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

June 18, 2025 updated by: Janssen Research & Development, LLC

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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. Four clinical cutoffs are planned. The first 3 clinical cutoffs will occur when approximately 134, 180, and 265 PFS events have been observed, respectively. The interim analyses and the final analysis of PFS will take place at these 3 clinical cutoffs, respectively; participant treatment assignment will be unblinded and placebo treatment will be stopped at the clinical cutoff for the final analysis of PFS. Treatment unblinding and stopping of placebo treatment could occur before the planned final analysis of PFS if recommended by the independent Data Monitoring Committee (DMC) after an interim analysis. 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
523

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
      • Ciudad Autonoma de Buenos Aires, Argentina
      • Cordoba, Argentina
      • La Capital, Argentina
      • Parana, Argentina
  • Australia
      • Adelaide, Australia
      • Auchenflower, Australia
      • Box Hill, Australia
      • Concord, Australia
      • Douglas, Australia
      • Gosford, Australia
      • Hobart, Australia
      • Prahran, Australia
  • Belgium
      • Antwerpen, Belgium
      • Brugge, Belgium
      • Brussels, Belgium
      • Gent, Belgium
      • Leuven, Belgium
      • Wilrijk, Belgium
      • Yvoir, Belgium
  • Brazil
      • Barretos, Brazil
      • Goiania, Brazil
      • Porto Alegre, Brazil
      • Ribeirao Preto, Brazil
      • Rio de Janeiro, Brazil
      • Sao Paulo, Brazil
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada
    • British Columbia
      • Vancouver, British Columbia, Canada
    • Ontario
      • Hamilton, Ontario, Canada
      • Ottawa, Ontario, Canada
    • Quebec
      • Montreal, Quebec, Canada
  • China
      • Beijing, China
      • Chengdu, China
      • Guangzhou, China
      • Hangzhou, China
      • Shanghai, China
      • Tianjin, China
  • Czechia
      • Brno, Czechia
      • Hradec Kralove, Czechia
      • Praha 10, Czechia
  • France
      • Creteil, France
      • F-75 730 Paris Cedex 15, France
      • Grenoble, France
      • Nantes, France
      • Paris, France
      • Pessac, France
      • Tours Cedex 9, France
  • Germany
      • Berlin, Germany
      • Heidelberg, Germany
      • Jena, Germany
      • Mainz, Germany
      • München, Germany
      • TÿBINGEN, Germany
      • Ulm, Germany
      • Villingen-Schwenningen, Germany
  • Greece
      • Athens, Greece
      • Athens Attica, Greece
      • Thessalonikis, Greece
  • Hungary
      • Budapest N/a, Hungary
      • Debrecen, Hungary
      • Kaposvár, Hungary
      • Pecs, Hungary
      • Szeged, Hungary
  • Ireland
      • Dublin, Ireland
      • Galway, Ireland
  • Israel
      • Afula, Israel
      • Beer-Sheva, Israel
      • Haifa, Israel
      • Jerusalem, Israel
      • Nahariya, Israel
      • Petach Tikva, Israel
      • Ramat-Gan, Israel
      • Tel Aviv, Israel
      • Zerifin, Israel
  • Japan
      • Fukuoka, Japan
      • Hiroshima, Japan
      • Kyoto, Japan
      • Nagoya, Japan
      • Osaka, Japan
      • Sapporo, Japan
      • Sendai-shi, Japan
      • Suita, Japan
      • Tokyo, Japan
  • Korea, Republic of
      • Gyeonggi-do, Korea, Republic of
      • Jeollanam-do, Korea, Republic of
      • Seoul, Korea, Republic of
  • Mexico
      • Monterrey, Mexico
      • Oaxaca, Mexico
  • Netherlands
      • Amsterdam Zuidoost, Netherlands
      • Dordrecht, Netherlands
      • Groningen, Netherlands
      • Leiden, Netherlands
      • Rotterdam, Netherlands
      • Utrecht, Netherlands
  • Poland
      • Bydgoszcz, Poland
      • Krakow, Poland
      • Olsztyn, Poland
      • Warszawa, Poland
      • Wroclaw, Poland
  • Puerto Rico
      • San Juan, Puerto Rico
  • Russian Federation
      • Chelyabinsk, Russian Federation
      • Ekaterinburg, Russian Federation
      • Krasnodar, Russian Federation
      • Moscow, Russian Federation
      • Moscow N/a, Russian Federation
      • Nizhny Novgorod, Russian Federation
      • Novosibirsk, Russian Federation
      • Petrozavodsk, Russian Federation
      • Rostov-Na-Donu, Russian Federation
      • Ryazan, Russian Federation
      • Sochi, Russian Federation
      • St-Petersburg, Russian Federation
      • St.Petersurg, Russian Federation
      • Syktyvkar, Russian Federation
      • Volgograd, Russian Federation
  • Slovakia
      • Banska Bystrica, Slovakia
      • Bratislava, Slovakia
      • Kosice, Slovakia
      • Martin, Slovakia
      • Presov 1, Slovakia
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • Oviedo, Spain
      • Palma De Mallorca, Spain
      • Salamanca, Spain
      • Santiago De Compostela, Spain
  • Sweden
      • Linköping, Sweden
      • Lund, Sweden
      • Stockholm, Sweden
      • Umeaa, Sweden
      • Uppsala, Sweden
  • Taiwan
      • Changhua, Taiwan
      • Kaohsiung County, Taiwan
      • Taichung, Taiwan
      • Tainan, Taiwan
      • Taipei, Taiwan
      • Taoyuan, Taiwan
  • Turkey
      • Adana, Turkey
      • Ankara, Turkey
      • Diyarbakir, Turkey
      • Istanbul, Turkey
      • Izmir, Turkey
      • Kayseri, Turkey
      • Mersin, Turkey
  • Ukraine
      • Cherkassy, Ukraine
      • Donetsk, Ukraine
      • Khmelnitskiy, Ukraine
      • Kiev, Ukraine
      • Lviv, Ukraine
  • United Kingdom
      • Canterbury, United Kingdom
      • Glasgow, United Kingdom
      • Leeds, United Kingdom
      • Leicester, United Kingdom
      • Liverpool, United Kingdom
      • London, United Kingdom
      • Manchester, United Kingdom
      • Plymouth, United Kingdom
      • Southampton, United Kingdom
      • Sutton, United Kingdom
  • United States
    • Arizona
      • Tucson, Arizona, United States
    • California
      • Burbank, California, United States
      • La Jolla, California, United States
      • Stanford, California, United States
    • Colorado
      • Denver, Colorado, United States
    • Connecticut
      • New Haven, Connecticut, United States
      • Stamford, Connecticut, United States
    • Illinois
      • Chicago, Illinois, United States
      • Maywood, Illinois, United States
      • Niles, Illinois, United States
      • Springfield, Illinois, United States
    • Indiana
      • Goshen, Indiana, United States
    • Iowa
      • Iowa City, Iowa, United States
      • Sioux City, Iowa, United States
    • Kansas
      • Topeka, Kansas, United States
      • Westwood, Kansas, United States
    • Kentucky
      • Lexington, Kentucky, United States
      • Louisville, Kentucky, United States
    • Louisiana
      • Metairie, Louisiana, United States
    • Michigan
      • Ann Arbor, Michigan, United States
      • Detroit, Michigan, United States
    • Missouri
      • Jefferson City, Missouri, United States
    • Nebraska
      • Lincoln, Nebraska, United States
    • New Jersey
      • Hackensack, New Jersey, United States
      • New Brunswick, New Jersey, United States
    • New Mexico
      • Albuquerque, New Mexico, United States
    • New York
      • Albany, New York, United States
      • Hawthorne, New York, United States
      • New York, New York, United States
    • North Carolina
      • Durham, North Carolina, United States
      • Greenville, North Carolina, United States
    • North Dakota
      • Bismarck, North Dakota, United States
      • Fargo, North Dakota, United States
    • Oregon
      • Eugene, Oregon, United States
      • Portland, Oregon, United States
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States
    • South Carolina
      • Greenville, South Carolina, United States
    • South Dakota
      • Watertown, South Dakota, United States
    • Tennessee
      • Nashville, Tennessee, United States
    • Texas
      • Houston, Texas, United States
      • San Antonio, Texas, United States
    • Vermont
      • Burlington, Vermont, United States
    • Washington
      • Spokane, Washington, United States
      • Vancouver, Washington, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

65 years and older (Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Progression-free Survival (PFS)
Time Frame: Up to 97 months
Progression-free survival (PFS) was defined as the interval between the date of randomization to the date of disease progression (PD) or relapse from complete response (CR) or death, whichever was first reported. Disease assessments were based on the 2007 Revised Response Criteria for Malignant Lymphoma. PD was defined as any new lesion or increase by 50 percent (%) of previously involved sites from nadir (PD 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).
Up to 97 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time-to-Next Treatment
Time Frame: Up to 97 months
Time-to-next treatment was measured from the date of randomization to the start date of any anti-mantle cell lymphoma (anti-MCL) treatment subsequent to the study treatment.
Up to 97 months
Minimal Residual Disease (MRD)-Negative Response Rate
Time Frame: Up to 97 months
Minimal residual disease negative rate was defined as the percentage of participants with a best overall response of CR with MRD-negative disease status (that is, <5 mantle cell lymphoma [MCL] cell per 10,000 leukocytes for detection using the MRD assay), as assessed by flow cytometry of a bone marrow and/or peripheral blood sample.
Up to 97 months
Time to Response
Time Frame: Up to 97 months
Time to response was defined as the interval between the date of randomization and the date of initial documentation of a response.
Up to 97 months
Overall Survival
Time Frame: From randomization (Day -3) up to 121 months
Overall survival was defined as the time from the date of randomization to the date of the participant's death. Kaplan-Meier estimate was used.
From randomization (Day -3) up to 121 months
Complete Response Rate
Time Frame: Up to 97 months
Complete response (CR) rate was defined as the percentage of participants who achieve CR (based on investigator assessment) on or prior to the initiation of subsequent anticancer 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 computed tomography (CT); spleen and liver: not palpable, nodules disappeared; bone marrow: infiltrate cleared on repeat biopsy.
Up to 97 months
Percentage of Participants With Overall Response
Time Frame: Up to 97 months
Percentage of participants with overall response was defined as the portion of participants who achieved 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. Criteria for PR: greater than or equal to (>=) 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.
Up to 97 months
Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Questionnaire
Time Frame: Up to 97 months
Time to worsening in the Lymphoma subscale of the FACT-Lym, defined as the interval from the date of randomization to the start date of worsening of participant symptoms. Worsening was defined by a 5-point decrease from baseline, death, or a missing assessment due to being "too ill", whichever occurred first. FACT-Lym Lymphoma subscale contains 15 questions, scores from 0 to 4 for each question (higher the worse). Lymphoma subscale score was the total of reverse scores, ranged 0 to 60. Higher scores indicated a better quality of life.
Up to 97 months
Duration of Response (DoR)
Time Frame: Up to 97 months
Duration of Response (DoR) was defined as the interval between the date of initial documentation of a response including PR and the date of first documented evidence of PD or death
Up to 97 months
Duration of Complete Response (DoCR)
Time Frame: Up to 97 months
Duration of complete response (DoCR) was defined as the interval between the date of initial documentation of a CR and the date of first documented evidence of PD or death whichever occurs first.
Up to 97 months
Number of Participants With Treatment-emergent Adverse Events (TEAEs)
Time Frame: Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months
Number of participants with TEAEs were reported. An AE was any untoward medical occurrence in a clinical study participant administered a medicinal (investigational or non investigational) product. An AE does not necessarily have a causal relationship with the intervention. Treatment-emergent adverse events 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, or the initiation of subsequent anticancer therapy, whichever is earlier.
Placebo + BR (Treatment A): From first dose of study treatment (Day 1) up to 100.1 months; Ibrutinib + BR (Treatment B): From first dose of study treatment (Day 1) up to 117.2 months
Oral Plasma Clearance (CL/F) of Ibrutinib
Time Frame: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2
CL/F was defined as apparent total systemic clearance of ibrutinib after extravascular administration. Cl/F of Ibrutinib was determined using population pharmacokinetics (PopPK modeling).
Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2
Oral Volume of Distribution at Steady State of Ibrutinib
Time Frame: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2
Oral volume of distribution at steady state of ibrutinib was determined using PopPK modeling.
Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2
Area Under the Concentration Curve of Ibrutinib During 24 Hours After Dosing at Steady State
Time Frame: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2
Area under the concentration curve of ibrutinib during 24 hours after dosing at steady state was determined using PopPK modeling.
Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2
Minimum Observed Plasma Concentration of Ibrutinib
Time Frame: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2
Minimum observed plasma concentration of ibrutinib was determined using PopPK modeling.
Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2
Maximum Observed Plasma Concentration of Ibrutinib
Time Frame: Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2
Maximum observed plasma concentration of ibrutinib was determined using PopPK modeling.
Pre-dose on Day 2 of Cycles 1, 2 and 3; and 1, 2 and 4 hours post-dose on Day 2 of Cycles 1 and 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Janssen Research & Development, LLC

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pharmacyclics LLC.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 16, 2013

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 24, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 24, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 24, 2013

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 28, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 8, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 18, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CR100967
  • PCI-32765MCL3002 (Other Identifier: Janssen Research & Development, LLC)
  • U1111-1137-0389 (Other Identifier: Universal Trial Number)
  • 2012-004056-11 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated device product

No

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