Trials / Terminated
TerminatedNCT04044560
Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant
Blinatumomab for Minimal Residual Disease (MRD) in Pre-B Cell Acute Lymphoblastic Leukemia Patients Following Hematopoietic Cell Transplantation: A Canadian, Multicentre Trial
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 8 (actual)
- Sponsor
- University of British Columbia · Academic / Other
- Sex
- All
- Age
- 1 Year
- Healthy volunteers
- Not accepted
Summary
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | blinatumomab | Continuous intravenous infusion |
Timeline
- Start date
- 2020-09-08
- Primary completion
- 2022-02-02
- Completion
- 2022-02-02
- First posted
- 2019-08-05
- Last updated
- 2022-02-21
Locations
3 sites across 1 country: Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04044560. Inclusion in this directory is not an endorsement.