Low Dose Ruxolitinib in Combination With Methylprednisolone

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    32
  • sponsor
    Chinese PLA General Hospital
Updated on 25 January 2021
cancer
corticosteroids
graft versus host disease
hematologic malignancy
blood disorder
cell transplantation
ruxolitinib 5 mg
regenerating islet derived protein 3
acute graft-versus-host disease
hematologic disorders

Summary

This study is to determine the efficacy and safety of combined Low dose Ruxolitinib With Methylprednisone as Initial Therapy for the aGVHD(acute graft-versus-host disease )

Description

Corticosteroid is used as a first-line treatment for acute GVHD. However, it is effective in only about half of patients. In this prospective study, the investigators prospectively combined low dose ruxolitinib and 1mg/kg methylprednisolone in the initial treatment of acute GVHD. In order to effectively control GVHD without exposing acute GVHD patients to more intense and prolonged immunosuppression, we used ruxolitinib (20mg/day, 10mg/day, 5mg/day, 2.5mg/day) combined with 1mg/kg methylprednisolone. To ally steroid-related complications, we decreased steroid exposure time (39 days) and cumulative methylprednisolone doses (15.4 mg/kg) to spare the associated toxicity of glucocorticoid therapy.

Details
Condition Acute Graft-versus-Host Disease, Acute GVHD, Acute Graft Versus Host Disease, Stem Cell Transplant Complications, aGVHD
Treatment ruxolitinib and 1mg/kg methylprednisolone, Ruxolitinib 10 mg twice a day combined with Corticosteroids, Ruxolitinib 5 mg twice a day combined with Corticosteroids, Ruxolitinib 5 mg once a day combined with Corticosteroids, Ruxolitinib 2.5 mg once a day combined with Corticosteroids
Clinical Study IdentifierNCT04397367
SponsorChinese PLA General Hospital
Last Modified on25 January 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 high risk aGVHD [based on suppression of tumorigenicity 2 (also ST2), Regenerating Islet Derived Protein 3 Alpha (also REG3a), 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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