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| Sponsor: | Pharmacyclics |
|---|---|
| Collaborator: |
Ohio State University |
| Information provided by (Responsible Party): | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT01217749 |
Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
B-cell Chronic Lymphocytic Leukemia Small Lymphocytic Lymphoma Diffuse Well-Differentiated Lymphocytic Lymphoma Prolymphocyctic Leukemia Richter's Transformation |
Drug: PCI-32765 |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase 1b/2 Study of PCI-32765, a Btk-inhibitor, and Ofatumumab in Subjects With Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma and Related Diseases |
| Estimated Enrollment: | 27 |
| Study Start Date: | December 2010 |
| Estimated Study Completion Date: | December 2012 |
| Estimated Primary Completion Date: | June 2012 (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:
Subjects must have failed ≥ 2 prior therapies for CLL including a nucleoside analog or ≥ 2 prior therapies not including nucleoside analog if there is a contraindication to such therapy
•> 10% expression of CD20 on tumor cells
Absolute neutrophil count (ANC) ≥ 1000/µL in the absence of bone marrow involvement Platelets ≥ 30,000/μL Total bilirubin ≤ 1.5 x institutional upper limit of normal unless due to Gilbert's disease AST(SGOT) ≤ 2.5 x institutional upper limit of normal unless due to infiltration of the liver Creatinine ≤ 2.0 mg/dL OR creatinine clearance ≥ 50 mL/min
Exclusion Criteria:
Contacts and Locations| United States, Ohio | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| Principal Investigator: | Samantha Jaglowski, MD | Ohio State University |
More Information
| Responsible Party: | Pharmacyclics |
| ClinicalTrials.gov Identifier: | NCT01217749 History of Changes |
| Other Study ID Numbers: | PCYC-1109-CA, PCI-32765 |
| Study First Received: | October 7, 2010 |
| Last Updated: | April 16, 2012 |
| Health Authority: | United States: Food and Drug Administration United States: Institutional Review Board |
|
Leukemia Leukemia, Lymphocytic, Chronic, B-Cell Leukemia, Lymphoid Lymphoma Neoplasms by Histologic Type Neoplasms |
Leukemia, B-Cell Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases |