Venetoclax Based Regimen for R/R T-ALL

Sponsor: The First Affiliated Hospital of Soochow University
Study ID: NCT05149378
Phase: PHASE2
Status: Completed

Conditions

Acute T-Lymphocytic Leukemia

Eligibility Criteria

Sex: ALL
Age: 15 Years - 70 Years
Healthy Volunteers: Not accepted

Interventions

Venetoclax combined with azacitidine regimen — 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

This study is to investigate the therapeutic efficacy and side effect of venetoclax based regimen for relapsed or refractroy T cell acute lymphoblastic leukemia.

Key Dates

Start date: Nov 1, 2021
Status verified: May 2025
Primary completion: Dec 31, 2024
Completion: Dec 31, 2024

Study Design

Enrollment: 25 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: Venetclax combined with azacitidine
Relapsed or refractroy acute lymphoblastic leukemia patients reveive venetclax 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) ]