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

Phase 1

• Conditions: Follicular Lymphoma; MedDRA version: 14.1Level: 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-IT
• Lead Sponsor: JANSSEN-CILAG INTERNATIONAL N.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-11
• Study Completion: 2016-05-18
• Last Update Posted: 21 December 2021

Recruitment & Eligibility

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

Inclusion Criteria

1 Histologic proof of Grade 1, 2, or 3a follicular lymphoma (FL) without clinical or pathological evidence of transformation 2 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) 3 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 4 At least 1 measurable site of disease according to International Working Group Revised Response Criteria for Malignant Lymphoma 5 Eastern Cooperative Oncology Group performance status grade 0 or 1 6 Hematology and biochemical laboratory values must be within protocol defined parameters within 7 days prior to enrollment 7 Agrees to protocol-defined use of effective contraception 8 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 5
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

1 Prior nitrosoureas within 6 weeks, chemotherapy within 3 weeks, therapeutic anticancer antibodies within 4 weeks, radio- or toxinimmunoconjugates within 10 weeks, radiation therapy or other investigational agents within 3 weeks, or major surgery within 4 weeks of first dose of study drug 2 Prior treatment with PCI-32765, other Bruton's tyrosine kinase inhibitors, or phosphoinositide 3-kinase delta inhibitors 3 Concurrent enrollment in another therapeutic investigational clinical treatment study 4 Received a prior allogeneic hematopoietic stem cell transplant (prior autologous hematopoietic stem cell transplant is allowed) 5 Known central nervous system lymphoma 6 History of prior malignancy except: a) malignancy treated with curative intent and with no known active disease present for >=3 years before enrollment; b) adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; c) adequately treated cervical carcinoma in situ wit hout evidence of disease) 7 History of stroke or intracranial hemorrhage within 6 months prior to enrollment 8 Requires anticoagulation with warfarin or equivalent vitamin K antagonists 9 Requires treatment with strong cytochrome P450 (CYP)3A4/5 inhibitors 10 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 11 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 12 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: ? Evaluate the duration of response ? Evaluate the safety;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)