Phase 2
N=17
Discontinuation or Continuation of Immunosuppressive Therapy in Participants With Chronic Graft Versus Host Disease
Chronic Graft Versus Host Disease
Bottom Line
View on ClinicalTrials.gov: NCT03483675 ↗Enrolled (actual)
17
Serious AEs
11.8%
Results posted
Jun 2021
Primary outcome: Primary: Feasibility of Enrolling Patients — 21 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Immunosuppressive Therapy (Biological); Survey Administration (Other)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Fred Hutchinson Cancer Center
- Primary completion
- May 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility of Enrolling Patients |
21 | — |
| SECONDARY Feasibility of Randomizing Patients |
17 | — |
| SECONDARY Compliance With Treatment |
7; 8 | — |
| SECONDARY Compliance With Data Collection |
48; 39; 3; 4; 5; 6 | — |
| SECONDARY Graft Versus Host Disease Manifestations |
2; 0 | — |
| SECONDARY Recurrent Malignancy |
0; 0 | — |
| SECONDARY Incidence of Grade >= 3 Infections |
1; 0 | — |
| SECONDARY Incidence of Grade >= 3 Organ Toxicity |
0; 0 | — |
| SECONDARY Enrollment Rate of Participants Who Are Not Local |
— | — |
| SECONDARY Quality of Data of Participants Who Are Not Local |
— | — |
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 immunosuppressive treatment may prevent graft-versus-host disease worsening.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- Inability to comply with study procedures
- Pregancy
Data sourced from ClinicalTrials.gov (NCT03483675). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.