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
Overview[ - collapse ][ - ]
Purpose | The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult patients with previously treated indolent Non-Hodgkin lymphoma. |
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Condition | Lymphoma |
Intervention | Drug: Bendamustine Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: PCI-32765 (Ibrutinib) Drug: Placebo |
Phase | Phase 3 |
Sponsor | Janssen Research & Development, LLC |
Responsible Party | Janssen Research & Development, LLC |
ClinicalTrials.gov Identifier | NCT01974440 |
First Received | October 28, 2013 |
Last Updated | April 16, 2014 |
Last verified | April 2014 |
Tracking Information[ + expand ][ + ]
First Received Date | October 28, 2013 |
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Last Updated Date | April 16, 2014 |
Start Date | January 2014 |
Estimated Primary Completion Date | August 2021 |
Current Primary Outcome Measures | Progression-free survival [Time Frame: Up to approximately 7 years after the first participant is randomized] [Designated as safety issue: No] |
Current Secondary Outcome Measures |
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Descriptive Information[ + expand ][ + ]
Brief Title | 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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Official Title | 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) |
Brief Summary | The purpose of this study is to evaluate the efficacy and safety of PCI-32765 (ibrutinib) administered in combination with either bendamustine and rituximab (BR) or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) in adult patients with previously treated indolent Non-Hodgkin lymphoma. |
Detailed Description | This is a randomized (individuals assigned to study treatment by chance), double-blind (individuals and study personnel will not know the identity of study treatments), placebo (an inactive substance that is compared with a drug to test whether the drug has a real effect in a clinical trial)-controlled study in approximately 400 adult patients with follicular lymphoma or marginal zone lymphoma. The study will include the following phases: screening, treatment, and a posttreatment follow-up. Eligible patients will be randomly assigned in a 1:1 ratio to either treatment Arm A (background immune-chemotherapy + placebo) or treatment Arm B (background immune-chemotherapy + 560 mg of ibrutinib). All participants will receive 6 cycles of background immune-chemotherapy with either BR or R-CHOP in combination with either placebo (Arm A) or ibrutinib (Arm B). Selection of background immune-chemotherapy will be based on prior treatment history and cardiac function. After completion of background immune-chemotherapy, study drug (ibrutinib or placebo) will continue until disease progression, unacceptable toxicity, or study end. Assessment of tumor response and progression will be conducted in accordance with the Revised Response Criteria for Malignant Lymphoma. Serial pharmacokinetic (study of what a drug does to the body) blood samples will be collected. Safety will be assessed throughout the study. |
Study Type | Interventional |
Study Phase | Phase 3 |
Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment |
Condition | Lymphoma |
Intervention | Drug: Bendamustine 90 mg/m2 administered intravenously on Days 1-2 Drug: Rituximab 375 mg/m2 administered intravenously on Day 1 Drug: Cyclophosphamide 750 mg/m2 administered intravenously on Day 1 Drug: Doxorubicin 50 mg/m2 administered intravenously on Day 1 Drug: Vincristine 1.4 mg/m2 (maximum total 2 mg) administered intravenously on Day 1 Drug: Prednisone 100 mg administered orally on Days 1-5 Drug: PCI-32765 (Ibrutinib) 560 mg capsules administered by mouth once daily, continuously starting on Cycle 1, Day 1 Drug: Placebo Matched to study drug administered by mouth once daily, continuously starting on Cycle 1, Day 1 |
Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
Recruitment Status | Recruiting |
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Estimated Enrollment | 400 |
Estimated Completion Date | August 2021 |
Estimated Primary Completion Date | October 2017 |
Eligibility Criteria | 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 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 |
Gender | Both |
Ages | 18 Years |
Accepts Healthy Volunteers | No |
Contacts | Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com |
Location Countries | United States, Argentina, Australia, Belgium, Brazil, France, Germany, Israel, Japan, Korea, Republic of, Poland, Russian Federation, Spain, Sweden, Turkey, United Kingdom |
Administrative Information[ + expand ][ + ]
NCT Number | NCT01974440 |
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Other Study ID Numbers | CR102786 |
Has Data Monitoring Committee | Yes |
Information Provided By | Janssen Research & Development, LLC |
Study Sponsor | Janssen Research & Development, LLC |
Collaborators | Pharmacyclics |
Investigators | Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC |
Verification Date | April 2014 |
Locations[ + expand ][ + ]
United States, Alabama | Birmingham, Alabama, United States Withdrawn |
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United States, Alabama | Huntsville, Alabama, United States Withdrawn |
United States, Arizona | Gilbert, Arizona, United States Not yet recruiting |
United States, Arkansas | Fayetteville, Arkansas, United States Withdrawn |
United States, California | La Jolla, California, United States Not yet recruiting |
United States, California | San Diego, California, United States Withdrawn |
United States, California | Stanford, California, United States Suspended |
United States, Colorado | Aurora, Colorado, United States Withdrawn |
United States, District of Columbia | Washington, District of Columbia, United States Withdrawn |
United States, Florida | Ocala, Florida, United States Recruiting |
United States, Florida | Orlando, Florida, United States Withdrawn |
United States, Georgia | Atlanta, Georgia, United States Not yet recruiting |
United States, Illinois | Chicago, Illinois, United States Not yet recruiting |
United States, Illinois | Springfield, Illinois, United States Withdrawn |
United States, Indiana | Indianapolis, Indiana, United States Not yet recruiting |
United States, Iowa | Sioux City, Iowa, United States Withdrawn |
United States, Kansas | Westwood, Kansas, United States Not yet recruiting |
United States, Kentucky | Lexington, Kentucky, United States Not yet recruiting |
United States, Kentucky | Louisville, Kentucky, United States Withdrawn |
United States, Louisiana | Baton Rouge, Louisiana, United States Withdrawn |
United States, Louisiana | Lafayette, Louisiana, United States Not yet recruiting |
United States, Louisiana | Marrero, Louisiana, United States Withdrawn |
United States, Maine | Scarborough, Maine, United States Not yet recruiting |
United States, Maryland | Baltimore, Maryland, United States Withdrawn |
United States, Maryland | Baltimore, Maryland, United States Not yet recruiting |
United States, Maryland | Bethesda, Maryland, United States Not yet recruiting |
United States, Massachusetts | Boston, Massachusetts, United States Not yet recruiting |
United States, Michigan | Battle Creek, Michigan, United States Recruiting |
United States, Michigan | Detroit, Michigan, United States Not yet recruiting |
United States, Michigan | Detroit, Michigan, United States Withdrawn |
United States, New Jersey | Denville, New Jersey, United States Not yet recruiting |
United States, New Jersey | Newark, New Jersey, United States Not yet recruiting |
United States, New York | New York, New York, United States Not yet recruiting |
United States, North Carolina | Greenville, North Carolina, United States Withdrawn |
United States, North Carolina | Hickory, North Carolina, United States Recruiting |
United States, North Carolina | Pinehurst, North Carolina, United States Not yet recruiting |
United States, North Dakota | Bismarck, North Dakota, United States Not yet recruiting |
United States, North Dakota | Fargo, North Dakota, United States Not yet recruiting |
United States, Oregon | Bend, Oregon, United States Not yet recruiting |
United States, Oregon | Portland, Oregon, United States Withdrawn |
United States, Pennsylvania | Pittsburgh, Pennsylvania, United States Not yet recruiting |
United States, South Carolina | Spartanburg, South Carolina, United States Not yet recruiting |
United States, South Dakota | Sioux Falls, South Dakota, United States Not yet recruiting |
United States, Texas | Houston, Texas, United States Not yet recruiting |
United States, Texas | Lubbock, Texas, United States Not yet recruiting |
United States, Vermont | Burlington, Vermont, United States Withdrawn |
United States, Washington | Spokane, Washington, United States Not yet recruiting |
Argentina | Buenos Aires, Argentina Withdrawn |
Argentina | Buenos Aires, Argentina Not yet recruiting |
Argentina | Ciudad Autonoma Buenos Aires, Argentina Not yet recruiting |
Argentina | Ciudad De Buenos Aires, Argentina Withdrawn |
Argentina | Cordoba, Argentina Withdrawn |
Argentina | La Capital, Argentina Not yet recruiting |
Argentina | Mendoza, Argentina Not yet recruiting |
Argentina | Santa Fe, Argentina Not yet recruiting |
Australia | Adelaide, Australia Recruiting |
Australia | Fitzroy, Australia Not yet recruiting |
Australia | Heidelberg, Australia Recruiting |
Australia | South Brisbane, Australia Recruiting |
Australia | Sydney, Australia Not yet recruiting |
Australia | Wahroonga, Australia Not yet recruiting |
Belgium | Brussel, Belgium Not yet recruiting |
Belgium | Edegem, Belgium Not yet recruiting |
Belgium | Gent, Belgium Not yet recruiting |
Belgium | Leuven, Belgium Recruiting |
Belgium | Namur, Belgium Recruiting |
Belgium | Wilrijk, Belgium Not yet recruiting |
Brazil | Porto Alegre, Brazil Not yet recruiting |
Brazil | Rio De Janeiro, Brazil Not yet recruiting |
Brazil | Salvador, Brazil Not yet recruiting |
Brazil | Sao Paulo, Brazil Not yet recruiting |
France | Montpellier, France Suspended |
France | Nice Cedex 2, France Recruiting |
France | Paris, France Not yet recruiting |
France | Pessac, France Recruiting |
France | Pierre Benite, France Recruiting |
France | Rennes, France Not yet recruiting |
Germany | Berlin, Germany Not yet recruiting |
Germany | Chemnitz, Germany Withdrawn |
Germany | Gießen, Germany Not yet recruiting |
Germany | Göttingen, Germany Not yet recruiting |
Germany | Heidelberg, Germany Withdrawn |
Germany | Ludwigshafen, Rp, Germany Not yet recruiting |
Germany | Magdeburg, Germany Not yet recruiting |
Germany | Mainz, Germany Not yet recruiting |
Germany | Munchen, Germany Not yet recruiting |
Germany | Wiesbaden, Germany Not yet recruiting |
Israel | Afula, Israel Withdrawn |
Israel | Haifa, Israel Recruiting |
Israel | Haifa, Israel Not yet recruiting |
Israel | Jerusalem, Israel Not yet recruiting |
Israel | Nahariya, Israel Not yet recruiting |
Israel | Netanya, Israel Not yet recruiting |
Israel | Petah Tikva, Israel Recruiting |
Israel | Tel Aviv, Israel Withdrawn |
Japan | Fukuoka, Japan Withdrawn |
Japan | Hiroshima, Japan Not yet recruiting |
Japan | Isehara, Japan Not yet recruiting |
Japan | Nagoya, Japan Not yet recruiting |
Japan | Osaka, Japan Withdrawn |
Japan | Osaka, Japan Not yet recruiting |
Japan | Osaka-Sayama, Japan Not yet recruiting |
Japan | Sapporo, Japan Recruiting |
Japan | Sendai, Japan Not yet recruiting |
Japan | Tokyo, Japan Not yet recruiting |
Korea, Republic of | Hwasun Gun, Korea, Republic of Not yet recruiting |
Korea, Republic of | Seoul, Korea, Republic of Not yet recruiting |
Korea, Republic of | Seoul, Korea, Republic of Recruiting |
Poland | Gdynia, Poland Not yet recruiting |
Poland | Olsztyn, Poland Not yet recruiting |
Poland | Warszawa, Poland Not yet recruiting |
Puerto Rico | Bayamon, Puerto Rico Recruiting |
Puerto Rico | Ponce, Puerto Rico Recruiting |
Puerto Rico | San Juan, Puerto Rico Not yet recruiting |
Russian Federation | Ekaterinburg, Russian Federation Withdrawn |
Russian Federation | Krasnodar, Russian Federation Not yet recruiting |
Russian Federation | Moscow, Russian Federation Withdrawn |
Russian Federation | Moscow, Russian Federation Not yet recruiting |
Russian Federation | Nizny Novgorod, Russian Federation Not yet recruiting |
Russian Federation | Novosibirsk, Russian Federation Withdrawn |
Russian Federation | Obninsk, Russian Federation Withdrawn |
Russian Federation | Petrozavodsk, Russian Federation Not yet recruiting |
Russian Federation | Pyatigorsk, Russian Federation Not yet recruiting |
Russian Federation | Rostov-Na-Donu, Russian Federation Not yet recruiting |
Russian Federation | Sochi, Russian Federation Withdrawn |
Russian Federation | St. Petersburg, Russian Federation Not yet recruiting |
Russian Federation | Syktyvkar, Russian Federation Not yet recruiting |
Russian Federation | Tomsk, Russian Federation Withdrawn |
Russian Federation | Velikiy Novgorod, Russian Federation Not yet recruiting |
Russian Federation | Volgograd, Russian Federation Not yet recruiting |
Spain | Barcelona, Spain Not yet recruiting |
Spain | Madrid, Spain Not yet recruiting |
Spain | Madrid, Spain Recruiting |
Spain | Málaga, Spain Withdrawn |
Spain | Salamanca, Spain Not yet recruiting |
Sweden | Göteborg, Sweden Recruiting |
Sweden | Linköping, Sweden Recruiting |
Sweden | Luleå, Sweden Recruiting |
Sweden | Lund, Sweden Withdrawn |
Sweden | Uppsala, Sweden Recruiting |
Turkey | Ankara, Turkey Not yet recruiting |
Turkey | Ankara, Turkey Recruiting |
Turkey | Bursa, Turkey Not yet recruiting |
Turkey | Istanbul, Turkey Not yet recruiting |
Turkey | Istanbul, Turkey Withdrawn |
Turkey | Izmir, Turkey Not yet recruiting |
Turkey | Izmir, Turkey Withdrawn |
Turkey | Kayseri, Turkey Not yet recruiting |
United Kingdom | Glasgow, United Kingdom Not yet recruiting |
United Kingdom | London, United Kingdom Not yet recruiting |
United Kingdom | London, United Kingdom Withdrawn |
United Kingdom | Newcastle Upon Tyne, United Kingdom Not yet recruiting |
United Kingdom | Plymouth, United Kingdom Not yet recruiting |
United Kingdom | Portsmouth, United Kingdom Not yet recruiting |
United Kingdom | Southampton, United Kingdom Withdrawn |
United Kingdom | Sutton, United Kingdom Not yet recruiting |
United Kingdom | Swansea, United Kingdom Not yet recruiting |