RecruitingPhase 3NCT06381817

Haplo-cord HCT vs. Haplo-HCT for T-ALL Patients

Haploidentical Hematopoietic Cell Transplantation Combined With an Unrelated Cord Blood Unit for Acute T Cell Lymphoblastic Leukemia Compared to Haploidentical Hematopoietic Cell Transplantation: a Multicenter, Randomized, Open-label Trial


Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

146 participants

Start Date

Apr 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The goal of this clinical trial is to learn if haploidentical hematopoietic cell transplantation combined with an unrelated cord blood unit (haplo-cord HCT) works to treat acute T cell lymphoblastic leukemia (T-ALL). It will also learn about the safety of the transplantation. The main questions it aims to answer are: Dose co-infusion of cord blood in haploidentical hematopoietic cell transplantation (haplo-HCT) lower the rate of relapse? What medical problems do participants have when having haplo-cord HCT? Researchers will compare haplo-cord HCT to haplo-HCT to see if haplo-cord HCT works to treat T-ALL. Participants will be infused an unrelated cord blood unit at the same day of haploidentical graft infusion.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study compares two types of stem cell transplants for patients with T-cell acute lymphoblastic leukemia (T-ALL): a haplo-cord transplant (using a half-matched donor plus cord blood) versus a standard half-matched (haploidentical) transplant alone. The goal is to see which approach leads to better outcomes. **You may be eligible if...** - You have T-cell acute lymphoblastic leukemia (a type of blood cancer) - Your disease can be tracked by sensitive tests (MRD testing) - You have a half-matched (haploidentical) donor available - You are willing to undergo a stem cell transplant - You are in reasonably good health (ECOG 0-3) **You may NOT be eligible if...** - You have another active cancer - A suitable cord blood unit cannot be found (for the haplo-cord group) - You have already had a stem cell transplant or CAR-T cell therapy - You have an uncontrolled infection 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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Interventions

BIOLOGICALHaplo-cord HCT

Haploidentical hematopoietic cell transplantation will be performed with coinfusion of an unrelated cord blood unit

BIOLOGICALHaplo-HCT

Hematopoietic cell transplantation will be performed with a haploidentical donor


Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT06381817


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