This is a single arm, open label, multi-centre phase II study using blinatumomab for treatment of detectable minimal residual disease (MRD) in the first year following allogeneic hematopoietic stem cell transplant (HSCT) for patients with B cell acute lymphoblastic leukemia (B-ALL). The study has 2 phases: 1. MRD testing phase and 2. blinatumomab treatment phase. Participants with B-ALL planning for HSCT meeting other eligibility criteria will be enrolled onto the MRD testing phase, which will involve centralized MRD testing of bone marrow aspirate samples on day +56, +100, +180, +270 following HSCT. Participants with detectable MRD ≥10\^-4 leukemic cells/total nucleated cells will enroll onto the treatment phase. Blinatumomab treatment will be started following detection of MRD after 7 to 42 days from enrollment onto the treatment phase to allow for initiation of taper of immunosuppressive medications.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Continuous intravenous infusion
Vancouver General Hospital - Leukemia/Bone Marrow Transplant Program
Vancouver, British Columbia, Canada
BC Children's Hospital
Vancouver, British Columbia, Canada
QEII - Health Sciences Centre
Halifax, Nova Scotia, Canada
MRD Response
To determine the proportion of patients with MRD response, defined as negative MRD as measured by flow cytometry, after 1 cycle of blinatumomab.
Time frame: Following 1st cycle of blinatumomab (each cycle is 28 days)
Safety and Tolerability
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).
Time frame: During Blinatumomab treatment, an average of 24 weeks
Survival
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.
Time frame: Up to 5 years
Incidence of MRD Post HSCT
To determine the proportion of patients developing detectable MRD following HSCT for B-ALL as measured by flow cytometry.
Time frame: Up to day +270 following stem cell transplant
Patient Recruitment (Number of Patients Recruited)
Feasibility
Time frame: Through Study Completion, an average of 2 years
Turnaround time of centralized MRD testing (days)
Feasibility
Time frame: Through Study Completion, an average of 2 years
Time to delivery of blinatumomab following MRD detection
Feasibility
Time frame: Through Study Completion, an average of 2 years
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