Multicenter, Platform-type Clinical Study of Refractory/Recurrent Acute Myeloid Leukemia

Sponsor
Institute of Hematology & Blood Diseases Hospital, China
Study ID
NCT06265545
Status
Recruiting
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Conditions

  • AML
  • Refractory
  • Relapsed

Eligibility Criteria

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

Interventions

Study Details

To study the optimal therapeutic strategies for salvage treatment of refractory/relapsed AML, and to clarify the effectiveness and safety of various salvage treatment options. A prospective, multicenter, platform-type study was conducted to explore the overall response rate, tolerability, and survival of patients with R/R AML with different treatment regimens.

Key Dates

First listed
Feb 20, 2024
Start date
Feb 22, 2024
Status verified
Aug 2026
Primary completion
Jan 30, 2028
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: Arm 1
    With IDH1 gene mutation(up to 2 cycles available):IVA : Ivosidenib 500mg d1-28 Azacitidine 75mg/m2/d d1-7 Venetoclax100mg d1, 200mg d2, 400mg d3, 800mg d4-14, d14-28(If the proportion of bone marrow blasts on day 14 is greater than 5% )
  • Experimental: Arm 2
    FLT3/ITD or FLT3/TKD gene mutation (up to 2 cycles available) GVA: Gilteritinib 80mg, d1-28 Azacitidine 75mg/m2/d d1-7 Venetoclax 100mg d1, 200mg d2, 400mg d3-14, 400mg d14-28 (if the proportion of bone marrow blasts on day 14 are greater than 5%)
  • Experimental: Arm 3
    For R/R AML patients without IDH1 or FLT3 mutations who have not been exposed to Venecra in the last 3 months, the investigators will determine whether they are fit patients based on physical status and comorbidivities, and if they are, they can be randomly assigned to Arm3 or Arm4 DAV/IAV/MAV Cytarabine 100mg/m2/d, d1-5 Daunorubicin 60mg/m2/d, d1-2, or Idarubicin 12mg/m2/d, d1-2, or mitoxantrone 8mg/m2/d d1-2 Venetoclax 100mg d3, 200mg d4, 400mg d5-11;
  • Experimental: Arm 4
    HAV : Cytarabine 100mg/m2/d, d1-5; Homoharringtonine 2mg/m2 d1-5; Venetoclax 100mg d3, 200mg d4, 400mg d5-11
  • Experimental: Arm 5
    A patient with R/R AML without IDH1 or FLT3 mutation who has not been exposed to Venetoclax in the last 3 months but who is judged by the investigators to be unfit based on physical fitness and comorbidivities is unfit to enter Arm5. Arm5: (up to 4 cycles available) VA : Azacytidine 75mg/m2/d d1-7; Venetoclax 100mg d1, 200mg d2, 400mg d3-21 400mg d22-28 (if the proportion of bone marrow blasts on day 21 are greater than 5%)
  • Experimental: Arm 6
    Patients with R/R AML without IDH1 or FLT3 mutations who have been exposed to Vinecra within the last 3 months may be enrolled in the exploratory protocol group based on a comprehensive assessment of local drug availability and patient status: Arm6: The Investigator's choice (IC) option involves a range of drugs such as clatabine, PI3K inhibitors, histone deacetylase inhibitors, celinisol, and novel liposomes.
  • Experimental: Arm 7
    DAV/IAV/MAV/HAV Regimen Cytarabine 100 mg/m²/day, days 1-5 Daunorubicin 60 mg/m²/day, days 1-2, or Idarubicin 12 mg/m²/day, days 1-2, or Mitoxantrone 8 mg/m²/day, days 1-2 / Homoharringtonine 2 mg/m²/day, days 1-5 Lisatoclax 200 mg on day 3, 400 mg on day 4, 600 mg on days 5-11
  • Experimental: Arm 8
    Azacitidine 75 mg/m²/day, days 1-7 Lisatoclax 200 mg on day 1, 400 mg on day 2, 600 mg on days 3-21, and 600 mg on days 22-28 (if bone marrow blast percentage on day 21 is greater than 5%)

Primary Outcome Measure

Complex response (CRc) rate (including CR and CRi) [ Time Frame: up to 4 years ]

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