None listed
Conditions
Interventions
Drug : Participants will receive the investigational medicinal product and/or combination therapy for 48 weeks from the date of randomization into the treatment group. The experimental group will rece
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Adult men and women aged 19 or older based on the date of signing on the informed consent form 2) On the screening visit, those who are diagnosed of a moderate to severe chronic graft-versus-host disease according to 2014 NIH consensus criteria -Moderate: At least one of the following conditions: >1 point for at least three organs >2 points for at least one organ except the lungs >1 point for the lungs -Severe: At least one of the following conditions: >3 points for at least one organ >At least 2 points for the lungs 3) Those who have no history of systemic treatment for chronic graft-versus-host disease and now need systemic corticosteroid treatment 4) Those whose ECOG (Eastern Cooperative Oncology Group) performance status is 0 to 2. 5) Regardless of the donor (matched sibling-family donor, matched unrelated donor, or partially matched family donor), those who have successfully taken same-type stem cell transplantation (alloSCT) from the marrow, peripheral blood stem cell, or cord blood 6) Those who voluntarily agree on participation in this clinical trial
Exclusion criteria
Exclusion criteria: 1) Those who meet the following criteria in laboratory tests during the screening and randomization visits -Those whose platelet count is less than or equal to 25,000/mm3 without blood transfusion -Those whose absolute neutrophil count is less than or equal to 1,000/mm3 -Those whose total bilirubin > 3 x ULN for any reason other than chronic graft-versus-host disease 2) Those with gastrointestinal troubles that hinder the intake and absorption of IMPs and concomitant medicines (systemic corticosteroid) (e.g.: signs such as ulcerative disease, unregulated nausea, vomiting, diarrhea, malabsorption, etc. or small intestine removal) 3) Those with a history of graft-versus-host disease treatment -Corticosteroid administration is permitted for chronic graft-versus-host disease treatment within 72 hours before the randomization visit -Except those who had therapeutic or preventive use of systemic corticosteroids and/or systemic immunosuppressants (CNI, MMF) for acute graft-versus-host disease (In case of prednisone administration for maintenance, only 0.5 mg/kg/day or less is permitted) 4) Those to whom the treatment for chronic graft-versus-host disease cannot begin as prednisone = 0.5 mg/kg/day 5) Those whose same-type stem cell transplantation (alloSCT) has been confirmed as engraft-failed within 6 months before the screening visit 6) Those with an experience of ruxolitinib administration for acute graft-versus-host disease treatment (however, the patient may participate on the assumption that the response to the acute graft-versus-host disease treatment reaches the level of complete or partial response and that there is no ruxolitinib administration history within 4 weeks before the randomization visit. In addition, if ruxolitinib administration was for another disease, the patient may participate unless there is no history of ruxolitinib administration within 4 weeks before the randomization visit.) 7) Those who suffer chronic graft-versus-host disease after an unscheduled donor lymphocyte infusion for proactive treatment to prevent the recurrence of a malignant tumor (Participation is allowed if the scheduled lymphocyte infusion is performed as part of the transplantation procedure, not for the prevention of the recurrence of a malignant tumor.) 8) Those found to have the following history in the screening visit: -Relapsed primary malignancy -Those found to involve an unregulated sinusoidal obstruction syndrome -Those with a history of progressive multifocal leukoencephalopathy (PML) -Nephropathy whose creatinine clearance rate is lower than 30 mL/min (Cockroft Gault equation) -Infections that are clinically active and uncontrolled, requiring treatment, including significant bacteria, fungi, viruses, or parasitic infections. (However, if there are no signs of progression at the time of screening due to appropriate treatment, the infection is considered controlled. The progression of infection is defined by hemodynamic instability due to sepsis, new symptoms caused by the infection, worsening physical signs, or radiological findings. A persistent fever without other signs or symptoms is not interpreted as progressive infection.) -Active tuberculosis -HIV-infected individual -Active infection of hepatitis B virus (HBV) or hepatitis C virus (HCV) that the investigator views as significant -Cardiovascular disease that the investigator considers as clinically significant (acute cardiac infarction (within 6 months before randomization), NYHA c
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall Response Rate(ORR) based on NIH Consensus Criteria | — |
Secondary
| Measure | Time frame |
|---|---|
| Ratio of subjects who are found steroid-refractory or steroid-dependent;Overall Response Rate (ORR) based on the NIH Consensus Criteria;Failure-free Survival (FFS);Duration of Response (DOR);Ratio of subjects whose daily dosage of systemic corticosteroid is reduced as much as at least 50% ;Ratio of subjects whose daily dosage of systemic corticosteroid is reduced ;Time up to the point of stopping systemic immunosuppressant administration (concomitant medicines other than IMPs);Change in FACT-BMT((Functional Assessment of Cancer Therapy – Bone Marrow Transplantation) score;Change in EQ-5D-5L(European Quality of Life 5 Dimension) score | — |
Countries
Korea, Republic of
Contacts
Public ContactDaehun Kwag
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed