The Efficacy and Safety of BCL-2 Inhibitors Combined with the HyperCVAD Regimen in the Treatment of Newly Diagnosed T-lymphoblastic Leukemia/ Lymphoma

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 2
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:

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

Locations
Other Locations
China
Shanghai General Hospital
RECRUITING
Shanghai
Contact Information
Primary
Xianmin Song,MD
shongxm@139.com
+8613501672508
Time Frame
Start Date: 2024-08-07
Estimated Completion Date: 2027-08-07
Participants
Target number of participants: 206
Treatments
Experimental: BCL-2 inhibitors combined with the HyperCVAD regimen for newly diagnosed T-ALL/LBL
Other: propensity score matching with historical data
Sponsors
Leads: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

This content was sourced from clinicaltrials.gov