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Clinical Trials/NCT02291770
NCT02291770
Unknown
Phase 3

Treatment of of Chronic Graft-Versus-Host Disease With Mesenchymal Stromal Cells. A Phase III Randomized Open Label Multi-center Study in Southern China.

Guangdong Provincial People's Hospital1 site in 1 country130 target enrollmentStarted: October 2014Last updated:
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ConditionsChronic Graft-Versus-Host Disease

Overview

Phase
Phase 3
Enrollment
130
Locations
1
Primary Endpoint
Proportion of patients responding to treatment of cGvHD with MSC
OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Overview

Brief Summary

Chronic Graft-versus-Host Disease (cGvHD) is a potentially lethal disorder. A variety of second line immunosuppressive agents have been investigated but no optimal treatment has emerged. There is therefore a need for novel treatment strategies. Mesenchymal stromal cells (MSC) exhibit immunomodulatory properties and a recent pilot study suggests a response rate of 70% in steroid- refractory patients. In the present randomized study the efficacy and safety of MSC treatment will be further studied in patients with cGvHD.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
14 Years to 65 Years (Child, Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Newly diagnosed cGvHD
  • •Informed consent obtained from patient and donor.
  • •Any patient who has undergone allogeneic stem cell transplantation with c GvHD.
  • •Have not received additional agent for cGVHD within 3 months.
  • •Expected life is more than 90 days.
  • •Adequate pulmonary function with no evidence of chronic obstructive or severe restrictive pulmonary disease.
  • •Adequate cardiac function with no evidence of uncontrolled high blood pressure,congestive heart failure, angina pectoris, acute myocardial infarction within 6 months prior to the process.

Exclusion Criteria

  • •Invasive fungal disease.
  • •Active cytomegalovirus (CMV)/Epstein-Barr virus(EBV)/varicella disease).
  • •Patient is with a history of hypersensitivity to bovine products.
  • •Relapsed malignancy.

Outcomes

Primary Outcomes

Proportion of patients responding to treatment of cGvHD with MSC

Time Frame: 90 days

Secondary Outcomes

  • Overall survival(2 year)
  • Adverse events(2 year)
  • Progression-free survival(2 year)
  • Cumulative incidents of non-relapse mortality(2 year)
  • Time without systemic immunosuppression(2 year)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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