Venetoclax Based Regimen for R/R T-ALL

Acute T-Lymphocytic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05149378
• Other study ID #: SZRTALL01
• Status: Recruiting
• Phase: Phase 2
• Start date: November 1, 2021
• Est. completion date: December 31, 2024

Study information

• Verified date: April 2024
• Source: The First Affiliated Hospital of Soochow University
• Contact: Sheng-Li Xue, M.D.
• Phone: 008651267781139
• Email: slxue[@]suda.edu.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 25
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acute T-Lymphocytic Leukemia
• Leukemia
• Leukemia, T-Cell
• Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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 .

Locations

Country	Name	City	State
China	The First Affliated Hospital of Soochow University	Suzhou	Jiangsu

Sponsors (7)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Soochow University	Affiliated Hospital of Nantong University, First Affiliated Hospital Bengbu Medical College, Jining Medical University, Northern Jiangsu People's Hospital, Suzhou Hospital of Traditional Chinese Medicine, The Second People's Hospital of Huai'an

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall Response Rate (ORR)	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.	At the end of Cycle 1 (each cycle is 21 days)
Primary	Complete Remission Rate (CRR)	The complete remission rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen.	At the end of Cycle 1 (each cycle is 21 days)
Secondary	Overall survial (OS)	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.	1 year
Secondary	Relapse-Free Survival (RFS)	It is measured from the date of entry into this trial to the date of hematologic relapse or death from any cause.	1 year
Secondary	Adverse events in hematological system	Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction.	1 month
Secondary	Adverse events in other organs or systems	Record of adverse events in other organs or systmes during and after designed venetoclax combined azacitidine regimen induction.	1 month