Know Cancer

or
forgot password

An Open-label, Multicenter, Single-arm, Phase 2 Study of PCI-32765 (Ibrutinib) in Subjects With Refractory Follicular Lymphoma


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Lymphoma

Thank you

Trial Information

An Open-label, Multicenter, Single-arm, Phase 2 Study of PCI-32765 (Ibrutinib) in Subjects With Refractory Follicular Lymphoma


This is an open-label (identity of assigned study drug will be known) study of PCI-32765
(ibrutinib) in approximately 110 patients with chemoimmunotherapy-resistant FL whose disease
has relapsed from at least 2 prior lines of therapy, including at least 1 rituximab
combination chemotherapy regimen. Each patient must have resistant disease to the last
therapy (defined as progression of disease during or within 12 months of the last dose of a
CD20 antibody combination chemotherapy regimen). The study will include the following
phases: screening (up to 30 days prior to the first dose of study drug), treatment (until
disease progression or unacceptable toxicity), and posttreatment follow-up (until death,
lost to follow up, withdrawal of consent, or study end [defined as 2 years after the last
patient is enrolled]). Patients will receive 560 mg of PCI-32765 by mouth once daily on a
21-day cycle. Treatment will be continuous (without interruption) and self-administered at
home. The treatment phase will extend from administration of the first dose of study
medication until disease progression or unacceptable toxicity. Posttreatment follow-up will
extend from the end of treatment until death, lost to follow up, withdrawal of consent, or
study end. Every patient, except for those who explicitly withdraw consent from further site
contact, will be followed for survival status until the study ends. In addition, data on
subsequent antineoplastic therapy will also be collected. Serial pharmacokinetic samples
will be collected and efficacy and safety will be monitored throughout the study.


Inclusion Criteria:



- Histologic proof of Grade 1, 2, or 3a follicular lymphoma (FL) without clinical or
pathological evidence of transformation

- Previously treated with at least 2 prior lines of therapy, including at least 1
rituximab combination chemotherapy regimen; last prior line of therapy includes an
anti CD20 monoclonal antibody-containing chemotherapy regimen (separate lines of
therapy are defined as different regimens that are either separated by disease
progression, refractory disease, or relapsed disease)

- Resistant disease to the last therapy, defined as progression of disease during or
within 12 months of the last dose of a CD20 antibody combination chemotherapy regimen

- At least 1 measurable site of disease according to International Working Group
Revised Response Criteria for Malignant Lymphoma

- Eastern Cooperative Oncology Group performance status grade 0 or 1

- Hematology and biochemical laboratory values must be within protocol-defined
parameters within 7 days prior to enrollment

- Agrees to protocol-defined use of effective contraception

- Women of childbearing potential must have a negative serum or urine pregnancy test at
screening

Exclusion Criteria:

- Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic
anticancer antibodies within 4 weeks, radio- or toxin-immunoconjugates within 10
weeks, radiation therapy or other investigational agents within 3 weeks, or major
surgery within 4 weeks of first dose of study drug

- Prior treatment with PCI-32765, other Bruton's tyrosine kinase inhibitors, or
phosphoinositide 3-kinase delta inhibitors

- Concurrent enrollment in another therapeutic investigational clinical treatment study

- Received a prior allogeneic hematopoietic stem cell transplant (prior autologous
hematopoietic stem cell transplant is allowed)

- Known central nervous system lymphoma

- History of prior malignancy (except malignancy treated with curative intent and with
no known active disease present for >=3 years before enrollment, adequately treated
non-melanoma skin cancer or lentigo maligna without evidence of disease, or
adequately treated cervical carcinoma in situ without evidence of disease)

- History of stroke or intracranial hemorrhage within 6 months prior to enrollment

- Requires anticoagulation with warfarin or equivalent vitamin K antagonists

- Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors

- Clinically significant cardiovascular disease such as uncontrolled or symptomatic
arrhythmias, congestive heart failure, or myocardial infarction within 6 months of
screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined
by the New York Heart Association Functional Classification

- Known history of Human Immunodeficiency Virus (HIV) or Hepatitis C or active
infection with Hepatitis B or any uncontrolled active systemic infection requiring
intravenous antibiotics

- Women who are pregnant or breastfeeding

- Any life-threatening illness, medical condition, or organ system dysfunction which,
in the investigator's opinion, could compromise the patient's safety, interfere with
the absorption or metabolism of PCI-32765 capsules, or put the study outcomes at
undue risk

Type of Study:

Interventional

Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall response rate

Outcome Time Frame:

Up to 2 years after the last patient is enrolled

Safety Issue:

No

Principal Investigator

Janssen Research & Development, LLC Clinical Trial

Investigator Role:

Study Director

Investigator Affiliation:

Janssen Research & Development, LLC

Authority:

Australia: Department of Health and Ageing Therapeutic Goods Administration

Study ID:

CR100956

NCT ID:

NCT01779791

Start Date:

April 2013

Completion Date:

September 2016

Related Keywords:

  • Lymphoma
  • Lymphoma
  • Refractory follicular lymphoma
  • Chemoimmunotherapy-resistant follicular lymphoma
  • PCI-32765
  • Ibrutinib
  • Lymphoma
  • Lymphoma, Follicular

Name

Location

Hinsdale, Illinois  60521
Albany, Georgia  31701
Fountain Valley, California  92708
Albany, New York  12208
Cleveland, Ohio  44195
Philadelphia, Pennsylvania  19104
Austin, Texas  78705
Seattle, Washington  98195
Flint, Michigan  48532
Louisville, Kentucky  40207
Kansas City, Kansas  66160
Hackensack, New Jersey  07601
Baltimore, Maryland  21287
Charlotte, North Carolina  
Eugene, Oregon  
South Burlington, Vermont  
Washington, District of Columbia