Steroids Combined With Ruxolitinib as First-Line Therapy for Grade II Acute Graft-versus-Host Disease

NCT07576010 | Active Not Recruiting Phase 1

• 1 other identifier: S2026-159-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the efficacy and safety of low-dose corticosteroids combined with ruxolitinib in the treatment of grade II acute graft-versus-host disease (aGVHD) after allogeneic hematopoietic stem cell transplantation.

Conditions

Acute Graft-versus-host Disease

Outcome Measures

Primary Outcomes (1)

• Graft-Versus-Host Disease-Free, Relapse-Free Survival

  Graft-versus-host disease-free, relapse-free survival (GRFS) refers to the time from the start of treatment (or from transplantation) to the first occurrence of any of the following events: grade III-IV acute graft-versus-host disease (aGVHD), chronic graft-versus-host disease (cGVHD) requiring systemic immunosuppressive therapy, disease relapse or progression, or death from any cause.

  1 years after treatment

Secondary Outcomes (9)

• Overall response rate

  28 day after treatment

• overall survival (OS)

  2 years after treatment

• Failure-free survival (FFS)

  2 years after treatment

• Transplant-related mortality (TRM)

  2 years after treatment

• disease free survival (DFS)

  2 years after treatment

Study Arms (1)

Experimental group

EXPERIMENTAL

Patients with grade II acute GVHD who receive low-dose steroids plus ruxolitinib as first-line treatment

Drug: steroids 、ruxolitinib

Interventions

steroids 、ruxolitinib DRUG

Patients with acute grade II GVHD are treated with a combination of methylprednisolone (0.5 mg/kg/day) and ruxolitinib.

Experimental group

Eligibility Criteria

• Age: Up to 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with malignant hematologic diseases eligible for allogeneic hematopoietic stem cell transplantation, including MDS-RAEB, acute leukemia, and chronic phase of CML.
• Availability of an HLA-matched sibling donor, unrelated donor, or haploidentical donor.
• Age ≥ 14 years. 4.Liver function: ALT and AST ≤ 2.5 × upper limit of normal (ULN), total bilirubin ≤ 2 × ULN.
• Renal function: serum creatinine ≤ ULN. 6.Absence of uncontrolled infection or severe psychiatric/psychological disorders.
• Eastern Cooperative Oncology Group (ECOG) performance status score of 0-2. 8.Signed informed consent. 9.Diagnosis of grade II acute GVHD as assessed by the modified Glucksberg grading criteria for acute GVHD.

You may not qualify if:

• Absence of an allogeneic donor. 2.Pregnancy of either the donor or the recipient. 3.Presence of psychiatric disorders or other conditions that preclude compliance with the study protocol.

Sponsors & Collaborators

• Daihong Liu: lead

Study Sites (1)

Chinese PLA General Hospital

Beijing, Beijing Municipality, 100853, China

Location

Study Officials

• Dai-Hong Liu, Dr.

  Chinese PLA General Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 4, 2026
• First Posted: May 8, 2026
• Study Start: January 17, 2025
• Primary Completion (Estimated): December 30, 2027
• Study Completion (Estimated): December 30, 2027
• Last Updated: May 8, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)