Venetoclax Based Regimen for R/R T-ALL

Sponsor

The First Affiliated Hospital of Soochow University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05149378

Collaborator

Jining Medical University (Other), The Second People's Hospital of Huai'an (Other), First Affiliated Hospital Bengbu Medical College (Other), Northern Jiangsu Province People's Hospital (Other), Affiliated Hospital of Nantong University (Other), Suzhou Hospital of Traditional Chinese Medicine (Other)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acute T-Lymphocytic Leukemia	Drug: Venetoclax combined with azacitidine regimen	Phase 2

Study Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Nov 1, 2021

Anticipated Primary Completion Date :

Dec 31, 2023

Anticipated Study Completion Date :

Dec 31, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Venetclax combined with azacitidine Relapsed or refractroy acute lymphoblastic leukemia patients reveive venetclax combined with azacitidine regimen treatment.	Drug: Venetoclax combined with azacitidine regimen 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 .

Arm

Intervention/Treatment

Experimental: Venetclax combined with azacitidine

Relapsed or refractroy acute lymphoblastic leukemia patients reveive venetclax combined with azacitidine regimen treatment.

Drug: Venetoclax combined with azacitidine regimen

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 .

Outcome Measures

Primary Outcome Measures

Overall Response Rate (ORR) [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.
Complete Remission Rate (CRR) [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 Outcome Measures

Overall survial (OS) [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.
Progression-Free Survival (PFS) [1 year]
It is measured from the date of entry into this trial to the date of progression or death.
Adverse events in hematological system [1 month]
Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction.
Adverse events in other organs or systems [1 month]
Record of adverse events in other organs or systmes during and after designed venetoclax combined azacitidine regimen induction.

Eligibility Criteria

Criteria

Ages Eligible for Study:

15 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

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.