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Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

A Prospective, Multi-Center Study to Evaluate the Efficacy and Safety of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-cell Acute Lymphoblastic Leukemia Patients

NCT05376111•The First Affiliated Hospital of Soochow University

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is a phase 2, open Label, single arm, multi-center study for newly diagnosed T-cell acute lymphoblastic leukemia patients. The patients will receive vanetoclax combined with azacitidine as the induction regimen.

Eligibility

Age

15 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients aged ≥ 15.
•2. Patients diagnosed with T-ALL according to 2016 WHO criteria for precursor lymphoid neoplasms.
•3. ECOG performance status score less than 3.
•4. Patients without serious heart, lung, liver, or kidney dysfunction.
•5. Ability to understand and voluntarily provide informed consent.

Exclusion Criteria

•1. Patients who are allergic to the study drug or drugs with similar chemical structures.
•2. Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.
•3. Patients with uncontrolled active infection
•4. Patients with active bleeding.
•5. Patients with new thrombosis, embolism, cerebral hemorrhage, or other diseases or a medical history within one year before enrollment.
•6. 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.
•7. Liver dysfunction (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).
•8. 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.
•9. Surgery on the main organs within the past six weeks.
•10. Drug abuse or long-term alcohol abuse that would affect the evaluation results.
+1 more criteria

Locations (1)

The First Affliated Hospital of Soochow University

Suzhou, Jiangsu, China

Key Dates

Start Date

April 1, 2022

Primary Completion Date

December 1, 2026

Completion Date

December 1, 2026

Last Updated

March 19, 2026

Enrollment

ESTIMATED participants

Conditions

T-cell Acute Lymphoblastic LeukemiaRecruiting

Interventions

Venetoclax, Azacitidine

DRUG

Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL

NCT05679895

T-cell Acute Lymphoblastic LeukemiaLymphoblastic T-Cell Lymphoma

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RECRUITINGPHASE1

Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma

NCT06934382

T-Cell Acute Lymphoblastic Leukemia/Lymphoma

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 19, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Safety and Efficacy of OC-1 Therapy in Patients With R/R T-ALL/LL

Anti-CD7 CAR-T Cells in Relapsed/Refractory T-Cell Acute Lymphoblastic Leukemia or Lymphoma

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