drugset / Trial / NCT01352312
Combination of Pentostatin, Bendamustine and Ofatumumab for Treatment of Chronic Lymphocytic Leukemia and Lymphoma
Phase 1
Terminated
10 enrolled
Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
GlaxoSmithKline · collabNovartis · collab
NaSingle-groupOpen-labelTreatment
Summary
This is a Phase 1 study with Cohort Expansion of Pentostatin, Bendamustine and Ofatumumab (PBO) for patients with previously treated Chronic Lymphocytic Leukemia (CLL) and B-cell Non-Hodgkin's Lymphoma (B- cell NHL). The purpose of this study is to determine the optimal dose of bendamustine in combination with pentostatin and ofatumumab, and then to see how safe these three drugs work together.
Timeline
- Start
- 2011-05-25
- Primary completion
- 2016-04-08
- Completion
- 2018-05-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Bendamustine | Small molecule | 40 mg/m2 | Intravenous |
| Subject | Bendamustine | Small molecule | 50 mg/m2 | Intravenous |
| Subject | Bendamustine | Small molecule | 70 mg/m2 | Intravenous |
| Subject | Bendamustine | Small molecule | 90 mg/m2 | Intravenous |
| Subject | Ofatumumab | Monoclonal antibody | 1000 mg | Intravenous |
| Subject | Pentostatin | Small molecule | 2 mg/m2 | Intravenous |
| Subject | Pentostatin | Small molecule | 4 mg/m2 | Intravenous |