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Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

Primary Purpose

T-cell Acute Lymphoblastic Leukemia, Recruiting

Status

Recruiting

Phase

Phase 2

Locations

China

Study Type

Interventional

Intervention

Venetoclax, Azacitidine

About this trial

This is an interventional treatment trial for T-cell Acute Lymphoblastic Leukemia focused on measuring Venetoclax, Azacitidine, T-ALL, Newly diagnosed

Eligibility Criteria

15 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients aged ≥ 15.
Patients diagnosed with T-ALL according to 2016 WHO criteria for precursor lymphoid neoplasms.
ECOG performance status score less than 3.
Patients without serious heart, lung, liver, or kidney dysfunction.
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.
Patients with uncontrolled active infection
Patients with 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 dysfunction (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 chemotherapy treatments related to the disease.

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

T-cell acute lymphoblastic leukemia patients reveive venetoclax 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.

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.

Number of adverse events

Adverse events are evaluated with CTCAE V5.0.

Full Information

NCT ID

NCT05376111

First Posted

May 11, 2022

Last Updated

July 17, 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

NCT05376111

Brief Title

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

Official Title

A Prospective, Multi-Center Study to Evaluate the Efficacy and Safety of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-cell Acute Lymphoblastic Leukemia Patients

Study Type

Interventional

2. Study Status

Record Verification Date

July 2023

Overall Recruitment Status

Recruiting

Study Start Date

April 1, 2022 (Actual)

Primary Completion Date

May 1, 2024 (Anticipated)

Study Completion Date

May 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

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

The purpose of this study is to evaluate the efficacy and safety of venetoclax combined with azacitidine regimen for newly diagnosed T-ALL patients.

Detailed Description

This is a phase 2, open Label, single arm, multi-center study for newly diagnosed T-cell acute lymphoblastic leukemia patients. The patients will receive vanetoclax combined with azacitidine as the induction regimen.

6. Conditions and Keywords

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

T-cell Acute Lymphoblastic Leukemia, Recruiting

Keywords

Venetoclax, Azacitidine, T-ALL, Newly diagnosed

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

28 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Venetclax combined with Azacitidine

Arm Type

Experimental

Arm Description

T-cell acute lymphoblastic leukemia patients reveive venetoclax combined with azacitidine regimen treatment.

Intervention Type

Drug

Intervention Name(s)

Venetoclax, Azacitidine

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)

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

2 years

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

2 years

Title

Number of adverse events

Description

Adverse events are evaluated with CTCAE V5.0.

Time Frame

2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

15 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients aged ≥ 15. Patients diagnosed with T-ALL according to 2016 WHO criteria for precursor lymphoid neoplasms. ECOG performance status score less than 3. Patients without serious heart, lung, liver, or kidney dysfunction. 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. Patients with uncontrolled active infection Patients with 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 dysfunction (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 chemotherapy treatments related to the disease.

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

(0086)51267781139

slxue@suda.edu.cn

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Study of Venetoclax Combined With Azacitidine Regimen in Newly Diagnosed T-ALL Patients

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