Study of VA Combined With HAAG Regimen in Newly Diagnosed Intermediate and High-risk AML Patients

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT06394011
Phase
PHASE2
Status
Recruiting
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Conditions

  • High Risk Acute Myeloid Leukemia
  • Intermediate Risk Acute Myeloid Leukemia

Eligibility Criteria

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

Interventions

  • venetoclax, azacitidine and HAAG regimen — DRUG
    Venetoclax:100mg, qd, d1;200mg, qd, d2;400 mg, qd, d3\~10, per os; Azacitidine:75mg/m2/d, d1\~7, subcutaneous injection; Homoharringtonine:1mg/d, d4\~10, intravenous infusion; Aclarubicin:10mg/d, d4\~7, intravenous infusion; Cytarabine:10mg/m2,q12h,d4\~10, subcutaneous injection; Granulocyte colony-stimulating factor (G-CSF): 50-300μg/d (when WBC counts are less than 20×10\^9/L ),subcutaneous injection;

Study Details

The purpose of this study is to evaluate the efficacy and safety of VA combined with HAAG in the induction treatment of newly diagnosed acute myeloid leukemia.

Key Dates

Start date
Feb 15, 2024
Status verified
Jan 2024
Primary completion
May 30, 2026
Completion
Dec 30, 2026

Study Design

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

Arms

  • Experimental: VA combined with HAAG
    This cohort will determine the safety and efficacy of venetoclax, azacitidine combined with HAAG regimen in newly diagnosed intermediate and high-risk AML patients.

Primary Outcome Measure

Composite complete response rate (CRc; CR+CRi) [ Time Frame: Day 28-35 of induction course ]

Central Contacts

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