Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant (OZM-097)
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|ClinicalTrials.gov Identifier: NCT04044560|
Recruitment Status : Recruiting
First Posted : August 5, 2019
Last Update Posted : April 28, 2021
|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|
|Actual Study Start Date :||September 8, 2020|
|Estimated Primary Completion Date :||September 8, 2022|
|Estimated Study Completion Date :||September 8, 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 firstname.lastname@example.org|
|Canada, British Columbia|
|Vancouver General Hospital - Leukemia/Bone Marrow Transplant Program||Recruiting|
|Vancouver, British Columbia, Canada, V5Z1M9|
|Contact: David Sanford, MD 6048754863|
|BC Children's Hospital||Recruiting|
|Vancouver, British Columbia, Canada, V5Z4H4|
|Contact: Amanda Li, MD|
|Canada, Nova Scotia|
|QEII - Health Sciences Centre||Not yet recruiting|
|Halifax, Nova Scotia, Canada, B3H 2Y9|
|Contact: Mahmoud Elsawy, MD|
|Principal Investigator:||David Sanford, MD||University of British Columbia|