drugset / Trial / NCT05025423
Phase II Trial of Venetoclax and Rituximab as Initial Therapy in Older Patients With Mantle Cell Lymphoma
Phase 2
Terminated
7 enrolled
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
AbbVie · collab
NaSequentialOpen-labelTreatment
Summary
The proposed study is an open-label, single arm phase II study of venetoclax in combination with rituximab in patients over the age of 60 with previously untreated mantle cell lymphoma. The primary objective of the trial is to determine whether the combination of venetoclax with rituximab in this patient population yields a clinically acceptable proportion of overall responses (ORR, assessed by PET/CT with Lugano criteria) without chemotherapy.
Timeline
- Start
- 2022-06-21
- Primary completion
- 2025-05-14
- Completion
- 2025-05-14
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Venetoclax | Small molecule | 400 mg | Oral |
| Subject | Venetoclax | Small molecule | 800 mg | Oral |
| Background | Bendamustine | Small molecule | 90 mg/m2 | — |
| Background | Rituximab | Monoclonal antibody | 375 mg/m2 | — |