Randomized Study of ABC-14 Regimen Compared With "3+7" Standard Induction Therapy or AB-14 for ND AML

Sponsor
Guangdong Provincial People's Hospital
Study ID
NCT06451861
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • Chidamide — DRUG
    Induction Therapy
  • Venetoclax — DRUG
    Induction Therapy
  • azacitidine — DRUG
    Induction Therapy
  • Anthracyclines or anthraquinones — DRUG
    Induction Therapy
  • cytarabine — DRUG
    Induction Therapy

Study Details

To compare the efficacy and safty of ABC-14 regimen with the traditional "3+7" regimen or AB-14 regimen in the treatment of newly diagnosed acute myeloid leukaemia

Key Dates

Start date
Aug 21, 2024
Status verified
Jun 2025
Primary completion
Dec 30, 2026
Completion
Jun 30, 2027

Study Design

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

Arms

  • Experimental: ABC-14 regimen
    AZA,Venetoclax,Chidamide
  • Active Comparator: 3+7 chemotherapy regimen
    Daunorubicin/idarubicin/mitoxantrone and cytarabine
  • Active Comparator: AB-14 regimen
    AZA,Venetoclax

Primary Outcome Measure

Composite complete remission (CRc) [ Time Frame: 2 months ]

Central Contacts

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