Clinical Trial

Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL

Recruiting Phase 2/3
View on ClinicalTrials.gov →
Summary
This study aims to evaluate an integrated treatment protocol for adults with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), combining induction chemotherapy, consolidation therapy, and allogeneic hematopoietic stem cell transplantation (allo-HSCT) to improve treatment efficacy and survival rates. The single-arm, open-label, multicenter study will enroll 50 newly diagnosed patients aged 18-60 years. The induction phase employs the VICP+VEN regimen (vindesine, idarubicin, cyclophosphamide, prednisone combined with venetoclax), followed by consolidation therapy with either Hyper-CVAD or CAM protocols, with eligible patients proceeding to allo-HSCT. Primary endpoints include disease-free survival (DFS) and complete remission (CR) rates, while secondary endpoints encompass relapse rate, overall survival (OS), and safety. Patients will be followed for 2 years with regular monitoring of minimal residual disease (MRD) and adverse events. The protocol is designed to reduce relapse risk through intensive therapy and transplantation, offering a potential cure for high-risk patients.The goal is to complete the entire treatment within 4 months after diagnosis.
Trial Details
NCT Number NCT07059156
Lead Sponsor Shanxi Bethune Hospital
Conditions Acute Lymphoblastic Leukemia, Adult
Enrollment 50 participants
Start Date 2025-06-01
Primary Completion 2027-06 (estimated)
Study Completion 2027-07 (estimated)
Updated on ClinicalTrials.gov 2025-07-10