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.

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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.

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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

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

403

Study ID:

NCT01974440

Recruitment Status:

Active, not recruiting

Sponsor:

Janssen Research & Development, LLC

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There is 1 Location for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Non Hodgkin Lymphoma

Phase:

Phase 3

Estimated Enrollment:

403

Study ID:

NCT01974440

Recruitment Status:

Active, not recruiting

Sponsor:


Janssen Research & Development, LLC

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