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

Chronic Graft-versus-host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02918188
• Other study ID #: NavyGHB-004
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2016
• Est. completion date: January 2031

Study information

• Verified date: July 2020
• Source: Navy General Hospital, Beijing
• Contact: Liren Qian, M.D.
• Phone: +861066957676
• Email: qlr2007[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 21
• Est. completion date: January 2031
• Est. primary completion date: January 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Graft-versus-host Disease
• Graft vs Host Disease

Intervention

Drug:
• Hydrogen
Patients will receive hydrogen-rich water orally (500mL three times one day, 0.6mM)

Locations

Country	Name	City	State
China	Navy General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Navy General Hospital, Beijing

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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