Phase 2
Completed N=17
Discontinuation or Continuation of Immunosuppressive Therapy in Participants With Chronic Graft Versus Host Disease
Source: ClinicalTrials.gov NCT03483675 ↗Enrolled (actual)
17
Serious AEs
11.8%
Results posted
Jun 2021
Primary outcomePrimary: Feasibility of Enrolling Patients — 21 Participants
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.
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 |
— | — |
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. Informational only — not medical advice.