Clinical Study Protocol of Venetoclax Combined With Azacitidine and Harringtonine in the Treatment of sAML

Sponsor
The First Affiliated Hospital with Nanjing Medical University
Study ID
NCT05513131
Phase
PHASE2
Status
Unknown

Conditions

  • Secondary Acute Myeloid Leukemia

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

This research is being done to assess the therapeutic efficacy and safety of a promising regimen (Venetoclax combined with Azacitidine and Harringtonine) in patients with secondary AML This study involves the following: Venetoclax combined with Azacitidine and Harringtonine

Key Dates

Start date
Sep 30, 2021
Status verified
Aug 2022
Primary completion
Sep 30, 2023
Completion
Sep 30, 2025

Study Design

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

Arms

  • Experimental: Venetoclax combined with Azacitidine and Harringtonine
    Venetoclax 100mg d1，200mg d2，400mg d3\~d14； Azacitidine 75mg/m2/d，d1\~d7； Homoharringtonine 2mg/d d1\~d7

Primary Outcome Measure

Percentage of participants with complete remission (CR) and complete remission with incomplete marrow recovery (CRi) [ Time Frame: From randomization to the end of Cycle 1 (each cycle is 28 days) ]

Central Contacts

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