Chronic Graft-versus-host Disease
Conditions
Brief summary
This study suggested that hydrogen has a potential as an effective and safe therapeutic agent on cGVHD.
Detailed description
The investigators will evaluate clinical response rate, time to treatment Failure (TTF), overall survival (OS), and toxicity in cGVHD patients.
Interventions
DRUGHydrogen
Patients will receive hydrogen-rich water orally (500mL three times one day, 0.6mM)
Sponsors
Navy General Hospital, Beijing
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate (ORR) | 12 months after date of start of Hydrogen | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Response Rate in each domain (RRD) | 12 months after date of start of Hydrogen | Response rate in each domain was measured in subjects that had had initial involvement in that domain |
Countries
China
Contacts
Primary ContactLiren Qian, M.D.
Outcome results
None listed