A Study of the Bruton's Tyrosine Kinase Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone in Patients With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Janssen Research & Development, LLC
Sponsor:
Collaborator:
Pharmacyclics
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01855750
First received: May 14, 2013
Last updated: August 7, 2014
Last verified: August 2014
  Purpose

The purpose of this study is to evaluate if ibrutinib administered in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) improves the clinical outcome in newly diagnosed patients with non-germinal center B-cell subtype (GCB) of diffuse large B-cell lymphoma (DLBCL).


Condition Intervention Phase
Lymphoma
Drug: Ibrutinib
Drug: Placebo
Drug: Rituximab
Drug: Cyclophosphamide
Drug: Doxorubicin
Drug: Vincristine
Drug: Prednisone (or equivalent)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Phase 3 Study of the Bruton's Tyrosine Kinase (BTK) Inhibitor, PCI-32765 (Ibrutinib), in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Subjects With Newly Diagnosed Non-Germinal Center B-Cell Subtype of Diffuse Large B-Cell Lymphoma

Resource links provided by NLM:


Further study details as provided by Janssen Research & Development, LLC:

Primary Outcome Measures:
  • Event-free survival [ Time Frame: Up to disease progression, relapse from complete response, initiation of subsequent systemic antilymphoma therapy after completion of at least 6 cycles of R-CHOP therapy, or death, whichever occurs first, up to Year 7 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to disease progression, relapse from complete response, or death, whichever occurs first, up to Year 7 ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: Up to the date of the participants death, up to Year 7 ] [ Designated as safety issue: No ]
  • Complete response rate [ Time Frame: Up to completion of chemotherapy treatment, up to Year 7 ] [ Designated as safety issue: No ]
  • Time to worsening symptoms in the Lym subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) [ Time Frame: Up to the start date of the worsening of patient symptoms, up to Year 7 ] [ Designated as safety issue: No ]
  • Oral plasma clearance of ibrutinib [ Time Frame: Predose Day 1 of Cycles 1, 2, and 3, and postdose 1 h, 2 h, and 4 h of Cycles 1 and 2 ] [ Designated as safety issue: No ]
  • Oral volume of distribution at steady state of ibrutinib [ Time Frame: Predose Day 1 of Cycles 1, 2, and 3, and postdose 1 h, 2 h, and 4 h of Cycles 1 and 2 ] [ Designated as safety issue: No ]
  • Area under the plasma concentration-time curve of ibrutinib [ Time Frame: Predose Day 1 of Cycles 1, 2, and 3, and postdose 1 h, 2 h, and 4 h of Cycles 1 and 2 ] [ Designated as safety issue: No ]
  • Minimum observed plasma concentration of ibrutinib [ Time Frame: Predose Day 1 of Cycles 1, 2, and 3, and postdose 1 h, 2 h, and 4 h of Cycles 1 and 2 ] [ Designated as safety issue: No ]
  • Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of study medication ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 800
Study Start Date: September 2013
Estimated Study Completion Date: June 2020
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment Arm A: placebo + R-CHOP
Treatment Arm A = placebo + R-CHOP (Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone)
Drug: Placebo
4 matched capsules administered by mouth once daily (21-day cycles)
Drug: Rituximab
375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Drug: Cyclophosphamide
750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Drug: Doxorubicin
50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Drug: Vincristine
1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Drug: Prednisone (or equivalent)
100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle
Experimental: Treatment Arm B: ibrutinib + R-CHOP
Treatment Arm B = ibrutinib + R-CHOP
Drug: Ibrutinib
560 mg capsules administered by mouth once daily (21-day cycles)
Drug: Rituximab
375 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Drug: Cyclophosphamide
750 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Drug: Doxorubicin
50 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Drug: Vincristine
1.4 mg/m2 administered intravenously once on Day 1 of each cycle (21-day cycles)
Drug: Prednisone (or equivalent)
100 mg capsules administered by mouth once daily on Day 1 to Day 5 of each cycle

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 to compare the efficacy and safety of ibrutinib in combination with R-CHOP versus R-CHOP alone in adult patients newly diagnosed non-GCB DLBCL. The study will include screening, active treatment, and posttreatment follow-up phases. The study will end when 50% of participants have died or the sponsor terminates the study, whichever occurs first (up to approximately 7 years). Approximately 800 participants will be randomly assigned in a 1:1 ratio to receive either placebo+R-CHOP (treatment arm A) or ibrutinib+R-CHOP (treatment arm B). All participants will receive R-CHOP as background therapy for 6 or 8 cycles (21 days per cycle) prespecified according to local practice. After 4 treatment cycles, an interim response assessment will be performed to evaluate disease progression for each participant. Participants with progressive disease or relapsed disease after complete response will be discontinued from treatment. Participants who discontinue R-CHOP without disease progression will continue study drug (placebo or ibrutinib) until 6 or 8 cycles are completed, disease progression, or unacceptable toxicity, whichever occurs first. After completion of study drug, participants will undergo assessment of tumor response based on the Revised Response Criteria for Malignant Lymphoma. Participants with documented residual disease upon completion of at least 6 cycles of R-CHOP therapy are considered eligible to initiate subsequent antilymphoma therapy. Serial pharmacokinetic samples will be collected before and after dosing, and safety will be monitored throughout the study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No prior treatment for diffuse B-cell lymphoma (DLBCL)
  • Histologically-confirmed non-germinal center B-cell subtype DLBCL
  • Stage II (not candidates for local x-ray therapy), III, or IV disease by the Ann Arbor Classification
  • At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
  • Revised International Prognostic Index score of >=1
  • Eastern Cooperative Oncology Group performance status grade of 0, 1, or 2
  • Hematology and biochemical laboratory values within protocol-defined parameters within 14 days prior to random assignment and at baseline
  • Left ventricular ejection fraction within institutional normal limits, as determined by echocardiography or multiple uptake gated acquisition (MUGA) scan
  • Agrees to protocol-defined use of effective contraception (for women, these restrictions apply for 12 months after the last dose of rituximab or 1 month after the last dose of study drug, whichever is later; for men, these restrictions apply for 12 months after the last dose of rituximab or 3 months after the last dose of study drug, whichever is later)
  • Men must agree to not donate sperm during and after the study for 12 months after the last dose of rituximab or 3 months after the last dose of study drug, whichever is later
  • Women of childbearing potential must have a negative serum or urine pregnancy test at screening

Exclusion Criteria:

  • Major surgery within 4 weeks of random assignment
  • Known central nervous system or primary mediastinal lymphoma
  • Prior history of indolent lymphoma
  • Diagnosed or treated for malignancy other than DLBCL, except: malignancy treated with curative intent and with no known active disease present for >=3 years before random assignment; adequately treated non-melanoma skin cancer or lentigo maligna without evidence of disease; adequately treated carcinoma in situ without evidence of disease
  • History of stroke or intracranial hemorrhage within 6 months prior to random assignment
  • Requires anticoagulation with warfarin or equivalent vitamin K antagonists
  • Requires treatment with strong CYP3A inhibitors
  • Prior anthracycline use >=150 mg/m2
  • Clinically significant cardiovascular disease such as uncontrolled or symptomatic arrhythmias, congestive heart failure, or myocardial infarction within 6 months of screening, or any Class 3 (moderate) or Class 4 (severe) cardiac disease as defined by the New York Heart Association Functional Classification
  • Known history of human immunodeficiency virus or active hepatitis C virus or active hepatitis B virus infection or any uncontrolled active systemic infection requiring intravenous antibiotics
  • Women who are pregnant or breastfeeding
  • Any life-threatening illness, medical condition, or organ system dysfunction which, in the investigator's opinion, could compromise the patient's safety, interfere with the absorption or metabolism of ibrutinib capsules, or put the study outcomes at undue risk
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01855750

Contacts
Contact: Use link at the bottom of the page to see if you qualify for an enrolling site (see list). If you still have questions: JNJ.CT@sylogent.com

  Hide Study Locations
Locations
United States, Arizona
Recruiting
Tucson, Arizona, United States
United States, California
Withdrawn
Burbank, California, United States
Recruiting
Greenbrae, California, United States
Recruiting
La Jolla, California, United States
Withdrawn
Los Angeles, California, United States
Not yet recruiting
Los Angeles, California, United States
Recruiting
Salinas, California, United States
Recruiting
Stanford, California, United States
United States, Connecticut
Recruiting
Danbury, Connecticut, United States
Recruiting
Hartford, Connecticut, United States
Withdrawn
Middletown, Connecticut, United States
United States, District of Columbia
Recruiting
Washington, District of Columbia, United States
United States, Florida
Withdrawn
Palm Beach Gardens, Florida, United States
Withdrawn
Tampa, Florida, United States
United States, Georgia
Recruiting
Atlanta, Georgia, United States
Recruiting
Marietta, Georgia, United States
United States, Idaho
Withdrawn
Post Falls, Idaho, United States
United States, Illinois
Withdrawn
Chicago, Illinois, United States
Withdrawn
Maywood, Illinois, United States
Recruiting
Peoria, Illinois, United States
United States, Indiana
Recruiting
Fort Wayne, Indiana, United States
Recruiting
Goshen, Indiana, United States
Recruiting
Indianapolis, Indiana, United States
United States, Kansas
Recruiting
Topeka, Kansas, United States
United States, Kentucky
Recruiting
Louisville, Kentucky, United States
United States, Louisiana
Recruiting
Baton Rouge, Louisiana, United States
Withdrawn
Metairie, Louisiana, United States
Recruiting
New Orleans, Louisiana, United States
United States, Maryland
Recruiting
Baltimore, Maryland, United States
Withdrawn
Baltimore, Maryland, United States
Withdrawn
Bethesda, Maryland, United States
Recruiting
Bethesda, Maryland, United States
Withdrawn
Rockville, Maryland, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
Withdrawn
Boston, Massachusetts, United States
Not yet recruiting
Boston, Massachusetts, United States
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States
United States, Missouri
Recruiting
St. Louis, Missouri, United States
United States, Nebraska
Recruiting
Omaha, Nebraska, United States
United States, New Jersey
Recruiting
Hackensack, New Jersey, United States
Recruiting
New Brunswick, New Jersey, United States
United States, New York
Recruiting
Bronx, New York, United States
Recruiting
Fresh Meadows, New York, United States
Recruiting
Johnson City, New York, United States
Recruiting
Mineola, New York, United States
Recruiting
New York, New York, United States
Recruiting
Rochester, New York, United States
United States, North Carolina
Recruiting
Charlotte, North Carolina, United States
Withdrawn
Goldsboro, North Carolina, United States
Completed
Greenville, North Carolina, United States
Recruiting
Hickory, North Carolina, United States
United States, Ohio
Withdrawn
Cincinnati, Ohio, United States
Recruiting
Columbus, Ohio, United States
United States, Oregon
Recruiting
Portland, Oregon, United States
United States, Pennsylvania
Withdrawn
Philadelphia, Pennsylvania, United States
Withdrawn
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Recruiting
N Charleston, South Carolina, United States
United States, Tennessee
Withdrawn
Nashville, Tennessee, United States
Not yet recruiting
Nashville, Tennessee, United States
United States, Texas
Recruiting
Houston, Texas, United States
Withdrawn
Houston, Texas, United States
Recruiting
Temple, Texas, United States
United States, Utah
Withdrawn
Salt Lake City, Utah, United States
United States, Vermont
Recruiting
Burlington, Vermont, United States
United States, Virginia
Withdrawn
Charlottesville, Virginia, United States
United States, Washington
Recruiting
Seattle, Washington, United States
United States, Wisconsin
Withdrawn
Marshfield, Wisconsin, United States
Argentina
Recruiting
Buenos Aires, Argentina
Withdrawn
Capital Federal, Argentina
Recruiting
Ciudad Autonoma Buenos Aires, Argentina
Recruiting
Ciudad De Buenos Aires, Argentina
Withdrawn
Cordoba, Argentina
Withdrawn
Córdoba, Argentina
Recruiting
La Capital, Argentina
Not yet recruiting
La Plata, Argentina
Withdrawn
Parana, Argentina
Australia
Recruiting
Adelaide, Australia
Recruiting
Concord, Australia
Recruiting
Darlinghurst, Australia
Withdrawn
Douglas, Australia
Recruiting
Freemantle, Australia
Recruiting
Hobart, Tasmania, Australia
Recruiting
Melbourne, Australia
Recruiting
Nedlands, Australia
Withdrawn
Perth, Australia
Recruiting
Randwick, Australia
Recruiting
South Brisbane, Australia
Withdrawn
Woden, Australia
Recruiting
Woolloongabba, Australia
Belgium
Recruiting
Antwerpen, Belgium
Recruiting
Brugge, Belgium
Recruiting
Brussel, Belgium
Recruiting
Gent, Belgium
Recruiting
Haine-Saint-Paul, La Louviere, Belgium
Recruiting
Kortrijk, Belgium
Recruiting
Leuven, Belgium
Brazil
Withdrawn
Brasília, Brazil
Withdrawn
Campinas, Brazil
Withdrawn
Curitiba, Brazil
Withdrawn
Jau, Brazil
Withdrawn
Porto Alegre, Brazil
Recruiting
Porto Alegre, Brazil
Withdrawn
Ribeirão Preto, Brazil
Recruiting
Rio De Janeiro, Brazil
Not yet recruiting
Sao Paulo, Brazil
Recruiting
Sao Paulo, Brazil
Withdrawn
São José Do Rio Preto, Brazil
Recruiting
São Paulo, Brazil
Canada, Alberta
Recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
Recruiting
Vancouver, British Columbia, Canada
Canada, Manitoba
Withdrawn
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
Withdrawn
Hamilton, Ontario, Canada
Withdrawn
Toronto, Ontario, Canada
Recruiting
Toronto, Ontario, Canada
Canada, Quebec
Recruiting
Levis, Quebec, Canada
Recruiting
Montreal, Quebec, Canada
China
Recruiting
Beijing, China
Completed
Beijing, China
Not yet recruiting
Changchun, China
Recruiting
Chengdu, China
Recruiting
Guangzhou, China
Recruiting
Harbin, China
Not yet recruiting
Jinan, China
Recruiting
Shanghai, China
Recruiting
Tianjin, China
Withdrawn
Tianjin, China
Czech Republic
Not yet recruiting
Brno, Czech Republic
Recruiting
Hradec Kralove, Czech Republic
Recruiting
Ostrava, Czech Republic
Recruiting
Praha 10, Czech Republic
Recruiting
Praha 2, Czech Republic
Denmark
Recruiting
Aarhus C, Denmark
Recruiting
Copenhagen, Denmark
Recruiting
Roskilde, Denmark
Recruiting
Vejle, Denmark
Finland
Recruiting
Helsinki, Finland
Recruiting
Jyväskylä, Finland
Recruiting
Oulu, Finland
Recruiting
Turku, Finland
France
Recruiting
Grenoble Cedex 9, France
Recruiting
Limoges, France
Withdrawn
Montpellier, France
Withdrawn
Nantes Cedex 1, France
Recruiting
Paris, France
Recruiting
Pessac, France
Not yet recruiting
Pierre Benite, France
Not yet recruiting
Rouen N/A, France
Recruiting
Tours, France
Recruiting
Villejuif, France
Germany
Recruiting
Bamberg, Germany
Recruiting
Berlin, Germany
Not yet recruiting
Dresden, Germany
Recruiting
Essen, Germany
Not yet recruiting
Frankfurt, Germany
Withdrawn
Frankfurt / Main, Germany
Not yet recruiting
Fulda, Germany
Withdrawn
Hannover, Germany
Withdrawn
Heidelberg, Germany
Recruiting
Jena, Germany
Withdrawn
Mainz, Germany
Recruiting
Muenchen, Germany
Not yet recruiting
Münster, Germany
Not yet recruiting
Villingen-Schwenningen, Germany
Hungary
Recruiting
Budapest N/A, Hungary
Recruiting
Debrecen, Hungary
Recruiting
Gyula, Hungary
Withdrawn
Szekesfehervar, Hungary
Recruiting
Szombathely, Hungary
Recruiting
Veszprem, Hungary
Israel
Recruiting
Beer-Sheva, Israel
Recruiting
Hadera, Israel
Recruiting
Haifa, Israel
Suspended
Nahariya, Israel
Recruiting
Petah Tikva, Israel
Recruiting
Ramat-Gan, Israel
Recruiting
Tel Aviv, Israel
Japan
Recruiting
Fukuoka, Japan
Recruiting
Hiroshima, Japan
Not yet recruiting
Isehara, Japan
Not yet recruiting
Kobe, Japan
Recruiting
Kyoto, Japan
Recruiting
Nagoya, Japan
Withdrawn
Nagoya, Japan
Recruiting
Osaka, Japan
Recruiting
Sapporo, Japan
Recruiting
Sendai, Japan
Recruiting
Suita, Japan
Recruiting
Tokyo, Japan
Korea, Republic of
Recruiting
Busan, Korea, Republic of
Recruiting
Goyang, Korea, Republic of
Withdrawn
Seognam-Si, Kyungki-Do, Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Mexico
Withdrawn
Mexico, Mexico
Not yet recruiting
Mexico, Mexico
Recruiting
Monterrey, Mexico
Not yet recruiting
Monterrey, Mexico
Recruiting
San Luis Potosi, Mexico
Withdrawn
Zapopan, Mexico
Netherlands
Recruiting
Amsterdam Zuidoost, Netherlands
Recruiting
Arnhem, Netherlands
Recruiting
Dordrecht, Netherlands
Recruiting
Groningen, Netherlands
Recruiting
Leiden, Netherlands
Recruiting
Nieuwegein, Netherlands
Recruiting
Rotterdam, Netherlands
Norway
Withdrawn
Bergen, Norway
Recruiting
Oslo, Norway
Recruiting
Tromsø, Norway
Poland
Recruiting
Brzozow, Poland
Recruiting
Chorzów, Poland
Suspended
Gdynia, Poland
Recruiting
Krakow, Poland
Recruiting
Lodz, Poland
Suspended
Lublin, Poland
Recruiting
Olsztyn, Poland
Recruiting
Poznan, Poland
Recruiting
Warszawa, Poland
Recruiting
Wroclaw, Poland
Russian Federation
Withdrawn
Chelyabinsk, Russian Federation
Completed
Ekaterinburg, Russian Federation
Withdrawn
Krasnodar, Russian Federation
Recruiting
Moscow, Russian Federation
Recruiting
Moscow N/A, Russian Federation
Recruiting
Nizhny Novgorod, Russian Federation
Withdrawn
Obninsk, Russian Federation
Completed
Rostov-Na-Donu, Russian Federation
Withdrawn
Saint Petersburg, Russian Federation
Recruiting
Sochi, Russian Federation
Recruiting
St. Petersburg, Russian Federation
Recruiting
Volgograd, Russian Federation
Spain
Recruiting
Barcelona, Spain
Recruiting
Madrid, Spain
Withdrawn
Madrid, Spain
Recruiting
Salamanca, Spain
Recruiting
Sevilla, Spain
Sweden
Withdrawn
Karlstad, Sweden
Recruiting
Linköping, Sweden
Recruiting
Luleå, Sweden
Not yet recruiting
Lund, Sweden
Recruiting
Uppsala, Sweden
Taiwan
Withdrawn
Changhua, Taiwan
Recruiting
Taichung, Taiwan
Not yet recruiting
Tainan, Taiwan
Recruiting
Tainan, Taiwan
Withdrawn
Taipei, Taiwan
Recruiting
Taoyuan County, Taiwan
Turkey
Recruiting
Adana, Turkey
Recruiting
Ankara, Turkey
Withdrawn
Edirne, Turkey
Recruiting
Istanbul, Turkey
Recruiting
Izmir, Turkey
Recruiting
Kayseri, Turkey
Recruiting
Samsun, Turkey
Ukraine
Recruiting
Cherkassy, Ukraine
Not yet recruiting
Dnepropetrovsk, Ukraine
Not yet recruiting
Donetsk, Ukraine
Recruiting
Khmelnitskiy, Ukraine
Recruiting
Kiev, Ukraine
Not yet recruiting
Kiev, Ukraine
Recruiting
Lviv, Ukraine
Recruiting
Makiivka, Ukraine
Withdrawn
Simferopol, Ukraine
United Kingdom
Not yet recruiting
Glasgow, United Kingdom
Recruiting
Liverpool, United Kingdom
Recruiting
London, United Kingdom
Withdrawn
London, United Kingdom
Recruiting
Maidstone, United Kingdom
Recruiting
Manchester, United Kingdom
Recruiting
Nottingham, United Kingdom
Recruiting
Oxford, United Kingdom
Recruiting
Romford, United Kingdom
Recruiting
Southampton, United Kingdom
Sponsors and Collaborators
Janssen Research & Development, LLC
Pharmacyclics
Investigators
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
  More Information

Additional Information:
No publications provided

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01855750     History of Changes
Other Study ID Numbers: CR102118, PCI-32765DBL3001, U1111-1139-6222, 2013-000959-40
Study First Received: May 14, 2013
Last Updated: August 7, 2014
Health Authority: Czech Republic: State Institute for Drug Control
United States: Food and Drug Administration
Hungary: National Institute for Quality and Organizational Development in Healthcare and Medicines
Spain: Spanish Agency of Medicines
Germany: Ethics Commission
Japan: Pharmaceuticals and Medical Devices Agency
Turkey: Ministry of Health

Keywords provided by Janssen Research & Development, LLC:
Lymphoma
B-cell lymphoma
Non-germinal center B-cell subtype
Diffuse large B-cell lymphoma
Bruton's tyrosine kinase inhibitor
PCI-32765
JNJ-54179060
Ibrutinib
Rituximab
Cyclophosphamide
Doxorubicin
Vincristine
Prednisone

Additional relevant MeSH terms:
Lymphoma
Lymphoma, B-Cell
Lymphoma, Large B-Cell, Diffuse
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, Non-Hodgkin
Cyclophosphamide
Rituximab
Liposomal doxorubicin
Doxorubicin
Prednisone
Vincristine
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antirheumatic Agents
Therapeutic Uses
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors

ClinicalTrials.gov processed this record on August 20, 2014