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
Status: Recruiting
Location: See location...
Intervention Type: Combination product
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Maximum Age: 75
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Chinese PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Li-ping Dou, Dr.
lipingruirui@163.com
86-10-66937079
Backup
Dai-hong Liu, Dr.
lipingruirui@163.com
86-10-66937079
Time Frame
Start Date:2025-01-01
Estimated Completion Date:2028-12-30
Participants
Target number of participants:200
Treatments
Active_comparator: Assigned Interventions
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)
No_intervention: The control group
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)