Non Hodgkin Lymphoma Clinical Trial
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
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.
Full 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 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
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There is 1 Location for this study
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
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