Comparing the Therapeutic Effects of Using Ruxolitinib and Steroids Concurrently to Steroids Alone as Initial Treatment In Patients Diagnosed With Chronic Graft-versus-host Disease at a Grade of Moderate or Higher Severity

PHASE2RecruitingINTERVENTIONAL
Enrollment

88

Participants

Timeline

Start Date

January 15, 2025

Primary Completion Date

November 1, 2027

Study Completion Date

August 31, 2029

Conditions
GVHD - Graft-Versus-Host DiseaseNeoplasmsHaematopoietic Stem Cell Transplantation
Interventions
DRUG

Prednisone + Jakavi(ruxolitinib)

"The experimental group will receive ruxolitinib 10 mg orally twice daily (BID) and prednisone (or equivalent) at a dosage of 1 mg/kg/day.~Subjects are orally administered with an investigational medicinal product (IMP) according to their designated treatment group for 48 weeks, and the investigator may adjust the dosage of IMPs based on symptoms of the target disease. (However, after the 48-week mark, participants in the ruxolitinib treatment group may continue to receive ruxolitinib for an additional maximum of 2 years, based on the investigator's judgment regarding the need for ongoing treatment. The total duration of ruxolitinib administration will not exceed 3 years.)"

DRUG

Prednisone

"The control group will receive prednisone (or equivalent) at a dosage of 1 mg/kg/day.~Subjects are orally administered with an investigational medicinal product (IMP) according to their designated treatment group for 48 weeks, and the investigator may adjust the dosage of IMPs based on symptoms of the target disease."

Trial Locations (1)

06591

RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital, Seoul

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Byung-Sik Cho

OTHER