Study of Hydrogen Therapy for Steroid-Refractory or Steroid-Dependent Chronic Graft-versus-Host Disease in Patients Up to 65 Years Old

What this Trial Is About

Researchers are studying the potential effects of hydrogen as a treatment for patients with chronic graft-versus-host disease cGVHD who are either steroid-refractory or steroid-dependent. This phase 2 trial aims to evaluate the clinical response rate, time until treatment failure, overall survival, and any toxic effects in these patients, addressing the need for alternative therapies in cases where steroids are not effective or tolerated. Participants in this study will receive hydrogen-rich water orally at a dose of 4 mL per kg of body weight, three times per day, with a concentration of 0.8 ppm. The treatment will be monitored over a 12-month period to assess its impact. This trial does not include a placebo or comparator group and is unblinded. During the study, researchers will track overall response rate at 12 months after starting hydrogen treatment along with response rates in various disease domains. Patients will be regularly assessed for survival, treatment failure, and any side effects. The study is sponsored by Navy General Hospital, Beijing, and participants may be involved up to 12 months from treatment start, with ongoing monitoring throughout this time.

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