Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Investigate the Comparative Effectiveness of Ibrutinib in Steroid Dependent/Refractory cGVHD Participants

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04852692
Recruitment Status : Recruiting
First Posted : April 21, 2021
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
Janssen Korea, Ltd., Korea

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of this study is to evaluate the effectiveness of ibrutinib compared to conventional salvage treatments in participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) by measuring overall cGVHD response (modified National Institutes of Health [NIH] response defined complete response [CR] and partial response [PR]) at Week 24.

Condition or disease
Chronic Graft vs Host Disease

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 224 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Retrospective/Prospective, Multicenter, Non-interventional, Historical Control Study Investigating Comparative Effectiveness of IMBRUVICA in Steroid Dependent/Refractory cGVHD Patients
Actual Study Start Date : July 9, 2021
Estimated Primary Completion Date : January 31, 2025
Estimated Study Completion Date : January 31, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ibrutinib

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
Part A: Retrospective Phase
Retrospective collection of data for eligible participants with steroid dependent/refractory chronic graft versus host disease (cGVHD) who initiated salvage treatments from initiation point (administration starting point of the salvage treatment) of the identified last-line of conventional salvage therapy for cGVHD treatment as their second-forth line therapy and will be collected for up to 24 weeks from the initiation point.
Part B: Prospective Phase
Prospectively enroll participants with steroid dependent/refractory cGVHD that are decided to be treated with ibrutinib in second-fourth line therapy for the treatment of cGVHD. Participants will continue to receive corticosteroids as a standard of care.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Part A and Part B: Percentage of Participants with Overall Response Rate [ Time Frame: Week 24 ]
    Overall response rate is defined as the percentage of participants who achieve complete response (CR) or partial response (PR) according to modified National Institutes of Health (NIH) response.


Secondary Outcome Measures :
  1. Part B: Rate of Sustained Response [ Time Frame: At least 5 months (up to 36 weeks) ]
    Sustained response rate will be assessed.

  2. Part B: Duration of Response [ Time Frame: Up to 5 months ]
    Duration of response will be assessed.

  3. Part A and Part B: Corticosteroid Requirement Changes Over Time [ Time Frame: Up to 24 weeks ]
    The change of the corticosteroid dose requirement during the treatment will be assessed.

  4. Part B: Time to cGVHD Progression [ Time Frame: Up to 36 weeks ]
    Time to chronic graft versus host disease (cGVHD) progression is defined as the time from the first dose of the ibrutinib to modified NIH response defined progression.

  5. Part B: Change in Lee cGVHD Symptom Scale [ Time Frame: Up to 36 weeks ]
    Change in Lee cGVHD symptom scale will be assessed. It is a participant reported improvement in symptom burden.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants with steroid dependent or refractory chronic graft versus host disease (cGVHD) will be included.
Criteria

Inclusion Criteria:

Part A and Part B

  • Must have a confirmed diagnosis of steroid dependent or refractory classic cGVHD defined at any time post-hematopoietic cell transplantation (HCT) as: a) refractory disease - progressive cGVHD manifestations requiring prednisolone at greater than or equal to (>=) 1 milligram per kilogram per day (mg/kg/day) for at least 1 week or persist without improvement despite continued treatment with glucocorticoid (prednisolone at >= 0.5 mg/kg/day or 1 mg/kg every other day) for at least 4 weeks; b) dependent disease: persistent cGVHD manifestations requiring glucocorticoid >= prednisolone 0.25 mg/kg/day or >=0.5mg/kg every other day for at least 8 weeks Part A
  • Treated at least 2 or more therapies for cGVHD (including glucocorticoids)
  • Participants whose identified last line of conventional salvage treatment is second-fourth line of therapy
  • Index date (initiation date of the identified last-line of conventional salvage therapy) at least 28 weeks before the study initiation date Part B
  • Treated at least 3 lines therapies for cGVHD (including glucocorticoids)
  • Participants who are treated with ibrutinib in their second-fourth line of therapy

Exclusion Criteria:

Part A and Part B

  • Known or suspected active acute GVHD
  • Received an investigational drug (including investigational vaccines) or used an invasive investigational medical device within 28 days Part A
  • Treated with an investigational agent for their identified last-line of conventional salvage therapy
  • Pregnant, breastfeeding during last-line of conventional salvage therapy Part B
  • Pregnant, breast-feeding, or of childbearing potential without a negative serum or urine pregnancy test within 7 days of enrollment. Male or female participants of childbearing potential unwilling to use effective contraceptive precautions throughout the trial
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04852692


Contacts
Layout table for location contacts
Contact: Study Contact 844-434-4210 JNJ.CT@sylogent.com

Locations
Layout table for location information
Korea, Republic of
Soonchunhyang University Bucheon Hospital Recruiting
Bucheon-Si, Korea, Republic of, 14584
Pusan National University Hospital Recruiting
Busan, Korea, Republic of, 49241
Kyungpook National University Hospital Recruiting
Daegu, Korea, Republic of, 41944
Chungnam National University Hospital Completed
Daejeon, Korea, Republic of, 35015
Chonnam National University Hwasun Hospital Withdrawn
Hwasun, Korea, Republic of, 58128
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 03080
Severance Hospital Recruiting
Seoul, Korea, Republic of, 03722
Soonchunhyang University Seoul Hospital Recruiting
Seoul, Korea, Republic of, 04401
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 06351
The Catholic University of Korea, Seoul St. Mary's Hospital Recruiting
Seoul, Korea, Republic of, 06591
Sponsors and Collaborators
Janssen Korea, Ltd., Korea
Investigators
Layout table for investigator information
Study Director: Janssen Korea, Ltd., Korea Clinical Trial Janssen Korea, Ltd., Korea
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Additional Information:

Layout table for additonal information
Responsible Party: Janssen Korea, Ltd., Korea
ClinicalTrials.gov Identifier: NCT04852692    
Other Study ID Numbers: CR108945
54179060GVH4001 ( Other Identifier: Janssen Korea, Ltd., Korea )
First Posted: April 21, 2021    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Janssen Korea, Ltd., Korea:
Chronic
Ibrutinib
Retrospective
Prospective
Additional relevant MeSH terms:
Layout table for MeSH terms
Graft vs Host Disease
Immune System Diseases