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 February 2016 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: February 9, 2016
Last verified: February 2016
  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 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
Completed
Tucson, Arizona, United States
United States, California
Withdrawn
Burbank, California, United States
Completed
Greenbrae, California, United States
Active, not recruiting
La Jolla, California, United States
Withdrawn
Los Angeles, California, United States
Recruiting
Los Angeles, California, United States
Active, not recruiting
Los Angeles, California, United States
Recruiting
Salinas, California, United States
Completed
Stanford, California, United States
United States, Connecticut
Recruiting
Danbury, Connecticut, United States
Completed
Hartford, Connecticut, United States
Withdrawn
Middletown, Connecticut, United States
United States, District of Columbia
Completed
Washington, District of Columbia, United States
United States, Florida
Withdrawn
Palm Beach Gardens, Florida, United States
Withdrawn
Tampa, Florida, United States
United States, Georgia
Completed
Atlanta, Georgia, United States
Active, not 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
Completed
Peoria, Illinois, United States
United States, Indiana
Active, not recruiting
Fort Wayne, Indiana, United States
Active, not recruiting
Goshen, Indiana, United States
Completed
Indianapolis, Indiana, United States
United States, Kansas
Completed
Topeka, Kansas, United States
United States, Kentucky
Active, not recruiting
Louisville, Kentucky, United States
United States, Louisiana
Completed
Baton Rouge, Louisiana, United States
Withdrawn
Metairie, Louisiana, United States
Active, not recruiting
New Orleans, Louisiana, United States
United States, Maryland
Completed
Baltimore, Maryland, United States
Withdrawn
Baltimore, Maryland, United States
Recruiting
Bethesda, Maryland, United States
Withdrawn
Bethesda, Maryland, United States
Withdrawn
Rockville, Maryland, United States
United States, Massachusetts
Active, not recruiting
Boston, Massachusetts, United States
Completed
Boston, Massachusetts, United States
Withdrawn
Boston, Massachusetts, United States
United States, Michigan
Completed
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
Active, not recruiting
New Brunswick, New Jersey, United States
United States, New York
Completed
Bronx, New York, United States
Withdrawn
Fresh Meadows, New York, United States
Recruiting
Johnson City, New York, United States
Active, not recruiting
Mineola, New York, United States
Recruiting
New York, New York, United States
Completed
New York, New York, United States
Active, not 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
Active, not recruiting
Hickory, North Carolina, United States
United States, Ohio
Withdrawn
Cincinnati, Ohio, United States
Recruiting
Columbus, Ohio, United States
United States, Oregon
Completed
Portland, Oregon, United States
United States, Pennsylvania
Withdrawn
Philadelphia, Pennsylvania, United States
Withdrawn
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Active, not recruiting
N Charleston, South Carolina, United States
United States, Tennessee
Recruiting
Nashville, Tennessee, United States
Withdrawn
Nashville, Tennessee, United States
United States, Texas
Active, not recruiting
Houston, Texas, United States
Withdrawn
Houston, Texas, United States
Completed
Temple, Texas, United States
United States, Utah
Withdrawn
Salt Lake City, Utah, United States
United States, Vermont
Completed
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
Withdrawn
Capital Federal, Argentina
Active, not recruiting
Ciudad Autonoma Buenos Aires, Argentina
Completed
Ciudad Autonoma De Buenos Aires, Argentina
Completed
Ciudad De Buenos Aires, Argentina
Withdrawn
Cordoba, Argentina
Withdrawn
Córdoba, Argentina
Active, not recruiting
La Capital, Argentina
Withdrawn
La Plata, Argentina
Withdrawn
Parana, Argentina
Australia
Active, not recruiting
Adelaide, Australia
Active, not recruiting
Concord, Australia
Recruiting
Darlinghurst, Australia
Withdrawn
Douglas, Australia
Active, not recruiting
Hobart, Australia
Active, not recruiting
Melbourne, Australia
Active, not recruiting
Nedlands, Australia
Active, not recruiting
Perth, Australia
Withdrawn
Perth, Australia
Withdrawn
Randwick, Australia
Terminated
South Brisbane, Australia
Withdrawn
Woden, Australia
Active, not recruiting
Woolloongabba, Australia
Belgium
Active, not recruiting
Antwerpen, Belgium
Active, not recruiting
Brugge, Belgium
Completed
Brussel, Belgium
Active, not recruiting
Gent, Belgium
Active, not recruiting
Haine-Saint-Paul, La Louviere, Belgium
Active, not recruiting
Kortrijk, Belgium
Recruiting
Leuven, Belgium
Brazil
Withdrawn
Brasília, Brazil
Withdrawn
Campinas, Brazil
Withdrawn
Curitiba, Brazil
Withdrawn
Jau, Brazil
Active, not recruiting
Porto Alegre, Brazil
Withdrawn
Porto Alegre, Brazil
Recruiting
Porto Alegre, Brazil
Withdrawn
Ribeirão Preto, Brazil
Completed
Rio De Janeiro, Brazil
Active, not recruiting
Sao Paulo, Brazil
Withdrawn
Sao Paulo, Brazil
Recruiting
Sao Paulo, Brazil
Withdrawn
São José Do Rio Preto, Brazil
Active, not recruiting
São Paulo, Brazil
Recruiting
São Paulo, Brazil
Canada, Alberta
Active, not recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
Active, not recruiting
Vancouver, British Columbia, Canada
Canada, Manitoba
Withdrawn
Winnipeg, Manitoba, Canada
Canada, Nova Scotia
Active, not recruiting
Halifax, Nova Scotia, Canada
Canada, Ontario
Withdrawn
Hamilton, Ontario, Canada
Active, not recruiting
Toronto, Ontario, Canada
Withdrawn
Toronto, Ontario, Canada
Canada, Quebec
Completed
Levis, Quebec, Canada
Active, not recruiting
Montreal, Quebec, Canada
China
Active, not recruiting
Beijing, China
Completed
Beijing, China
Active, not recruiting
Changchun, China
Active, not recruiting
Chengdu, China
Active, not recruiting
Guangzhou, China
Active, not recruiting
Hangzhou, China
Active, not recruiting
Harbin, China
Active, not recruiting
Jinan, China
Active, not recruiting
Nanjing, China
Withdrawn
Shanghai, China
Active, not recruiting
Shanghai, China
Withdrawn
Tianjin, China
Active, not recruiting
Tianjin, China
Czech Republic
Active, not recruiting
Brno, Czech Republic
Active, not recruiting
Hradec Kralove, Czech Republic
Active, not recruiting
Ostrava, Czech Republic
Active, not recruiting
Praha 10, Czech Republic
Active, not recruiting
Praha 2, Czech Republic
Denmark
Active, not recruiting
Aarhus C, Denmark
Active, not recruiting
Copenhagen, Denmark
Active, not recruiting
Roskilde, Denmark
Recruiting
Vejle, Denmark
Finland
Active, not recruiting
Helsinki, Finland
Active, not recruiting
Jyväskylä, Finland
Active, not recruiting
Oulu, Finland
Recruiting
Turku, Finland
France
Completed
Grenoble Cedex 9, France
Completed
Limoges, France
Withdrawn
Montpellier, France
Withdrawn
Nantes Cedex 1, France
Active, not recruiting
Paris, France
Recruiting
Pessac, France
Completed
Pierre Benite, France
Recruiting
Rouen, France
Active, not recruiting
Tours, France
Active, not recruiting
Villejuif, France
Germany
Completed
Augsburg, Germany
Active, not recruiting
Bamberg, Germany
Recruiting
Berlin, Germany
Recruiting
Dresden, Germany
Active, not recruiting
Essen, Germany
Completed
Frankfurt, Germany
Withdrawn
Frankfurt / Main, Germany
Withdrawn
Fulda, Germany
Withdrawn
Hannover, Germany
Withdrawn
Heidelberg, Germany
Active, not recruiting
Jena, Germany
Withdrawn
Mainz, Germany
Active, not recruiting
Muenchen, Germany
Active, not recruiting
Münster, Germany
Active, not recruiting
Villingen-Schwenningen, Germany
Hungary
Completed
Budapest N/A, Hungary
Active, not recruiting
Debrecen, Hungary
Terminated
Gyula, Hungary
Withdrawn
Szekesfehervar, Hungary
Active, not recruiting
Szombathely, Hungary
Active, not recruiting
Veszprem, Hungary
Israel
Completed
Beer-Sheva, Israel
Active, not recruiting
Hadera, Israel
Active, not recruiting
Haifa, Israel
Suspended
Nahariya, Israel
Active, not recruiting
Petah Tikva, Israel
Active, not recruiting
Ramat-Gan, Israel
Active, not recruiting
Tel Aviv, Israel
Japan
Active, not recruiting
Fukuoka, Japan
Active, not recruiting
Hiroshima, Japan
Active, not recruiting
Isehara, Japan
Active, not recruiting
Kobe, Japan
Active, not recruiting
Kumamoto, Japan
Active, not recruiting
Kyoto, Japan
Completed
Nagano, Japan
Active, not recruiting
Nagoya, Japan
Completed
Nagoya, Japan
Active, not recruiting
Narita, Japan
Active, not recruiting
Osaka, Japan
Active, not recruiting
Osaka-Sayama, Japan
Active, not recruiting
Sapporo, Japan
Active, not recruiting
Sendai, Japan
Active, not recruiting
Suita, Japan
Active, not recruiting
Tachikawa, Japan
Active, not recruiting
Tokyo, Japan
Completed
Tokyo, Japan
Active, not recruiting
Tsukuba, Japan
Korea, Republic of
Active, not recruiting
Busan, Korea, Republic of
Active, not recruiting
Goyang, Korea, Republic of
Withdrawn
Seongnam, Korea, Republic of
Active, not recruiting
Seoul, Korea, Republic of
Mexico
Withdrawn
Mexico, Mexico
Completed
Mexico, Mexico
Active, not recruiting
Monterrey, Mexico
Withdrawn
Monterrey, Mexico
Completed
San Luis Potosi, Mexico
Withdrawn
Zapopan, Mexico
Netherlands
Recruiting
Amsterdam Zuidoost, Netherlands
Recruiting
Arnhem, Netherlands
Active, not recruiting
Dordrecht, Netherlands
Active, not recruiting
Groningen, Netherlands
Recruiting
Leiden, Netherlands
Active, not recruiting
Nieuwegein, Netherlands
Active, not recruiting
Rotterdam, Netherlands
Norway
Withdrawn
Bergen, Norway
Active, not recruiting
Oslo, Norway
Active, not recruiting
Tromsø, Norway
Poland
Recruiting
Brzozow, Poland
Recruiting
Chorzów, Poland
Recruiting
Krakow, Poland
Completed
Lodz, Poland
Recruiting
Olsztyn, Poland
Completed
Poznan, Poland
Recruiting
Warszawa, Poland
Recruiting
Wroclaw, Poland
Russian Federation
Withdrawn
Chelyabinsk, Russian Federation
Completed
Ekaterinburg, Russian Federation
Withdrawn
Krasnodar, Russian Federation
Active, not recruiting
Moscow, Russian Federation
Active, not recruiting
Nizhny Novgorod, Russian Federation
Withdrawn
Obninsk, Russian Federation
Completed
Rostov-Na-Donu, Russian Federation
Withdrawn
Rostov-On-Don, Russian Federation
Withdrawn
Saint Petersburg, Russian Federation
Active, not recruiting
Saint-Petersburg,, Russian Federation
Completed
Sochi, Russian Federation
Active, not recruiting
St. Petersburg, Russian Federation
Active, not recruiting
Volgograd, Russian Federation
Spain
Completed
Barcelona, Spain
Active, not recruiting
Barcelona, Spain
Completed
Madrid, Spain
Withdrawn
Madrid, Spain
Active, not recruiting
Madrid, Spain
Active, not recruiting
Salamanca, Spain
Active, not recruiting
Sevilla, Spain
Sweden
Withdrawn
Karlstad, Sweden
Completed
Linköping, Sweden
Completed
Luleå, Sweden
Completed
Lund, Sweden
Active, not recruiting
Uppsala, Sweden
Taiwan
Withdrawn
Changhua, Taiwan
Active, not recruiting
Taichung, Taiwan
Active, not recruiting
Tainan, Taiwan
Withdrawn
Taipei, Taiwan
Recruiting
Taoyuan County, Taiwan
Turkey
Active, not recruiting
Adana, Turkey
Completed
Ankara, Turkey
Active, not recruiting
Ankara, Turkey
Withdrawn
Edirne, Turkey
Active, not recruiting
Istanbul, Turkey
Active, not recruiting
Izmir, Turkey
Active, not recruiting
Kayseri, Turkey
Active, not recruiting
Samsun, Turkey
Ukraine
Active, not recruiting
Cherkassy, Ukraine
Withdrawn
Dnepropetrovsk, Ukraine
Withdrawn
Donetsk, Ukraine
Active, not recruiting
Khmelnitskiy, Ukraine
Active, not recruiting
Kiev, Ukraine
Withdrawn
Kiev, Ukraine
Withdrawn
Lutsk, Ukraine
Active, not recruiting
Lviv, Ukraine
Completed
Makiivka, Ukraine
Withdrawn
Simferopol, Ukraine
United Kingdom
Active, not recruiting
Glasgow, United Kingdom
Active, not recruiting
Liverpool, United Kingdom
Active, not recruiting
London, United Kingdom
Withdrawn
London, United Kingdom
Active, not recruiting
Maidstone, United Kingdom
Active, not recruiting
Manchester, United Kingdom
Active, not recruiting
Nottingham, United Kingdom
Recruiting
Oxford, United Kingdom
Active, not recruiting
Romford, United Kingdom
Active, not 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: February 9, 2016
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
Australia: Department of Health and Ageing Therapeutic Goods Administration
Great Britain: Medicines and Healthcare Products Regulatory Agency
Great Britain: Research Ethics Committee
Germany: Federal Institute for Drugs and Medical Devices

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
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoma, Non-Hodgkin
Lymphoproliferative Disorders
Neoplasms
Neoplasms by Histologic Type
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Prednisone
Rituximab
Vincristine
Alkylating Agents
Anti-Inflammatory Agents
Antibiotics, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Alkylating
Antineoplastic Agents, Hormonal
Antineoplastic Agents, Phytogenic
Antirheumatic Agents
Enzyme Inhibitors
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Immunologic Factors

ClinicalTrials.gov processed this record on February 09, 2016