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

Primary Purpose

Chronic Graft-versus-host Disease

Status
Recruiting
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
Hydrogen
Sponsored by
Navy General Hospital, Beijing
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Graft-versus-host Disease

Eligibility Criteria

undefined - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Navy General HospitalRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hydrogen

Arm Description

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

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

Response Rate in each domain (RRD)
Response rate in each domain was measured in subjects that had had initial involvement in that domain

Full Information

First Posted
September 27, 2016
Last Updated
July 17, 2020
Sponsor
Navy General Hospital, Beijing
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1. Study Identification

Unique Protocol Identification Number
NCT02918188
Brief Title
Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent cGVHD
Official Title
Therapeutic Effects of Hydrogen on Steroid-refractory/or Steroid-dependent Chronic Graft-versus-host-disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Recruiting
Study Start Date
January 2016 (undefined)
Primary Completion Date
January 2026 (Anticipated)
Study Completion Date
January 2031 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Navy General Hospital, Beijing

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Graft-versus-host Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
21 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Hydrogen
Arm Type
Experimental
Arm Description
Patients will receive hydrogen-rich water (4mL/kg three times one day, 0.8 ppm)
Intervention Type
Drug
Intervention Name(s)
Hydrogen
Other Intervention Name(s)
Hydrogen-rich water
Intervention Description
Patients will receive hydrogen-rich water orally (500mL three times one day, 0.6mM)
Primary Outcome Measure Information:
Title
Overall Response Rate (ORR)
Description
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)
Time Frame
12 months after date of start of Hydrogen
Secondary Outcome Measure Information:
Title
Response Rate in each domain (RRD)
Description
Response rate in each domain was measured in subjects that had had initial involvement in that domain
Time Frame
12 months after date of start of Hydrogen

10. Eligibility

Sex
All
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Liren Qian, M.D.
Phone
+861066957676
Email
qlr2007@126.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Liren Qian, M.D.
Organizational Affiliation
Navy General Hospital, Beijing
Official's Role
Study Chair
Facility Information:
Facility Name
Navy General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100048
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liren Qian, M.D.
Phone
+861066957676
Email
qlr2007@126.com

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33324415
Citation
Qian L, Liu M, Shen J, Cen J, Zhao D. Hydrogen in Patients With Corticosteroid-Refractory/Dependent Chronic Graft-Versus-Host-Disease: A Single-Arm, Multicenter, Open-Label, Phase 2 Trial. Front Immunol. 2020 Nov 25;11:598359. doi: 10.3389/fimmu.2020.598359. eCollection 2020.
Results Reference
derived

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

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