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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| The First Affliated Hospital of Soochow University Coordinator of this site? Confirm its status | Suzhou | China | Unknown status |
Related publications
- Venetoclax plus azacitidine in relapsed or refractory T-cell acute lymphoblastic leukaemia: a multicentre, single-arm, phase 2 trial.Lancet Haematol · 2025 · PMID 41338863
This page is information, not medical advice. Discuss any trial with your doctor.