Actively Recruiting
Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
Led by Shanxi Bethune Hospital · Updated on 2025-07-10
50
Participants Needed
1
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 60 years
- Diagnosis following Chinese Guidelines for Adult Acute Lymphoblastic Leukemia (2024 Edition) with MICM integration and WHO 2022 classification
- Morphological and immunophenotyping confirmation with bone marrow aspiration and biopsy at initial diagnosis
- At least 20% blasts or immature lymphocytes in bone marrow (or comprehensive evaluation if less due to specific conditions)
- ECOG Performance Status of 0 to 2
You will not qualify if you...
- History of intracranial hemorrhage
- Pregnancy
- Psychiatric disorders or other conditions that may prevent following the study protocol
- Severe cardiac arrhythmia with ECG abnormalities, specifically QTc interval greater than 500 ms
AI-Screening
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Trial Site Locations
Total: 1 location
1
Shanxi Bethune Hospital
Taiyuan, Shanxi, China, 030000
Actively Recruiting
Research Team
T
Tao Wang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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