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

Phase 2

Recruiting

• Conditions: Chronic Graft-versus-host Disease
• Interventions: Drug: Hydrogen

• Registration Number: NCT02918188
• Lead Sponsor: Navy General Hospital, Beijing

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-27
• Study First Posted: 2016-09-28
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-17
• Last Update Posted: 2020-07-21
• Primary Completion: 2026-01
• Study Completion: 2031-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hydrogen	Hydrogen	Patients will receive hydrogen-rich water (4mL/kg three times one day, 0.8 ppm)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Navy General Hospital; 🇨🇳 Beijing, Beijing, China