Trials Sponsors Conditions Drugs Pricing

Conditions

Chronic Graft vs Host Disease

Keywords

ChronicIbrutinibRetrospectiveProspective

Outcome Measures

Primary Outcomes (1)

Part A and Part B: Percentage of Participants with Overall Response Rate
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.
Week 24

Secondary Outcomes (5)

Part B: Rate of Sustained Response
At least 5 months (up to 36 weeks)
Part B: Duration of Response
Up to 5 months
Part A and Part B: Corticosteroid Requirement Changes Over Time
Up to 24 weeks
Part B: Time to cGVHD Progression
Up to 36 weeks
Part B: Change in Lee cGVHD Symptom Scale
Up to 36 weeks

Study Arms (2)

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.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Participants with steroid dependent or refractory chronic graft versus host disease (cGVHD) will be included.

You may qualify if:

Part A and Part B

Sponsors & Collaborators

Janssen Korea, Ltd., Korea
Industrylead

Study Sites (8)

Soonchunhyang University Bucheon Hospital

Bucheon-si, 14584, South Korea

Pusan National University Hospital

Busan, 49241, South Korea

Kyungpook National University Hospital

Daegu, 41944, South Korea

Seoul National University Hospital

Seoul, 03080, South Korea

Severance Hospital

Seoul, 03722, South Korea

Soonchunhyang University Seoul Hospital

Seoul, 04401, South Korea

Samsung Medical Center

Seoul, 06351, South Korea

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Study Officials

Janssen Korea, Ltd., Korea Clinical Trial
Janssen Korea, Ltd., Korea
STUDY DIRECTOR

Enrollment

15 participants (actual enrollment reported by the registry).

Study Design

Study Type: observational
Observational Model: COHORT
Time Perspective: PROSPECTIVE
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

April 16, 2021

First Posted

April 21, 2021

Study Start

June 21, 2021

Actual (reported)

Study Stopped

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Part A: Retrospective Phase

Part B: Prospective Phase

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (5)

Study Arms (2)

Part A: Retrospective Phase

Part B: Prospective Phase

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (8)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations