Venetoclax Based Regimen for R/R T-ALL

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    25
  • sponsor
    The First Affiliated Hospital of Soochow University
Updated on 15 December 2021

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.

Details
Condition Acute T-Lymphocytic Leukemia
Treatment Venetoclax combined with azacitidine regimen
Clinical Study IdentifierNCT05149378
SponsorThe First Affiliated Hospital of Soochow University
Last Modified on15 December 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients aged ≥ 15 and ≤ 65 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
Refractory T-ALL/LBL disease was defined as follows: Failure to achieve CR at the end of induction
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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