RecruitingPhase 2NCT06447090

VMAC+DLI Treatment of Patients With Relapse of AML After Allo-HSCT

Study on the Efficacy and Safety of VMAC Combined With Donor Lymphocyte Infusion (DLI) in the Treatment of Patients With Relapse of Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation


Sponsor

Institute of Hematology & Blood Diseases Hospital, China

Enrollment

30 participants

Start Date

Apr 12, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

This clinical trial included 30 cases and aimed to understand the effectiveness and safety of the VMAC regimen combined with donor lymphocyte infusion (DLI) in the treatment of patients with acute myeloid leukemia who have relapsed after allogeneic hematopoietic stem cell transplantation. The main questions it aims to answer are: The safety and efficacy of VMAC combined with DLI in the treatment of allo HSCT recurrence in AML patients;


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study tests a combination treatment called VMAC (a multi-drug regimen) together with donor lymphocyte infusion (DLI) — a procedure that infuses immune cells from the original stem cell donor — in patients with acute myeloid leukemia (AML) who have relapsed after a stem cell transplant from a donor. **You may be eligible if...** - You are between 18 and 65 years old with confirmed AML that has relapsed after an allogeneic (donor) stem cell transplant - Your bone marrow shows 5% or more blast cells (a sign of relapse) - You are in reasonable health (ECOG 0–2) **You may NOT be eligible if...** - You have had a second transplant - You have had another cancer treated within the past 3 years - You have HIV, active hepatitis B or C, or active syphilis - You are pregnant or cannot use contraception during treatment - You have active serious heart disease (heart failure, low heart function, recent heart attack, or severe arrhythmia) - You have a mental illness that prevents cooperation with treatment 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

DRUGMitoxantrone hydrochloride liposome

Veneclatra (VEN) 400 mg/d (reduced to 100 mg when combined with an azole), d1-7; Mitoxantrone Liposomal 30 mg/m2, d1; Cytosine arabinoside(Ara-C) 100 mg/m2/d, d1-7; Cyclophosphamide (CTX) 400 mg/m2/d, d2, 5); After 1 day of rest, cryopreserved donor stem cells MNC1-2X10\^8 /kg infusion, add low-dose (25 mg Bid) and short-course treatment (stop 2-3 weeks after DLI) oral cyclosporine (CSA) to prevent graft-versus-host disease (GVHD) 3 days before cryopreserved stem cell infusion.


Locations(1)

Institute of Hematology & Blood Diseases Hospital, China

Tianjin, Tianjin Municipality, China

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NCT06447090