Venetoclax+HMA+Aclarubicin Versus Venetoclax+HMA in Treatment-Naive Elderly Patients With AML

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05264883
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
60 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This research is being done to assess the therapeutic efficacy and safety of a promising regimen (Venetoclax combined with Decitabine/Azacitidine and Aclarubicin) versus Venetoclax combined with Decitabine/Azacitidine in treatment-naive elderly patients with Acute Myeloid Leukemia. This study involves the following: Venetoclax, Decitabine/Azacitidine, Aclarubicin (investigational combination) Venetoclax and Decitabine/Azacitidine (per standard of care)

Key Dates

Start date
Mar 1, 2021
Status verified
May 2023
Primary completion
Jun 28, 2023
Completion
Feb 28, 2025

Study Design

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

Arms

  • Experimental: Venetoclax combined with Decitabine/Azacitidine and Aclarubicin
    Venetoclax (Ven): oral once daily (100 mg d1, 200 mg d2, 400 mg d3-28); Decitabine (DAC): 20mg/m2 intravenous for 1 hour daily (d1 to d5); Azacitidine (AZA): 75mg/m2 subcutaneous at two different sites daily (d1 to d7);(Choose decitabine or azacitidine according to the patient's wishes) Aclarubicin (Acla): 10mg/m2 intravenous daily (d1 to d3);
  • Active Comparator: Venetoclax combined with Decitabine/Azacitidine
    Venetoclax (Ven): oral once daily (100 mg d1, 200 mg d2, 400 mg d3-28); Decitabine (DAC): 20mg/m2 intravenous for 1 hour daily (d1 to d5); Azacitidine (AZA): 75mg/m2 subcutaneous at two different sites daily (d1 to d7);(Choose decitabine or azacitidine according to the patient's wishes)

Primary Outcome Measure

Percentage of participants with complete remission (CR) and complete remission with incomplete marrow recovery (CRi) [ Time Frame: From randomization to the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts

Related Studies