Blinatumomab Bridging Therapy for Reducing Leukemia Before Transplant

Sponsor: Michael Burke

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04556084

Provider View

This study is testing a treatment called blinatumomab to see if it can help reduce leukemia cells in patients before they undergo a bone marrow transplant. The goal is to improve outcomes after the transplant.

Patient Parameters

Program Overview

The study is exploring the use of blinatumomab, a type of therapy that engages T-cells to target leukemia cells, to reduce the amount of leukemia in patients before they receive a bone marrow transplant. This treatment is being tested in children, adolescents, and young adults with a type of leukemia called B-ALL that has returned or is persistent. Participants will receive one or two cycles of blinatumomab, each lasting 28 days, before proceeding to the transplant. The effectiveness of the treatment will be assessed using advanced techniques to measure leukemia levels in the bone marrow.

Description

This clinical trial is investigating whether blinatumomab, a therapy that helps the immune system target leukemia cells, can reduce leukemia in patients before they undergo a bone marrow transplant. The study is focused on children, adolescents, and young adults with B-ALL, a type of leukemia that has either returned or is not responding to treatment. Participants will receive one or two cycles of blinatumomab, each lasting 28 days, before their transplant. The study will use advanced methods to measure the amount of leukemia in the bone marrow after treatment. If the leukemia is significantly reduced after one cycle, patients can proceed to transplant. If not, they may receive a second cycle. If leukemia is still present after two cycles, they will not continue in the study.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with B-ALL in remission with minimal residual disease (MRD) in the bone marrow.
  • In first relapse or have high-risk B-ALL going to transplant in first remission.
  • Persistent MRD after initial therapy.
  • Plan to undergo a bone marrow transplant with a donor available.
  • Aged 25 years or younger.
  • Good overall health with specific organ function levels.
  • At least 7 days since last chemotherapy.
  • No active Graft-versus-Host Disease if relapsed after a previous transplant.
  • At least 7 days since last biologic therapy, and 42 days since last immunotherapy.
  • Women of childbearing potential must use effective contraception during and after treatment.
  • Must provide written consent to participate.

Exclusion Criteria

  • History of or active central nervous system (CNS) disease.
  • Receiving other cancer treatments not specified in the study.
  • Uncontrolled infections.
  • Pregnant or breastfeeding women.
  • Known allergy to blinatumomab.
  • Participating in another Phase 1 or 2 study.

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