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

Phase 2

Active, not recruiting

• Conditions: Lymphoblastic Lymphoma, Adult; Lymphoblastic Leukemia, Acute T-cell
• Interventions: Drug: BCL-2 inhibitors combined with the HyperCVAD regimen; Other: Propensity score matching historical data

• Registration Number: NCT06598722
• Lead Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-07
• Status Verified: 2024-09
• Study First Submitted: 2024-09-03
• Study First Submitted QC: 2024-09-11
• Last Update Submitted: 2024-09-11
• Study First Posted: 2024-09-19
• Last Update Posted: 2024-09-19
• Primary Completion: 2026-08-07
• Study Completion: 2027-08-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 206

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
BCL-2 inhibitors combined with the HyperCVAD regimen for newly diagnosed T-ALL/LBL	BCL-2 inhibitors combined with the HyperCVAD regimen	-
propensity score matching with historical data	Propensity score matching historical data	-

Primary Outcome Measures

Name	Time	Method
AE	at the end of cycle 2(each cycle is 28 days)	adverse events during research
The best overall response rate	at the end of cycle 2（each cycle is 28 days）	complete remission and partial remission
Evaluate the best complete remission rate (CR)	at the end of cycle 4 of chemotherapy（each cycle is 28 days）

Secondary Outcome Measures

Name	Time	Method
Duration of remission	1 year	Duration of remission
OS	2 year	2 year overall survival
PFS	2 year	2 year progression free survival
the proportion of successful bridging to allogeneic hematopoietic stem cell transplantation	the end of the study	he proportion of successful bridging to allogeneic hematopoietic stem cell transplantation

Trial Locations

Locations (1)

Shanghai General Hospital; 🇨🇳 Shanghai, China