drugset / Trial / NCT05660473
Pediatric-inspired Regimen Combined With Venetoclax for Adolescent and Adult Patients With de Novo Philadelphia Chromosome-Negative Acute Lymphoblastic Leukemia
NaSingle-groupOpen-labelTreatment
Summary
The pediatric-inspired regimen has greatly improved the prognosis of adult patients with with Philadelphia chromosome-negative acute lymphoblastic leukemia (Ph- ALL), but relapse remains a great challenge. Venetoclax (Ven) is an oral, selective inhibitor of B-cell lymphoma 2 (Bcl-2). Although this drug is currently used primarily for acute myeloid leukemia, in vitro as well as small cohort studies suggest a effect in acute lymphoblastic leukemia. This study proposes to combine pediatric-inspired regimen with venetoclax for the treatment of adult patients with Ph- ALL, aiming to improve the MRD-negative complete remission rate measured by flow cytometry after induction and to reduce relapse, thus further improving patients overall survival.
Timeline
- Start
- 2022-08-01
- Primary completion
- 2027-12-15
- Completion
- 2027-12-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | 400 mg | Oral |
| Background | Cyclophosphamide | Other / unclassified | 1200 mg/m2 | Intravenous |
| Background | Cytarabine | Small molecule | — | — |
| Background | Daunorubicin | Small molecule | 30 mg/m2 | Intravenous |
| Background | Dexamethasone | Small molecule | — | — |
| Background | MERCAPTOPURINE ANHYDROUS | Small molecule | — | — |
| Background | Methotrexate | Small molecule | — | — |
| Background | Pegaspargase | Protein / enzyme biologic | 2500 unknown | Intramuscular |
| Background | Prednisone | Other / unclassified | 0.5 mg/kg | Oral |
| Background | Vincristine | Small molecule | 1.4 mg/m2 | Intravenous |