NCT06686108

Demethylating Agents Combined With Venetoclax for High-risk T-cell Lymphoblastic Lymphoma/Leukemia Post-Transplant Relapse Prevention

Safety and Efficacy Study of Demethylating Agents With Venetoclax in Preventing Recurrence of High-risk T-cell Lymphoblastic Lymphoma/Leukemia After Transplantation

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 59 (estimated)
• Sponsor: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine · Academic / Other
• Sex: All
• Age: 14 Years – 55 Years
• Healthy volunteers: Not accepted

Summary

This study is a prospective, phase II clinical trial with the primary objective of assessing the effectiveness of demethylating agents combined with venetoclax in the prevention of recurrence after allogeneic hematopoietic stem cell transplantation (allo-HSCT) of high risk T-lymphoblastic lymphoma/leukemia (T-LBL/ALL) patients.

Detailed description

The experimental group included high risk T-ALL/LBL patients after allo-HSCT, who received relapse prevention treatment with demethylating agents such as azacitidine or decitabine, combined with venetoclax. The historical control consisted of high-risk T-ALL/LBL patients who received allo-HSCT but did not receive any prophylactic treatment from multiple centers, and their basic information, disease information, treatment details, and efficacy data were collected. Propensity score matching was conducted with historical data to compare the advantages and disadvantages of the experimental regimen with the control group. The primary endpoint was the relapse-free survival(RFS) rate after prophylaxis, while secondary endpoints included cumulative incidence of relapse (CIR), overall survival (OS), and the GVHD-relapse-free survival (GRFS). This study aims to provide a effective and safer prophylaxis treatment for high-risk T-LBL/ALL patients after all-HSCT.

Conditions

• T-cell Acute Lymphoblastic Leukemia
• ALLOGENEIC HEMATOPOIETIC STEM CELL TRANSPLANTATION
• Relapse

Interventions

Type	Name	Description
DRUG	Azacitidine (AZA) Days 1 - 5	Azacitidine, ih, 32mg/m2/d, days 1-5 of each 28-day cycle
DRUG	Decitabine (DAC)	decitabine, 5mg/m2/d, days 1-5 of each 28-day cycle.
DRUG	Venetoclax	venetoclax, 400mg/d, days 1-7 of each 28-day cycle

Timeline

• Start date: 2024-10-30
• Primary completion: 2027-10-30
• Completion: 2028-10-30
• First posted: 2024-11-13
• Last updated: 2025-05-07

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study