 2 component of the study will consist of up to a 28-day screening period, approximately 70 to 112 days of study treatment, a 30-day (+/- 3days) safety follow up, and long-term follow up that will conclude with the final analysis of the phase 3 component, estimated at 30 months after initiation of the phase 3 component. For the phase 3 component, the study will consist of up to a 28-day screening period, a treatment period of up to approximately 168 days, a 30-day safety follow-up visit, and long-term follow up. Long-term follow up will conclude with the final analysis.In the phase 2 component, enrolled subjects will receive blinatumomab monotherapy. In the phase 3 component, enrolled subjects will be randomized in a 1:1 ratio to blinatumomab or IC chemotherapy.
In March 2019, decision made to not proceed with phase 3.
- Conditions
- B-Cell Non Hodgkin Lymphoma
- Being tested
- Blinatumomab
- Keywords
- Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma, Blinatumomab, Leukemia, Standard of Care, SOC, Cancer, Chemotherapy
- Medical subject headings
- Lymphoma, B-Cell, Recurrence, Leukemia, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlinatumomabDrug
Also called AMG 103, Blincyto
Blinatumomab monotherapy
| Study group | Role | What they receive |
|---|---|---|
| Blinatumomab | Experimental | Blinatumomab is administered as a continuous intravenous infusion (CIVI). A single cycle of blinatumomab is continuous infusion with step dosing of 9 µg/day x 7 days, 28 µg/day x 7 days, and 112 µg/days until the end of the cycle. Receives: Drug: Blinatumomab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase 2: Percentage of Participants Who Achieved Complete Metabolic Response (CMR)
Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.
Measured: Up to 12 weeks after first dose of blinatumomab
Phase 3: Number of Participants Who Achieved Complete Metabolic Response (CMR)
Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.
Measured: Up to 12 weeks after first dose of study treatment
Secondary outcomes (22)
Phase 2: Overall Survival (OS)
OS was defined as the time from the date of randomization until death due to any cause.
OS was calculated using Kaplan-Meier estimates.
Measured: From randomization until the end of study, up to 30 months
Phase 2: Objective Response Rate (ORR)
ORR is inclusive of all participants who achieved CMR or those who achieved partial metabolic response (PMR), as determined by central radiographic assessment of PET/CT scans using the Lugano Classification.
Measured: Up to 12 weeks after first dose of blinatumomab
Phase 2: Progression Free Survival (PFS)
PFS was defined as the time from start of treatment with blinatumomab until the date of diagnosis of progression of lymphoma, or date of death, whichever is earliest. PFS was estimated using Kaplan-Meier method.
Measured: From first dose of blinatumomab until the end of study, up to 30 months
Phase 2: Duration of Response (DOR)
DOR was calculated only for participants who achieve a response (CMR or PMR). The duration was calculated from the date a response, CMR or PMR, was first achieved until the earliest date of a disease assessment indicating disease progression or death, whichever occured first. DOR was estimated using Kaplan-Meier method.
Measured: From first dose of blinatumomab up to 12 weeks
Phase 2: Percentage of Participants Who Experienced Successful Mobilization
Successful mobilization rate was defined as the percentage of participants who initiated mobilization while in remission and without any other anti-tumor therapy where the mobilization procedure had an outcome of 'Successful'. Successful mobilization was dictated by institutional standards and defined when the target cell dose was no less than 2 x 10^6 CD34+ cells/kg.
Measured: From first dose of blinatumomab until the end of study, up to 30 months
Phase 2: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT)
The percentage of responders per investigator's review (participants who achieved either CMR or PMR during the treatment) who have undergone allogeneic (allo) HSCT or autologous (auto) HSCT while in remission and without any other anti-cancer treatment.
Measured: From baseline HSCT until the end of study, up to 30 months
Phase 2: Cumulative Incidence Function Estimate of 100-day Mortality After HSCT Presented as Percentage of Participants That Died Not Due to Relapse, With Relapse and Death Due to Relapse as Competing Events
Non-relapse mortality rate at 100 days after HSCT was calculated as the percentage of participants who died not due to relapse. Only participants who achieved a response per investigator's review and underwent autoHSCT are included.
Measured: 100 days after HSCT
Phase 2: Blinatumomab Steady State Concentrations (Css)
Pharmacokinetic (PK) parameters were estimated by non compartmental analysis. The Css of blinatumomab was summarized as the observed concentrations collected after at least 24 hours after the start of continuous IV infusion or start of dose step, where appropriate.
Measured: Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Phase 2: Blinatumomab Clearance (CL)
Serum blinatumomab CL was calculated as CL=R0/Css,DN; where R0 is the infusion rate (μg/hr) and Css,DN is the dose normalized average Css. For the CL calculation, the Css,DN was normalized to the 112 μg/day dose in which the value of dose in units of μg/hr was used for the infusion rate.
Measured: Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Phase 2: Half-life of Blinatumomab
Measured: Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Treatment-emergent adverse events were events with an onset after the administration of the first dose of blinatumomab.
TEAEs were graded using the Common Terminology Criteria for Adverse Events (CTCAE).
Grade 2 Moderate; minimal, local or noninvasive intervention indicated; limited age appropriate instrumental activities of daily life (ADL).
Grade 3 Severe or medically significant but not immediately life-threatening; hospitalization or prolonged hospitalization indicated; disabling; limited self care ADL.
Grade 4 Life-threatening consequences; urgent interventions indicated.
Measured: From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days
Phase 3: Objective Response Rate (ORR)
Measured: Up to 12 weeks after first dose of study treatment
Phase 3: Progression Free Survival (PFS)
Measured: From first dose of study treatment until the end of study, up to 30 months
Phase 3: Duration of Response (DOR)
Measured: From first dose of study treatment up to 12 weeks
Phase 3: Percentage of Participants Who Experienced Successful Mobilization
Measured: From baseline until the end of study, up to 30 months
Phase 3: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT)
Measured: From baseline HSCT until the end of study, up to 30 months
Phase 3: Percentage of Participants Who Died Within 100 Days After Hematopoietic Stem Cell Transplantation (HSCT) That Was Not Due to Relapse
Measured: 100 days after HSCT
Phase 3: Change From Baseline in Patient Reported Clinical Outcome Assessments Quality of Life (QOLCOA) Scores
Measured: Up to 30 days after last dose after study treatment
Phase 3: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Measured: From first dose of study treatment until 30 days after last dose
Phase 3: Serum Blinatumomab Steady State Concentration (Css)
Measured: 24 hours after first dose of blinatumomab
Phase 3: Blinatumomab Clearance (CL)
Measured: Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Phase 3: Half-life of Blinatumomab
Measured: Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2016 (estimated)
- Study start23 Jan 2017
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for B-Cell Non Hodgkin LymphomaStudies of the same condition, open and under way.
- More trials run by AmgenThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02910063
- Sponsor's protocol ID
- 20150292
- Other IDs
- 2016-002044-16, 2016
- Status last verified
- Dec 2020
- First submitted
- 30 Aug 2016
- Last updated
- 13 Jan 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
Publications
Coyle L, Morley NJ, Rambaldi A, Mason KD, Verhoef G, Furness CL, Zhang A, Jung AS, Cohan D, Franklin JL. Open-Label, phase 2 study of blinatumomab as second salvage therapy in adults with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. Leuk Lymphoma. 2020 Sep;61(9):2103-2112. doi: 10.1080/10428194.2020.1759055. Epub 2020 Jun 16.
PubMed 32546071
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2/3 Multi-center Study to Evaluate the Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma
- ClinicalTrials.gov ID
- NCT02910063
- Acronym / sponsor ID
- 20150292
- Conditions
- B-Cell Non Hodgkin Lymphoma
- Keywords
- Relapsed/Refractory Aggressive B-Cell Non Hodgkin Lymphoma, Blinatumomab, Leukemia, Standard of Care, SOC, Cancer, Chemotherapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 23 Jan 2017 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 21 Sep 2016 (estimated)
- Results
- Posted 13 Jan 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with Relapsed/Refractory (R/R) aggressive B-NHL not achieving CMR after 2 cycles of standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to Investigator's Choice chemotherapy.
In March 2019, decision made to not proceed with phase 3.
Detailed description
This is a phase 2/3 open label, multicenter trial testing blinatumomab monotherapy for the treatment of subjects with R/R aggressive B-NHL not achieving CMR after standard platinum-based chemotherapy regimens administered as S1. This study incorporates multiple interim analyses for futility, efficacy, and unblinded sample-size re-estimation. In the phase 3 part of the study, blinatumomab will be compared to IC chemotherapy.The phase 2 component of the study will consist of up to a 28-day screening period, approximately 70 to 112 days of study treatment, a 30-day (+/- 3days) safety follow up, and long-term follow up that will conclude with the final analysis of the phase 3 component, estimated at 30 months after initiation of the phase 3 component. For the phase 3 component, the study will consist of up to a 28-day screening period, a treatment period of up to approximately 168 days, a 30-day safety follow-up visit, and long-term follow up. Long-term follow up will conclude with the final analysis.In the phase 2 component, enrolled subjects will receive blinatumomab monotherapy. In the phase 3 component, enrolled subjects will be randomized in a 1:1 ratio to blinatumomab or IC chemotherapy.
In March 2019, decision made to not proceed with phase 3.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Blinatumomab | Experimental | Drug: BlinatumomabBlinatumomab is administered as a continuous intravenous infusion (CIVI). A single cycle of blinatumomab is continuous infusion with step dosing of 9 µg/day x 7 days, 28 µg/day x 7 days, and 112 µg/days until the end of the cycle. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Biopsy proven aggressive B-cell Non-Hodgkin Lymphoma (B-NHL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), follicular lymphoma Grade 3B, PMBCL, T-cell rich B-cell lymphoma, or DLBCL that represents transformation of indolent non-Hodgkin's Lymphoma (NHL), (including follicular, marginal zone, and lymphoplasmacytoid lymphoma) excluding chronic lymphocytic leukemia or Hodgkin Lymphoma. The following histologies are not eligible:
- Refractory (no prior CR/CMR) or relapsed (prior CMR) following front line treatment of standard multiagent chemotherapy containing an anthracycline AND an approved anti-CD20 agent. For subjects with refractory disease and who have received radiotherapy, PET positivity should be demonstrated no less than 6 weeks after the last dose of radiotherapy
- Biopsy proven confirmation of relapsed disease.
- Received a minimum of 2 cycles of standard of care platinum-based chemotherapy in the S1 setting and had a response of progressive metabolic disease (PMD), no metabolic response (NMR), partial metabolic response (PMR) as centrally assessed by PET-/ CT scan or received at least 1 cycle of S1 chemotherapy and had evidence of PMD as centrally assessed. A pre-salvage scan is required to be submitted to the central reader if a subject had only 1 cycle of pre-salvage chemotherapy.
- Radiographically measurable disease with a demarcated nodal lesion at least 1.5 cm in its largest dimension or a target extranodal lesion at least 1.0 cm in its largest dimension
Key exclusion criteria (19 listed)
- CMR following S1 chemotherapy
- Treatment within 30 days prior to randomization with another investigational device or drug study (ies).
- Prior anti-CD19-directed therapies
- Prior HDT with autologous HSCT
- Prior allogeneic HSCT
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 |
|---|---|---|
| BlinatumomabAlso: AMG 103, BlincytoBlinatumomab monotherapy | Drug | Blinatumomab |
Primary outcome
Phase 2: Percentage of Participants Who Achieved Complete Metabolic Response (CMR)
Time frame: Up to 12 weeks after first dose of blinatumomab
Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.
Phase 3: Number of Participants Who Achieved Complete Metabolic Response (CMR)
Time frame: Up to 12 weeks after first dose of study treatment
Complete metabolic response (CMR) was determined by central radiographic assessment of positron emission tomography and computed tomography (PET/CT) scans using the Lugano Classification.
22 secondary outcomes
Phase 2: Overall Survival (OS)
Time frame: From randomization until the end of study, up to 30 months
Phase 2: Objective Response Rate (ORR)
Time frame: Up to 12 weeks after first dose of blinatumomab
Phase 2: Progression Free Survival (PFS)
Time frame: From first dose of blinatumomab until the end of study, up to 30 months
Phase 2: Duration of Response (DOR)
Time frame: From first dose of blinatumomab up to 12 weeks
Phase 2: Percentage of Participants Who Experienced Successful Mobilization
Time frame: From first dose of blinatumomab until the end of study, up to 30 months
Phase 2: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT)
Time frame: From baseline HSCT until the end of study, up to 30 months
Phase 2: Cumulative Incidence Function Estimate of 100-day Mortality After HSCT Presented as Percentage of Participants That Died Not Due to Relapse, With Relapse and Death Due to Relapse as Competing Events
Time frame: 100 days after HSCT
Phase 2: Blinatumomab Steady State Concentrations (Css)
Time frame: Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Phase 2: Blinatumomab Clearance (CL)
Time frame: Pre-dose on Day 1, and post-dose on Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Phase 2: Half-life of Blinatumomab
Time frame: Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Phase 2: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame: From first dose of blinatumomab until 30 days after last dose. The maximum treatment duration for blinatumomab was 114 days
Phase 3: Objective Response Rate (ORR)
Time frame: Up to 12 weeks after first dose of study treatment
Phase 3: Progression Free Survival (PFS)
Time frame: From first dose of study treatment until the end of study, up to 30 months
Phase 3: Duration of Response (DOR)
Time frame: From first dose of study treatment up to 12 weeks
Phase 3: Percentage of Participants Who Experienced Successful Mobilization
Time frame: From baseline until the end of study, up to 30 months
Phase 3: Percentage of Participants Who Had Allogeneic or Autologous Post-baseline Hematopoietic Stem Cell Transplant (HSCT)
Time frame: From baseline HSCT until the end of study, up to 30 months
Phase 3: Percentage of Participants Who Died Within 100 Days After Hematopoietic Stem Cell Transplantation (HSCT) That Was Not Due to Relapse
Time frame: 100 days after HSCT
Phase 3: Change From Baseline in Patient Reported Clinical Outcome Assessments Quality of Life (QOLCOA) Scores
Time frame: Up to 30 days after last dose after study treatment
Phase 3: Number of Participants Who Experienced a Treatment-emergent Adverse Event (TEAE)
Time frame: From first dose of study treatment until 30 days after last dose
Phase 3: Serum Blinatumomab Steady State Concentration (Css)
Time frame: 24 hours after first dose of blinatumomab
Phase 3: Blinatumomab Clearance (CL)
Time frame: Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Phase 3: Half-life of Blinatumomab
Time frame: Pre-dose on Day 1, and Days 2, 9 and 16 of Cycle 1 (Cycle 1 was 70 days)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32546071Coyle L, Morley NJ, Rambaldi A, Mason KD, Verhoef G, Furness CL, Zhang A, Jung AS, Cohan D, Franklin JL. Open-Label, phase 2 study of blinatumomab as second salvage therapy in adults with relapsed/refractory aggressive B-cell non-Hodgkin lymphoma. Leuk Lymphoma. 2020 Sep;61(9):2103-2112. doi: 10.1080/10428194.2020.1759055. Epub 2020 Jun 16.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request
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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.
MD study director
Amgen
31 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Blinatumomab in people with B-Cell Non Hodgkin Lymphoma, run by Amgen at 31 sites in 8 countries.
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 18 inclusion and 19 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 13 Jan 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 31 sites in Italy, Spain, Australia, United States, Belgium and 3 more countries. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 13 Jan 2021). 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?
Phase 2: Percentage of Participants Who Achieved Complete Metabolic Response (CMR) (time frame: Up to 12 weeks after first dose of blinatumomab). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02910063, which also lists 1 linked publication.
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 13 Jan 2021.