NCT06598722

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

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
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 206 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	BCL-2 inhibitors combined with the HyperCVAD regimen	BCL-2 inhibitors combined with the HyperCVAD regimen for newly diagnosed adult T-ALL/LBL
OTHER	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.

Timeline

• Start date: 2024-08-07
• Primary completion: 2026-08-07
• Completion: 2027-08-07
• First posted: 2024-09-19
• Last updated: 2024-09-24

Locations

1 site across 1 country: China