NCT07340723 Novel First-line Therapies for Grade II Acute GVHD(Graft-versus-host Disease )
| NCT ID | NCT07340723 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Daihong Liu |
| Condition | GVHD,Acute |
| Study Type | INTERVENTIONAL |
| Enrollment | 168 participants |
| Start Date | 2025-06-01 |
| Primary Completion | 2027-06-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 168 participants in total. It began in 2025-06-01 with a primary completion date of 2027-06-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Diagnosed with hematological diseases. 2. 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. 3. New onset of grade II acute GVHD or intermediate or high risk aGVHD (based on modified GVHD Glucksberg criteria) within 100 days post-transplantation. Exclusion Criteria: 1. Recipients of second allogeneic stem cell transplant. 2. Acute GVHD induced by donor lymphocyte infusion, interferon. 3. Received first line aGVHD treatment before enrollment. 4. Overlap GVHD syndrome. 5. Pregnant or breast-feeding women. 6. Pregnant or breast-feeding women. 7. Serum creatinine \> 2.0 mg/dL or creatinine clearance \< 40 mL/min measured or calculated by Cockroft-Gault equation. 8. Uncontrolled infection. 9. Human immunodeficiency virus infection. 10. Active hepatitis b virus, hepatitis C virus infection and need antivirus treatment. 11. Subjects with evidence of relapsed primary disease, or subjects who have been treated for relapse after the allo-HSCT was performed, or graft rejection. 12. Allergic history to Janus kinase inhibitors. 13. Severe organ dysfunction unrelated to underlying GVHD, including: (1)Cholestatic disorders or unresolved veno-occlusive disease of the liver (defined as persistent bilirubin abnormalities not attributable to GVHD and ongoing organ dysfunction). (2)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. (3)Clinically significant respiratory disease that requires mechanical ventilation support or 50% oxygen. 14.Received Janus kinase inhibitor therapy after allo-HSCT for any indication. 15.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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07340723 clinical trial?
This trial is open to participants of all sexes, aged 14 Years or older, studying GVHD,Acute. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07340723 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07340723 currently recruiting?
Yes, NCT07340723 is actively recruiting participants. Contact the research team at lipingruirui@163.com for enrollment information.
Where is the NCT07340723 trial being conducted?
This trial is being conducted at Beijing, China.
Who is sponsoring the NCT07340723 clinical trial?
NCT07340723 is sponsored by Daihong Liu. The trial plans to enroll 168 participants.