Chidamide, Venetoclax, and Azacitidine for Newly Diagnosed Acute Myeloid Leukemia

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06386302
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Chidamide — DRUG
    30 mg/d orally twice-weekly
  • Venetoclax — DRUG
    100 mg d1 200 mg d 2 400 mg d3-d28 Orally
  • azacitidine — DRUG
    75 mg/m 2 /d subcutaneous injection or IV d1-d7

Study Details

To evaluate the feasibility, effectiveness and safety of chidamide combined with venetoclax and azacitidine in the treatment of newly diagnosed acute myeloid leukemia (AML) who are not suitable for intensive chemotherapy.

Key Dates

Start date
Aug 5, 2024
Status verified
Dec 2024
Primary completion
Dec 30, 2027
Completion
Dec 30, 2027

Study Design

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

Arms

  • Experimental: Chidamide combined with venetoclax, azacitidine group
    Chidamide (C): 30 mg/d orally on d1, 4, 8, 11 or 10 mg QD, d1-d14, adjusted according to patient tolerance Azacitidine (A): 75 mg/m 2 /d subcutaneous injection d1-d7 Venetoclax (V): 100 mg d1 200 mg d 2 400 mg d3-d28 Orally A treatment cycle is 28 days , and subjects will continue to receive treatment allocation according to the investigator's assessment until documented disease progression, intolerable toxicity, withdrawal of consent, or the subject meets other conditions for terminating treatment. Program Standards (whichever occurs first).
  • Active Comparator: venetoclax, azacitidine group
    azacitidine: 75 mg/m 2 /d subcutaneous injection d1-d7 Venetoclax: 100 mg day 1, 200 mg day 2, 400 mg day 3-d28 orally A treatment cycle is 28 days , and subjects will continue to receive treatment allocation according to the investigator's assessment until documented disease progression, intolerable toxicity, withdrawal of consent, or the subject meets other conditions for terminating treatment. Program Standards (whichever occurs first).

Primary Outcome Measure

Composite complete remission rate [ Time Frame: 2 months ]

Central Contacts

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