A Study of PCI-32765 (Ibrutinib) in Patients with Refractory Follicular Lymphoma

Phase 1

• Conditions: Follicular Lymphoma; MedDRA version: 15.1Level: HLGTClassification code 10025320Term: Lymphomas non-Hodgkin's B-cellSystem Organ Class: 10005329 - Blood and lymphatic system disorders; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-004097-26-ES
• Lead Sponsor: Janssen-Cilag International NV

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-11
• Last Update Posted: 13 June 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 110

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 55
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 55

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to evaluate the ORR of PCI-32765, as assessed by the Independent Review Committee (IRC), in subjects with chemoimmunotherapy-resistant FL;Secondary Objective: The secondary objectives are to:<br>? Evaluate the duration of response<br>? Evaluate the safety of PCI-32765;Primary end point(s): Overall response rate;Timepoint(s) of evaluation of this end point: Time frame = every 12 weeks during the first 24 months, followed by every 24 weeks thereafter until disease progression (up to 2 years after the last patient is enrolled)

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Duration of response;Timepoint(s) of evaluation of this end point: Time frame = every 12 weeks during the first 24 months, followed by every 24 weeks thereafter until disease progression (up to 2 years after the last patient is enrolled)