A Study of PCI-32765 (Ibrutinib) in Patients With Refractory Follicular Lymphoma
An Open-Label, Multicenter, Single-Arm, Phase 2 Study of PCI-32765 (Ibrutinib) in Subjects With Refractory Follicular Lymphoma
3 other identifiers
interventional
110
9 countries
54
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered to patients with chemoimmunotherapy-resistant follicular lymphoma (FL).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 lymphoma
Started Apr 2013
Shorter than P25 for phase_2 lymphoma
54 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 25, 2013
CompletedFirst Posted
Study publicly available on registry
January 30, 2013
CompletedStudy Start
First participant enrolled
April 17, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 18, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
May 18, 2016
CompletedJuly 18, 2017
July 1, 2017
3.1 years
January 25, 2013
July 14, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Overall response rate
Up to 2 years after the last patient is enrolled
Secondary Outcomes (11)
Duration of response
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)
Progression-free survival
Up to progressive disease, death, lost to follow-up, withdrawal of consent, or study end (up to 2 years after the last patient is enrolled)
Overall survival
Up to death, lost to follow-up, withdrawal of consent, or study end (up to 2 years after the last patient is enrolled)
Time to response
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)
Number of patients experiencing resolution of lymphoma-related B symptoms
Day 1 of every cycle during the first 12 months, thereafter every other cycle (up to 2 years after the last patient is enrolled)
- +6 more secondary outcomes
Study Arms (1)
PCI-32765 (Ibrutinib)
EXPERIMENTALInterventions
560 mg capsules administered orally once daily, continuously on a 21-day cycle until progressive disease.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 PI3K 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Janssen Research & Development, LLClead
- Pharmacyclics LLC.collaborator
Study Sites (54)
Unknown Facility
Los Angeles, California, United States
Unknown Facility
Stanford, California, United States
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Washington D.C., District of Columbia, United States
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Atlanta, Georgia, United States
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Chicago, Illinois, United States
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Westwood, Kansas, United States
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Lexington, Kentucky, United States
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Louisville, Kentucky, United States
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Baltimore, Maryland, United States
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Detroit, Michigan, United States
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Hackensack, New Jersey, United States
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New Brunswick, New Jersey, United States
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New York, New York, United States
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Greenville, North Carolina, United States
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Portland, Oregon, United States
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Philadelphia, Pennsylvania, United States
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Pittsburgh, Pennsylvania, United States
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Houston, Texas, United States
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Burlington, Vermont, United States
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Seattle, Washington, United States
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Adelaide, Australia
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Concord, Australia
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Melbourne, Australia
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Milton, Australia
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Prahran, Australia
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Courrière, Belgium
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Ghent, Belgium
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Leuven, Belgium
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Créteil, France
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Nice, France
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Nîmes, France
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Paris, France
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Pessac, France
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Pierre-Bénite, France
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Rennes, France
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Cologne, Germany
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Heidelberg, Germany
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Mainz, Germany
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Ulm, Germany
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Krakow, Poland
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Warsaw, Poland
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Wroclaw, Poland
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Moscow, Russia
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Nizhny Novgorod, Russia
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Saint Petersburg, Russia
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Volgograd, Russia
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Yekaterinburg, Russia
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Barcelona, Spain
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Marbella, Spain
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Salamanca, Spain
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Liverpool, United Kingdom
Unknown Facility
London, United Kingdom
Unknown Facility
Manchester, United Kingdom
Unknown Facility
Southampton, United Kingdom
Related Publications (2)
Balasubramanian S, Hodkinson B, Schuster SJ, Fowler NH, Trotman J, Hess G, Cheson BD, Schaffer M, Sun S, Deshpande S, Vermeulen J, Salles G, Gopal AK. Identification of a genetic signature enriching for response to ibrutinib in relapsed/refractory follicular lymphoma in the DAWN phase 2 trial. Cancer Med. 2022 Jan;11(1):61-73. doi: 10.1002/cam4.4422. Epub 2021 Nov 17.
PMID: 34791836DERIVEDGopal AK, Schuster SJ, Fowler NH, Trotman J, Hess G, Hou JZ, Yacoub A, Lill M, Martin P, Vitolo U, Spencer A, Radford J, Jurczak W, Morton J, Caballero D, Deshpande S, Gartenberg GJ, Wang SS, Damle RN, Schaffer M, Balasubramanian S, Vermeulen J, Cheson BD, Salles G. Ibrutinib as Treatment for Patients With Relapsed/Refractory Follicular Lymphoma: Results From the Open-Label, Multicenter, Phase II DAWN Study. J Clin Oncol. 2018 Aug 10;36(23):2405-2412. doi: 10.1200/JCO.2017.76.8853. Epub 2018 May 31.
PMID: 29851546DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2013
First Posted
January 30, 2013
Study Start
April 17, 2013
Primary Completion
May 18, 2016
Study Completion
May 18, 2016
Last Updated
July 18, 2017
Record last verified: 2017-07