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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Janssen Research & Development, LLC
Information provided by (Responsible Party):
Pharmacyclics
ClinicalTrials.gov Identifier:
NCT01109069
First received: April 19, 2010
Last updated: October 30, 2013
Last verified: October 2013
  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Janssen Research & Development, LLC
Investigators
Study Director: Elizabeth Bilotti, MSN, MSJ, ANP-BC, RN 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: October 30, 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, Non-Hodgkin
Lymphoma, Follicular
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 August 19, 2014