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Venetoclax Based Regimen for R/R T-ALL

Primary Purpose

Acute T-Lymphocytic Leukemia

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Venetoclax combined with azacitidine regimen

About this trial

This is an interventional treatment trial for Acute T-Lymphocytic Leukemia focused on measuring venetoclax, relapse, refractory

Eligibility Criteria

15 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

The First Affliated Hospital of Soochow UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Venetclax combined with azacitidine

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Complete Remission Rate (CRR)

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)

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)

It is measured from the date of entry into this trial to the date of progression or death.

Adverse events in hematological system

Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction.

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.

Full Information

NCT ID

NCT05149378

First Posted

November 25, 2021

Last Updated

April 26, 2023

Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT05149378

Brief Title

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

2. Study Status

Record Verification Date

April 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 1, 2021 (Actual)

Primary Completion Date

December 31, 2023 (Anticipated)

Study Completion Date

December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

The First Affiliated Hospital of Soochow University

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute T-Lymphocytic Leukemia

Keywords

venetoclax, relapse, refractory

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Venetclax combined with azacitidine

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

Venetoclax combined with azacitidine regimen

Intervention Description

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 .

Primary Outcome Measure Information:

Title

Overall Response Rate (ORR)

Description

Time Frame

At the end of Cycle 1 (each cycle is 21 days)

Title

Complete Remission Rate (CRR)

Description

The complete remission rate achieved after one or two courses (21 days) induction therapy by venetoclax combined azacitidine regimen.

Time Frame

At the end of Cycle 1 (each cycle is 21 days)

Secondary Outcome Measure Information:

Title

Overall survial (OS)

Description

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.

Time Frame

1 year

Title

Progression-Free Survival (PFS)

Description

It is measured from the date of entry into this trial to the date of progression or death.

Time Frame

1 year

Title

Adverse events in hematological system

Description

Record of adverse events in hematological system during and after designed venetoclax combined azacitidine regimen induction.

Time Frame

1 month

Title

Adverse events in other organs or systems

Description

Record of adverse events in other organs or systmes during and after designed venetoclax combined azacitidine regimen induction.

Time Frame

1 month

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Sheng-Li Xue, M.D.

Phone

008651267781139

slxue@suda.edu.cn

Facility Information:

Facility Name

The First Affliated Hospital of Soochow University

City

Suzhou

State/Province

Jiangsu

ZIP/Postal Code

215006

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Sheng-Li Xue, M.D.

Phone

+8651267781139

slxue@suda.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Venetoclax Based Regimen for R/R T-ALL

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