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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/NCT01024036
Registration number
NCT01024036
Ethics application status
Date submitted
30/11/2009
Date registered
2/12/2009
Date last updated
21/03/2018
Titles & IDs
Public title
A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease
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Scientific title
A Randomized, Double Blind, Placebo Controlled Study to Assess the Efficacy and Safety of CNTO 328 (Anti IL 6 Monoclonal Antibody) Plus Best Supportive Care Compared With Best Supportive Care in Subjects With Multicentric Castleman's Disease
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Secondary ID [1]
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CNTO328MCD2001
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Secondary ID [2]
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CR016705
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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:
Multicentric Castleman's Disease
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Condition category
Condition code
Cardiovascular
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Diseases of the vasculature and circulation including the lymphatic system
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Inflammatory and Immune System
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Siltuximab
Treatment: Drugs - Placebo
Treatment: Drugs - Best Supportive Care (BSC)
Experimental: Siltuximab+best supportive care (BSC) - Siltuximab 11 mg/kg will be administered as a 1-hour intravenous infusion every 3 weeks + BSC.
Placebo Comparator: Placebo+BSC - Placebo will be administered as a 1-hour intravenous infusion every 3 weeks + BSC. Participants who do not respond to placebo during the blinded treatment period will have option to crossover and receive siltuximab 11 mg/kg which will be administered by 1-hour intravenous infusion every 3 weeks + BSC during the unblinded treatment period.
Treatment: Drugs: Siltuximab
Siltuximab 11 mg/kg will be administered by 1-hour intravenous infusion every 3 weeks
Treatment: Drugs: Placebo
Placebo will be administered by 1-hour intravenous infusion every 3 weeks
Treatment: Drugs: Best Supportive Care (BSC)
BSC included treatment for effusions, antipyretics, antipuretics, antihistamines, pain medication, treatment for infections, transfusions, management of infusion-related reactions, and corticosteroids.
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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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Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review
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Assessment method [1]
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Durable tumor and symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks. The statistical analysis shows difference in symptomatic response rate (siltuximab+best supportive care [BSC] minus Placebo+BSC).
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Timepoint [1]
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From Day 1 of Cycle 1 of treatment with study medication until treatment failure or discontinuation of treatment or withdrawal from study, or up to 48 weeks after last participant started study medication(approximately 3 years), whichever occurred earlier
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Secondary outcome [1]
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Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review
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Assessment method [1]
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Duration of tumor and symptomatic response is defined as time from first documentation of tumor and symptomatic response (CR or PR) to treatment failure. Whenever possible, treatment failure documented by the appearance of new lesions should be confirmed by histologic examination of the new lesions. Symptomatic response is complete response (CR) + partial response (PR). CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion) and resolution of baseline symptoms attributed to multicentric Castleman's disease, sustained for at least 18 weeks. PR: >=50 percent decrease in sum of the product of the diameters of indicator lesion(s), with at least stable disease in all other evaluable disease in the absence of treatment failure sustained for at least 18 weeks.
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Timepoint [1]
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From the date when durable tumour and symptomatic response is achieved until treatment failure, as assessed until 48 weeks after the last participant started study treatment (approximately 3 years)
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Secondary outcome [2]
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Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review
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Assessment method [2]
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Overall tumor response is CR + PR assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC).
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Timepoint [2]
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From Day 1 of Cycle 1 until the date when durable tumour and symptomatic response is achieved, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years)
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Secondary outcome [3]
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Median Duration of Tumor Response - by Independent Radiology Review
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Assessment method [3]
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Duration of tumor response is defined as time from first documentation of tumor response to tumor progression. Tumour response is complete response (CR) + partial response (PR) as assessed according to Cheson criteria. CR: complete disappearance of all measurable and evaluable disease (eg, pleural effusion). PR: a >=50 percent decrease in sum of the product of the diameters of index lesion(s), with at least stable disease in all other evaluable disease. Statistical analysis shows difference of overall response rates (siltuximab+best supportive care [BSC] minus Placebo+BSC).
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Timepoint [3]
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From the date when tumour response is achieved until tumour progression, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years)
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Secondary outcome [4]
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Time to Treatment Failure
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Assessment method [4]
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Time to treatment failure was defined as the time from randomization until the participant fails treatment. Treatment failure was defined as any of the following: a sustained increase from baseline in disease related symptoms >=Grade 2 persisting for at least 3 weeks despite best supportive care (BSC); onset of any new disease related Grade 3 or higher symptom despite BSC; sustained (ie, at least 3 weeks) deterioration in performance status (increase from baseline in Eastern Cooperative Oncology Group Performance Status by more than 1 point) despite BSC; radiologic progression, as measured by modified Cheson criteria; Initiation of any other therapy intended to treat multicentric Castleman's disease ie, prohibited treatments. Statistical analysis shows difference in treatment failure rate (siltuximab+BSC minus Placebo+BSC).
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Timepoint [4]
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From the date of randomization until a participant fails treatment, as assessed up to 48 weeks after the last participant started study treatment (approximately 3 years), whichever occurred earlier
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Secondary outcome [5]
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Percentage of Participants Who Achieved Greater Than or Equal to (>=) 15 Gram Per Liter (g/L) Hemoglobin at Week 13 (Hemoglobin Response Rate)
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Assessment method [5]
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Hemoglobin response rate is defined as percentage of participants who achieved >= 15 g/L hemoglobin at Week 13.
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Timepoint [5]
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Week 13
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Secondary outcome [6]
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Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)
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Assessment method [6]
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Hemoglobin response rate is defined as percentage of participants who achieved >= 20 g/L hemoglobin at Week 13.
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Timepoint [6]
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Week 13
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Secondary outcome [7]
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Percentage of Participants Who Discontinued Corticosteroids
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Assessment method [7]
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Percentage of participants who discontinued corticosteroids during blinded treatment period and who were dependent on corticosteroids at baseline (Day 1 of Cycle 1).
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Timepoint [7]
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From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment (approximately 3 years)
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Secondary outcome [8]
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6-year Survival Rate
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Assessment method [8]
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Overall survival was defined as percent chance of survival of participants who were still alive at 6 years from time of first study treatment was analyzed.
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Timepoint [8]
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until 6 years
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Secondary outcome [9]
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Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman's Disease Symptom Scale (MCD-SS) Score From Baseline
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Assessment method [9]
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A patient-reported symptom scale. Symptom presence/absence and severity are noted on an anchor-based numeric scale. Scores range from 1 (very mild) to 5 (very severe).
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Timepoint [9]
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From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)
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Secondary outcome [10]
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Median Time Required to Achieve >=3-point Increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores From Baseline
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Assessment method [10]
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The FACIT-F, a 13-item instrument, was designed to measure patient-reported fatigue. It is one of the suite of FACIT instruments developed for outcomes in cancer. Concepts measured in the scale include tiredness, weakness, and difficulty conducting usual functional activities or social interaction due to fatigue. Response options range from "not at all" (0) to "very much" (4), and yield a summary score. Total FACIT-F score is the sum of 13 items, ranging from 0 (not at all) to 52 (very much). Higher scores represent better outcomes.
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Timepoint [10]
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From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)
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Secondary outcome [11]
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Median Time Required to Achieve >=5-point Increase in the Short-Form-36 (SF-36) Physical Component Summary (PCS) Scores From Baseline
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Assessment method [11]
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SF-36 is a questionnaire and PCS is a part of subscale assessing physical functioning, role-physical, bodily pain, and general health. The scores range from 0 (worst score) to 100 (best score), with a higher score indicating better quality of life.
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Timepoint [11]
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From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years)
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Eligibility
Key inclusion criteria
- Measurable and symptomatic Multicentric Castleman's Disease
- Adequate organ function as assessed by laboratory values evaluated by the investigator
to determine eligibility prior to treatment
- Eastern Cooperative Oncology Group performance status of 0, 1, or 2
- Corticosteroids dose that does not exceed 1 mg/kg/day of prednisone, and has remained
stable or decreased over the 4 weeks before treatment
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Minimum age
18
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
- Human Immunodeficiency Virus or Human Herpes Virus-8 positive
- Skin lesions as sole measurable manifestation of Multicentric Castleman's Disease
- Previous history of lymphoma
- Malignancies, except for adequately treated basal cell or squamous cell carcinoma of
the skin, carcinoma in situ of the cervix, or cancer other than lymphoma, from which
the patient has been disease-free for 3 or more years
- Concurrent medical condition or disease that may interfere with study participation
- Prior exposure to Interleukin-6 or Interleukin-6 receptor targeted therapies
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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 assessing the outcomes
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 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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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
18/03/2010
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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
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Actual
24/02/2017
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Sample size
Target
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Accrual to date
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Final
79
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Recruitment in Australia
Recruitment state(s)
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Recruitment hospital [1]
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- East Melbourne
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Recruitment postcode(s) [1]
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- East Melbourne
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Recruitment outside Australia
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Arkansas
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California
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Florida
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Massachusetts
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Washington
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Brussels
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Leuven
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Brasilia
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Brazil
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Porto Alegre
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Brazil
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Beijing
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Chengdu
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China
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Guangzhou
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China
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Hangzhou
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Clermont Ferrand
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France
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France
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Lille Cedex
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France
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Paris
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France
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Rennes
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France
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Vandoeuvre Les Nancy
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Germany
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Berlin
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Germany
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Mainz
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Germany
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München
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Sha Tin
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Budapest
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Hyderabad N/A
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India
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Pune
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Israel
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Petach Tikva
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Israel
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Ramat Gan
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Korea, Republic of
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Seoul
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Malaysia
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Pandan
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Rotterdam
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Auckland
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Norway
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Oslo
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Russian Federation
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Kazan
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Russian Federation
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Moscow
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Russian Federation
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Russian Federation
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Singapore
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Barcelona
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Spain
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Madrid
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Taipei
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United Kingdom
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London
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United Kingdom
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Manchester
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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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Ethics approval
Ethics application status
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Summary
Brief summary
The purpose of this study is to demonstrate that CNTO 328 when administered in combination
with best supportive care (BSC) is superior to BSC in terms of durable tumor and symptomatic
response (complete response or partial response) among patients with Multicentric Castleman's
Disease.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01024036
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
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Janssen Research & Development, LLC Clinical Trial
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Address
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Janssen Research & Development, LLC
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01024036
Download to PDF