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Recruiting Phase 3

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

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About this study

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.

Condition
Acute Myeloid Leukemia, Myelodysplastic Syndromes
Tested
Fludarabine, busulfan and melphalan, Fludarabine and Busulfan
Sponsor
Shanghai Jiao Tong University School of Medicine

Who can join

Age
16 to 55 years
Sex
All sexes
Healthy volunteers
Not accepted

Inclusion 7

  • Minimum age: 16 years
  • Maximum age: 55 years
  • Study condition: Acute Myeloid Leukemia, Myelodysplastic Syndromes
  • 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 6

  • 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

Where

9 sites, 9 recruiting

Fujian Medical University Union Hospital

Fuzhou, Fujian, China

Recruiting

920th Hospital PLA

Kunming, China

Recruiting

First Affiliated Hospital of Nanjin Medical Unviersity

Nanjin, Jiangsu, China

Recruiting

923th Hospital PLA

Nanning, Guangxi, China

Recruiting

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Recruiting

Shanghai No10 Hospital

Shanghai, Shanghai Municipality, China

Recruiting

and 3 more sites on ClinicalTrials.gov

Contact

Potential match only. Final eligibility is determined by the study team.