- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01400503
A Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Patients With Multicentric Castleman's Disease
April 25, 2018 updated by: Janssen Research & Development, LLC
An Open-label, Multicenter Study to Evaluate the Safety of Long-term Treatment With Siltuximab in Subjects With Multicentric Castleman's Disease
The purpose of this study is to evaluate the long-term safety of siltuximab in patients with multicentric Castleman's disease (MCD).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This is an open-label (all people know the identity of the intervention), multicenter (study conducted in multiple sites), non-randomized (patients are not assigned by chance to treatment groups), Phase 2b study.
Up to 75 patients with MCD will be eligible for the study, the majority of whom will be on active therapy with siltuximab at the time of enrollment.
Patients will be either siltuximab-naive or have not progressed on siltuximab in the opinion of the investigator.
Duration of disease control and survival will be assessed.
Data collection for patients who discontinue treatment will be limited to survival, occurrence of malignancies, and subsequent therapies for MCD, which will be assessed twice per year until the patient has been lost to follow up or has withdrawn consent for the study, whichever occurs first.
An interim analysis will be conducted (no later than 2 years after the start of enrollment) to further evaluate the benefit and safety of long-term treatment with siltuximab in patients with MCD.
A data will occur at 6 years after the start of enrollment and for those patients remaining on treatment after the data cutoff, data collection will be limited to pregnancies and serious adverse events (SAEs), including information on study agent administration and concomitant medications associated with an SAE.
Safety evaluations for adverse events, clinical laboratory tests, vital signs, and physical examination will be performed throughout the study.
The end of study is the date of the last assessment for the last patient.
Study Type
Interventional
Enrollment (Actual)
60
Phase
- Phase 2
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
-
-
-
Leuven, Belgium
-
-
-
-
-
Sao Paulo, Brazil
-
-
-
-
-
Toronto, Canada
-
-
-
-
-
Beijing, China
-
Chengdu, China
-
-
-
-
-
Cairo, Egypt
-
-
-
-
-
Montpellier, France
-
Tours Cedex 9, France
-
Vandoeuvre Les Nancy, France
-
-
-
-
-
Berlin, Germany
-
-
-
-
-
Sha Tin, Hong Kong
-
-
-
-
-
Ramat Gan, Israel
-
-
-
-
-
Seoul, Korea, Republic of
-
-
-
-
-
Auckland, New Zealand
-
-
-
-
-
Oslo, Norway
-
-
-
-
-
Singapore, Singapore
-
-
-
-
-
Madrid, Spain
-
-
-
-
-
Taipei, Taiwan
-
-
-
-
-
Manchester, United Kingdom
-
-
-
-
Arkansas
-
Little Rock, Arkansas, United States
-
-
Florida
-
Tampa, Florida, United States
-
-
Michigan
-
Lansing, Michigan, United States
-
-
North Carolina
-
Chapel Hill, North Carolina, United States
-
-
South Carolina
-
Greenville, South Carolina, United States
-
-
Texas
-
Houston, Texas, United States
-
-
Washington
-
Seattle, 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
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Has multicentric Castleman's disease
- Have previously been enrolled in Study C0328T03 or CNTO328MCD2001 (either treatment arm)
- Have had their last administration of study treatment (siltuximab or placebo) less than 6 weeks (window of plus 2 weeks) prior to first dose
- Patients must not have had disease progression while receiving siltuximab. For those patients originally assigned to placebo in the CNTO328MCD2001 study, patients who have received less than 4 months of siltuximab following crossover will also be eligible
- Have adequate clinical laboratory parameters within 2 weeks prior to the first dose of siltuximab for this study
Exclusion Criteria:
- Unmanageable toxicity, an adverse event, progression of disease, or withdrawal of consent as reason for discontinuing treatment from previous sponsor-initiated siltuximab study
- Vaccination with live, attenuated vaccines within 4 weeks of first dose of this study
- Known unmanageable allergies, hypersensitivity, intolerance to monoclonal antibodies, to murine, chimeric, human proteins or their excipients
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: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Siltuximab
Siltuximab 11 mg/kg, intravenous infusion, given as a 1-hour infusion every 3 weeks.
|
Type=exact number, unit=mg/kg, number=11, form=intravenous solution, route=intravenous.
Siltuximab given as a 1-hour infusion every 3 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Adverse Events (AEs)
Time Frame: Up to 6 years
|
An adverse event (AE) is any untoward medical event that occurs in a participant administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.
|
Up to 6 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Previously Responding Participants Who Maintained Disease Control
Time Frame: Up to 6 years
|
Percentage of participants maintaining disease control (defined as stable or better response) was defined as the percentage of previously responding participants who had not progressed during the long-term safety extension based on investigator assessment.
A worsening in any of the measures will be considered as a progression of the disease.
|
Up to 6 years
|
Percentage of Siltuximab-naive Participants Who Experienced Disease Control
Time Frame: Up to 6 years
|
Percentage of participants experiencing disease control was defined as the percentage of siltuximab-naïve participants who had stable or better response during the long-term safety extension based on investigator's judgment.
Disease control was defined as stable or better response assessed by the investigators.
|
Up to 6 years
|
Duration of Disease Control
Time Frame: Up to 6 years
|
Duration of disease control (DODC) was defined as the time from the first siltuximab administration in this study to disease progression as assessed by the investigator.
Disease control was defined as stable or better response assessed by the investigators.
Kaplan-Meier method was used to estimate the duration of disease control.
|
Up to 6 years
|
Overall Survival
Time Frame: Up to 6 years
|
Overall survival was defined as the time between the first study siltuximab administration and death due to any cause.
Kaplan-Meier method was used to estimate the overall survival.
|
Up to 6 years
|
Number of Participants Positive for Antibodies to Siltuximab
Time Frame: Up to 6 years
|
Serum samples were screened for antibodies binding to siltuximab and number of participants positive for antibodies to siltuximab was reported.
|
Up to 6 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
April 1, 2011
Primary Completion (Actual)
March 1, 2017
Study Completion (Actual)
March 1, 2017
Study Registration Dates
First Submitted
April 21, 2011
First Submitted That Met QC Criteria
July 21, 2011
First Posted (Estimate)
July 22, 2011
Study Record Updates
Last Update Posted (Actual)
May 22, 2018
Last Update Submitted That Met QC Criteria
April 25, 2018
Last Verified
April 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR018469
- CNTO328MCD2002 (Other Identifier: Janssen Research & Development, LLC)
- 2010-022837-27 (EudraCT Number)
Drug and device information, study documents
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Multicentric Castleman's Disease
-
EusaPharma (UK) LimitedTerminatedIdiopathic Multicentric Castleman's DiseaseUnited States
-
EusaPharma (UK) LimitedUniversity of Sheffield (ScHARR); KMC Health Care; Castleman Disease Collaborative...Not yet recruitingIdiopathic Multicentric Castleman's Disease
-
Beijing VDJBio Co., LTD.RecruitingIdiopathic Multicentric Castleman's DiseaseChina
-
Peking Union Medical College HospitalRecruitingZanuburutinib in Relapsed and Refractory iMCD: a Prospective, Single-center, Single-arm Trial (iMCD)Idiopathic Multicentric Castleman's DiseaseChina
-
Peking Union Medical College HospitalRecruitingIdiopathic Multicentric Castleman's DiseaseChina
-
Hoffmann-La RocheCompleted
-
University of PennsylvaniaRecruitingCastleman Disease | Castleman's Disease, MulticentricUnited States
-
Peking Union Medical College HospitalUnknownMulticentric Castleman DiseaseChina
-
UNC Lineberger Comprehensive Cancer CenterFogarty International Center of the National Institute of HealthRecruitingMulticentric Castleman DiseaseMalawi
-
Janssen Research & Development, LLCCompletedMulticentric Castleman's DiseaseUnited States, Canada, France, United Kingdom, China, Germany, Taiwan, Spain, Belgium, Israel, India, Korea, Republic of, Netherlands, Singapore, Brazil, Russian Federation, New Zealand, Hungary, Norway, Australia, Egypt, Hong Kong, Malaysi...
Clinical Trials on Siltuximab
-
Carla Greenbaum, MDJanssen Research & Development, LLCCompleted
-
Centocor, Inc.CompletedLymphoma, Non-Hodgkin | Multiple Myeloma | Giant Lymph Node HyperplasiaUnited States
-
University of Alabama at BirminghamRecruitingLymphoma, Non-Hodgkin | Multiple Myeloma | Acute Lymphoblastic Leukemia | Cytokine Release Syndrome | ICANSUnited States
-
Janssen Research & Development, LLCCompletedHigh-risk Smoldering Multiple MyelomaUnited States, United Kingdom, Belgium, Germany, France, Spain, Korea, Republic of, Australia, Israel, Greece, Sweden
-
Janssen Research & Development, LLCCompletedMultiple Myeloma | Monoclonal Gammopathy of Undetermined Significance | Plasma Cell NeoplasmUnited States, Belgium, Russian Federation
-
Centocor, Inc.Completed
-
EusaPharma (UK) LimitedTerminatedIdiopathic Multicentric Castleman's DiseaseUnited States
-
H. Lee Moffitt Cancer Center and Research InstituteEUSA Pharma, Inc.RecruitingLarge Granular Lymphocyte LeukemiaUnited States
-
Centocor, Inc.CompletedCarcinoma, Renal CellFrance, United Kingdom, Netherlands, Czech Republic
-
Janssen Research & Development, LLCTerminatedMyelodysplastic SyndromeUnited States, Belgium, Spain, Australia, Sweden, Netherlands, Russian Federation