HAV Versus DAV/IAV Induction Regimen in Elderly Patients With AML

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06744556
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • daunorubicin — DRUG
    Used in combination with cytarabine and venetoclax for induction therapy in DAV.
  • Venetoclax — DRUG
    Used in combination with cytarabine and daunorubicin for induction therapy in DAV.
  • cytarabine — DRUG
    Used in combination with venetoclax and daunorubicin for induction therapy in DAV or used by intermediate does for consolidation therapy.
  • azacitidine — DRUG
    Used in combination with venetoclax for maintenance therapy.
  • Homoharringtonine — DRUG
    Used in combination with cytarabine and venetoclax for induction therapy in HAV.
  • Idarubicin — DRUG
    Used in combination with cytarabine and venetoclax for induction therapy in IAV.

Study Details

Acute myeloid leukemia (AML) is the most common leukemia in China, with a high incidence in elderly patients (≥60 years), who comprise over half of all cases (median age \~68 years). Elderly AML patients have a poor prognosis and carry multiple high-risk factors, with a 5-year overall survival (OS) of only 3-8%. Before the era of novel targeted agents, the classic "3+7" regimen was the standard intensive chemotherapy for eligible elderly patients, yielding an induction complete remission (CR) rate of 40-60%. Long-term survival remained poor, as most elderly patients are not candidates for allogeneic hematopoietic stem cell transplantation. Recent clinical studies have shown that combinations of novel targeted agents with hypomethylating agents improve outcomes in elderly or unfit patients. In a previously initiated multicenter, prospective, randomized controlled trial (NCT06066242), the investigators aimed to identify the optimal induction regimen for elderly fit patients with newly diagnosed AML. Preliminary data indicate that the DNR/IDA + Ara-C + venetoclax (DAV/IAV) regimen achieved a higher induction remission rate (77.3%) compared with DA/IA (3+7) or Ven + azacitidine (45-59%). However, this rate remains below that observed in younger adults (\>85%), highlighting the need for further optimization.

Key Dates

Start date
Jan 21, 2025
Status verified
May 2026
Primary completion
Dec 1, 2027
Completion
Jun 1, 2028

Study Design

Enrollment
41 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: DAV/IAV
    Induction therapy: Ara-C 100mg/m2/d, d1-5 Daunorubicin 60mg/m2/d, d1-2 or Idarubicin 10mg/m2/d, d1-2 Venetoclax 100mg d3, 200mg d4,400mg d5-11 If the treatment achieves CR/CRi/CRh, proceed directly to consolidation therapy. If the treatment does not achieve CR/CRi/CRh, enter the second induction phase with a different treatment regimen. Second Induction Phase: For patients with FLT3 or IDH1 mutations, targeted therapy can be chosen. If there is no FLT3 or IDH1 mutation or the patient is unwilling to use FLT3 or IDH1 inhibitors, switch to the HAV induction regimen. Consolidation therapy: 1\. intermediate-dose Ara-C (ID-Ara-C): 2 cycles are used. Ara-C 1 g/m2/q12h on days 1, 3, and 5 (for patients aged 60-70 years) or Ara-C 500 mg/m2/q12h on days 1, 3, and 5 (for patients aged 70 years or older) Maintenance therapy: VA regimen: 6 courses Azacitidine 75 mg/m2/d on days 1-5, Venetoclax 400 mg on days 1-7.
  • Experimental: HAV
    Induction Therapy: Ara-C 100mg/m2/d, d1-5 HHT 2mg/m2/d, d1-5 Venetoclax 100mg d3, 200mg d4,400mg d5-11 If CR/CRi/CRh is achieved, proceed directly to consolidation therapy. If the treatment does not reach CR/CRi/CRh, enter the second induction phase with a different treatment regimen. Second course: For patients with FLT3 or IDH1 mutations, the corresponding targeted therapy can be selected, as before. For patients without FLT3 or IDH1 mutations or those who do not want to use FLT3 or IDH1 inhibitors, the DAV/IAV induction regimen is changed. If the treatment does not reach CR/CRi/CRh after two courses, the patient is discharged. Consolidation therapy: 1\. intermediate-dose Ara-C (ID-Ara-C): 2 cycles are used. Ara-C 1 g/m2/q12h on days 1, 3, and 5 (for patients aged 60-70 years) or Ara-C 500 mg/m2/q12h on days 1, 3, and 5 (for patients aged 70 years or older) Maintenance therapy: VA : 6 courses

Primary Outcome Measure

Event-free survival (EFS) [ Time Frame: Up to approximately 1 years after the date of the last enrolled participants ]

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