RecruitingPhase 4NCT07101588

Ruxolitinib-Decitabine Intensified Conditioning Regimen for AML: A Randomized Trial

Ruxolitinib and Decitabine-Enhanced Conditioning Versus Modified Bu/Cy or BuF Conditioning for the Impact on Relapse of Acute Myeloid Leukemia in First Complete Remission (CR1)After Allogeneic Hematopoietic Stem Cell Transplantation: A Multicenter, Prospective Randomized Controlled Trial


Sponsor

Chinese PLA General Hospital

Enrollment

200 participants

Start Date

Jan 1, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

This study aims to determine whether the recurrence rate of high-risk acute myeloid leukemia CR1 patients who received allogeneic hematopoietic stem cell transplantation with the Ruxolitinib, Decitabine combined with Bu/Cy or BuF intensive pretreatment regimen is reduced compared with the traditional Bu/Cy or BuFpretreatment regimen.


Eligibility

Min Age: 14 YearsMax Age: 75 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether adding two drugs — ruxolitinib and decitabine — to the standard preparation regimen before a stem cell transplant can improve outcomes for patients with acute myeloid leukemia (AML). **You may be eligible if...** - You have acute myeloid leukemia and are eligible for a stem cell transplant from a donor - Your leukemia is in first complete remission - You are between 12 and 64 years old - You have a suitable donor (matched sibling, half-matched donor, or unrelated matched donor) - Your liver, kidney, and overall health are in acceptable range **You may NOT be eligible if...** - You have a type of AML called acute promyelocytic leukemia (M3) - You or your donor is pregnant - You have a mental illness that prevents you from following the study - You have uncontrolled infections 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

COMBINATION_PRODUCTRuxolitinib, Decitabine

1. Decitabine: 20 mg/m²/day, administered from Day -15 to Day -10. 2. Ruxolitinib: * 10 mg twice daily (bid), Day -15 to Day -5 * 5 mg twice daily (bid), Day -4 to Day -3 * 5 mg once daily (Qd), Day -2


Locations(1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, China

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NCT07101588


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