Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant (OZM-097)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT04044560|
Recruitment Status : Not yet recruiting
First Posted : August 5, 2019
Last Update Posted : March 25, 2020
|Condition or disease||Intervention/treatment||Phase|
|B-cell Adult Acute Lymphoblastic Leukemia Stem Cell Leukemia Minimal Residual Disease||Biological: blinatumomab||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Sequential Assignment|
|Intervention Model Description:||Participants will be monitored for MRD post transplant during the testing phase of the trial. If they have detectable MRD, they will be enrolled into the blinatumomab treatment phase.|
|Masking:||None (Open Label)|
|Official Title:||Blinatumomab for Minimal Residual Disease (MRD) in Pre-B Cell Acute Lymphoblastic Leukemia Patients Following Hematopoietic Cell Transplantation: A Canadian, Multicentre Trial|
|Estimated Study Start Date :||September 2020|
|Estimated Primary Completion Date :||February 2022|
|Estimated Study Completion Date :||September 2026|
Experimental: Blinatumomab Treatment
Eligible patients with detectable MRD will taper immunosuppressive medications, if applicable, and undergo treatment with blinatumomab. The duration of each cycle of blinatumomab treatment is 6 weeks. Adult and pediatric patients will be treated for 4 weeks followed by a 2-week treatment free period. Patients may receive up to 4 cycles total of blinatumomab therapy.
Continuous intravenous infusion
- MRD Response [ Time Frame: Following 1st cycle of blinatumomab (each cycle is 28 days) ]To determine the proportion of patients with MRD response, defined as negative MRD as measured by flow cytometry, after 1 cycle of blinatumomab.
- Safety and Tolerability [ Time Frame: During Blinatumomab treatment, an average of 24 weeks ]Safety of delivering blinatumomab will be monitored early during the post-transplant course. Safety will be evaluated by the onset of treatment emergent adverse events (TEAEs) and by documentation of the incidence and severity of acute and chronic graft versus host disease (GvHD).
- Survival [ Time Frame: Up to 5 years ]Clinically relevant survival outcomes for patients enrolled onto the study including: 2-year and 5-year overall survival (OS) and event free-survival (EFS) and median OS.
- Incidence of MRD Post HSCT [ Time Frame: Up to day +270 following stem cell transplant ]To determine the proportion of patients developing detectable MRD following HSCT for B-ALL as measured by flow cytometry.
- Patient Recruitment (Number of Patients Recruited) [ Time Frame: Through Study Completion, an average of 2 years ]Feasibility
- Turnaround time of centralized MRD testing (days) [ Time Frame: Through Study Completion, an average of 2 years ]Feasibility
- Time to delivery of blinatumomab following MRD detection [ Time Frame: Through Study Completion, an average of 2 years ]Feasibility
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): NCT04044560
|Contact: David Sanford, MD||604 875 email@example.com|
|Principal Investigator:||David Sanford, MD||University of British Columbia|