RecruitingPhase 2NCT06816134

Study on the Efficacy and Safety of the TmBU Conditioning Regimen in High-risk or Relapsed/Refractory Acute Leukemia

A Prospective, Randomized Controlled Clinical Study on the Efficacy and Safety of the TmBU Regimen Versus mBUCY Regimen for Conditioning Before Allo-HSCT in High-risk or Relapsed/Refractory Acute Leukemia

Sponsor

The First Affiliated Hospital of Soochow University

Enrollment

48 participants

Start Date

Jan 30, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia Acute Myeloid Leukemia Transplantation, Stem Cell Conditioning Therapy

Summary

This project is a prospective, single-center, randomized controlled clinical study. The subjects were high-risk or relapsed/refractory AML or ALL patients aged ≤ 65 years diagnosed by bone marrow cell morphology, immunology, genetics and therapeutic efficacy evaluation. The TmBU scheme or modified Bu/Cy (mBuCy) scheme was used for pretreatment in allo-HSCT. The primary endpoint of the study was the 2-year cumulative incidence of relapse (CIR) after allo-HSCT, and the secondary endpoints were 2-year overall survival rate (OS), progressing-free survival rate (PFS), non-relapse mortality rate (NRM), graft-versus-host disease (GVHD)-free relapse-free survival (GRFS) rate.

Eligibility

Min Age: 15 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating a new chemotherapy regimen called TmBU as preparation (conditioning) before a bone marrow or stem cell transplant in patients with high-risk or relapsed/treatment-resistant acute leukemia (AML or ALL). The conditioning regimen destroys remaining cancer cells and prepares the body to receive donated stem cells. The study aims to show this combination is both effective and safe. **You may be eligible if...** - You are between 15 and 65 years old - You have been diagnosed with AML or ALL and have high-risk features, or your leukemia has relapsed or not responded to prior treatment - You are scheduled to receive a stem cell transplant (allo-HSCT) - Your heart, kidneys, and lungs are functioning adequately **You may NOT be eligible if...** - Your overall health score suggests you are too frail for the transplant process - You have serious organ dysfunction - You have active 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

DRUGTmBU conditioning Regimen

TmBU conditioning Regimen and GVHD Prophylaxis of Haploid transplantation (Haplo-HSCT) and unrelated donor transplantation (UDT) : Cyclosporine A (CsA) + Mycophenolate mofetil dispersible tablets (MMF) + short-term low-dose methotrexate (MTX) + rabbit anti-human antithymocyte globulin (ATG) or GVHD Prophylaxis of Matched Sibling Donor Hematopoietic Stem Cell Transplantation (MSD-HSCT)：Cyclosporine A (CsA) + short-term low-dose methotrexate (MTX), then stem cells are infused into patient's blood.

DRUGmBUCY conditioning regimen

mBUCY conditioning Regimen and GVHD Prophylaxis of Haploid transplantation (Haplo-HSCT) and unrelated donor transplantation (UDT): Cyclosporine A (CsA) + Mycophenolate mofetil dispersible tablets (MMF) + short-term low-dose methotrexate (MTX) + rabbit anti-human antithymocyte globulin (ATG) or GVHD Prophylaxis of Matched Sibling Donor Hematopoietic Stem Cell Transplantation (MSD-HSCT)：Cyclosporine A (CsA) + short-term low-dose methotrexate (MTX), then stem cells are infused into patient's blood.

Locations(1)

The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, China

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NCT06816134

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