Novel First-line Therapies for Grade II Acute GVHD: a Randomized Controlled Trial
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
The purpose of this study is to determine the efficacy and safety of combined Ruxolitinib With Corticosteroids as First Line Therapy for grade II acute GVHD (graft-versus-host disease )
Eligibility
Participation Requirements
Sex: All
Minimum Age: 14
Healthy Volunteers: f
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• 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 acute GVHD or intermediate or high risk aGVHD (based on modified GVHD Glucksberg criteria) within 100 days post-transplantation.
Locations
Other Locations
China
Department of Hematology, Senior Department of Hematology, The Fifth Medical Center of PLA General Hospital
RECRUITING
Beijing
Contact Information
Primary
Liping Dou, M.D., Ph.D.
lipingruirui@163.com
010-66937079
Time Frame
Start Date: 2025-06-01
Estimated Completion Date: 2027-06-01
Participants
Target number of participants: 168
Treatments
Experimental: Ruxolitinib Arm
Ruxolitinib combined with Corticosteroids
Active_comparator: Comparator arm
Related Therapeutic Areas
Sponsors
Leads: Daihong Liu