Trials / Completed
CompletedNCT01217749
Efficacy and Safety Study of PCI-32765 Combine With Ofatumumab in CLL
An Open-label, Phase 1b/2, Safety and Efficacy Study of the Bruton's Tyrosine Kinase (Btk) Inhibitor, PCI-32765, and Ofatumumab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Prolymphocytic Leukemia
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 71 (actual)
- Sponsor
- Pharmacyclics LLC. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine the efficacy and safety of a fixed-dose, daily regimen of orally administered PCI-32765 combined with ofatumumab in subjects with relapsed/refractory CLL/SLL and related diseases
Conditions
- B-cell Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Prolymphocyctic Leukemia
- Richter's Transformation
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PCI-32765 | 420 mg PO daily |
| DRUG | ofatumumab | per package insert as an IV infusion |
Timeline
- Start date
- 2010-12-01
- Primary completion
- 2013-06-01
- Completion
- 2014-05-01
- First posted
- 2010-10-08
- Last updated
- 2015-06-25
- Results posted
- 2015-04-16
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01217749. Inclusion in this directory is not an endorsement.