Venetoclax Based Regimen for R/R T-ALL

NCT05149378 | Completed Phase 2

• 1 other identifier: SZRTALL01
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Acute T-Lymphocytic Leukemia

Keywords

venetoclax; relapse; refractory

Outcome Measures

Primary Outcomes (2)

• Overall Response Rate (ORR)

  The overall response (complete remission, complete remission with incomplete blood count recovery) rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen.

  At the end of Cycle 1 (each cycle is 21 days)

• Complete Remission Rate (CRR)

  The complete remission rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen.

  At the end of Cycle 1 (each cycle is 21 days)

Secondary Outcomes (4)

• Overall survial (OS)

  1 year

• Relapse-Free Survival (RFS)

  1 year

• Adverse events in hematological system

  1 month

• Adverse events in other organs or systems

  1 month

Study Arms (1)

Venetclax combined with azacitidine

EXPERIMENTAL

Relapsed or refractroy acute lymphoblastic leukemia patients reveive venetclax combined with azacitidine regimen treatment.

Drug: Venetoclax combined with azacitidine regimen

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 .

Venetclax combined with azacitidine

Eligibility Criteria

• Age: 15 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged ≥ 15 and ≤ 70 years.
• Patients diagnosed with T-ALL/LBL according to 2017 WHO lymphoid malignant disease diagnosis standard.
• Patients with T-ALL/LBL must meet one of the following criteria, A or B.
• A: Refractory T-ALL/LBL disease was defined as follows: Failure to achieve CR at the end of induction.
• B: Relapsed T-ALL/LBL disease was defined as follows: Reappearance of blasts in the blood or bone marrow (\>5%) or in any extramedullary site after a CR.
• ECOG performance status score less than 3.
• Expected survival time \>3 months.
• Patients without serious heart, lung, liver, or kidney disease.
• Ability to understand and voluntarily provide informed consent.

You may not qualify if:

• Patients who are allergic to the study drug or drugs with similar chemical structures.
• Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
• Active infection.
• Active bleeding.
• Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
• Patients with mental disorders or other conditions whereby informed consent cannot be obtained and where the requirements of the study treatment and procedures cannot be met.
• Liver function abnormalities (total bilirubin \> 1.5 times the upper limit of the normal range, ALT/AST \> 2.5 times the upper limit of the normal range or patients with liver involvement whose ALT/AST \> 1.5 times the upper limit of the normal range), or renal anomalies (serum creatinine \> 1.5 times the upper limit of the normal value).
• Patients with a history of clinically significant QTc interval prolongation (male \> 450 ms; female \> 470 ms), ventricular heart tachycardia and atrial fibrillation, II-degree heart block, myocardial infarction attack within one year before enrollment, and congestive heart failure, and patients with coronary heart disease who have clinical symptoms and requiring drug treatment.
• Surgery on the main organs within the past six weeks.
• Drug abuse or long-term alcohol abuse that would affect the evaluation results.
• Patients who have received organ transplants (excepting bone marrow transplantation).
• Patients not suitable for the study according to the investigator's assessment.

Sponsors & Collaborators

• The First Affiliated Hospital of Soochow University: lead
• Jining Medical University: collaborator
• The Second People's Hospital of Huai'an: collaborator
• The First Affiliated Hospital of Bengbu Medical University: collaborator
• Affiliated Hospital of Nantong University: collaborator
• Suzhou Hospital of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Anhui Medical University: collaborator
• Southern Medical University, China: collaborator
• Nanyang Central Hospital of Henan Province: collaborator
• Canglang Hospital of Suzhou: collaborator

Study Sites (1)

The First Affliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China

Location

Related Publications (1)

• Cao HY, Zhang H, Zhang Y, Hu XH, Yang L, Yang YL, Zhang YM, Wu B, Huang ZQ, Huang R, Wang RJ, Wan CL, Wu DP, Dai HP, Xue SL. Venetoclax plus azacitidine in relapsed or refractory T-cell acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 trial. Lancet Haematol. 2025 Dec;12(12):e946-e955. doi: 10.1016/S2352-3026(25)00284-4.

  PMID: 41338863 DERIVED

MeSH Terms

Conditions

Precursor T-Cell Lymphoblastic Leukemia-Lymphoma; Recurrence

Condition Hierarchy (Ancestors)

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Study Record Dates

• First Submitted: November 25, 2021
• First Posted: December 8, 2021
• Study Start: November 1, 2021
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)