Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

Sponsor
The First Affiliated Hospital of Soochow University
Study ID
NCT05376111
Phase
PHASE2
Status
Recruiting
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Conditions

  • Recruiting
  • T-cell Acute Lymphoblastic Leukemia

Eligibility Criteria

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

Interventions

  • Venetoclax, Azacitidine — DRUG
    Venetoclax orally once daily (100 mg d1, 200 mg d2, 400 mg d3-21); azacitidine 75 mg/m2 subcutaneously once daily on days 1-7.

Study Details

The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with azacitidine regimen for newly diagnosed T-ALL patients.

Key Dates

Start date
Apr 1, 2022
Status verified
Mar 2026
Primary completion
Dec 1, 2026
Completion
Dec 1, 2026

Study Design

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

Arms

  • Experimental: Venetclax combined with Azacitidine
    T-cell acute lymphoblastic leukemia patients reveive venetoclax combined with azacitidine regimen treatment.

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: At the end of Cycle 1 (each cycle is 21 days) ]

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