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| Sponsor: | Pharmacyclics |
|---|---|
| Information provided by (Responsible Party): | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT01109069 |
Purpose
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).
| Condition | Intervention | Phase |
|---|---|---|
|
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 |
Drug: PCI-32765 |
Phase I |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia. |
| Estimated Enrollment: | 100 |
| Study Start Date: | June 2010 |
| Estimated Study Completion Date: | April 2016 |
| Estimated Primary Completion Date: | April 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: PCI-32765 |
Drug: PCI-32765
420 mg daily
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| United States, New York | |
| New York Presbyterian Hospital Cornell Medical Center | |
| New York, New York, United States, 10065 | |
| United States, Oregon | |
| Willametter Valley Cancer Institute | |
| Springfield, Oregon, United States, 97477 | |
| United States, Texas | |
| University of Texas, MD Anderson | |
| Houston, Texas, United States, 77030 | |
| United States, Vermont | |
| University of Vermont and Fletcher Allen Health Care | |
| Burlington, Vermont, United States, 05405 | |
| United States, Washington | |
| Northwest Cancer Specialist, P.C. | |
| Vancouver, Washington, United States, 98684 | |
| Yakima Valley Memorial Hospital /North Star Lodge | |
| Yakima, Washington, United States, 98902 | |
| Study Director: | Eric Hedrick, MD | Pharmacyclics |
More Information
| Responsible Party: | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT01109069 History of Changes |
| Other Study ID Numbers: | PCYC-1103-CA, PCI-32765 |
| Study First Received: | April 19, 2010 |
| Last Updated: | December 1, 2011 |
| Health Authority: | United States: Food and Drug Administration |
|
PCI-32765 Lymphoma, B-Cell Leukemia, Lymphoid Leukemia, B-Cell Bruton's Tyrosine Kinase |
|
Burkitt Lymphoma Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Lymphoma, Follicular Lymphoma, Non-Hodgkin Waldenstrom Macroglobulinemia Lymphoma, B-Cell Lymphoma, Mantle-Cell Epstein-Barr Virus Infections Herpesviridae Infections DNA Virus Infections Virus Diseases Tumor Virus Infections |
Neoplasms by Histologic Type Neoplasms Neoplasms, Experimental Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Leukemia, B-Cell Neoplasms, Plasma Cell Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases |