Ruxolitinib-Decitabine Intensified Conditioning Regimen for AML: A Randomized Trial

Sponsor
Chinese PLA General Hospital
Study ID
NCT07101588
Phase
PHASE4
Status
Recruiting
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Conditions

  • Allogeneic Hematopoietic Stem Cell Transplantation (HSCT)

Eligibility Criteria

Sex
ALL
Age
14 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ruxolitinib, Decitabine — COMBINATION_PRODUCT
    1. Decitabine: 20 mg/m²/day, administered from Day -15 to Day -10. 2. Ruxolitinib: * 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

Study Details

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.

Key Dates

Start date
Jan 1, 2025
Status verified
Jul 2025
Primary completion
Jan 1, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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)

Primary Outcome Measure

GRFS [ Time Frame: 1 year ]

Central Contacts

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