Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
NCT01109069 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 199
Last updated 2020-05-27
Summary
The purpose of this study is to determine the long-term safety of a fixed-dose, daily regimen of PCI-32765 PO in subjects with B cell lymphoma or chronic lymphocytic leukemia/small lymphocytic leukemia (CLL/SLL).
Conditions
- B-cell Chronic Lymphocytic Leukemia
- Small Lymphocytic Lymphoma
- Diffuse Well-differentiated Lymphocytic Lymphoma
- B Cell Lymphoma
- Follicular Lymphoma
- Mantle Cell Lymphoma
- Non-Hodgkin's Lymphoma
- Waldenstrom Macroglobulinemia
- Burkitt Lymphoma
- B-Cell Diffuse Lymphoma
Interventions
- DRUG
-
PCI-32765
Dose based on parent protocol
Sponsors & Collaborators
-
Janssen Research & Development, LLC
collaborator INDUSTRY -
Pharmacyclics LLC.
lead INDUSTRY
Principal Investigators
-
James Dean, MD · Medical Monitor
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2010-06-30
- Primary Completion
- 2019-04-26
- Completion
- 2019-04-26
Countries
- United States
Study Locations
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