A Study of Ruxolitinib in Patients With Graft-Versus Host Disease
ConditionGraft-Versus-Host Disease
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age0+
SponsorNovartis Pharmaceuticals
About this trial
This study aims to evaluate the safety and effectiveness of Jakavi® (ruxolitinib) in patients with acute graft-versus host disease (GVHD) and chronic GVHD in clinical practice.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with acute and chronic GVHD
Patients treated with ruxolitinib
Disqualifiers
None
Trial population
Patients treated with ruxolitinib for acute and chronic GVHD after its approval.
Trial design
Design model
Cohort
Time perspective
Retrospective
Treatments tested in this trial
Not listed
Trial groups
395 Participants
are grouped into 1 trial groupGroup A: Ruxolitinib Cohort
Trial outcomes
Primary outcomes
1
Number and Percentage of Patients With Common Terminology Criteria for Adverse Event (CTCAE) Grade ≥ 3 Infections
Grade ≥ 3 infections according to the CTCAE v5.0.
Time frame
Up to 1 year2
Number and Percentage of Deaths Due to Infection
Time frame
Up to 1 year3
Time to First Event
Time to first event is defined as the time from the start date of treatment with ruxolitinib to the first onset date of infection. Grade ≥ 4 infections according to the CTCAE v5.0.
Time frame
Up to 1 yearSecondary outcomes
1
Number and Percentage of CTCAE Grade ≥ 3 Infections
Grade ≥ 3 infections according to the CTCAE v5.0.
Time frame
Up to 1 year2
Odds Ratio of CTCAE Grade ≥ 3 Infections
Odds ratios of infections and their 95% confidence intervals summarized by risk factors for infection.
Time frame
Up to 1 year3
Number and Percentage of Patients With Adverse Events Other Than Infections
Time frame
Up to 1 year4
Number and Percentage of Patients who Died From Reasons Other Than Infection
Time frame
Up to 1 yearSponsors and contacts
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Source ClinicalTrials.gov