Single Arm Study of Azacitidine and Venetoclax for Treatment of Newly Diagnosed Fit Acute Myeloid Leukemia Patients

Sponsor
Zhujiang Hospital
Study ID
NCT05471700
Status
Completed

Conditions

  • Leukemia, Myeloid, Acute

Eligibility Criteria

Sex
ALL
Age
45 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Subjects will receive Azacitidine 75 mg/m2 on days 1-7.Each course is 28 days long.
  • Venetoclax — DRUG
    Subjects would receive Venetoclax once daily by oral. The doses of Venetoclax is 100 mg on Day 1, 200 mg on Day 2, reaching a target dose of 400 mg on Day 3 and continuing through Day 28. Each course is 28 days long.

Study Details

The goal of this clinical research study is to evaluate the safety and efficacy of Azacytidine in combination with Venetoclax in patients with newly diagnosed fit acute myeloid leukemia.

Key Dates

Start date
Sep 1, 2022
Status verified
Jul 2025
Primary completion
Apr 4, 2023
Completion
Apr 4, 2023

Study Design

Enrollment
40 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Azacitidine combined with Venetoclax
    Each course is 28 days long. Subjects with newly diagnosed AML receive Venetoclax once daily by oral. The doses of Venetoclax is 100 mg on Day 1, 200 mg on Day 2, reaching a target dose of 400 mg on Day 3 and continuing through Day 28. If concomitantly receiving azoles, the dose of Venetoclax will be adjusted according to the instructions. At the same time patients will receive Azacitidine 75mg/m2 subcutaneous on Days 1-7.The induction therapy includes 1-2 cycle until subjects get remission. Once complete remission, subjects will receive consolidation. Azacitidine combined with Venetoclax or middle to high dose of arabinoside based chemotherapy would be given at the discretion of the physician.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 36 months ]

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