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OncoMatch/Clinical Trials/NCT05991908

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

Is NCT05991908 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Fludarabine, busulfan and melphalan and Fludarabine and Busulfan for acute myeloid leukemia.

Phase 3RecruitingShanghai Jiao Tong University School of MedicineNCT05991908Data as of May 2026

Treatment: Fludarabine, busulfan and melphalan · Fludarabine and BusulfanFludarabine 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.

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Extracted eligibility criteria

Cancer type

Acute Myeloid Leukemia

Myelodysplastic Syndrome

Disease stage

Required: Stage 1ST COMPLETE REMISSION

Lab requirements

Kidney function

no abnormal renal function

Liver function

no abnormal liver function

Cardiac function

no cardiac dysfunction

patients with abnormal liver function, renal function, respiratory or cardiac dysfunction

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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