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Trial record 3 of 23 for:    "Angiomatous lymphoid hamartoma"

A Study to Evaluate the Efficacy and Safety of CNTO328 Plus Best Supportive Care in Multicentric Castleman's Disease

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ClinicalTrials.gov Identifier: NCT01024036
Recruitment Status : Completed
First Posted : December 2, 2009
Results First Posted : August 20, 2014
Last Update Posted : March 21, 2018
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Multicentric Castleman's Disease
Interventions: Drug: Siltuximab
Drug: Placebo
Drug: Best Supportive Care (BSC)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
79 participants were enrolled at 38 study centers in 19 countries. The first participant signed the informed consent on 09 Feb 2010, and the last participant's last visit for the primary analysis was 28 Feb 2013. The data until the end of study is presented here.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
79 participants were enrolled, randomized and treated during the blinded treatment period. 53 received siltuximab+best supportive care (BSC) and 26 received placebo+BSC.13 participants who did not respond to placebo+BSC during the blinded treatment period, received siltuximab+BSC during the unblinded treatment period.

Reporting Groups
  Description
Siltuximab + Best Supportive Care (BSC) Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Placebo + Best Supportive Care (BSC) Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.

Participant Flow for 3 periods

Period 1:   Blinded Treatment
    Siltuximab + Best Supportive Care (BSC)   Placebo + Best Supportive Care (BSC)
STARTED   53   26 
COMPLETED   31   6 
NOT COMPLETED   22   20 
Adverse Event                1                1 
Lack of Efficacy                16                14 
Physician Decision                1                0 
Death                0                2 
Withdrawal by Subject                4                3 

Period 2:   Unblinded Treatment
    Siltuximab + Best Supportive Care (BSC)   Placebo + Best Supportive Care (BSC)
STARTED   0 [1]   13 [2] 
COMPLETED   0   10 
NOT COMPLETED   0   3 
Adverse Event                0                1 
Lack of Efficacy                0                2 
[1] No participants in this group received treatment during unblinded treatment period
[2] Placebo participants had an option to receive siltuximab in unblinded treatment period

Period 3:   Follow-Up Period
    Siltuximab + Best Supportive Care (BSC)   Placebo + Best Supportive Care (BSC)
STARTED [1]   14   6 
COMPLETED   9   3 
NOT COMPLETED   5   3 
Lost to Follow-up                1                1 
Withdrawal by Subject                0                1 
Adverse Event                4                1 
[1] Any participant who discontinued blinded/unblinded treatment could entered Follow-up period



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Placebo + Best Supportive Care (BSC) Participants received placebo as a 1-hour IV infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. If a participant had documented treatment failure and wished to continue treatment, the participant’s treatment assignment was unblinded. Upon unblinding placebo participants who received blinded treatment had an option to receive unblinded treatment with siltuximab. Participants who discontinued or completed treatment period up to Week 48 and who consented to enter follow-up period were continued to be followed up during the course of follow-up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50% of participants, or end of the study, whichever occurred earlier.
Siltuximab + Best Supportive Care (BSC) Participants received siltuximab 11 milligram per kilogram (mg/kg) as a 1 hour intravenous (IV) infusion every 3 weeks along with BSC until treatment failure, discontinuation of treatment, withdrawal from study, or until 48 weeks after last participant started study treatment, whichever occurred earlier. Participants who discontinued treatment for any reason, completed End-of-Treatment (EOT) visit and entered Follow-up period. If a participant had documented treatment failure and wished to continue treatment, participant’s treatment assignment was unblinded. Upon unblinding, if participant was assigned to siltuximab, study treatment was discontinued, and the participant completed EOT Visit and enter Follow up period (up to 3 months after last study drug intake) wherein participants were followed until death, lost to follow-up, withdrawal of consent, death of 50 percent (%) of participants, or end of the study, whichever occurred earlier.
Total Total of all reporting groups

Baseline Measures
   Placebo + Best Supportive Care (BSC)   Siltuximab + Best Supportive Care (BSC)   Total 
Overall Participants Analyzed 
[Units: Participants]
 26   53   79 
Age 
[Units: Years]
Mean (Standard Deviation)
 47.7  (13.4)   44.4  (13.32)   45.5  (13.35) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      4  15.4%      23  43.4%      27  34.2% 
Male      22  84.6%      30  56.6%      52  65.8% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
AUSTRALIA   0   1   1 
BELGIUM   0   3   3 
BRAZIL   2   4   6 
CANADA   1   0   1 
CHINA   5   11   16 
EGYPT   1   0   1 
FRANCE   2   2   4 
GERMANY   1   0   1 
HONG KONG   2   3   5 
ISRAEL   1   1   2 
NEW ZEALAND   1   1   2 
NORWAY   1   1   2 
RUSSIAN FEDERATION   0   3   3 
SINGAPORE   0   3   3 
SOUTH KOREA   2   4   6 
SPAIN   1   1   2 
TAIWAN   1   3   4 
UNITED KINGDOM   1   2   3 
UNITED STATES   4   10   14 


  Outcome Measures

1.  Primary:   Percentage of Participants Who Achieved Durable Tumor and Symptomatic Response - by Independent Radiology Review   [ Time Frame: 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 ]

2.  Secondary:   Median Duration of Tumor and Symptomatic Response - by Independent Radiology Review   [ Time Frame: 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) ]

3.  Secondary:   Percentage of Participants Who Achieved Complete Response (CR) + Partial Response (PR) (Tumor Response Rate) - by Independent Radiology Review   [ Time Frame: 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) ]

4.  Secondary:   Median Duration of Tumor Response - by Independent Radiology Review   [ Time Frame: 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) ]

5.  Secondary:   Time to Treatment Failure   [ Time Frame: 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 ]

6.  Secondary:   Percentage of Participants Who Achieved Greater Than or Equal to (>=) 15 Gram Per Liter (g/L) Hemoglobin at Week 13 (Hemoglobin Response Rate)   [ Time Frame: Week 13 ]

7.  Secondary:   Percentage of Participants Who Achieved >= 20 g/L Hemoglobin at Week 13 (Hemoglobin Response Rate)   [ Time Frame: Week 13 ]

8.  Secondary:   Percentage of Participants Who Discontinued Corticosteroids   [ Time Frame: From Day 1 of Cycle 1 until 48 weeks after the after the last participant started study treatment (approximately 3 years) ]

9.  Secondary:   6-year Survival Rate   [ Time Frame: until 6 years ]

10.  Secondary:   Median Time Required to Achieve >=1 Point Decrease in the Multicentric Castleman’s Disease Symptom Scale (MCD-SS) Score From Baseline   [ Time Frame: From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years) ]

11.  Secondary:   Median Time Required to Achieve >=3-point Increase in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scores From Baseline   [ Time Frame: From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years) ]

12.  Secondary:   Median Time Required to Achieve >=5-point Increase in the Short-Form-36 (SF-36) Physical Component Summary (PCS) Scores From Baseline   [ Time Frame: From Day 1 of Cycle 1 (baseline) until 48 weeks after the last participant started study treatment (approximately 3 years) ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: DIRECTOR CLINICAL RESEARCH
Organization: Janssen R&D US
e-mail: ClinicalTrialDisclosure@its.jnj.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Janssen Research & Development, LLC
ClinicalTrials.gov Identifier: NCT01024036     History of Changes
Other Study ID Numbers: CR016705
CNTO328MCD2001 ( Other Identifier: Janssen Research & Development, LLC )
2009-012380-34 ( EudraCT Number )
First Submitted: November 30, 2009
First Posted: December 2, 2009
Results First Submitted: May 16, 2014
Results First Posted: August 20, 2014
Last Update Posted: March 21, 2018