BCL-2 Inhibitors Combined with the HyperCVAD Regimen for Newly Diagnosed T-lymphoblastic Leukemia/lymphoma.

NCT ID: NCT06598722

Last Updated: 2024-09-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 206 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-08-07
• Study Completion Date: 2027-08-07

Brief Summary

The experimental group included patients diagnosed with T-ALL/LBL (T-lymphoblastic leukemia/ lymphoma) at initial diagnosis, who received treatment with BCL-2 inhibitors combined with the Hyper CVAD regimen. The control group consisted of patients diagnosed with T-ALL/LBL from multiple centers, for whom basic information, disease information, treatment details, and efficacy data were collected. Propensity score matching was conducted with historical data (matching factors included age, gender, initial LDH levels, and the presence or absence of a large mediastinal mass at diagnosis) to compare the advantages and disadvantages of the experimental regimen with previous induction treatment protocols. The primary endpoint was the complete remission (CR) rate after induction chemotherapy, while secondary endpoints included duration of remission (DOR), progression-free survival (PFS), overall survival (OS), and the occurrence of adverse events. This study aims to provide a more effective and safer treatment option for patients with T-LBL.

Conditions

Lymphoblastic Lymphoma, Adult; Lymphoblastic Leukemia, Acute T-cell

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

BCL-2 inhibitors combined with the HyperCVAD regimen for newly diagnosed T-ALL/LBL

Group Type: EXPERIMENTAL

BCL-2 inhibitors combined with the HyperCVAD regimen

Intervention Type: DRUG

BCL-2 inhibitors combined with the HyperCVAD regimen for newly diagnosed adult T-ALL/LBL

propensity score matching with historical data

Group Type: OTHER

Propensity score matching historical data

Intervention Type: OTHER

Propensity score matching was conducted with historical data (matching factors included age, gender, initial LDH levels, and the presence or absence of a large mediastinal mass at diagnosis) to compare the advantages and disadvantages of the experimental regimen with previous induction treatment protocols.

Interventions

BCL-2 inhibitors combined with the HyperCVAD regimen

BCL-2 inhibitors combined with the HyperCVAD regimen for newly diagnosed adult T-ALL/LBL

Intervention Type: DRUG

Propensity score matching historical data

Propensity score matching was conducted with historical data (matching factors included age, gender, initial LDH levels, and the presence or absence of a large mediastinal mass at diagnosis) to compare the advantages and disadvantages of the experimental regimen with previous induction treatment protocols.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

Liver and kidney function, as well as cardiopulmonary function, meet the following requirements:

Exclusion Criteria

Any situation that the investigator believes would compromise participant safety or interfere with the study objectives, or any individual deemed inappropriate for participation by the investigator Individuals with diseases affecting their ability to sign the written informed consent form or comply with study procedures; those unwilling or unable to adhere to study requirements

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

OTHER

Sponsor Role: lead

Responsible Party

Xianmin Song, MD

Investigator Official Title

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai General Hospital

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Xianmin Song，MD

Role: CONTACT

shongxm@139.com

+8613501672508

Other Identifiers

SHSYXY-T-LBL-VEN-2024

Identifier Type: -

Identifier Source: org_study_id