Spots Global Cancer Trial Database for 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
The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.
Trial Identification
Brief Title: 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
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)
Study ID: NCT01974440
Conditions
Study Description
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 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.
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
, Gilbert, Arizona, United States
, Campbell, California, United States
, Duarte, California, United States
, La Jolla, California, United States
, Los Angeles, California, United States
, Orange, California, United States
, Ocala, Florida, United States
, Chicago, Illinois, United States
, Maywood, Illinois, United States
, Indianapolis, Indiana, United States
, Westwood, Kansas, United States
, Lexington, Kentucky, United States
, Lafayette, Louisiana, United States
, Scarborough, Maine, United States
, Baltimore, Maryland, United States
, Bethesda, Maryland, United States
, Boston, Massachusetts, United States
, Ann Arbor, Michigan, United States
, Battle Creek, Michigan, United States
, Detroit, Michigan, United States
, Saint Louis Park, Minnesota, United States
, Denville, New Jersey, United States
, New York, New York, United States
, Hickory, North Carolina, United States
, Pinehurst, North Carolina, United States
, Bend, Oregon, United States
, Pittsburgh, Pennsylvania, United States
, Sioux Falls, South Dakota, United States
, Houston, Texas, United States
, Lubbock, Texas, United States
, Spokane, Washington, United States
, Green Bay, Wisconsin, United States
, Buenos Aires, , Argentina
, Ciudad Autonoma Buenos Aires, , Argentina
, Cordoba, , Argentina
, La Capital, , Argentina
, Mendoza, , Argentina
, Santa Fe, , Argentina
, Adelaide, , Australia
, Fitzroy, , Australia
, Heidelberg, , Australia
, South Brisbane, , Australia
, Wahroonga, , Australia
, Westmead, , Australia
, Anderlecht, , Belgium
, Edegem, , Belgium
, Gent, , Belgium
, Leuven, , Belgium
, Namur, , Belgium
, Wilrijk, , Belgium
, Porto Alegre, , Brazil
, Rio De Janeiro, , Brazil
, Salvador, , Brazil
, Sao Paulo, , Brazil
, São Paulo, , Brazil
, Beijing, , China
, Chengdu, , China
, Guangzhou, , China
, Hangzhou, , China
, Harbin, , China
, Nanjing, , China
, Shanghai, , China
, Tianjin, , China
, Nice Cedex 2, , France
, Paris, , France
, Pessac, , France
, Pierre Benite, , France
, Rennes, , France
, Berlin, , Germany
, Gießen, , Germany
, Göttingen, , Germany
, Ludwigshafen, Rp, , Germany
, Magdeburg, , Germany
, Mainz, , Germany
, Munchen, , Germany
, Wiesbaden, , Germany
, Hadera, , Israel
, Haifa, , Israel
, Jerusalem, , Israel
, Nahariya, , Israel
, Netanya, , Israel
, Petah Tikva, , Israel
, Ramat Gan, , Israel
, Chuo-Ku, , Japan
, Hiroshima-shi, , Japan
, Isehara, , Japan
, Kobe, , Japan
, Nagoya-shi, , Japan
, Osaka-Sayama-shi, , Japan
, Sapporo-shi, , Japan
, Sendai-shi, , Japan
, Suita-shi, , Japan
, Tokyo, , Japan
, Jeollanam-do, , Korea, Republic of
, Seoul, , Korea, Republic of
, Gdynia, , Poland
, Olsztyn, , Poland
, Warszawa, , Poland
, Bayamon, , Puerto Rico
, Ponce, , Puerto Rico
, San Juan, , Puerto Rico
, Krasnodar, , Russian Federation
, Moscow, , Russian Federation
, Nizny Novgorod, , Russian Federation
, Petrozavodsk, , Russian Federation
, Pyatigorsk, , Russian Federation
, Rostov-On-Don, , Russian Federation
, St. Petersburg, , Russian Federation
, Syktyvkar, , Russian Federation
, Volgograd, , Russian Federation
, Barcelona, , Spain
, Madrid, , Spain
, Pozuelo de Alarcon, , Spain
, Salamanca, , Spain
, Göteborg, , Sweden
, Linköping, , Sweden
, Luleå, , Sweden
, Uppsala, , Sweden
, Ankara, , Turkey
, Antalya, , Turkey
, Istanbul, , Turkey
, Izmir, , Turkey
, Kayseri, , Turkey
, Cherkasy, , Ukraine
, Ivano-Frankivsk, , Ukraine
, Khmelnitskiy, , Ukraine
, Kiev, , Ukraine
, Lviv, , Ukraine
, Uzhgorod, , Ukraine
, Glasgow, , United Kingdom
, London, , United Kingdom
, Newcastle upon Tyne, , United Kingdom
, Plymouth, , United Kingdom
, Portsmouth, , United Kingdom
, Sutton, , United Kingdom
, Swansea, , United Kingdom
Contact Details
Name: Janssen Research & Development, LLC Clinical Trial
Affiliation: Janssen Research & Development, LLC
Role: STUDY_DIRECTOR
Take Control of Your Skin and Body Changes Today.
Try out Spots for free, set up only takes 2 mins.
Join others from around the world:
