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 (SELENE)

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ClinicalTrials.gov Identifier: NCT01974440

Recruitment Status : Completed

First Posted : November 1, 2013

Results First Posted : April 14, 2023

Last Update Posted : September 13, 2023

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Sponsor:

Collaborator:

Pharmacyclics LLC.

Information provided by (Responsible Party):

Janssen Research & Development, LLC

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.

Condition or disease	Intervention/treatment	Phase
Lymphoma	Drug: Bendamustine Drug: Rituximab Drug: Cyclophosphamide Drug: Doxorubicin Drug: Vincristine Drug: Prednisone Drug: PCI-32765 (Ibrutinib) Drug: Placebo	Phase 3

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	405 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
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)
Actual Study Start Date :	January 31, 2014
Actual Primary Completion Date :	May 30, 2022
Actual Study Completion Date :	June 21, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma Steroids

Drug Information available for: Cyclophosphamide Prednisone Vincristine sulfate Bendamustine Doxorubicin Rituximab Ibrutinib

Genetic and Rare Diseases Information Center resources: Lymphosarcoma Marginal Zone Lymphoma Follicular Lymphoma

U.S. FDA Resources

Arms and Interventions

Arm	Intervention/treatment
Placebo Comparator: Treatment Arm A Treatment Arm A = background immune-chemotherapy (bendamustine and rituximab [BR] or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) for 6 cycles + placebo.	Drug: Bendamustine 90 milligram per meter square (mg/m^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6. Drug: Rituximab 375 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6. Drug: Cyclophosphamide 750 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6. Drug: Doxorubicin 50 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6. Drug: Vincristine 1.4 mg/m^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6. Drug: Prednisone 100 mg administered orally on Days 1 to 5 of Cycles 1 to 6. Drug: Placebo Placebo (4 capsules) matched to ibrutinib administered orally once daily, continuously starting on Cycle 1, Day 1.
Experimental: Treatment Arm B Treatment Arm B = background immune-chemotherapy (BR or R-CHOP) for 6 cycles + PCI-32765 (Ibrutinib).	Drug: Bendamustine 90 milligram per meter square (mg/m^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6. Drug: Rituximab 375 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6. Drug: Cyclophosphamide 750 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6. Drug: Doxorubicin 50 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6. Drug: Vincristine 1.4 mg/m^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6. Drug: Prednisone 100 mg administered orally on Days 1 to 5 of Cycles 1 to 6. Drug: PCI-32765 (Ibrutinib) 560 mg (4*140 mg) capsules administered orally once daily, continuously starting on Cycle 1, Day 1.

Arm

Intervention/treatment

Placebo Comparator: Treatment Arm A

Treatment Arm A = background immune-chemotherapy (bendamustine and rituximab [BR] or rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone [R-CHOP]) for 6 cycles + placebo.

Drug: Bendamustine

90 milligram per meter square (mg/m^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6.

Drug: Rituximab

375 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.

Drug: Cyclophosphamide

750 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.

Drug: Doxorubicin

50 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.

Drug: Vincristine

1.4 mg/m^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6.

Drug: Prednisone

100 mg administered orally on Days 1 to 5 of Cycles 1 to 6.

Drug: Placebo

Placebo (4 capsules) matched to ibrutinib administered orally once daily, continuously starting on Cycle 1, Day 1.

Experimental: Treatment Arm B

Treatment Arm B = background immune-chemotherapy (BR or R-CHOP) for 6 cycles + PCI-32765 (Ibrutinib).

Drug: Bendamustine

90 milligram per meter square (mg/m^2) administered intravenously on Days 1 to 2 of Cycles 1 to 6.

Drug: Rituximab

375 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.

Drug: Cyclophosphamide

750 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.

Drug: Doxorubicin

50 mg/m^2 administered intravenously on Day 1 of Cycles 1 to 6.

Drug: Vincristine

1.4 mg/m^2 (maximum total 2 mg) administered intravenously on Day 1 of Cycles 1 to 6.

Drug: Prednisone

100 mg administered orally on Days 1 to 5 of Cycles 1 to 6.

Drug: PCI-32765 (Ibrutinib)

560 mg (4*140 mg) capsules administered orally once daily, continuously starting on Cycle 1, Day 1.

Outcome Measures

Primary Outcome Measures :

Primary Analysis: Progression Free Survival (PFS): Stratified Analysis [ Time Frame: Up to 8 years ]
PFS was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from complete response (CR) or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by greater than or equal to (>=) 50 percent (%) of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 centimeters (cm) in any axis, 50% increase in sum of product of diameters (SPD) of greater than (>) 1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Supplementary Analysis: Progression Free Survival: Unstratified Analysis - Participants With Marginal Zone Lymphoma (MZL) [ Time Frame: Up to 8 years ]
PFS in MZL participants was defined as duration (in months) from the date of randomization to the date of disease progression or relapse from CR or death, whichever was first reported. PFS was assessed by the investigator based on the 2007 Revised Response Criteria for Malignant Lymphoma. Disease progression was defined as any new lesion or increase by >=50% of previously involved sites from nadir disease progression criteria: Appearance of new nodal lesion 1.5 cm in any axis, 50% increase in SPD of >1 node or 50% increase in longest diameter of previously identified node 1 cm in short axis. Participants who were progression-free and alive or had unknown status were censored at the last tumor assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.

Secondary Outcome Measures :

Primary Analysis: Overall Survival (OS): Stratified Analysis [ Time Frame: Up to 8 years ]
OS was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Supplementary Analysis: Overall Survival: Unstratified Analysis - Participants With MZL [ Time Frame: Up to 8 years ]
OS in MZL participants was defined as the interval (in months) between the date of randomization and the date of the participant's death due to any cause. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Primary Analysis: Complete Response Rate (CRR): Stratified Analysis [ Time Frame: Up to 8 years ]
CRR was defined as the percentage of participants who achieved a complete response (CR); (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if positron emission tomography (PET) negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Supplementary Analysis: Complete Response Rate: Unstratified Analysis - Participants With MZL [ Time Frame: Up to 8 years ]
CRR in MZL participants was defined as the percentage of participants who achieved a CR (based on investigator assessment) on or prior to the initiation of subsequent antilymphoma therapy. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Primary Analysis: Overall Response Rate (ORR): Stratified Analysis [ Time Frame: Up to 8 years ]
ORR was defined as the percentage of participants who achieved a CR or partial response (PR). Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Supplementary Analysis: Overall Response Rate: Unstratified Analysis - Participants With MZL [ Time Frame: Up to 8 years ]
ORR in MZL participants was defined as the percentage of participants who achieved a CR or PR. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Primary Analysis: Duration of Response (DOR): Stratified Analysis [ Time Frame: Up to 8 years ]
DOR was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. Stratification factors were used for the analysis.
Supplementary Analysis: Duration of Response: Unstratified Analysis - Participants With MZL [ Time Frame: Up to 8 years ]
DOR in MZL participants was defined as the interval (in months) between the date of initial documentation of response (CR or PR) and the date of first documented evidence of progressive disease (or relapse for participants who experienced CR during the study) or death, whichever occurred first. Criteria for CR: disappearance of all evidence of disease; mass of any size permitted if PET negative; regression to normal size on CT; spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy and no new sites of disease detected during assessment. Criteria for PR: >=50% decrease in sum of the diameter of all target lesions compared with baseline, in absence of new lesions or unequivocal progression of non-target lesions. Kaplan-Meier method was used for the analysis. For this outcome measure, unstratified analysis was performed on participants with MZL.
Primary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire [ Time Frame: Up to 8 years ]
Time-to-worsening in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life.
Supplementary Analysis: Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy - Lymphoma Subscale (FACT-LymS) Questionnaire: Participants With MZL [ Time Frame: Up to 8 years ]
TTW in MZL participants in the Lymphoma subscale of the FACT-Lym was defined as the time (in months) from the date of randomization to the start date of the worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline in participant symptoms. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (0 = not at all, 1 = a little bit, 2 = some what, 3 = quite a bit and 4 = very much, where the higher score indicated worse condition). Lymphoma subscale score is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life.
Primary Analysis: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Up to 8 years ]
Number of participants with TEAEs were reported. Adverse event (AE) was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication.
Supplementary Analysis: Number of Participants With TEAEs: Participants With MZL [ Time Frame: Up to 8 years ]
Number of MZL participants with TEAEs were reported. AE was defined as any untoward medical occurrence in a clinical study participant administered a pharmaceutical (investigational or non investigational) product. An AE did not necessarily have a causal relationship with the pharmaceutical/biological agent under study. TEAEs were defined as adverse events with onset or worsening on or after date of first dose of study treatment up to and including 30 days after date of last dose of study medication.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01974440

Locations

Show 136 study locations

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United States, Arizona

Gilbert, Arizona, United States
United States, California

Campbell, California, United States

Duarte, California, United States

La Jolla, California, United States

Los Angeles, California, United States

Orange, California, United States
United States, Florida

Ocala, Florida, United States
United States, Illinois

Chicago, Illinois, United States

Maywood, Illinois, United States
United States, Indiana

Indianapolis, Indiana, United States
United States, Kansas

Westwood, Kansas, United States
United States, Kentucky

Lexington, Kentucky, United States
United States, Louisiana

Lafayette, Louisiana, United States
United States, Maine

Scarborough, Maine, United States
United States, Maryland

Baltimore, Maryland, United States

Bethesda, Maryland, United States
United States, Massachusetts

Boston, Massachusetts, United States
United States, Michigan

Ann Arbor, Michigan, United States

Battle Creek, Michigan, United States

Detroit, Michigan, United States
United States, Minnesota

Saint Louis Park, Minnesota, United States
United States, New Jersey

Denville, New Jersey, United States
United States, New York

New York, New York, United States
United States, North Carolina

Hickory, North Carolina, United States

Pinehurst, North Carolina, United States
United States, Oregon

Bend, Oregon, United States
United States, Pennsylvania

Pittsburgh, Pennsylvania, United States
United States, South Dakota

Sioux Falls, South Dakota, United States
United States, Texas

Houston, Texas, United States

Lubbock, Texas, United States
United States, Washington

Spokane, Washington, United States
United States, Wisconsin

Green Bay, Wisconsin, United States
Argentina

Buenos Aires, Argentina

Ciudad Autonoma Buenos Aires, Argentina

Cordoba, Argentina

La Capital, Argentina

Mendoza, Argentina

Santa Fe, Argentina
Australia

Adelaide, Australia

Fitzroy, Australia

Heidelberg, Australia

South Brisbane, Australia

Wahroonga, Australia

Westmead, Australia
Belgium

Anderlecht, Belgium

Edegem, Belgium

Gent, Belgium

Leuven, Belgium

Namur, Belgium

Wilrijk, Belgium
Brazil

Porto Alegre, Brazil

Rio De Janeiro, Brazil

Salvador, Brazil

Sao Paulo, Brazil

São Paulo, Brazil
China

Beijing, China

Chengdu, China

Guangzhou, China

Hangzhou, China

Harbin, China

Nanjing, China

Shanghai, China

Tianjin, China
France

Nice Cedex 2, France

Paris, France

Pessac, France

Pierre Benite, France

Rennes, France
Germany

Berlin, Germany

Gießen, Germany

Göttingen, Germany

Ludwigshafen, Rp, Germany

Magdeburg, Germany

Mainz, Germany

Munchen, Germany

Wiesbaden, Germany
Israel

Hadera, Israel

Haifa, Israel

Jerusalem, Israel

Nahariya, Israel

Netanya, Israel

Petah Tikva, Israel

Ramat Gan, Israel
Japan

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
Korea, Republic of

Jeollanam-do, Korea, Republic of

Seoul, Korea, Republic of
Poland

Gdynia, Poland

Olsztyn, Poland

Warszawa, Poland
Puerto Rico

Bayamon, Puerto Rico

Ponce, Puerto Rico

San Juan, Puerto Rico
Russian Federation

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
Spain

Barcelona, Spain

Madrid, Spain

Pozuelo de Alarcon, Spain

Salamanca, Spain
Sweden

Göteborg, Sweden

Linköping, Sweden

Luleå, Sweden

Uppsala, Sweden
Turkey

Ankara, Turkey

Antalya, Turkey

Istanbul, Turkey

Izmir, Turkey

Kayseri, Turkey
Ukraine

Cherkasy, Ukraine

Ivano-Frankivsk, Ukraine

Khmelnitskiy, Ukraine

Kiev, Ukraine

Lviv, Ukraine

Uzhgorod, Ukraine
United Kingdom

Glasgow, United Kingdom

London, United Kingdom

Newcastle upon Tyne, United Kingdom

Plymouth, United Kingdom

Portsmouth, United Kingdom

Sutton, United Kingdom

Swansea, United Kingdom

Sponsors and Collaborators

Janssen Research & Development, LLC

Pharmacyclics LLC.

Investigators

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Study Director:	Janssen Research & Development, LLC Clinical Trial	Janssen Research & Development, LLC

Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:

Study Protocol [PDF] August 29, 2022

Statistical Analysis Plan [PDF] June 15, 2022

More Information

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Responsible Party:	Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:	NCT01974440
Other Study ID Numbers:	CR102786 PCI-32765FLR3001 ( Other Identifier: Janssen Research & Development, LLC ) 2013-003093-27 ( EudraCT Number )
First Posted:	November 1, 2013 Key Record Dates
Results First Posted:	April 14, 2023
Last Update Posted:	September 13, 2023
Last Verified:	August 2023

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Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by Janssen Research & Development, LLC:


Lymphoma Follicular lymphoma Marginal zone lymphoma Indolent Non-Hodgkin lymphoma PCI-32765 Ibrutinib Bendamustine	Rituximab Cyclophosphamide Doxorubicin Vincristine Prednisone R-CHOP

Additional relevant MeSH terms:

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Lymphoma Lymphoma, Non-Hodgkin Neoplasms by Histologic Type Neoplasms Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Prednisone Cyclophosphamide Bendamustine Hydrochloride Rituximab Doxorubicin Vincristine Ibrutinib	Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Antineoplastic Agents, Alkylating Alkylating Agents Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Myeloablative Agonists Antineoplastic Agents, Immunological Antibiotics, Antineoplastic Topoisomerase II Inhibitors Topoisomerase Inhibitors Enzyme Inhibitors Anti-Inflammatory Agents

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