RecruitingPhase 2NCT04746209

Blinatumomab After TCR Alpha Beta/CD19 Depleted HCT

Alpha/Beta T-cell and B-cell Depleted Allogeneic Transplantation (IDE 13641) Followed by Blinatumomab Therapy for High-Risk B-Acute Lymphoblastic Leukemia: A Pilot Study

Sponsor

Medical College of Wisconsin

Enrollment

25 participants

Start Date

Feb 1, 2021

Study Type

INTERVENTIONAL

Conditions

B-cell Acute Lymphoblastic Leukemia B-cell Childhood Acute Lymphoblastic Leukemia B-Cell ALL, Childhood

Summary

This trial will assess the feasibility of alpha/beta T-cell and B-cell depleted allogeneic hematopoietic cell transplantation (HCT) followed by blinatumomab therapy for high-risk B cell acute lymphoblastic leukemia (ALL) as a means of reducing rates of subsequent relapse and improving survival, while also minimizing treatment-related morbidity/ mortality and late effects. The conditioning regimens will be dependent on the patient's minimal residual disease (MRD) status prior to HCT using high throughput sequencing.

Eligibility

Max Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether giving blinatumomab (a drug that helps the immune system find and kill leukemia cells) after a stem cell transplant helps prevent relapse in children and young adults with B-cell acute lymphoblastic leukemia (B-ALL). **You may be eligible if...** - You have B-cell ALL and no evidence of cancer remaining in the bone marrow (MRD-negative) - You are in remission after at least a first relapse, OR - You have very high-risk features in your first remission (such as treatment failure, certain genetic changes, or minimal disease still detected) - You have received an allogeneic (donor) stem cell transplant **You may NOT be eligible if...** - There is still measurable cancer in your bone marrow before transplant - You have active severe infection or graft-versus-host disease - You have significant organ dysfunction - Your leukemia is not of B-cell type Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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