VEN+DAC+Bu2Flu4 vs Bu2Flu5 Conditioning Regimen for Elderly Myeloid Malignancies Undergoing Allo-HSCT

Sponsor
Nanfang Hospital, Southern Medical University
Study ID
NCT07052422
Phase
PHASE2/PHASE3
Status
Not Yet Recruiting

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Conditions

  • Conditioning
  • Hematopoietic Stem Cell Transplantation (HSCT)
  • Myeloid Malignancies
  • Older Patients

Eligibility Criteria

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

Interventions

  • Venetoclax (VEN) — DRUG
    Venetoclax (VEN) was administered at 400mg/day on days -10 to -4.
  • Decitabine (DAC) — DRUG
    Decitabine (DAC) was administered at 20mg/m2/day on days -10 to -8.
  • Busulfan (Bu) — DRUG
    Busulfan (Bu) was administered at 3.2 mg/kg/day on days -5 to -4.
  • Fludarabine (Flu) — DRUG
    Fludarabine (Flu) was administered at 30mg/m2/day on days -5 to -2.
  • Fludarabine (Flu) — DRUG
    Fludarabine (Flu) was administered at 30mg/m2/day on days -6 to -2.

Study Details

The purpose of this study is to compare the efficacy and safety of venetoclax+decitabine+busulfan+fludarabine (VEN+DAC+Bu2Flu4) regimen with busulfan+fludarabine (Bu2Flu5) regimen in older patients with myeloid malignancies undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).

Key Dates

Start date
Jul 15, 2025
Status verified
Jul 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2029

Study Design

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

Arms

  • Experimental: VEN+DAC+Bu2Flu4
    Venetoclax+Decitabine+Busulfan+Fludarabine
  • Active Comparator: Bu2Flu5
    Busulfan+Fludarabine

Primary Outcome Measure

Disease-free survival (DFS) rate [ Time Frame: 2 year ]

Central Contacts

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