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Blinatumomab for MRD in Pre-B ALL Patients Following Stem Cell Transplant

NCT04044560 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 8

Last updated 2022-02-21

No results posted yet for this study

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

  • B-cell Adult Acute Lymphoblastic Leukemia
  • Stem Cell Leukemia
  • Minimal Residual Disease

Interventions

BIOLOGICAL

blinatumomab

Continuous intravenous infusion

Sponsors & Collaborators

  • Amgen

    collaborator INDUSTRY

  • University of British Columbia

    lead OTHER

Principal Investigators

  • David Sanford, MD · University of British Columbia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
1 Year
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-08
Primary Completion
2022-02-02
Completion
2022-02-02
FDA Drug
Yes

Countries

  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04044560 on ClinicalTrials.gov