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

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

Detailed Description
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The investigators will evaluate clinical response rate, time to treatment Failure (TTF), overall survival (OS), and toxicity in cGVHD patients.

Official Title
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Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent Chronic Graft-versus-host-disease

Conditions
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Chronic Graft-versus-host Disease

Intervention / Treatment
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* Drug: Hydrogen


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hydrogen<br>Patients will receive hydrogen-rich water (4mL/kg three times one day, 0.8 ppm) | Drug: Hydrogen<br>* Patients will receive hydrogen-rich water orally (500mL three times one day, 0.6mM)<br>* Other names: Hydrogen-rich water;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Response Rate (ORR) | Overall Response Rate (ORR) is defined as an Objective improvement at sixth month, and includes at least 1 of the following criteria: At least 50% reduction of body surface area involved; Reduction (at least 20%) of skin sclerosis, measured by Rodnan score Improvement>1 point in functional pulmonary tests, evaluated by LFS score; >50% steroid reduction (for at least 4 weeks) | 12 months after date of start of Hydrogen | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response Rate in each domain (RRD) | Response rate in each domain was measured in subjects that had had initial involvement in that domain | 12 months after date of start of Hydrogen |