First Line Therapy for High Risk Acute GVHD

  • STATUS
    Recruiting
  • End date
    Dec 30, 2025
  • participants needed
    198
  • sponsor
    Chinese PLA General Hospital
Updated on 1 June 2021
cancer
corticosteroids
graft versus host disease
hematologic malignancy
blood disorder
cell transplantation
acute graft-versus-host disease
hematologic disorders

Summary

The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the Treatment of High risk aGVHD(acute graft-versus-host disease )

Description

Acute graft-versus-host disease (aGVHD) is treated with systemic corticosteroid immunosuppression as first line therapy. Many patients with high risk aGVHD do not respond to primary therapy, high-dose systemic corticosteroids; therefore, survival for those patients remains particularly poor. Here we determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for the Treatment of High risk aGVHD.

Details
Condition Acute Graft-versus-Host Disease, Acute GVHD, Acute Graft Versus Host Disease, Stem Cell Transplant Complications, aGVHD
Treatment Ruxolitinib, Corticosteroid
Clinical Study IdentifierNCT04061876
SponsorChinese PLA General Hospital
Last Modified on1 June 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

diagnosed with hematological diseases
Have undergone first allogeneic hematopoietic stem cell transplantation (allo-HSCT) from any donor source using bone marrow, peripheral blood stem cells, or cord blood for hematologic malignancies
new onset of grade II~IV aGVHD or intermediate or high risk aGVHD (based on ST2, REG3a, other experimental objects) within 100 days post-transplantation

Exclusion Criteria

recipients of second allogeneic stem cell transplant
acute GVHD induced by donor lymphocyte infusion, interferon
received first line aGVHD treatment before enrollment
overlap GVHD syndrome
pregnant or breast-feeding women
absolute neutrophil count (ANC) <0.510e9/L or platelet count (PLT) < 2010e9/L
Serum creatinine > 2.0 mg/dL or creatinine clearance < 40 mL/min measured or calculated by Cockroft-Gault equation
uncontrolled infection
human immunodeficiency virus infection
active hepatitis b virus, hepatitis C virus infection and need antivirus treatment
Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allo-HSCT was performed, or graft rejection
allergic history to Janus kinase inhibitors
Severe organ dysfunction unrelated to underlying GVHD, including
Cholestatic disorders or unresolved veno-occlusive disease of the liver
(defined as persistent bilirubin abnormalities not attributable to GVHD and
ongoing organ dysfunction)
Clinically significant or uncontrolled cardiac disease including unstable
angina, acute myocardial infarction within 6 months from Day 1 of study drug
administration, New York Heart Association Class III or IV congestive heart
failure, circulatory collapse requiring vasopressor or inotropic support, or
arrhythmia that requires therapy
Clinically significant respiratory disease that requires mechanical
ventilation support or 50% oxygen
\. Received Janus kinase inhibitor therapy after allo-HSCT for any
indication
\. Any condition that would, in the investigator's judgment, interfere with
full participation in the study, including administration of study drug and
attending required study visits; pose a significant risk to the subject; or
interfere with interpretation of study data
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