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

• Register: EUCTR
• Last refreshed on: 30 June 2019
• Main ID: EUCTR2012-004097-26-GB
• Date of registration: 23/11/2012
• Prospective Registration: Yes
• Primary sponsor: Janssen-Cilag International NV
• Public title: A Study of PCI-32765 (Ibrutinib) in Patients with Refractory Follicular Lymphoma
• Scientific title: An Open-label, Multicenter, Single-arm, Phase 2 Study of PCI-32765 (ibrutinib) in Subjects with Refractory Follicular Lymphoma
• Date of first enrolment: 19/02/2013
• Target sample size: 110
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-004097-26
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: yes; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: no; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no; Number of treatment arms in the trial: 1
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Australia, Belgium, France, Germany, Italy, Poland, Russian Federation, Spain, United Kingdom, United States

Contacts

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

• Name: Clinical Registry Group
• Affiliation: Janssen-Cilag International NV

Key inclusion & exclusion criteria

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 chemotherapy in 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 or other Bruton's tyrosine kinase
inhibitors (patients who progressed or became refractory while on
treatment with P13K inhibitors are excluded)
•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 active infection with 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



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Cancer [C04]

Follicular Lymphoma
MedDRA version: 18.1 Level: HLGT Classification code 10025320 Term: Lymphomas non-Hodgkin's B-cell System Organ Class: 10005329 - Blood and lymphatic system disorders

Intervention(s)

Product Name: Ibrutinib
Product Code: JNJ-54179060
Pharmaceutical Form: Capsule
INN or Proposed INN: Ibrutinib
CAS Number: 936563-96-1
Current Sponsor code: JNJ-54179060
Other descriptive name: IBRUTINIB
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 140-

Primary Outcome(s)

Secondary Objective: The secondary objectives are to:
? Evaluate the duration of response
? Evaluate the safety of ibrutinib

Timepoint(s) of evaluation of this end point: up to 2 years after the last patient is enrolled

Main Objective: The primary objective of the study is to evaluate the ORR of ibrutinib, as assessed by the Independent Review Committee (IRC), in subjects with chemoimmunotherapy-resistant FL

Primary end point(s): Overall response rate

Secondary Outcome(s)

Secondary end point(s): Duration of response

Timepoint(s) of evaluation of this end point: Time frame = every 12 weeks during the first 96 weeks, followed by every 24 weeks thereafter until disease progression (up to 2 years after the last patient is enrolled)

Secondary ID(s)

2012-004097-26-BE

PCI-32765FLR2002

Source(s) of Monetary Support

Janssen Research & Development, LLC

Ethics review

Status: Approved
Approval date:
Contact:

Results

• Results available: Yes
• Date Posted: 27/05/2017
• Date Completed: 18/05/2016
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-004097-26/results