RecruitingPhase 3NCT05991908

Randomized Study of Conditioning of Fludarabine Combined With Single or Dual Alkylating Agents in Myeloid Malignancies

Multiple-center Randomized Study to Compare Fludarabine and Busulfan Versus Fludarabine, Busulfan and Melphalan in Adult Patients With Acute Myeloid Leukemia (AML) and Myelodysplasia Syndrome (MDS)


Sponsor

Shanghai Jiao Tong University School of Medicine

Enrollment

222 participants

Start Date

Oct 19, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

Fludarabine and busulfan becomes standard conditioning regimen for adult patients with acute myeloid leukemia (AML) or myelodysplasia syndrome (MDS). The overall relapse rate is 15\~20%. More recently, the investigators demonstrated that conditioning regimen with dual alkylating agents consistent of fludarabine, busulfan and melphalan achieved a low incidence of relapse (\<10%). This multiple-center randomize study is aim to compare the transplantation outcome in adult patients with AML/MDS undergoing allo-HSCT with conditioning regimen of Flu-Bu4 vs. FLu-Bu-Mel.


Eligibility

Min Age: 16 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two different chemotherapy preparation regimens (called conditioning) before a bone marrow transplant for people with blood cancers. The goal is to find the best approach to prepare the body for the transplant and reduce relapse. **You may be eligible if...** - You have acute myeloid leukemia (AML) in your first complete remission, or myelodysplastic syndrome (a pre-leukemia bone marrow disorder) with a certain level of abnormal cells - You have a matched bone marrow donor (related, unrelated, or half-matched) - You have provided informed consent **You may NOT be eligible if...** - Your AML has spread to the brain or other areas outside the bone marrow - You currently have an active serious infection (viral, bacterial, or fungal) - You have a specific AML type called acute promyelocytic leukemia 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

DRUGFludarabine, busulfan and melphalan

FLudarabine 150mg/m2 + Busulfan 6.4mg.kg + Mel 140mg/m2

DRUGFludarabine and Busulfan

FLudarabine 150mg/m2 + Busulfan 12.8mg.kg


Locations(9)

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Zhongshan Hospital, Xianmen University

Xiamen, Fujian, China

923th Hospital PLA

Nanning, Guangxi, China

First Affiliated Hospital of Nanjin Medical Unviersity

Nanjin, Jiangsu, China

First Affiliatied Hospital of Soochow University

Suzhou, Jiangsu, China

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Shanghai No10 Hospital

Shanghai, Shanghai Municipality, China

920th Hospital PLA

Kunming, China

Shanghai No 6 Hospital

Shanghai, China

View Full Details on ClinicalTrials.gov

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NCT05991908


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