Study on Blinatumomab After Specialized Transplant for High-Risk B Cell Acute Lymphoblastic Leukemia

Sponsor: Medical College of Wisconsin

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04746209

Provider View

This clinical trial is exploring a new treatment approach for patients with high-risk B cell acute lymphoblastic leukemia (ALL) to reduce the chance of cancer returning and improve survival rates. The study involves a special type of transplant followed by the drug blinatumomab.

Patient Parameters

Program Overview

The trial aims to test if a special transplant that removes certain immune cells, followed by the drug blinatumomab, can help prevent leukemia from coming back in patients with high-risk B cell acute lymphoblastic leukemia (ALL). The study will also look at whether this approach can improve survival while reducing side effects and complications from treatment. The type of transplant and treatment will depend on the patient's cancer status before the transplant.

Description

This study is testing a new treatment for high-risk B cell acute lymphoblastic leukemia (ALL) that involves a special type of transplant followed by the drug blinatumomab. Blinatumomab is a medication that helps the immune system target and destroy cancer cells. The transplant involves removing certain immune cells to reduce the risk of a complication called graft-versus-host disease (GVHD). Patients will receive different types of conditioning treatments before the transplant based on their cancer status. The study is open to children, adolescents, and young adults who have relapsed or have high-risk leukemia. The goal is to see if this treatment can lower the chance of the cancer returning and improve survival rates.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with B cell acute lymphoblastic leukemia (ALL) with no minimal residual disease in the bone marrow.
  • In remission after a first relapse or have very high-risk leukemia going to transplant in first remission.
  • Have a suitable unrelated or partially matched donor for transplant.
  • Aged 25 years or younger.
  • Good overall health with a performance status score of 60% or higher.
  • Acceptable organ function, including kidney, liver, heart, and lung health.
  • No active or chronic graft-versus-host disease if relapsed after a previous transplant.
  • At least 42 days since any previous immunotherapy, except blinatumomab.
  • Agree to use effective birth control during and after treatment.
  • Provide written consent to participate in the study.
  • Must have participated in the Blinatumomab Bridging Therapy (BBT) Trial.

Exclusion Criteria

  • Have active disease outside the bone marrow or specific types of leukemia-related disease.
  • Receiving other cancer treatments not specified in the study.
  • Have an uncontrolled infection.
  • Pregnant or breastfeeding.
  • Allergic to any study medications.
  • Participating in another early-phase clinical trial.
  • Have another active cancer besides B-ALL.

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