Clinical trial · Interventional
Reduced Intensity Conditioning Regimens for Acute Myeloid Leukemia and Myelodysplastic Syndrome
Reduced Intensity Conditioning With Fludarabine and Busulfan Versus Fludarabine and Melphalan Before Allogeneic Stem Cell Transplantation for Acute Myeloid Leukemia and Myelodysplastic Syndrome: A Randomised, Multi-Center, Phase III Study
- 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)
The goal of this clinical trial is to compare outcomes of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation (HSCT) for acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) patients. The main questions it aims to answer are: * The safety of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years. * The efficacy of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan) in allogeneic hematopoietic stem cell transplantation for adult AML/MDS patients with HCT-CI≥3 or aged ≥55 years. Participants will be randomized to one of two reduced intensity conditioning (RIC) regimens (fludarabine plus busulfan and fludarabine plus melphalan)
Conditions
Conditions (3)
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, Adult | Adult Acute Myeloid Leukemia | ONTOLOGY_EXACT | 0.98 |
| Allogeneic Hematopoietic Stem Cell Transplantation | — | UNRESOLVED | — |
| Myelodysplastic Syndrome(MDS) | Myelodysplastic Syndrome | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fludarabine and Busulfan | Drug | — | UNRESOLVED |
| Fludarabine and Melphalan | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- fludarabine and busulfan
- description
- fludarabine (30 mg/m\^2/day, days -6 to days -2, the total dase is 150 mg/m\^2) and busulfan (3.2 mg/kg/day, days -3 to days -2, the total dose is 6.4 mg/kg)
- interventionNames
- Drug: Fludarabine and Busulfan
- type
- EXPERIMENTAL
- label
- fludarabine and melphalan
- description
- fludarabine (30 mg/m\^2/day, days -6 to days -2, the total dose is 150 mg/m\^2) and melphalan (70 mg/m\^2/day, days -3 to days -2, the total dose is 140 mg/m\^2)
- interventionNames
- Drug: Fludarabine and Melphalan
Primary outcomes (1)
- measure
- Progression-Free Survival (PFS)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age equal or more than 18 years old. * Patients diagnosed with AML or MDS. * Patients who have related or unrelated bone marrow or peripheral blood donors and plan to undergo hematopoietic stem cell transplantation. * Hct-specific complication index score (HCT-CI) more than or equal to 3 or the age of Patients ≥55 years. * Sign the informed consent, promise to abide by the research procedures, and cooperate with the implementation of the whole process of the research. Exclusion Criteria: * Patients with central nervous system involvement. * Patients with HIV seropositive. * Patients with other serious diseases and a life expectancy of less than six months * Patients with severe mental or psychological disorders. * Patients without written informed consent.
References
Publications (15)
- BACKGROUNDScott BL. Allogeneic stem cell transplantation for high-risk acute leukemia and maintenance therapy: no time to waste. Blood Adv. 2020 Jul 14;4(13):3200-3204. doi: 10.1182/bloodadvances.2019000388. PMID 32663296
- BACKGROUNDSophie S, Yves B, Frederic B. Current Status and Perspectives of Allogeneic Hematopoietic Stem Cell Transplantation in Elderly Patients with Acute Myeloid Leukemia. Stem Cells Transl Med. 2022 May 27;11(5):461-477. doi: 10.1093/stcltm/szac015. PMID 35438781
- BACKGROUNDAoudjhane M, Labopin M, Gorin NC, Shimoni A, Ruutu T, Kolb HJ, Frassoni F, Boiron JM, Yin JL, Finke J, Shouten H, Blaise D, Falda M, Fauser AA, Esteve J, Polge E, Slavin S, Niederwieser D, Nagler A, Rocha V; Acute Leukemia Working Party (ALWP) of the European group for Blood and Marrow Transplantation (EBMT). Comparative outcome of reduced intensity and myeloablative conditioning regimen in HLA identical sibling allogeneic haematopoietic stem cell transplantation for patients older than 50 years of age with acute myeloblastic leukaemia: a retrospective survey from the Acute Leukemia Working Party (ALWP) of the European group for Blood and Marrow Transplantation (EBMT). Leukemia. 2005 Dec;19(12):2304-12. doi: 10.1038/sj.leu.2403967. PMID 16193083
- BACKGROUNDCraddock C, Jackson A, Loke J, Siddique S, Hodgkinson A, Mason J, Andrew G, Nagra S, Malladi R, Peniket A, Gilleece M, Salim R, Tholouli E, Potter V, Crawley C, Wheatley K, Protheroe R, Vyas P, Hunter A, Parker A, Wilson K, Pavlu J, Byrne J, Dillon R, Khan N, McCarthy N, Freeman SD. Augmented Reduced-Intensity Regimen Does Not Improve Postallogeneic Transplant Outcomes in Acute Myeloid Leukemia. J Clin Oncol. 2021 Mar 1;39(7):768-778. doi: 10.1200/JCO.20.02308. Epub 2020 Dec 29. PMID 33373276
- BACKGROUNDLuger SM, Ringden O, Zhang MJ, Perez WS, Bishop MR, Bornhauser M, Bredeson CN, Cairo MS, Copelan EA, Gale RP, Giralt SA, Gulbas Z, Gupta V, Hale GA, Lazarus HM, Lewis VA, Lill MC, McCarthy PL, Weisdorf DJ, Pulsipher MA. Similar outcomes using myeloablative vs reduced-intensity allogeneic transplant preparative regimens for AML or MDS. Bone Marrow Transplant. 2012 Feb;47(2):203-11. doi: 10.1038/bmt.2011.69. Epub 2011 Mar 28.