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

Non-Hodgkin's Lymphoma Clinical Trial

Official title:

A Long-term Safety Study of Bruton's Tyrosine Kinase (Btk) Inhibitor PCI-32765 in B Cell Lymphoma and Chronic Lymphocytic Leukemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01109069
• Other study ID #: PCYC-1103-CA
• Secondary ID: PCI-32765
• Status: Completed
• Phase: Phase 2
• Start date: June 2010
• Est. completion date: April 26, 2019

Study information

• Verified date: March 2020
• Source: Pharmacyclics LLC.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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 information / eligibility

• Status: Completed
• Enrollment: 199
• Est. completion date: April 26, 2019
• Est. primary completion date: April 26, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• PCI-32765
Dose based on parent protocol

Locations

Country	Name	City	State
United States	Fletcher Allen Health Care and University of Vermont	Burlington	Vermont
United States	University of Chicago	Chicago	Illinois
United States	MD Anderson Cancer Center	Houston	Texas
United States	Stanford University	Stanford	California
United States	Yakima Valley Memorial Hospital/North Star Lodge	Yakima	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Pharmacyclics LLC.	Janssen Research & Development, LLC

Country where clinical trial is conducted

United States, 

Outcome

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

External Links

•   Home page of Pharmacyclics