Study to Evaluate Safety and Efficacy of Blinatumomab in Subjects With Relapsed/Refractory (R/R) Aggressive B-Cell NHL
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|ClinicalTrials.gov Identifier: NCT02910063|
Recruitment Status : Active, not recruiting
First Posted : September 21, 2016
Last Update Posted : October 25, 2019
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.
|Condition or disease||Intervention/treatment||Phase|
|B-Cell Non Hodgkin Lymphoma||Drug: Blinatumomab||Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Actual Study Start Date :||January 23, 2017|
|Estimated Primary Completion Date :||March 12, 2020|
|Estimated Study Completion Date :||March 12, 2020|
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.
- Phase 2 Complete Metabolic Response [ Time Frame: Approximately 70 days after initiating blinatumomab. ]Complete metabolic response (CMR) as determined by central radiographic assessment of positron emission tomography-computed tomography (PET-CT) scans using the Lugano Classification
- Phase 2 Objective Response Rate [ Time Frame: Approximately 30 months ]Objective Response Rate ORR; Complete Metabolic Response Rate + Partial Metabolic Response Rate
- Phase 2 Progression-Free Survival [ Time Frame: Approximately 30 months ]Progression-free survival (PFS): calculated as the time from start of blinatumomab until the date of diagnosis of progression of lymphoma, or date of death, whichever is earliest. Subjects who are alive and did not have progression will be censored at the last date of tumor assessment.
- Phase 2 Duration of Response [ Time Frame: Approximately 30 months ]Duration of response (DOR): calculated only for subjects who achieve an objective response rate (ORR.) The duration will be calculated from the date a response, complete metabolic response (CMR) or partial metabolic response (PMR), is first achieved until the earliest date of a disease assessment indicating a relapse event or death, whichever occurs first. Subjects who do not 2 Years have a relapse event will be censored on their last disease assessment date. If the last disease assessment date is after the date that triggers the analysis, the subject will be censored at the analysis trigger date. A sensitivity analysis will censor subjects who receive a hematopoietic stem cell transplant (HSCT) at the time of HSCT unless there is no assessment after the HSCT, in which case the last assessment prior to the HSCT will be used as the censoring time.
- Phase 2 Successful Mobilization Rate [ Time Frame: Approximately 30 months ]Successful Mobilization Rate (defined as CD34+ cell 2x10^6/kg)
- Phase 2 Hematopoietic Stem Cell Transplant rates (both autologous and allogeneic) [ Time Frame: Approximately 30 months ]Hematopoietic Stem Cell Transplant rates among subjects with post-blinatumomab complete metabolic response and partial metabolic response.
- Phase 2 100 Day non-relapse mortality after autologous HSCT [ Time Frame: 100 days after autologous HSCT ]100 Day non-relapse mortality after autologous Hematopoietic Stem Cell Transplant
- Phase 2 Blinatumomab concentration steady state [ Time Frame: Approximately 70 days post initiation of blinatumomab ]Blinatumomab concentration steady state
- Phase 2 Incidence and severity of adverse events [ Time Frame: Approximately 2 Years after treatment ]Incidence and severity of treatment-emergent adverse events
- Phase 2 Blinatumomab clearance [ Time Frame: Approximately 70 days post initiation of blinatumomab ]Blinatumomab clearance
- Phase 2 Blinatumomab half life [ Time Frame: Approximately 70 days post initiation of blinatumomab ]Blinatumomab half life
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02910063
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