A PMS of Jakavi® in Patients With Steroid-Refractory Graft-versus-Host Disease (SR-GvHD) in Korea

Recruiting

• Conditions: Graft-versus-Host Disease
• Interventions: Other: ruxolitinib

• Registration Number: NCT05621733
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

This study is a prospective, open-label, multi-center, non-comparative, observational study to assess safety and effectiveness of Jakavi® (ruxolitinib) in the real-world clinical setting in Korean Graft-versus-Host disease (GvHD) patients

Detailed Description

The dosage and duration of treatment may be considered and decided by the investigator in accordance with prescribing information of Jakavi®. All participants who receive at least one dose of the drug and are in the follow-up assessment or early discontinuation (withdrawal) will be the safety population. This study will enroll patients who are newly starting Jakavi® and patients who have been taking Jakavi® prior to study participation. Considering the current clinical practice, a 24 weeks follow-up period of ruxolitinib treatment is needed to assess the safety and the durable effectiveness of the treatment. Mandatory additional safety monitoring will be conducted following the last dose of the treatment for further AE assessments.

Study Timeline

• Study First Submitted: 2022-11-10
• Study First Submitted QC: 2022-11-10
• Study First Posted: 2022-11-18
• Study Start: 2023-04-07
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-11
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-05-13
• Study Completion: 2026-05-13

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 127

Inclusion Criteria

1. Patients who diagnosed with GvHD and currently receiving or going to receive Jakavi® treatment according to locally approved label
2. Patients who are willing to provide written informed consent prior to study enrollment

Exclusion Criteria

1. Patients under 12 years old
2. Patients with contraindication according to locally approved label of Jakavi®
3. Patients who receive or are going to receive any investigational medicine during the observation period.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ruxolitinib	ruxolitinib	Patients currently receiving or going to receive Jakavi® treatment according to locally approved label

Primary Outcome Measures

Name	Time	Method
Proportion of patients with a SAE/ SADR	Up to 24 weeks	Proportion of patients with a serious AE (SAE)/ serious ADR (SADR) will be provided
Proportion of patients with an AE/ ADR	Up to 24 weeks	Proportion of patients with an adverse event (AE)/ adverse drug reaction (ADR) will be provided
Proportion of patients with an UAE/ UADR	Up to 24 weeks	Proportion of patients with an unexpected AE (UAE)/ unexpected ADR (UADR) will be provided
Proportion of patients with a SUAE/ SUADR	Up to 24 weeks	Proportion of patients with a serious unexpected AE (SUAE)/ serious unexpected ADR (SUADR) will be provided

Secondary Outcome Measures

Name	Time	Method
Treatment failure rate	Week 4 and Week 24	Treatment failure will be analyzed to the proportion of all participants demonstrating lack of response except for CR or PR.
Percentage change in CBC	Baseline and Week 24	Percentage change in CBC (hemoglobin, hematocrit, platelets, white blood cell (WBC) counts) will be provided
Death rate	Week 4 and Week 24	Death rate will be provided
Overall response rate (ORR)	Week 4 and Week 24	ORR will be analyzed to the proportion of all participants demonstrating complete response (CR) or partial response (PR).

Trial Locations

Locations (1)

Novartis Investigative Site; 🇰🇷 Taegu, Korea, Republic of