Clinical trial · Interventional
Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomized Study of Different Dose of Melphalan
Conditioning Regimen of Melphalan-busulfan and Fludarabine: a Randomize Study Comparing 100mg/m2 to 140mg/m2 Melphalan for Adult Patients With Acute Myeloid Leukemia or Myelodysplasia Syndrome.
- 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)
Conditioning regimen with melphalan-busulfan and fludarabine (MBF) achieved low relapse rate in patients with acute myeloid leukemia (AML) and myelodysplasia syndrome (MDS). In our previous retrospective study, we demonstrated that melphalan dose at 100 or 140mg/m2 had similar incidence of relapse but it might had lower toxicities. In this prospective randomize study, we aim to compare the transplantation outcome in adult patients with AML/MDS receiving either MBF with 100 or 140 mg/m2 melphalan.
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 |
|---|---|---|---|
| Survivorship | — | UNRESOLVED | — |
| Toxicities | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| melphalan | Drug | Melphalan | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- MBF100
- description
- Patients receive condoning regimen with melphalan (100mg/m2) with busulfan and fludarabine.
- interventionNames
- Drug: melphalan
- type
- ACTIVE_COMPARATOR
- label
- MBF140
- description
- Patients receive condoning regimen with melphalan (140mg/m2) with busulfan and fludarabine.
- interventionNames
- Drug: melphalan
Primary outcomes (1)
- measure
- Toxicities
- timeFrame
- up to 100 days
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 55 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with AML in first remission * Patients with MDS with bone marrow blast \>5% but remain less than 20% before transplantation * Donor available: HLA matched sibling donor, 9\~10/10 matched unrelated donor or haplo-identical donor * Inform consent provided Exclusion Criteria: * Patients with active infection (bacteria, fungal or viral) * Patients with abnormal liver, renal and cardiac function
References
Publications (0)
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