Safety and Tolerability Study of PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

Completed · Phase 2

Conditions studied: 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

In brief

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).

Key facts

Study ID

NCT01109069

Run by

Pharmacyclics LLC.

People needed

199

Starts

2010-06-01

Expected to finish

2019-04-26

Last updated by the study team

2020-05-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Stanford University — Stanford, California, United States
• Study site — Stanford, California, United States
• University of Chicago — Chicago, Illinois, United States
• Study site — Boston, Massachusetts, United States
• Study site — New Hyde Park, New York, United States
• Study site — New York, New York, United States
• Study site — Rochester, New York, United States
• Study site — Columbus, Ohio, United States
• Study site — Springfield, Oregon, United States
• Study site — Nashville, Tennessee, United States
• MD Anderson Cancer Center — Houston, Texas, United States
• Study site — Houston, Texas, United States
• Study site — Tyler, Texas, United States
• Fletcher Allen Health Care and University of Vermont — Burlington, Vermont, United States
• Study site — Vancouver, Washington, United States
• Yakima Valley Memorial Hospital/North Star Lodge — Yakima, Washington, United States

Full record on ClinicalTrials.gov

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