Clinical Study of Venetoclax Combined with CACAG Regimen in the Treatment of Newly Diagnosed Acute Myeloid Leukemia

Sponsor
Chinese PLA General Hospital
Study ID
NCT05659992
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • azacytidine;cytarabine;aclamycin;Chidamide;venetoclax;granulocyte — DRUG
    1. azacytidine (75 mg/m2/day, days 1 to 7). 2. cytarabine (75 mg/m2 bid, days 1 to 5). 3. aclamycin (10 mg/m2/day, day1,3,5). 4. Chidamide (30 mg/day , days 0,3). 5. venetoclax (100 mg day 1, 200 mg day 2, 400mg days 3 to 14 ). 6. granulocyte colony-stimulating factor (5ug/kg/day, day 0 until agranulocytosis recovery)

Study Details

The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with CACAG regimen in the treatment of newly diagnosed acute myeloid leukemia.

Key Dates

Start date
Dec 25, 2022
Status verified
Nov 2022
Primary completion
Aug 14, 2023
Completion
Aug 14, 2024

Study Design

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

Arms

  • Experimental: treatment group
    Experimental: Venetoclax combined CACAG regimen for newly diagnosed AML. All recipients in this arm received azacytidine, cytarabine.aclamycin, chidamide,venetoclax and granulocyte colony-stimulating factor.Azacytidine was uesd as 75 mg/m2/day from day-1 to day-7.Cytarabine was uesd as 75 mg/m2 bid from day-1 to day-5. Aclamycin was uesd as 10 mg/m2/day on day1,3,5). Chidamide was uesd as 30 mg/day twice per week for 2 weeks. Venetoclax was uesd as 100 mg on day 1, 200 mg on day 2, 400mg from day-3 to day-14.Granulocyte colony-stimulating factor was uesd as 5ug/kg/day from day 0 until agranulocytosis recovery.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: 1 month after study treatment ]

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