A Study of PCI-32765 (Ibrutinib) in Combination With Either Bendamustine and Rituximab or Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Participants With Previously Treated Indolent Non-Hodgkin Lymphoma
Conditions
Lymphoma
Conditions: official terms
Lymphoma - Lymphoma, Non-Hodgkin
Conditions: Keywords
Lymphoma, Follicular lymphoma, Marginal zone lymphoma, Indolent Non-Hodgkin lymphoma, PCI-32765, Ibrutinib, Bendamustine, Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, Prednisone, R-CHOP
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
Intervention
Name: Bendamustine Type: Drug
Name: Rituximab Type: Drug
Name: Cyclophosphamide Type: Drug
Name: Doxorubicin Type: Drug
Name: Vincristine Type: Drug
Name: Prednisone Type: Drug
Name: PCI-32765 (Ibrutinib) Type: Drug
Name: Placebo Type: Drug
Overall Status
Recruiting
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 participants 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 participants with follicular lymphoma or marginal zone lymphoma. The study will include the following phases: Screening, Treatment, and a Post-treatment Follow-up. Eligible participants 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 milligram [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, whichever comes first. 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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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 initial diagnosis and without evidence of pathological transformation or clinical signs suggesting transformation

- At least 1 prior treatment with a CD20 antibody combination chemo-immunotherapy regimen

- Disease that has relapsed or was refractory after prior chemo-immunotherapy

- 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

- Requires treatment with strong CYP3A inhibitors

- Clinically significant cardiovascular disease

- Known history of human immunodeficiency virus or active hepatitis C virus (HCV; ribonucleic acid [RNA] polymerase chain reaction [PCR]-positive) or active hepatitis B virus (HBV; DNA PCR-positive) infection 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
Locations
Birmingham, Alabama, United States
Status: Withdrawn
Huntsville, Alabama, United States
Status: Withdrawn
Gilbert, Arizona, United States
Status: Recruiting
Fayetteville, Arkansas, United States
Status: Withdrawn
Duarte, California, United States
Status: Recruiting
La Jolla, California, United States
Status: Recruiting
Los Angeles, California, United States
Status: Recruiting
Orange, California, United States
Status: Recruiting
San Diego, California, United States
Status: Withdrawn
San Jose, California, United States
Status: Recruiting
Stanford, California, United States
Status: Withdrawn
Aurora, Colorado, United States
Status: Withdrawn
Washington, District of Columbia, United States
Status: Withdrawn
Ocala, Florida, United States
Status: Completed
Orlando, Florida, United States
Status: Withdrawn
Atlanta, Georgia, United States
Status: Withdrawn
Chicago, Illinois, United States
Status: Recruiting
Maywood, Illinois, United States
Status: Recruiting
Springfield, Illinois, United States
Status: Withdrawn
Indianapolis, Indiana, United States
Status: Recruiting
Sioux City, Iowa, United States
Status: Withdrawn
Westwood, Kansas, United States
Status: Recruiting
Lexington, Kentucky, United States
Status: Completed
Louisville, Kentucky, United States
Status: Withdrawn
Baton Rouge, Louisiana, United States
Status: Withdrawn
Lafayette, Louisiana, United States
Status: Recruiting
Marrero, Louisiana, United States
Status: Withdrawn
Scarborough, Maine, United States
Status: Recruiting
Baltimore, Maryland, United States
Status: Recruiting
Baltimore, Maryland, United States
Status: Withdrawn
Bethesda, Maryland, United States
Status: Recruiting
Boston, Massachusetts, United States
Status: Completed
Ann Arbor, Michigan, United States
Status: Recruiting
Battle Creek, Michigan, United States
Status: Recruiting
Detroit, Michigan, United States
Status: Withdrawn
Detroit, Michigan, United States
Status: Recruiting
St. Louis Park, Minnesota, United States
Status: Recruiting
Denville, New Jersey, United States
Status: Recruiting
Newark, New Jersey, United States
Status: Withdrawn
New York, New York, United States
Status: Recruiting
Greensboro, North Carolina, United States
Status: Withdrawn
Greenville, North Carolina, United States
Status: Withdrawn
Hickory, North Carolina, United States
Status: Recruiting
Pinehurst, North Carolina, United States
Status: Recruiting
Bismarck, North Dakota, United States
Status: Withdrawn
Fargo, North Dakota, United States
Status: Withdrawn
Bend, Oregon, United States
Status: Completed
Portland, Oregon, United States
Status: Withdrawn
Philadelphia, Pennsylvania, United States
Status: Withdrawn
Pittsburgh, Pennsylvania, United States
Status: Recruiting
Spartanburg, South Carolina, United States
Status: Withdrawn
Sioux Falls, South Dakota, United States
Status: Recruiting
Sioux Falls, South Dakota, United States
Status: Withdrawn
Houston, Texas, United States
Status: Recruiting
Lubbock, Texas, United States
Status: Recruiting
Burlington, Vermont, United States
Status: Withdrawn
Spokane, Washington, United States
Status: Recruiting
Green Bay, Wisconsin, United States
Status: Recruiting
Buenos Aires, Argentina
Status: Recruiting
Buenos Aires, Argentina
Status: Withdrawn
Ciudad Autonoma Buenos Aires, Argentina
Status: Recruiting
Ciudad De Buenos Aires, Argentina
Status: Withdrawn
Cordoba, Argentina
Status: Withdrawn
Cordoba, Argentina
Status: Recruiting
La Capital, Argentina
Status: Recruiting
Mendoza, Argentina
Status: Recruiting
Santa Fe, Argentina
Status: Recruiting
Adelaide, Australia
Status: Recruiting
Fitzroy, Australia
Status: Recruiting
Heidelberg, Australia
Status: Recruiting
South Brisbane, Australia
Status: Recruiting
Sydney, Australia
Status: Recruiting
Wahroonga, Australia
Status: Recruiting
Brussel, Belgium
Status: Recruiting
Edegem, Belgium
Status: Recruiting
Gent, Belgium
Status: Recruiting
Leuven, Belgium
Status: Recruiting
Namur, Belgium
Status: Recruiting
Wilrijk, Belgium
Status: Recruiting
Porto Alegre, Brazil
Status: Recruiting
Rio De Janeiro, Brazil
Status: Recruiting
Salvador, Brazil
Status: Recruiting
Sao Paulo, Brazil
Status: Recruiting
Beijing, China
Status: Recruiting
Beijing, China
Status: Withdrawn
Chengdu, China
Status: Recruiting
Guangzhou, China
Status: Withdrawn
Guangzhou, China
Status: Recruiting
Hangzhou, China
Status: Recruiting
Hangzhou, China
Status: Withdrawn
Harbin, China
Status: Recruiting
Nanjing, China
Status: Recruiting
Shanghai, China
Status: Recruiting
Shanghai, China
Status: Withdrawn
Tianjin, China
Status: Withdrawn
Tianjin, China
Status: Recruiting
Montpellier, France
Status: Withdrawn
Nice Cedex 2, France
Status: Recruiting
Paris, France
Status: Recruiting
Pessac, France
Status: Recruiting
Pierre Benite, France
Status: Recruiting
Rennes, France
Status: Recruiting
Berlin, Germany
Status: Recruiting
Chemnitz, Germany
Status: Withdrawn
Gießen, Germany
Status: Recruiting
Göttingen, Germany
Status: Recruiting
Heidelberg, Germany
Status: Withdrawn
Ludwigshafen, Rp, Germany
Status: Recruiting
Magdeburg, Germany
Status: Recruiting
Mainz, Germany
Status: Recruiting
Munchen, Germany
Status: Recruiting
Wiesbaden, Germany
Status: Recruiting
Afula, Israel
Status: Withdrawn
Hadera, Israel
Status: Recruiting
Haifa, Israel
Status: Recruiting
Jerusalem, Israel
Status: Recruiting
Nahariya, Israel
Status: Recruiting
Netanya, Israel
Status: Recruiting
Petah Tikva, Israel
Status: Recruiting
Ramat Gan, Israel
Status: Recruiting
Tel Aviv, Israel
Status: Withdrawn
Fukuoka, Japan
Status: Withdrawn
Hiroshima, Japan
Status: Recruiting
Isehara, Japan
Status: Active, not recruiting
Kobe, Japan
Status: Recruiting
Nagoya, Japan
Status: Recruiting
Osaka-Sayama, Japan
Status: Active, not recruiting
Osaka, Japan
Status: Recruiting
Osaka, Japan
Status: Withdrawn
Sapporo, Japan
Status: Recruiting
Sendai, Japan
Status: Recruiting
Tokyo, Japan
Status: Recruiting
Hwasun Gun, Korea, Republic of
Status: Recruiting
Seoul, Korea, Republic of
Status: Recruiting
Gdansk, Poland
Status: Withdrawn
Gdynia, Poland
Status: Recruiting
Olsztyn, Poland
Status: Recruiting
Warszawa, Poland
Status: Recruiting
Bayamon, Puerto Rico
Status: Recruiting
Ponce, Puerto Rico
Status: Recruiting
San Juan, Puerto Rico
Status: Recruiting
Ekaterinburg, Russian Federation
Status: Withdrawn
Krasnodar, Russian Federation
Status: Completed
Moscow, Russian Federation
Status: Recruiting
Nizny Novgorod, Russian Federation
Status: Recruiting
Novosibirsk, Russian Federation
Status: Withdrawn
Obninsk, Russian Federation
Status: Withdrawn
Petrozavodsk, Russian Federation
Status: Recruiting
Pyatigorsk, Russian Federation
Status: Completed
Rostov-Na-Donu, Russian Federation
Status: Withdrawn
Rostov-On-Don, Russian Federation
Status: Recruiting
Sochi, Russian Federation
Status: Withdrawn
St. Petersburg, Russian Federation
Status: Recruiting
Syktyvkar, Russian Federation
Status: Recruiting
Tomsk, Russian Federation
Status: Withdrawn
Velikiy Novgorod, Russian Federation
Status: Withdrawn
Volgograd, Russian Federation
Status: Recruiting
Barcelona, Spain
Status: Recruiting
Madrid, Spain
Status: Recruiting
Málaga, Spain
Status: Withdrawn
Pozuelo De Alarcon, Spain
Status: Recruiting
Salamanca, Spain
Status: Recruiting
Göteborg, Sweden
Status: Recruiting
Linköping, Sweden
Status: Recruiting
Luleå, Sweden
Status: Recruiting
Lund, Sweden
Status: Withdrawn
Uppsala, Sweden
Status: Recruiting
Ankara, Turkey
Status: Recruiting
Antalya, Turkey
Status: Recruiting
Bursa, Turkey
Status: Withdrawn
Istanbul, Turkey
Status: Withdrawn
Istanbul, Turkey
Status: Recruiting
Izmir, Turkey
Status: Recruiting
Izmir, Turkey
Status: Withdrawn
Kayseri, Turkey
Status: Recruiting
Cherkassy, Ukraine
Status: Recruiting
Dnepropetrovsk, Ukraine
Status: Withdrawn
Donetsk, Ukraine
Status: Withdrawn
Ivano-Frankivsk, Ukraine
Status: Recruiting
Kharkiv, Ukraine
Status: Withdrawn
Khmelnitskiy, Ukraine
Status: Recruiting
Kiev, Ukraine
Status: Recruiting
Lutsk, Ukraine
Status: Withdrawn
Lviv, Ukraine
Status: Recruiting
Makiivka, Ukraine
Status: Withdrawn
Poltava, Ukraine
Status: Withdrawn
Uzhgorod, Ukraine
Status: Recruiting
Glasgow, United Kingdom
Status: Recruiting
London, United Kingdom
Status: Recruiting
London, United Kingdom
Status: Withdrawn
Newcastle Upon Tyne, United Kingdom
Status: Recruiting
Plymouth, United Kingdom
Status: Recruiting
Portsmouth, United Kingdom
Status: Recruiting
Southampton, United Kingdom
Status: Withdrawn
Sutton, United Kingdom
Status: Recruiting
Swansea, United Kingdom
Status: Recruiting
Start Date
January 2014
Completion Date
August 2021
Sponsors
Janssen Research & Development, LLC
Source
Janssen Research & Development, LLC
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page