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NCT05149378CompletedPhase 2

Venetoclax Based Regimen for R/R T-ALL

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

Source: ClinicalTrials.gov · Last updated 14 May 2025

Brief summary (registry, in English)

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

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
25 (actual)
First submitted
25 Nov 2021
Start date
Nov 2021
Primary completion date
Dec 2024
Lead sponsor
The First Affiliated Hospital of Soochow University
NCT number
NCT05149378

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 25
  • From Nov 2021 to the primary completion date, Dec 2024
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior 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).

Other illness

  • Patients who are allergic to the study drug or drugs with similar chemical structures.
  • 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.

Lab values

  • 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.

Age

  • Pregnant or lactating women, and women of childbearing age who do not want to practice effective methods of contraception.

Other

  • Patients not suitable for the study according to the investigator's assessment.

Who the study is looking for

  • 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.

Age in the registry: 15 years to 70 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
The First Affliated Hospital of Soochow University
Coordinator of this site? Confirm its status
SuzhouChinaUnknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.