Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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28 August 2023 |
Main ID: |
EUCTR2013-003093-27-PL |
Date of registration:
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21/05/2014 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients with Previously Treated Indolent Non-Hodgkin Lymphoma
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Scientific title:
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A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination with Either Bendamustine and Rituximab (BR) or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects with Previously Treated Indolent Non-Hodgkin Lymphoma (iNHL) |
Date of first enrolment:
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22/07/2014 |
Target sample size:
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400 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-003093-27 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Argentina
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Australia
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Belgium
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Brazil
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China
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France
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Germany
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Israel
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Italy
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Japan
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Korea, Republic of
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Poland
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Russian Federation
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Spain
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Sweden
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Turkey
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Ukraine
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United Kingdom
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United States
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Contacts
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333CM
Leiden
Netherlands |
Telephone:
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+31(0)71524 21 66 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Name:
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Clinical Registry Group
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Address:
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Archimedesweg 29
2333CM
Leiden
Netherlands |
Telephone:
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+31(0)71524 21 66 |
Email:
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ClinicalTrialsEU@its.jnj.com |
Affiliation:
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Janssen-Cilag International NV |
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Key inclusion & exclusion criteria
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Inclusion criteria: - Histologically confirmed diagnosis of B-cell indolent Non-Hodgkin lymphoma with histological subtype limited to follicular lymphoma or marginal zone lymphoma
- At least 1 prior treatment with a CD20 antibody combination chemotherapy regimen
- Disease that has relapsed or was refractory after prior chemoimmunotherapy
- At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma 2007
- Eastern Cooperative Oncology Group performance status grade 0 or 1
- Laboratory values within protocol-defined parameters
- Agrees to protocol-defined use of effective contraception
- Men must agree not to donate sperm during and after the study for 6 months after the last dose of bendamustine, 12 months after the last dose of rituximab, or 3 months after the last dose of study medication, whichever is later
- 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 200 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 200
Exclusion criteria: -Prior treatment according to protocol-defined criteria
-Unable to receive background chemotherapy based on prior treatment history and cardiac function
-Known central nervous system lymphoma
-Diagnosed or treated for malignancy other than indolent Non-Hodgkin lymphoma
-History of stroke or intracranial hemorrhage within 6 months prior to randomization
-Requires anticoagulation with warfarin or equivalent Vitamin K antagonists or treatment with strong CYP3A4/5 inhibitors
-Clinically significant cardiovascular disease
-Known history of human immunodeficiency virus or active infection with hepatitis C or B or any uncontrolled active systemic infection requiring intravenous antibiotics
-Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator’s opinion, could compromise the participant’s safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
-Women who are pregnant or breastfeeding
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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Therapeutic area: Diseases [C] - Cancer [C04]
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Indolent Non-Hodgkin Lymphoma (iNHL) MedDRA version: 20.0
Level: HLT
Classification code 10029621
Term: Non-Hodgkin's lymphomas unspecified histology indolent
System Organ Class: 100000004851
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Intervention(s)
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Product Name: Ibrutinib Product Code: JNJ-54179060 Pharmaceutical Form: Capsule INN or Proposed INN: Ibrutinib Current Sponsor code: Ibrutinib Other descriptive name: IBRUTINIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 140- Pharmaceutical form of the placebo: Capsule Route of administration of the placebo: Oral use
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Primary Outcome(s)
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Timepoint(s) of evaluation of this end point: Up to approximately 7 years after the first participant is randomized
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Main Objective: The primary objective of this study is to evaluate whether the addition of ibrutinib to bendamustine and rituximab (BR) combination or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) combination will result in prolongation of PFS compared with either BR or R-CHOP alone in subjects with previously treated iNHL (FL or MZL).
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Primary end point(s): Progression-free survival
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Secondary Objective: The secondary objectives are to compare treatment groups in terms of the following: ? overall survival (OS) ? complete response rate (CR) ? overall response rate ORR (CR+PR) ? duration of response (DOR) ? patient-reported lymphoma symptoms and concerns as measured by the Lym subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) ? safety of ibrutinib when combined with BR or R-CHOP
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Secondary Outcome(s)
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Secondary end point(s): Overall survival
1/ Overall survival
2/ Complete response rate
3/ Overall response rate
4/ Duration of response
5/ Participants with change in patient-reported lymphoma symptoms and concerns as measured by the Lym subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym)
6/ Number of participants affected by adverse events by MedDRA system organ class (SOC) and Preferred term (PT)
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Timepoint(s) of evaluation of this end point: 1/ Up to approximately 7 years after the first participant is randomized
2/ Up to approximately 7 years after the first participant is randomized
3/ Up to approximately 7 years after the first participant is randomized
4/ Up to approximately 7 years after the first participant is randomized
5/ Up to approximately 7 years after the first participant is randomized
6/ Up to 30 days after the last dose of study medication
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Secondary ID(s)
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2013-003093-27-SE
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PCI-32765FLR3001
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Source(s) of Monetary Support
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Janssen Research & Development, LLC
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Ethics review
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Status: Approved
Approval date: 21/05/2014
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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