Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent cGVHD

• Status: Recruiting
• Trial end date: 2031-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study suggested that hydrogen has a potential as an effective and safe therapeutic agent on cGVHD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Navy General Hospital, Beijing

Criteria

Inclusion Criteria:

• Written informed consent

• Male

• not pregnant female

• patients <65 years old

• Diagnosis of cGVHD steroid refractory (no response after Prednisone ≥1mg/kg ) or steroid-dependent cGVHD (had an initial response followed by a cGVHD flare upon steroid taper)

• Patient intolerant to steroid therapy

Exclusion Criteria:

• Patients with stable disease, not well controlled by the current treatment

• Pregnancy

• HIV positive

• Severe liver or renal impairment: serum creatinine >2.5 mg/dl; serum bilirubin>2.5 mg/dl (without evidence of hepatic cGVHD)

• Uncontrolled malignancies including the persistence of the underlying malignancy before the Allogeneic Transplantation and the relapse of hematopoietic malignancy

• Any other investigational agents administered within last four weeks

• Cardiac insufficiency (>grade II, New York Heart Association classification)

• Inability to comply with medical therapy or follow-up