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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01776840
Registration number
NCT01776840
Ethics application status
Date submitted
24/01/2013
Date registered
28/01/2013
Date last updated
7/06/2024
Titles & IDs
Public title
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
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Scientific 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
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Secondary ID [1]
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0
PCI-32765MCL3002
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Secondary ID [2]
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0
CR100967
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Mantle Cell Lymphoma
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0
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Condition category
Condition code
Cancer
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0
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0
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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0
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0
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Bendamustine
Treatment: Drugs - Rituximab
Treatment: Drugs - Ibrutinib
Treatment: Drugs - Placebo
Placebo Comparator: Treatment Arm A -
Experimental: Treatment Arm B -
Treatment: Drugs: Bendamustine
90 mg/m2 administered intravenously on Days 1-2, Cycles 1-6
Treatment: Drugs: 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
Treatment: Drugs: 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
Treatment: Drugs: 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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS)
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Assessment method [1]
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Progression-free survival (PFS) is 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 is first reported. Disease assessments were based on the 2007 Revised Response Criteria for Malignant Lymphoma. PD is 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).
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Timepoint [1]
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Up to 97 months
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Secondary outcome [1]
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Overall Survival
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Assessment method [1]
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Overall survival is defined as the time from the date of randomization to the date of the participant's death.
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Timepoint [1]
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0
Up to 97 months
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Secondary outcome [2]
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Complete Response Rate
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Assessment method [2]
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Complete response (CR) rate is 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.
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Timepoint [2]
0
0
Up to 97 months
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Secondary outcome [3]
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Time-to-Next Treatment
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Assessment method [3]
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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.
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Timepoint [3]
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0
Up to 97 months
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Secondary outcome [4]
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Percentage of Participants With Overall Response
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Assessment method [4]
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Percentage of participants with overall response that is participants who achieved CR or PR was reported. 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.
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Timepoint [4]
0
0
Up to 97 months
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Secondary outcome [5]
0
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Minimal Residual Disease (MRD)-Negative Response Rate
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Assessment method [5]
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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.
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Timepoint [5]
0
0
Up to 97 months
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Secondary outcome [6]
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Time to Worsening (TTW) in the Lymphoma (Lym) Subscale of the Functional Assessment of Cancer Therapy-Lymphoma (FACT-Lym) Questionnaire
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Assessment method [6]
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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 is the total of reverse scores, range 0 to 60. Higher scores indicate a better quality of life.
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Timepoint [6]
0
0
Up to 97 months
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Secondary outcome [7]
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Duration of Response (DoR)
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Assessment method [7]
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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.
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Timepoint [7]
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Up to 97 months
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Secondary outcome [8]
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Duration of Complete Response (DoCR)
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Assessment method [8]
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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, for participants who achieved CR.
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Timepoint [8]
0
0
Up to 97 months
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Secondary outcome [9]
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0
Time to Response
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Assessment method [9]
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Time to response was defined as the interval between the date of randomization and the date of initial documentation of a response.
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Timepoint [9]
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Up to 97 months
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Secondary outcome [10]
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Number of Participants With Treatment-emergent Adverse Events (TEAEs)
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Assessment method [10]
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Number of participants with TEAEs were reported. Treatment-emergent adverse events are 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.
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Timepoint [10]
0
0
Up to 97 months
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Secondary outcome [11]
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Oral Plasma Clearance (CL/F) of Ibrutinib
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Assessment method [11]
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CL/F of Ibrutinib was determined using population pharmacokinetics (PopPK modeling).
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Timepoint [11]
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Day 2 of Cycles 1, 2 and 3 (each cycle was of 28 days)
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Secondary outcome [12]
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Oral Volume of Distribution at Steady State of Ibrutinib
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Assessment method [12]
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Oral volume of distribution at steady state of ibrutinib was determined using PopPK modeling.
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Timepoint [12]
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Day 2 of Cycles 1, 2 and 3 (each cycle was of 28 days)
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Secondary outcome [13]
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Area Under the Concentration Curve of Ibrutinib During 24 Hours After Dosing at Steady State
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Assessment method [13]
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Area under the concentration curve of ibrutinib during 24 hours after dosing at steady state was determined using PopPK modeling.
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Timepoint [13]
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Day 2 of Cycles 1, 2 and 3 (each cycle was of 28 days)
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Secondary outcome [14]
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Minimum Observed Plasma Concentration of Ibrutinib
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Assessment method [14]
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Minimum observed plasma concentration of ibrutinib was determined using PopPK modeling.
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Timepoint [14]
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Day 2 of Cycles 1, 2 and 3 (each cycle was of 28 days)
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Secondary outcome [15]
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Maximum Observed Plasma Concentration of Ibrutinib
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Assessment method [15]
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Maximum observed plasma concentration of ibrutinib was determined using PopPK modeling.
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Timepoint [15]
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Day 2 of Cycles 1, 2 and 3 (each cycle was of 28 days)
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Eligibility
Key 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
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Minimum age
65
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key 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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people analysing the results/data
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Active, not recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/05/2013
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/06/2024
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Actual
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Sample size
Target
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Accrual to date
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Final
523
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- Adelaide
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Recruitment hospital [2]
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- Auchenflower
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Recruitment hospital [3]
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- Box Hill
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Recruitment hospital [4]
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- Concord
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Recruitment hospital [5]
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- Douglas
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Recruitment hospital [6]
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0
- Gosford
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Recruitment hospital [7]
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- Hobart
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Recruitment hospital [8]
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- Prahran
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Recruitment postcode(s) [1]
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- Adelaide
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Recruitment postcode(s) [2]
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- Auchenflower
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Recruitment postcode(s) [3]
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- Box Hill
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Recruitment postcode(s) [4]
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- Concord
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Recruitment postcode(s) [5]
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- Douglas
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Recruitment postcode(s) [6]
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- Gosford
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Recruitment postcode(s) [7]
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- Hobart
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Recruitment postcode(s) [8]
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- Prahran
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Recruitment outside Australia
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United States of America
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Arizona
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California
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Colorado
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Connecticut
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Illinois
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Indiana
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Iowa
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Kansas
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Kentucky
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Louisiana
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Michigan
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Missouri
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Nebraska
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Ciudad Autonoma de Buenos Aires
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Goiania
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France
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F-75 730 Paris Cedex 15
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France
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Grenoble
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France
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Berlin
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Germany
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Heidelberg
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Germany
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Jena
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Mainz
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Germany
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Germany
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Ulm
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Germany
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Greece
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Athens Attica
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Hungary
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Budapest N/a
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Debrecen
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Hungary
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Pecs
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Szeged
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Beer-Sheva
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Country [86]
0
0
Israel
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State/province [86]
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0
Haifa
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Country [87]
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0
Israel
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State/province [87]
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0
Jerusalem
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Country [88]
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0
Israel
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State/province [88]
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0
Nahariya
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Country [89]
0
0
Israel
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State/province [89]
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0
Petach Tikva
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Country [90]
0
0
Israel
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State/province [90]
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0
Ramat-Gan
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Country [91]
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0
Israel
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State/province [91]
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0
Tel Aviv
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Country [92]
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0
Israel
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State/province [92]
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0
Zerifin
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Country [93]
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0
Japan
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State/province [93]
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Fukuoka
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Country [94]
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0
Japan
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State/province [94]
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0
Hiroshima
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Country [95]
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0
Japan
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State/province [95]
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Kyoto
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Country [96]
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0
Japan
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State/province [96]
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Nagoya
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Country [97]
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0
Japan
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State/province [97]
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Osaka
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Country [98]
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Japan
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State/province [98]
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Sapporo
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Country [99]
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Japan
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State/province [99]
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Sendai-shi
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Country [100]
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0
Japan
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State/province [100]
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Suita
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Country [101]
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0
Japan
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State/province [101]
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Tokyo
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Country [102]
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Korea, Republic of
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State/province [102]
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0
Gyeonggi-do
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Country [103]
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0
Korea, Republic of
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State/province [103]
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Jeollanam-do
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Country [104]
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Korea, Republic of
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State/province [104]
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Seoul
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Country [105]
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Mexico
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State/province [105]
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Monterrey
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Country [106]
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Mexico
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State/province [106]
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Oaxaca
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Country [107]
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Netherlands
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State/province [107]
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Amsterdam Zuidoost
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Country [108]
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Netherlands
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State/province [108]
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Dordrecht
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Country [109]
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Netherlands
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State/province [109]
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Groningen
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Country [110]
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0
Netherlands
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State/province [110]
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Leiden
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Country [111]
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Netherlands
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State/province [111]
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Rotterdam
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Country [112]
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0
Netherlands
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State/province [112]
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Utrecht
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Country [113]
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Poland
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State/province [113]
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Bydgoszcz
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Country [114]
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Poland
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State/province [114]
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Krakow
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Country [115]
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Poland
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State/province [115]
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Olsztyn
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Country [116]
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Poland
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State/province [116]
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Warszawa
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Country [117]
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Poland
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State/province [117]
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Wroclaw
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Country [118]
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Puerto Rico
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State/province [118]
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San Juan
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Country [119]
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Russian Federation
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State/province [119]
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Chelyabinsk
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Country [120]
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Russian Federation
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State/province [120]
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0
Ekaterinburg
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Country [121]
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Russian Federation
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State/province [121]
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Krasnodar
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Country [122]
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Russian Federation
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State/province [122]
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Moscow N/a
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Country [123]
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0
Russian Federation
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State/province [123]
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Moscow
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Country [124]
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0
Russian Federation
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State/province [124]
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Nizhny Novgorod
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Country [125]
0
0
Russian Federation
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State/province [125]
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Novosibirsk
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Country [126]
0
0
Russian Federation
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State/province [126]
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Petrozavodsk
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Country [127]
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0
Russian Federation
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State/province [127]
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Rostov-Na-Donu
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Country [128]
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Russian Federation
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State/province [128]
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Ryazan
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Country [129]
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0
Russian Federation
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State/province [129]
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Sochi
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Country [130]
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0
Russian Federation
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State/province [130]
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St-Petersburg
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Country [131]
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Russian Federation
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State/province [131]
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St.Petersurg
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Country [132]
0
0
Russian Federation
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State/province [132]
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Syktyvkar
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Country [133]
0
0
Russian Federation
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State/province [133]
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0
Volgograd
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Country [134]
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0
Slovakia
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State/province [134]
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Banska Bystrica
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Country [135]
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Slovakia
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State/province [135]
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Bratislava
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Country [136]
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Slovakia
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State/province [136]
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Kosice
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Country [137]
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0
Slovakia
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State/province [137]
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Martin
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Country [138]
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Slovakia
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State/province [138]
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0
Presov 1
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Country [139]
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0
Spain
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State/province [139]
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Barcelona
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Country [140]
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0
Spain
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State/province [140]
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Madrid
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Country [141]
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Spain
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State/province [141]
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Oviedo
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Country [142]
0
0
Spain
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State/province [142]
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0
Palma De Mallorca
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Country [143]
0
0
Spain
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State/province [143]
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0
Salamanca
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Country [144]
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0
Spain
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State/province [144]
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0
Santiago De Compostela
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Country [145]
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0
Sweden
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State/province [145]
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Linköping
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Country [146]
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0
Sweden
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State/province [146]
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Lund
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Country [147]
0
0
Sweden
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State/province [147]
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0
Stockholm
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Country [148]
0
0
Sweden
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State/province [148]
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0
Umeaa
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Country [149]
0
0
Sweden
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State/province [149]
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0
Uppsala
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Country [150]
0
0
Taiwan
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State/province [150]
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0
Changhua
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Country [151]
0
0
Taiwan
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State/province [151]
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0
Kaohsiung County
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Country [152]
0
0
Taiwan
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State/province [152]
0
0
Taichung
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Country [153]
0
0
Taiwan
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State/province [153]
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0
Tainan
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Country [154]
0
0
Taiwan
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State/province [154]
0
0
Taipei
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Country [155]
0
0
Taiwan
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State/province [155]
0
0
Taoyuan
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Country [156]
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0
Turkey
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State/province [156]
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Adana
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Country [157]
0
0
Turkey
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State/province [157]
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0
Ankara
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Country [158]
0
0
Turkey
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State/province [158]
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0
Diyarbakir
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Country [159]
0
0
Turkey
Query!
State/province [159]
0
0
Istanbul
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Country [160]
0
0
Turkey
Query!
State/province [160]
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0
Izmir
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Country [161]
0
0
Turkey
Query!
State/province [161]
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0
Kayseri
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Country [162]
0
0
Turkey
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State/province [162]
0
0
Mersin
Query!
Country [163]
0
0
Ukraine
Query!
State/province [163]
0
0
Cherkassy
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Country [164]
0
0
Ukraine
Query!
State/province [164]
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0
Donetsk
Query!
Country [165]
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0
Ukraine
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State/province [165]
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0
Khmelnitskiy
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Country [166]
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0
Ukraine
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State/province [166]
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Kiev
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Country [167]
0
0
Ukraine
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State/province [167]
0
0
Lviv
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Country [168]
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0
United Kingdom
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State/province [168]
0
0
Canterbury
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Country [169]
0
0
United Kingdom
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State/province [169]
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0
Glasgow
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Country [170]
0
0
United Kingdom
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State/province [170]
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0
Leeds
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Country [171]
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0
United Kingdom
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State/province [171]
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0
Leicester
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Country [172]
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0
United Kingdom
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State/province [172]
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0
Liverpool
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Country [173]
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0
United Kingdom
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State/province [173]
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0
London
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Country [174]
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0
United Kingdom
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State/province [174]
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Manchester
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Country [175]
0
0
United Kingdom
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State/province [175]
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0
Plymouth
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Country [176]
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0
United Kingdom
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State/province [176]
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0
Southampton
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Country [177]
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0
United Kingdom
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State/province [177]
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0
Sutton
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Janssen Research & Development, LLC
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Address
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Country
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Other collaborator category [1]
0
0
Commercial sector/Industry
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Name [1]
0
0
Pharmacyclics LLC.
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Address [1]
0
0
Query!
Country [1]
0
0
Query!
Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01776840
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
0
0
Janssen Research & Development, LLC Clinical Trial
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Address
0
0
Janssen Research & Development, LLC
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Country
0
0
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Phone
0
0
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Fax
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0
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01776840
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