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

NCT06598722 | Recruiting Phase 2

• 1 other identifier: SHSYXY-T-LBL-VEN-2024
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• AE

  adverse events during research

  at the end of cycle 2(each cycle is 28 days)

• The best overall response rate

  complete remission and partial remission

  at the end of cycle 2（each cycle is 28 days）

• Evaluate the best complete remission rate (CR)

  at the end of cycle 4 of chemotherapy（each cycle is 28 days）

Secondary Outcomes (6)

• Duration of remission

  1 year

• OS

  1 year

• OS

  2 year

• PFS

  1 year

• PFS

  2 year

Study Arms (2)

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

EXPERIMENTAL

Drug: BCL-2 inhibitors combined with the HyperCVAD regimen

propensity score matching with historical data

OTHER

Other: Propensity score matching historical data

Interventions

BCL-2 inhibitors combined with the HyperCVAD regimen DRUG

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

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

Propensity score matching historical data 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.

propensity score matching with historical data

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

Shanghai General Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Precursor Cell Lymphoblastic Leukemia-Lymphoma; Precursor T-Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Xianmin Song，MD

CONTACT

+8613501672508; shongxm@139.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Investigator Official Title

Study Record Dates

• First Submitted: September 3, 2024
• First Posted: September 19, 2024
• Study Start: August 7, 2024
• Primary Completion: August 7, 2026
• Study Completion (Estimated): August 7, 2027
• Last Updated: September 24, 2024

Record last verified: 2024-09

Locations

CN (1)