Study of Azacitidine，Venetoclax，and Flumatinib in Newly Diagnosed Ph-positive Acute Leukemia and CML-AP/BP Patients

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT05433532
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Azacitidine — DRUG
    Azacitidine: 75mg/m2 qd, d1-d7, subcutaneous injection
  • Venetoclax — DRUG
    Venetoclax: 100mg d1, 200mg d2, 300mg d3, 400mg d4-d14 or 21, oral (Adjusted according to the peripheral blood BCR/ABL1 results on day 14)
  • Flumatinib — DRUG
    Flumatinib: 600mg qd, d4-d21, oral

Study Details

The purpose of this study is to evaluate the efficacy and safety of azacitidine，venetoclax，and flumatinib in newly diagnosed Philadelphia chromosome-positive acute leukemia and accelerated phase or blast phase chronic myeloid leukemia patients.

Key Dates

Start date
May 1, 2022
Status verified
Apr 2024
Primary completion
Apr 13, 2024
Completion
Apr 13, 2024

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Azacitidine，Venetoclax，and Flumatinib Regimen
    See Detailed Description.

Primary Outcome Measure

CMR [ Time Frame: End of cycle 2 (each cycle is 28 days) ]

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