Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Myeloid Leukemia | Acute Myeloid Leukemia | CURATED_BROADER | 0.80 |
| Myelodysplastic Syndromes | Myelodysplastic Syndrome | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine and Busulfan | Drug | — | UNRESOLVED |
| Fludarabine, busulfan and melphalan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Flu-Bu2-Mel140
- description
- Patients receive fludarabine, busulfan and melphalan as conditioning regimen
- interventionNames
- Drug: Fludarabine, busulfan and melphalan
- type
- ACTIVE_COMPARATOR
- label
- Flu-Bu4
- description
- Patients receive fludarabine and busulfan as conditioning regimen
- interventionNames
- Drug: Fludarabine and Busulfan
Primary outcomes (1)
- measure
- disease-free survival
- timeFrame
- 2 year
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 16 Years
- Maximum age
- 55 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available