Combination of Venetoclax, Hypomethylation Agent and Low-dose Cytarabine as a Salvage Therapy for Acute Myeloid Leukemia

Sponsor
Beijing 302 Hospital
Study ID
NCT05362942
Phase
PHASE2
Status
Unknown

Conditions

  • Minimal Residual Disease
  • Refractory Acute Myeloid Leukemia
  • Relapsed Acute Myeloid Leukemia

Eligibility Criteria

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

Interventions

  • Venetoclax, Decitabine, Azacytidine, Cytarabine — DRUG
    Venetoclax was given at a dose of 400 mg/day for 28 days per cycle. Decitabine was given at a dose of 20 mg/m2/day for 5 days (n=3) or azacytidine (n=8) was given at a dose of 75 mg/m2/day for 7 days at the discretion of the treating physician. Cytarabine was given at a dose of 10 mg/m2 twice daily for 7 days.

Study Details

Although studies are ongoing to evaluate the efficiency and safety of venetoclax-based therapy, alone or in combination with hypomethylation agent or low-dose cytarabine, in relapsed/refractory acute myeloid leukemia, data are scarce and heterogenous. In this study, the investigators aimed to assess safety and response to a new venetoclax-based triple-drug combination regimen (venetoclax + hypomethylation agent + low-dose cytarabine) in acute myeloid leukemia patients who had relapsed/refractory disease or positive minimal residual disease.

Key Dates

Start date
May 1, 2022
Status verified
May 2022
Primary completion
Apr 30, 2023
Completion
Apr 30, 2024

Study Design

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

Arms

  • Experimental: venetoclax + Hypomethylation agent + low-dose cytarabine treatment group
    patients treated with venetoclax combined with decitabine/azacytidine and low-dose cytarabine

Primary Outcome Measure

Complete remission rate [ Time Frame: At the end of Cycle 2 (each cycle is 28 days) ]

Central Contacts

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