Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia
This study is enrolling participants by invitation only.
Sponsor:
Pharmacyclics
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01109069
First received: April 19, 2010
Last updated: April 16, 2013
Last verified: June 2012
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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 2 |
| 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. |
Resource links provided by NLM:
Further study details as provided by Pharmacyclics:
Primary Outcome Measures:
- Adverse Events/ Safety Tolerability [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]Frequency, severity, and relatedness of adverse events
Secondary Outcome Measures:
- Progression-free survival [ Time Frame: Frequency of tumor assessments done per standard of care ] [ Designated as safety issue: No ]Tumor response will be assessed per established response criteria. This study will capture time to progression-free survival
- Duration of Response [ Time Frame: Time to disease progression ] [ Designated as safety issue: No ]Duration of response as measured by established response criteria for B cell lymphoma and chronic lymphocytic leukemia
- Overall Survival [ Time Frame: Every 3 months (±7 days) until the end of study ] [ Designated as safety issue: No ]After disease progression, attempts to follow for subject survival status (including cause of death) by clinic visit, or phone contact as well as collection of subsequent anti cancer therapy should be performed once every 3 months (±7 days) until the end of study.
- Tolerability [ Time Frame: 30 days after last dose of study drug ] [ Designated as safety issue: Yes ]Long term tolerability as measured by treatment related SAEs and discontinuation of study treatment due to AEs.
| Estimated Enrollment: | 200 |
| 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
Dose based on parent protocol
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Men and women with recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL) according to WHO classification (including, but not limited to, CLL/SLL, Waldenström's macroglobulinemia [WM], mantle cell lymphoma [MCL], and diffuse large B cell lymphoma [DLBCL) who have met requirements for roll over from their parent protocol and want to continue study drug.
- Female subjects of childbearing potential must have a negative serum or urine pregnancy test within 3 days of the first dose of study drug and agree to use dual methods of contraception during the study and for 1 month following the last dose with study drug. Post menopausal females (>45 years old and without menses for >1 year) and surgically sterilized females are exempt from this criterion.
- Male subjects must use an effective barrier method of contraception during the study and for 3 months following the last dose if sexually active with a female of childbearing potential.
- Willing and able to participate in all required evaluations and procedures in this study protocol including swallowing capsules without difficulty
- Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (in accordance with national and local patient privacy regulations).
Exclusion Criteria:
- A life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the subject's safety, interfere with the absorption or metabolism of PCI-32765 PO, or put the study outcomes at undue risk
- Known history of Human Immunodeficiency Virus (HIV) or active infection with Hepatitis C Virus (HCV) or Hepatitis B Virus (HBV) or any uncontrolled active systemic infection.
- Lactating or pregnant
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01109069
Locations
| United States, California | |
| Stanford University School of Medicine | |
| Stanford, California, United States, 94305 | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute | |
| Boston, Massachusetts, United States, 02215 | |
| United States, New York | |
| CLL Research and Treatment Program | |
| New Hyde Park, New York, United States, 11042 | |
| New York Presbyterian Hospital Cornell Medical Center | |
| New York, New York, United States, 10065 | |
| University of Rochester Cancer Center | |
| Rochester, New York, United States, 14642-0001 | |
| United States, Ohio | |
| The Ohio State University | |
| Columbus, Ohio, United States, 43210 | |
| United States, Oregon | |
| Willametter Valley Cancer Institute | |
| Springfield, Oregon, United States, 97477 | |
| United States, Tennessee | |
| Sarah Cannon | |
| Nashville, Tennessee, United States, 37203 | |
| United States, Texas | |
| University of Texas, MD Anderson | |
| Houston, Texas, United States, 77030 | |
| MD Anderson Cancer Center | |
| Houston, Texas, United States, 77030 | |
| Texas Oncology - Tyler | |
| Tyler, Texas, United States, 75702 | |
| 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 | |
Sponsors and Collaborators
Pharmacyclics
Investigators
| Study Director: | Alvina Chu, MD | Pharmacyclics |
More Information
Additional Information:
No publications provided
| 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: | April 16, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Pharmacyclics:
|
PCI-32765 Lymphoma, B-Cell Leukemia, Lymphoid Leukemia, B-Cell Bruton's Tyrosine Kinase |
Additional relevant MeSH terms:
|
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 |
ClinicalTrials.gov processed this record on June 17, 2013