drugset / Trial / NCT06361329
Comparing the Efficacy of VHAG and Traditional Chemotherapy Regimens in Newly Diagnosed ETP-ALL
RandomizedParallel-groupOpen-labelTreatment
Summary
ETP-ALL is a subtype of T-cell acute lymphoblastic leukemia (T-ALL) with poor outcomes and prognosis. Effective induction therapy is crucial in improving the treatment effect. Based on our laboratory research and clinical practice, the venetoclax plus HAG regimen shows promising efficacy in treating ETP-ALL. Therefore, we plan to conduct a prospective, multicenter Phase III clinical study to evaluate the efficacy of the venetoclax plus HAG regimen in treating newly diagnosed ETP-ALL patients.
Timeline
- Start
- 2024-04-03
- Primary completion
- 2026-03-31
- Completion
- 2027-03-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | — | Intravenous |
| Comparator | Daunorubicin | Small molecule | — | Intravenous |
| Comparator | Dexamethasone | Small molecule | — | Intravenous |
| Subject | Homoharringtonine | Small molecule | 1.4 mg/m2 | Intravenous |
| Comparator | L-ASP | Unknown | — | Subcutaneous |
| Subject | Venetoclax | Small molecule | 400 mg | Oral |
| Comparator | Vindesine | Small molecule | — | Intravenous |
| Background | Cytarabine | Small molecule | 10 mg/m2 | Subcutaneous |
| Background | G-CSF | Unknown | 100 ug/m2 | Subcutaneous |