A Study of the Bruton's Tyrosine Kinase Inhibitor Ibrutinib Given in Combination With Bendamustine and Rituximab in Patients With Newly Diagnosed Mantle Cell Lymphoma

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Janssen Research & Development, LLC
Sponsor:
Collaborator:
Pharmacyclics
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01776840
First received: January 24, 2013
Last updated: September 24, 2014
Last verified: September 2014
  Purpose

The purpose of this study is to evaluate the efficacy and safety of ibrutinib given in combination with bendamustine and rituximab in patients 65 years of age or older with newly diagnosed mantle cell lymphoma.


Condition Intervention Phase
Mantle Cell Lymphoma
Drug: Bendamustine
Drug: Rituximab
Drug: Ibrutinib
Drug: Placebo
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 Bendamustine and Rituximab (BR) in Subjects With Newly Diagnosed Mantle Cell Lymphoma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Up to the end-of-study visit until 265 progression-free survival events have been observed (up to 7 years after the last patient is randomized) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Overall survival [ Time Frame: Up to the end-of-study visit until 60% of all enrolled patients have died (up to 7 years after the last patient is randomized) ] [ Designated as safety issue: No ]
  • Overall response rate [ Time Frame: Up to the end-of-study visit up to 7 years after the last patient is randomized ] [ Designated as safety issue: No ]
  • Number of participants with change in Lym subscale scores of the Functional Assessment of Cancer Therapy-Lymphoma (FACT Lym) [ Time Frame: Screening, Day 1 of the first 6 cycles, then every 12 weeks in the first 12 months, thereafter every 16 weeks up to 7 years after the last patient is randomized ] [ Designated as safety issue: No ]
  • Minimal residual disease negative rate [ Time Frame: For participants with complete response, every 12 weeks in the first 12 months, thereafter every 16 weeks and at disease progression or up to the end-of-study visit (up to 7 years after the last patient is randomized) ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Up to the end-of-study visit up to 7 years after the last patient is randomized ] [ Designated as safety issue: No ]
  • Time-to-next treatment [ Time Frame: Up to the end-of-study visit up to 7 years after the last patient is randomized ] [ Designated as safety issue: No ]
  • Number of participants affected by an adverse event [ Time Frame: Up to 30 days after the last dose of any study treatment ] [ Designated as safety issue: Yes ]
  • Oral plasma clearance of ibrutinib as derived from population pharmacokinetics [ Time Frame: Predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1 and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose ] [ Designated as safety issue: No ]
  • Oral volume of distribution at steady state of ibrutinib as derived from population pharmacokinetics [ Time Frame: Predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1 and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose ] [ Designated as safety issue: No ]
  • Area under the concentration curve of ibrutinib as derived from population pharmacokinetics [ Time Frame: Predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1 and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose ] [ Designated as safety issue: No ]
  • Minimum observed plasma concentration of ibrutinib as derived from population pharmacokinetics [ Time Frame: Predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1 and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose ] [ Designated as safety issue: No ]
  • Maximum observed plasma concentration of ibrutinib as derived from population pharmacokinetics [ Time Frame: Predose on Day 2 Cycles 1-3, postdose on Day 2 Cycles 1 and 2 at 1, 2, and 4 hours after administration of ibrutinib study dose ] [ Designated as safety issue: No ]

Estimated Enrollment: 520
Study Start Date: May 2013
Estimated Study Completion Date: October 2019
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Treatment Arm A Drug: Bendamustine
90 mg/m2 administered intravenously on Days 1-2, Cycles 1-6
Drug: Rituximab
375 mg/m2 administered intravenously on Day 1, Cycles 1-6; if complete response or partial response is achieved, 375 mg/m2 is administered on Day 1 of every second cycle for a maximum of 12 additional doses
Drug: Placebo
4 capsules administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or the final analysis of progression-free survival
Experimental: Treatment Arm B Drug: Bendamustine
90 mg/m2 administered intravenously on Days 1-2, Cycles 1-6
Drug: Rituximab
375 mg/m2 administered intravenously on Day 1, Cycles 1-6; if complete response or partial response is achieved, 375 mg/m2 is administered on Day 1 of every second cycle for a maximum of 12 additional doses
Drug: Ibrutinib
560 mg (4 x 140 mg capsules) administered orally once daily continuously starting on Day 1, Cycle 1 until disease progression, or unacceptable toxicity, or study end

Detailed Description:

This is a randomized (individuals assigned to study treatment by chance), double blind (neither physician nor participant knows the treatment that the participant receives), 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 given in combination with bendamustine and rituximab (BR) with BR alone in participants newly diagnosed with mantle cell lymphoma (MCL) who are 65 years of age or older. Approximately 520 participants will be randomly assigned in a 1:1 ratio and stratified by simplified Mantle Cell Lymphoma International Prognostic Index (MIPI) score (low risk [0-3] versus intermediate risk [4-5] versus high risk [6-11]). The treatment phase will extend from randomization until discontinuation of all study treatment or the clinical cutoff for the end of study. A cycle is defined as 28 days. All participants will receive open-label (identity of assigned study drug will be known) BR background therapy for a maximum of 6 cycles; participants with a complete response or partial response will continue to receive open-label background therapy with rituximab maintenance every second cycle for a maximum of 12 additional doses. In addition to the background therapy, all participants will receive blinded study drug (ibrutinib or placebo). Participants randomized to treatment Arm A will receive placebo capsules and participants randomized to treatment Arm B will receive ibrutinib capsules. Study drug will be administered daily and continuously until disease progression, unacceptable toxicity, or study end. Participants with stable disease after initial chemoimmunotherapy (BR+ibrutinib/placebo) should continue treatment with ibrutinib/placebo until disease progression, unacceptable toxicity, or study end. Participants with progressive disease must discontinue all study treatment. For participants who discontinue background therapy and do not have progressive disease, treatment with study drug will continue until disease progression or unacceptable toxicity or the clinical cutoff for the final analysis of progression-free survival (PFS). Participants receiving BR, rituximab, or ibrutinib at the clinical cutoff for the final analysis of PFS will continue open-label treatment until disease progression or unacceptable toxicity. Placebo will be stopped when the study is unblinded for the clinical cutoff for the final analysis of PFS. The posttreatment follow-up phase will begin once a participant discontinues bendamustine and rituximab and study drug. Participants who discontinue for reasons other than disease progression must continue to have disease evaluations as outlined in the protocol. Participants who discontinue due to disease progression will be followed for survival and subsequent anti-MCL therapy. The posttreatment follow-up phase will continue until death, lost to follow up, consent withdrawal, or study end, whichever occurs first. Three clinical cutoffs are planned. The first 2 clinical cutoffs will occur when approximately 134 and 265 PFS events have been observed, respectively. The interim analysis and the final analysis of PFS will take place at these 2 clinical cutoffs, respectively; participant treatment assignment will be unblinded at the clinical cutoff for the final analysis of PFS. The last cutoff will occur at the end of study, when 60% of the randomized participants have died or the Sponsor terminates the study, whichever comes first. Efficacy assessments will be conducted in accordance with the Revised Response Criteria for Malignant Lymphoma. Safety will be monitored throughout the study and summarized. Blood samples will be drawn for assessment of pharmacokinetic parameters. Blood and bone marrow will be collected for assessment of minimal residual disease and biomarker studies.

  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of mantle cell lymphoma (MCL) reviewed and approved by central laboratory: diagnosis must include morphology and expression of either cyclin D1 in association with other relevant markers (eg, CD19, CD20, PAX5 and CD5) or evidence of t(11;14) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR)
  • Clinical Stage II, III, or IV by Ann Arbor Classification
  • At least 1 measurable site of disease according to Revised Response Criteria for Malignant Lymphoma
  • No prior therapies for MCL
  • Eastern Cooperative Oncology Group (ECOG) performance status grade 0 or 1
  • Hematology and biochemical laboratory values within protocol-defined limits
  • Agrees to protocol-defined use of effective contraception
  • Negative blood or urine pregnancy test at screening

Exclusion Criteria:

  • Major surgery within 4 weeks of random assignment
  • Known central nervous system lymphoma
  • Diagnosed or treated for malignancy other than MCL, 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 cervical carcinoma in situ without evidence of disease
  • Patients for whom the goal of therapy is tumor debulking prior to stem cell transplant
  • 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
  • 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
  • Vaccinated with live, attenuated vaccines within 4 weeks of random assignment
  • Known history of human immunodeficiency virus (HIV) or active hepatitis C virus or active hepatitis B virus 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 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: NCT01776840

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
Berkeley, California, United States
Recruiting
Burbank, California, United States
Recruiting
La Jolla, California, United States
Withdrawn
Santa Monica, California, United States
Recruiting
Stanford, California, United States
United States, Colorado
Withdrawn
Aurora, Colorado, United States
Recruiting
Denver, Colorado, United States
United States, Connecticut
Recruiting
New Haven, Connecticut, United States
Recruiting
Stamford, Connecticut, United States
United States, Florida
Withdrawn
Tampa, Florida, United States
Withdrawn
West Palm Beach, Florida, United States
United States, Georgia
Withdrawn
Atlanta, Georgia, United States
United States, Illinois
Recruiting
Chicago, Illinois, United States
Recruiting
Maywood, Illinois, United States
Recruiting
Niles, Illinois, United States
Completed
Springfield, Illinois, United States
Withdrawn
Urbana, Illinois, United States
United States, Indiana
Recruiting
Goshen, Indiana, United States
Withdrawn
Indianapolis, Indiana, United States
Withdrawn
Vincennes, Indiana, United States
United States, Iowa
Recruiting
Iowa City, Iowa, United States
Recruiting
Sioux City, Iowa, United States
United States, Kansas
Recruiting
Topeka, Kansas, United States
Recruiting
Westwood, Kansas, United States
United States, Kentucky
Recruiting
Lexington, Kentucky, United States
Recruiting
Louisville, Kentucky, United States
Withdrawn
Paducah, Kentucky, United States
United States, Louisiana
Withdrawn
Metairie, Louisiana, United States
Recruiting
Metairie, Louisiana, United States
United States, Michigan
Recruiting
Ann Arbor, Michigan, United States
Recruiting
Detroit, Michigan, United States
United States, Minnesota
Withdrawn
Woodbury, Minnesota, United States
United States, Mississippi
Withdrawn
Hattiesburg, Mississippi, United States
United States, Missouri
Recruiting
Jefferson City, Missouri, United States
United States, Nebraska
Recruiting
Lincoln, Nebraska, United States
United States, Nevada
Withdrawn
Henderson, Nevada, United States
United States, New Jersey
Recruiting
Hackensack, New Jersey, United States
Withdrawn
Morristown, New Jersey, United States
Recruiting
New Brunswick, New Jersey, United States
United States, New Mexico
Recruiting
Albuquerque, New Mexico, United States
United States, New York
Recruiting
Albany, New York, United States
Withdrawn
New Hyde Park, New York, United States
Recruiting
New York, New York, United States
Recruiting
Valhalla, New York, United States
United States, North Carolina
Recruiting
Durham, North Carolina, United States
Recruiting
Greenville, North Carolina, United States
United States, North Dakota
Withdrawn
Bismarck, North Dakota, United States
Withdrawn
Fargo, North Dakota, United States
United States, Oregon
Recruiting
Eugene, Oregon, United States
Recruiting
Portland, Oregon, United States
Withdrawn
Portland, Oregon, United States
United States, Pennsylvania
Completed
Philadelphia, Pennsylvania, United States
Withdrawn
Pittsburgh, Pennsylvania, United States
United States, South Carolina
Recruiting
Greenville, South Carolina, United States
United States, South Dakota
Withdrawn
Sioux Falls, South Dakota, United States
Recruiting
Watertown, South Dakota, United States
United States, Tennessee
Recruiting
Nashville, Tennessee, United States
United States, Texas
Recruiting
Houston, Texas, United States
Recruiting
San Antonio, Texas, United States
United States, Vermont
Recruiting
Burlington, Vermont, United States
United States, Washington
Withdrawn
Spokane, Washington, United States
Recruiting
Vancouver, Washington, United States
United States, West Virginia
Withdrawn
Morgantown, West Virginia, United States
Argentina
Recruiting
Buenos Aires, Argentina
Not yet recruiting
Buenos Aires, Argentina
Recruiting
Cordoba, Argentina
Withdrawn
Cordoba, Argentina
Withdrawn
Córdoba, Argentina
Withdrawn
Federal, Argentina
Recruiting
La Capital, Argentina
Withdrawn
La Plata, Argentina
Recruiting
Parana, Argentina
Australia
Recruiting
Adelaide, Australia
Recruiting
Box Hill, Australia
Recruiting
Concord, Australia
Recruiting
Douglas, Australia
Recruiting
Gosford, Australia
Recruiting
Hobart, Australia
Withdrawn
Melbourne, Australia
Recruiting
Prahran, Australia
Recruiting
South Brisbane, Australia
Withdrawn
Westmead, Australia
Belgium
Recruiting
Antwerpen, Belgium
Recruiting
Brugge, Belgium
Recruiting
Brussels, Belgium
Withdrawn
Edegem, Belgium
Recruiting
Gent, Belgium
Recruiting
Leuven, Belgium
Withdrawn
Liege, Belgium
Recruiting
Wilrijk, Belgium
Recruiting
Yvoir, Belgium
Brazil
Recruiting
Barretos, Brazil
Withdrawn
Florianopolis, Brazil
Recruiting
Goiania, Brazil
Withdrawn
Juiz De Fora, Brazil
Withdrawn
Porto Alegre, Brazil
Recruiting
Porto Alegre, Brazil
Recruiting
Ribeirao Preto, Brazil
Recruiting
Rio De Janeiro, Brazil
Recruiting
Sao Paulo, Brazil
Recruiting
São Paulo, Brazil
Recruiting
São Paulol, Brazil
Canada, Alberta
Recruiting
Edmonton, Alberta, Canada
Canada, British Columbia
Recruiting
Vancouver, British Columbia, Canada
Canada, Ontario
Recruiting
Hamilton, Ontario, Canada
Recruiting
Ottawa, Ontario, Canada
Canada, Quebec
Recruiting
Montreal, Quebec, Canada
China
Recruiting
Beijing, China
Recruiting
Chengdu, China
Recruiting
Guangzhou, China
Recruiting
Hangzhou, China
Recruiting
Shanghai, China
Recruiting
Tianjin, China
Czech Republic
Recruiting
Brno, Czech Republic
Recruiting
Hradec Kralove, Czech Republic
Recruiting
Praha 10, Czech Republic
Withdrawn
Praha 2, Czech Republic
France
Recruiting
Creteil, France
Recruiting
F-75 730 Paris Cedex 15, France
Recruiting
Grenoble, France
Recruiting
Nantes, France
Recruiting
Paris, France
Recruiting
Pessac, France
Recruiting
Tours Cedex 9, France
Germany
Recruiting
Berlin, Germany
Withdrawn
Essen, Germany
Recruiting
Heidelberg, Germany
Recruiting
Jena, Germany
Withdrawn
Köln, Germany
Recruiting
Mainz, Germany
Recruiting
München, Germany
Recruiting
Tÿbingen, Germany
Recruiting
Ulm, Germany
Recruiting
Villingen-Schwenningen, Germany
Withdrawn
Würzburg, Germany
Greece
Recruiting
Athens, Greece
Recruiting
Athens Attica, Greece
Recruiting
Thessalonikis, Greece
Hong Kong
Withdrawn
Hong Kong, Hong Kong
Hungary
Recruiting
Budapest N/A, Hungary
Withdrawn
Budapest N/A, Hungary
Recruiting
Debrecen, Hungary
Recruiting
Kaposvár, Hungary
Recruiting
Pécs N/A, Hungary
Recruiting
Szeged N/A, Hungary
Withdrawn
Szolnok, Hungary
Ireland
Suspended
Dublin, Ireland
Recruiting
Galway N/A, Ireland
Israel
Completed
Afula, Israel
Recruiting
Beer-Sheva, Israel
Recruiting
Haifa, Israel
Recruiting
Jerusalem, Israel
Recruiting
Nahariya, Israel
Recruiting
Petach Tikva, Israel
Recruiting
Ramat-Gan, Israel
Recruiting
Tel Aviv, Israel
Recruiting
Zerifin, Israel
Japan
Withdrawn
Fukuoka, Japan
Recruiting
Fukuoka, Japan
Recruiting
Hiroshima, Japan
Withdrawn
Isehara, Japan
Withdrawn
Kumamoto, 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
Gyeonggi-Do, Korea, Republic of
Recruiting
Hwasun Gun, Korea, Republic of
Recruiting
Seoul, Korea, Republic of
Mexico
Withdrawn
Guadalajara, Mexico
Withdrawn
Mexico, Mexico
Recruiting
Monterrey, Mexico
Recruiting
Oaxaca, Mexico
Withdrawn
Queretaro, Mexico
Withdrawn
Zapopan, Mexico
Netherlands
Recruiting
Amsterdam Zuidoost, Netherlands
Withdrawn
Den Haag, Netherlands
Recruiting
Dordrecht, Netherlands
Recruiting
Groningen, Netherlands
Recruiting
Leiden, Netherlands
Withdrawn
Nieuwegein, Netherlands
Recruiting
Rotterdam, Netherlands
Recruiting
Utrecht, Netherlands
Poland
Recruiting
Bydgoszcz, Poland
Recruiting
Krakow, Poland
Recruiting
Olsztyn, Poland
Withdrawn
Warszawa, Poland
Recruiting
Warszawa, Poland
Recruiting
Wroclaw, Poland
Withdrawn
Zamosc, Poland
Puerto Rico
Recruiting
San Juan, Puerto Rico
Russian Federation
Withdrawn
Arkhangelsk, Russian Federation
Completed
Chelyabinsk, Russian Federation
Withdrawn
Ekaterinburg, Russian Federation
Withdrawn
Izhevsk, Russian Federation
Withdrawn
Kazan, Russian Federation
Withdrawn
Kirov, Russian Federation
Recruiting
Krasnodar, Russian Federation
Withdrawn
Moscow, Russian Federation
Withdrawn
Moscow N/A, Russian Federation
Recruiting
Moscow N/A, Russian Federation
Recruiting
Nizhny Novgorod, Russian Federation
Withdrawn
Novosibirsk, Russian Federation
Withdrawn
Obninsk, Russian Federation
Withdrawn
Perm, Russian Federation
Recruiting
Petrozavodsk, Russian Federation
Withdrawn
Rostov-Na-Donu, Russian Federation
Recruiting
Ryazan, Russian Federation
Withdrawn
Saint Petersburg, Russian Federation
Withdrawn
Saint-Petersburg, Russian Federation
Withdrawn
Sochi, Russian Federation
Withdrawn
St, Russian Federation
Recruiting
St-Petersburg, Russian Federation
Withdrawn
St.-Petersburg, Russian Federation
Withdrawn
St.Petersurg, Russian Federation
Recruiting
Syktyvkar, Russian Federation
Recruiting
Volgograd, Russian Federation
Singapore
Withdrawn
Singapore, Singapore
Slovakia
Recruiting
Banska Bystrica, Slovakia
Recruiting
Bratislava, Slovakia
Completed
Kosice, Slovakia
Recruiting
Martin, Slovakia
Completed
Presov 1, Slovakia
Spain
Recruiting
Barcelona, Spain
Withdrawn
Barcelona, Spain
Recruiting
Madrid, Spain
Recruiting
Oviedo, Spain
Recruiting
Palma De Mallorca, Spain
Recruiting
Salamanca, Spain
Recruiting
Santiago De Compostela, Spain
Sweden
Recruiting
Linköping, Sweden
Recruiting
Lund, Sweden
Recruiting
Stockholm, Sweden
Recruiting
Umeaa, Sweden
Recruiting
Uppsala, Sweden
Taiwan
Recruiting
Changhua, Taiwan
Recruiting
Kaohsiung County, Taiwan
Recruiting
Taichung City, Taiwan
Recruiting
Tainan, Taiwan
Recruiting
Taipei, Taiwan
Recruiting
Taoyuan, Taiwan
Turkey
Recruiting
Adana, Turkey
Withdrawn
Ankara, Turkey
Recruiting
Ankara, Turkey
Recruiting
Diyarbakir, Turkey
Withdrawn
Istanbul, Turkey
Recruiting
Istanbul, Turkey
Recruiting
Izmir, Turkey
Recruiting
Kayseri, Turkey
Recruiting
Mersin, Turkey
Ukraine
Recruiting
Cherkassy, Ukraine
Not yet recruiting
Dnepropetrovsk, Ukraine
Recruiting
Donetsk, Ukraine
Recruiting
Khmelnitskiy, Ukraine
Recruiting
Kiev, Ukraine
Withdrawn
Kiev, Ukraine
Recruiting
Lviv, Ukraine
Withdrawn
Simferopol, Ukraine
United Kingdom
Recruiting
Canterbury, United Kingdom
Recruiting
Glasgow, United Kingdom
Withdrawn
Leeds, United Kingdom
Recruiting
Leicester, United Kingdom
Recruiting
Liverpool, United Kingdom
Recruiting
London, United Kingdom
Recruiting
Manchester, United Kingdom
Recruiting
Plymouth, United Kingdom
Recruiting
Southampton, United Kingdom
Recruiting
Sutton, United Kingdom
Withdrawn
Truro, 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: NCT01776840     History of Changes
Other Study ID Numbers: CR100967, PCI-32765MCL3002, U1111-1137-0389, 2012-004056-11
Study First Received: January 24, 2013
Last Updated: September 24, 2014
Health Authority: United States: Food and Drug Administration
Australia: Department of Health and Ageing Therapeutic Goods Administration
Germany: Ethics Commission
Czech Republic: State Institute for Drug Control
China: Food and Drug Administration
Japan: Pharmaceuticals and Medical Devices Agency
Korea: Food and Drug Administration
Taiwan: Department of Health
Belgium: Federal Agency for Medicinal Products and Health Products
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Hungary: Institutional Ethics Committee
Ireland: Irish Medicines Board
Italy: The Italian Medicines Agency
Israel: Ministry of Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation
Slovakia: State Institute for Drug Control
Spain: Comité Ético de Investigación Clínica
Sweden: Medical Products Agency
Turkey: Ministry of Health
Ukraine: State Pharmacological Center - Ministry of Health
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Brazil: National Health Surveillance Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Canada: Health Canada

Keywords provided by Janssen Research & Development, LLC:
Mantle cell lymphoma
Ibrutinib
Bruton's tyrosine kinase inhibitor
Bendamustine hydrochloride
Rituximab

Additional relevant MeSH terms:
Lymphoma, Mantle-Cell
Lymphoma
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Rituximab
Bendamustine
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 30, 2014