Clinical trial · Interventional
Ruxolitinib-Decitabine Intensified Conditioning Regimen for AML: A Randomized Trial
Ruxolitinib and Decitabine-Enhanced Conditioning Versus Modified Bu/Cy or BuF Conditioning for the Impact on Relapse of Acute Myeloid Leukemia in First Complete Remission (CR1)After Allogeneic Hematopoietic Stem Cell Transplantation: A Multicenter, Prospective Randomized Controlled Trial
NCT07101588CI-TRIAL-00106087recruitingPhase 4ClinicalTrials.gov clinicaltrialsProvenance
- 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)
This study aims to determine whether the recurrence rate of high-risk acute myeloid leukemia CR1 patients who received allogeneic hematopoietic stem cell transplantation with the Ruxolitinib, Decitabine combined with Bu/Cy or BuF intensive pretreatment regimen is reduced compared with the traditional Bu/Cy or BuFpretreatment regimen.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Allogeneic Hematopoietic Stem Cell Transplantation (HSCT) | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ruxolitinib, Decitabine | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Assigned Interventions
- description
- 1. Decitabine: 20 mg/m²/day, administered from Day -15 to Day -10. 2. Ruxolitinib(with Voriconazole): * 10 mg twice daily (bid), Day -15 to Day -5 * 5 mg twice daily (bid), Day -4 to Day -3 * 5 mg once daily (Qd), Day -2 3. Busulfan (Bu): 0.8 mg/kg every 6 hours (Q6h), Day -8 to Day -6. 4. Carmustine (BCNU): 250 mg every 8 hours (Q8h), Day -3. 5. Cytarabine (Ara-C): * 4 g/m²/day, Day -10 to Day -9 (for unrelated or haploidentical donors) * 4 g/m²/day, Day -9 only (for matched sibling donors) 6. Cyclophosphamide (CTX): 50 mg/kg/day, Day -5 to Day -4. or Fludarabine 30mg/m2/day, iv, Day -6 to Day -2; 7. Antithymocyte Globulin (ATG): * 10 mg/kg/day, Day -5 to Day -2 (for unrelated or haploidentical donors) * 5 mg/kg/day, Day -5 to Day -2 (for matched sibling donors)
- interventionNames
- Combination Product: Ruxolitinib, Decitabine
- type
- NO_INTERVENTION
- label
- The control group
- description
- 1. Busulfan (Bu): 0.8 mg/kg every 6 hours (Q6h), Day -8 to Day -6. 2. Carmustine (BCNU): 250 mg every 8 hours (Q8h), Day -3. 3. Cytarabine (Ara-C): * 4 g/m²/day, Day -10 to Day -9 (for unrelated or haploidentical donors) * 4 g/m²/day, Day -9 only (for matched sibling donors) 4. Cyclophosphamide (CTX): 50 mg/kg/day, Day -5 to Day -4. or Fludarabine 30mg/m2/day, iv, Day -6 to Day -2; 5. Antithymocyte Globulin (ATG): * 10 mg/kg/day, Day -5 to Day -2 (for unrelated or haploidentical donors) * 5 mg/kg/day, Day -5 to Day -2 (for matched sibling donors)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 14 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * 1\) Acute myeloid leukemia with indications for allogeneic hematopoietic stem cell transplantation, CR1 2) Have HLA-matched sibling donors or haploidentical donors or ≥8/10 HLA-matched unrelated donors 3) The patients' ages range from 12 to 64 years old 4) Liver function: ALT and AST≤2.5 times the upper limit of normal values, bilirubin ≤2 times the upper limit of normal values 5) Renal function: Creatinine ≤ the upper limit of the normal value 6) There are no uncontrollable infections or serious mental and psychological disorders 7) Sign the informed consent form. Exclusion Criteria: * 1\. Patients with acute promyelocytic leukemia (M3) 2. One of the donor and recipient is pregnant 3. Suffering from mental illness or other conditions that prevent one from following the plan.
References
Publications (10)
- BACKGROUNDXuan L, Dai M, Jiang E, Wang Y, Huang F, Fan Z, Xu N, Nie D, Liang X, Chen H, Ye J, Shi P, Liu H, Jin H, Lin R, Yan C, Zhang Y, Sun J, Han M, Liu Q. The effect of granulocyte-colony stimulating factor, decitabine, and busulfan-cyclophosphamide versus busulfan-cyclophosphamide conditioning on relapse in patients with myelodysplastic syndrome or secondary acute myeloid leukaemia evolving from myelodysplastic syndrome undergoing allogeneic haematopoietic stem-cell transplantation: an open-label, multicentre, randomised, phase 3 trial. Lancet Haematol. 2023 Mar;10(3):e178-e190. doi: 10.1016/S2352-3026(22)00375-1. Epub 2023 Jan 23. PMID 36702138
- BACKGROUNDLi Z, Shi W, Lu X, Lu H, Cao X, Tang L, Yan H, Zhong Z, You Y, Xia L, Hu Y, Wang H. Decitabine-Intensified Modified Busulfan/Cyclophosphamide Conditioning Regimen Improves Survival in Acute Myeloid Leukemia Patients Undergoing Related Donor Hematopoietic Stem Cell Transplantation: A Propensity Score Matched Analysis. Front Oncol. 2022 Mar 16;12:844937. doi: 10.3389/fonc.2022.844937. eCollection 2022. PMID 35371981
- BACKGROUNDWatanabe T. [Drug tolerance in microorganisms, with special reference to genetic study of its transmission]. Nihon Saikingaku Zasshi. 1969 Oct;24(9):418-25. No abstract available. Japanese. PMID 4908810
- BACKGROUNDTang X, Valdez BC, Ma Y, Zhang Q, Qu C, Dai H, Yin J, Li Z, Xu T, Xu Y, Chen J, Zhu X, Chen Z, Wu D, Andersson BS. Low-dose decitabine as part of a modified Bu-Cy conditioning regimen improves survival in AML patients with active disease undergoing allogeneic hematopoietic stem cell transplantation. Bone Marrow Transplant. 2021 Jul;56(7):1674-1682. doi: 10.1038/s41409-021-01238-5. Epub 2021 Feb 26. PMID 33637882
- BACKGROUNDTsukada T, Fukushima M, Takebe H, Nakai Y. Vasoactive intestinal peptide gene expression in the rat pheochromocytoma cell line PC12. Mol Cell Endocrinol. 1995 Feb;107(2):231-9. doi: 10.1016/0303-7207(94)03448-3. PMID 7768335
- BACKGROUNDSchmid C, Schleuning M, Schwerdtfeger R, Hertenstein B, Mischak-Weissinger E, Bunjes D, Harsdorf SV, Scheid C, Holtick U, Greinix H, Keil F, Schneider B, Sandherr M, Bug G, Tischer J, Ledderose G, Hallek M, Hiddemann W, Kolb HJ. Long-term survival in refractory acute myeloid leukemia after sequential treatment with chemotherapy and reduced-intensity conditioning for allogeneic stem cell transplantation. Blood. 2006 Aug 1;108(3):1092-9. doi: 10.1182/blood-2005-10-4165. Epub 2006 Mar 21.