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Completed

NCT Number: NCT05149378

Venetoclax Based Regimen for R/R T-ALL

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

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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 .

Primary outcomes

  1. Overall Response Rate (ORR)

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

    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.

  2. Complete Remission Rate (CRR)

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

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

Secondary outcomes

  1. Overall survial (OS)

    Time frame: 1 year

    It is measured from the date of entry into this trial to the date of death from any cause; patients not known to have died at last follow-up are censored on the date they were last known to be alive.

  2. Relapse-Free Survival (RFS)

    Time frame: 1 year

    It is measured from the date of entry into this trial to the date of hematologic relapse or death from any cause.

  3. Adverse events in hematological system

    Time frame: 1 month

    Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction.

  4. Adverse events in other organs or systems

    Time frame: 1 month

    Record of adverse events in other organs or systmes during and after designed venetoclax combined azacitidine regimen induction.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Soochow University

Other

Collaborators

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

Registry information

Official study title

Venetoclax Based Regimen for the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Dec 8, 2021
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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