VAC Regimen for AML Patients Who Failed to Response to VA Regimen

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT06220162
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • chidamide in combination with venetoclax and azacitidine (VAC) — DRUG
    Enrolled patients were given chidamide 10 mg every day on days 1-14, azacitidine 75mg/m2 every day on days 1-7, and oral venetoclax began at 100mg on day 1 and increased stepwise over 3 days to reach the target dose of 400mg (100mg, 200mg, and 400mg) on days 1-28. Dose adjustments for concomitant venetoclax with CYP3A4 inhibitors were made according to the literature.

Study Details

Chidamide in combination with venetoclax and azacitidine (VAC) were expected to improve remission rate of patients following to VA regimen treatment failure.

Key Dates

Start date
Feb 1, 2024
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: VAC regimen

Primary Outcome Measure

ORR(overall response rate) [ Time Frame: 1 month ]

Central Contacts

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