Maintenance Venetoclax in AML Fit Patients

Sponsor
Sohag University
Study ID
NCT07244367
Status
Recruiting
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Conditions

  • Acute Myeloid Leukaemia (AML)

Eligibility Criteria

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

Interventions

  • SC cytarabine +Venetoclax — DRUG
    SC Cytarabine (20 mg) administrated on days 1-7 ,,Venetoclax (100 mg ) administrated on days 1-7,,Voriconazole 200 mg 1x2 administrated on days , Best supportive care as needed . Up to 12 cycles or until patients undergo bone marrow transplantation

Study Details

this study will explore the efficacy of maintenance SC cytarabine + venetoclax therapy as regard disease free survival (DFS) in AML fit patients who achieved CR after highly aggressive chemotherapy as bridge for BMT or if BMT will be delayed or canceled due to any other reason.

Key Dates

Start date
Sep 1, 2025
Status verified
Nov 2025
Primary completion
Sep 1, 2026
Completion
Sep 1, 2027

Study Design

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

Arms

  • Active Comparator: Arm A
    will receive SC cytarabine + venetoclax till bone marrow transplantation or for 12 cycles for patient will not undergo BMT , SC Cytarabine (20 mg) administrated on days 1-7 , Venetoclax (100 mg ) administrated on days 1-7 , Voriconazole 200 mg 1x2 administrated on days 1-7 + best supportive care BSC
  • No Intervention: Arm B
    Patients Will receive Best supportive care( BSC )only

Primary Outcome Measure

Disease free survival DFS [ Time Frame: 24 months ]

Central Contacts

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