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

Phase 2

Completed

Conditions: B-cell Chronic Lymphocytic Leukemia
Diffuse Well-differentiated Lymphocytic Lymphoma
B Cell Lymphoma
Waldenstrom Macroglobulinemia
Small Lymphocytic Lymphoma
Follicular Lymphoma
Non-Hodgkin's Lymphoma
Mantle Cell Lymphoma
Burkitt Lymphoma
B-Cell Diffuse Lymphoma

Brief 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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
PCI-32765	PCI-32765	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Adverse Events	30 days after last dose of study drug, continue up to 6 months	Subjects were to receive ibrutinib once daily at the dose level the subject was receiving in the parent study until disease progression or unacceptable toxicity. The study included Screening, Treatment (from the first dose until study drug discontinuation), and Follow-up Phases.

Secondary Outcome Measures

Name	Time	Method
Progressive Disease (PD)	30 days after last dose of study drug, continue up to 6 months	A progressive disease confirmed by a CT scan.
Death Event	30 days after last dose of study drug	All death events are due to AE, progressive disease, and other reasons.
Documented Responses	30 days after last dose of study drug, continue up to 6 months	Investigator-assessed responses were summarized descriptively for subjects with CLL/SLL and listed for subjects with other NHLs based on the efficacy population.

Locations (5): University of Chicago
🇺🇸
Chicago, Illinois, United States
Fletcher Allen Health Care and University of Vermont
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Burlington, Vermont, United States
MD Anderson Cancer Center
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Houston, Texas, United States
Yakima Valley Memorial Hospital/North Star Lodge
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Yakima, Washington, United States
Stanford University
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Stanford, California, United States