Status:
COMPLETED
Discontinuation or Continuation of Immunosuppressive Therapy in Participants With Chronic Graft Versus Host Disease
Lead Sponsor:
Fred Hutchinson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Chronic Graft Versus Host Disease
Eligibility:
All Genders
Phase:
PHASE2
Brief Summary
This randomized trial studies how well discontinuation or continuation of immunosuppressive therapy works in treating participants with chronic graft versus host disease. Continuation of immunosuppres...
Detailed Description
PRIMARY OBJECTIVE: I. Assess feasibility of enrolling and randomizing patients with chronic graft versus host disease (GVHD) to discontinuation (standard of care) versus continuation (investigation) ...
Eligibility Criteria
Inclusion
- Prior first allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis
- Patients who are on one systemic immunosuppressive agent for chronic GVHD with a plan to withdraw all systemic IST; hydrocortisone or prednisone continued for treatment of adrenal insufficiency is not considered a systemic IST
- No evidence of malignancy at the time of enrollment
- Agree to be evaluated at the transplant center or by local provider every 3 months for 12 months after randomization
- Agreement to be contacted by phone or e-mail for health status evaluation for up to 3 years
- Signed, informed consent
Exclusion
- Inability to comply with study procedures
- Pregancy
Key Trial Info
Start Date :
June 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2021
Estimated Enrollment :
21 Patients enrolled
Trial Details
Trial ID
NCT03483675
Start Date
June 6 2018
End Date
March 3 2021
Last Update
June 23 2021
Active Locations (1)
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1
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, United States, 98109