Multicenter Study of Combined Chemotherapy and Transplantation for Adult ALL
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.
Timeline
- Start
- 2025-06-01
- Primary completion
- 2027-06
- Completion
- 2027-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 200 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 750 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Cytarabine | Small molecule | 1 g | Intravenous |
| Subject | Dexamethasone | Small molecule | 40 mg | Oral |
| Subject | Idarubicin | Small molecule | 8 mg/m2 | — |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 50 mg/m2 | Oral |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 75 mg/m2 | Oral |
| Subject | Methotrexate | Small molecule | 1 g | Intravenous |
| Subject | Prednisone | Other / unclassified | 0.5 mg/kg | Oral |
| Subject | Prednisone | Other / unclassified | 1 mg/kg | Oral |
| Subject | Venetoclax | Small molecule | 400 mg | — |
| Subject | Vindesine | Small molecule | 3 mg/m2 | — |