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

• Status: Recruiting
• Trial end date: 2026-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Shanghai Jiao Tong University School of Medicine
• Treatments: Busulfan; Fludarabine; Fludarabine phosphate; Melphalan; Vidarabine

Criteria

Inclusion Criteria:

• acute myeloid leukemia (acute promyelocytic leukemia excluded) in 1st complete remission

• myelodysplasia syndrome with bone marrow blast >5% and remaining less than 20% at transplantation

• patients with HLA matched sibling donor, 9-10 matched unrelated donor or haplo-identical related donors

• inform consent provided

Exclusion Criteria:

• AML patients with active CNS or extramedullary diseases

• patients with active viral, bacterial or fungal infection

• patients with hepatitis B virus >1X103 copy/ml

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

• patients with uncontrolled mental disorders

• patients with HIV