Clinical trial NCT05149378: Venetoclax Based Regimen for R/R T-ALL
Official title: Venetoclax Based Regimen for the Treatment of Relapsed or Refractory T-cell Acute Lymphoblastic Leukemia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Acute T-Lymphocytic Leukemia
Keywords: venetoclax
relapse
refractory
Lead sponsor: The First Affiliated Hospital of Soochow University
Sponsor class: OTHER
Collaborators: name: Jining Medical University
name: The Second People's Hospital of Huai'an
name: The First Affiliated Hospital of Bengbu Medical University
name: Affiliated Hospital of Nantong University
name: Suzhou Hospital of Traditional Chinese Medicine
name: The First Affiliated Hospital of Anhui Medical University
name: Southern Medical University, China
name: Nanyang Central Hospital of Henan Province
name: Canglang Hospital of Suzhou
First posted: 2021-12-08
Enrollment: 25
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Patients aged ≥ 15 and ≤ 70 years.
2. Patients diagnosed with T-ALL/LBL according to 2017 WHO lymphoid malignant disease diagnosis standard.
3. 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.
4. ECOG performance status score less than 3.
5. Expected survival time \>3 months.
6. Patients without serious heart, lung, liver, or kidney disease.
7. 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. Active infection.
4. 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 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).
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.
11. Patients who have received organ transplants (excepting bone marrow transplantation).
12. Patients not suitable for the study according to the investigator's assessment.

Primary outcomes:
measure: Overall Response Rate (ORR)
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
measure: Complete Remission Rate (CRR)
timeFrame: At the end of Cycle 1 (each cycle is 21 days)
Secondary outcomes:
measure: Overall survial (OS)
timeFrame: 1 year
measure: Relapse-Free Survival (RFS)
timeFrame: 1 year
measure: Adverse events in hematological system
timeFrame: 1 month
measure: Adverse events in other organs or systems
timeFrame: 1 month
Other outcomes:
Locations:
city: Suzhou
country: China
facility: The First Affliated Hospital of Soochow University
state: Jiangsu
Study officials:
References: