Hydrogen treatment for chronic graft-versus-host disease
Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent Chronic Graft-versus-host-disease
This study is testing if hydrogen treatment can help people with chronic graft-versus-host disease who haven't responded well to steroid medications.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 21 (estimated) |
| Ages | N/A to 65 Years |
| Sex | All |
| Sponsor | Navy General Hospital, Beijing Academic / other |
| Drugs / interventions | Prednisone |
| Locations | 1 site (Beijing, Beijing Municipality) |
| Trial ID | NCT02918188 on ClinicalTrials.gov |
What this trial studies
This study evaluates the therapeutic effects of hydrogen in patients with steroid-refractory or steroid-dependent chronic graft-versus-host disease (cGVHD). The investigators will assess clinical response rates, time to treatment failure, overall survival, and toxicity associated with hydrogen treatment. The aim is to determine if hydrogen can serve as an effective and safe alternative therapy for patients who do not respond to standard steroid treatments.
Who should consider this trial
Good fit: Ideal candidates for this study are male patients under 65 years old with steroid-refractory or steroid-dependent cGVHD.
Not a fit: Patients with stable disease not well controlled by current treatment or those with severe liver or renal impairment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from chronic graft-versus-host disease who are unresponsive to steroids.
How similar studies have performed: While the use of hydrogen as a therapeutic agent is novel, other studies have explored alternative treatments for cGVHD, but the efficacy of hydrogen specifically remains untested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Beijing, Beijing Municipality
- Navy General Hospital — Beijing, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Liren Qian, M.D.
- Email: qlr2007@126.com
- Phone: +861066957676
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.