Clinical Trial

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

Recruiting Phase 2
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Record status
This record was last updated September 24, 2024 (before its estimated August 7, 2026 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2024-09-11.
Status change: Active, Not Recruiting → Recruiting 2024-09-23
Trial Details
NCT Number NCT06598722
Lead Sponsor Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
Conditions Lymphoblastic Lymphoma, Adult, Lymphoblastic Leukemia, Acute T-cell
Enrollment 206 participants
Start Date 2024-08-07
Primary Completion 2026-08-07 (estimated)
Study Completion 2027-08-07 (estimated)
Updated on ClinicalTrials.gov 2024-09-24