drugset / Trial / NCT04243434
PK Study on Ready-to-Use Injection (VSLI-RTU) 1 Vial & 3 Vial Formulation Marqibo® in Hematological Malignant Patients
RandomizedCrossoverOpen-labelTreatment
Summary
This is a Phase 1, randomized, open-label, 2-way crossover, pharmacokinetic study in adult patients with hematological malignancies eligible to receive either cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) regimen or rituximab-CHOP (R-CHOP) regimen.
Timeline
- Start
- 2020-08-15
- Primary completion
- 2020-08-15
- Completion
- 2020-10-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Vincristine | Small molecule | 2.25 mg/m2 | Intravenous |
| Background | Cyclophosphamide | Other / unclassified | — | — |
| Background | Doxorubicin | Other / unclassified | — | — |
| Background | Prednisone | Other / unclassified | — | — |
| Background | Rituximab | Monoclonal antibody | — | — |