Discontinuation or Continuation of Immunosuppressive Therapy in Participants With Chronic Graft Versus Host Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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) of immunosuppressive therapy (IST). SECONDARY OBJECTIVES: I. Assess feasibility of enrolling and randomizing patients who are not local, and evaluate the quality of data received for those patients. II. Assess whether prolonged IST decreases the need for pulses of high dose IST. III. Evaluate the effect of prolonged IST on chronic GVHD manifestations and severity, risk of relapse, infection and organ toxicity. OUTLINE: Participants are randomized to 1 of 2 arms. ARM I: Participants have their IST tapered and discontinued per the plan. ARM II: Participants continue to receive a fixed dose IST for an additional 9 months with no taper. After completion of study treatment, participants are followed up annually.

Official Title
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Randomized Feasibility Study of Discontinuation Versus Continuation of Immunosuppressive Therapy (IST) in Patients With Chronic Graft Versus Host Disease (GVHD)

Conditions
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Chronic Graft Versus Host Disease

Intervention / Treatment
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* Biological: Immunosuppressive Therapy
* Biological: Immunosuppressive Therapy
* Other: Survey Administration


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm I (discontinued IST)<br>Participants have their IST tapered and discontinued per the plan. | Biological: Immunosuppressive Therapy<br>* Discontinued IST<br>* Other names: immunosuppression;Other: Survey Administration<br>* Ancillary studies<br>|
| Experimental: Arm II (continued IST)<br>Participants continue to receive a fixed dose IST for an additional 9 months with no taper. | Biological: Immunosuppressive Therapy<br>* Continued IST<br>* Other names: immunosuppression;Other: Survey Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Enrolling Patients | Descriptive summary of number of patients enrolled on the study (signed consent) | 22.9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of Randomizing Patients | Descriptive summary of percentage of patients randomized. | 22.9 months | 
| Compliance With Treatment | Rate of patients following study immunosuppressive therapy management based on study arm (standard taper or continuation of low dose). | Up to 12 months after randomization | 
| Compliance With Data Collection | Count of surveys completed by physicians and patients | Up to 12 months after randomization | 
| Graft Versus Host Disease Manifestations | New chronic graft versus host disease (GVHD) manifestations and/or worsening of existing manifestations | Up to 12 months after randomization | 
| Recurrent Malignancy | Incidence of relapse of primary disease | Up to 12 months after randomization | 
| Incidence of Grade >= 3 Infections | Incidence of grade >= 3 infections | Up to 12 months after randomization | 
| Incidence of Grade >= 3 Organ Toxicity | Incidence of grade >= 3 organ toxicity | Up to 12 months after randomization | 
| Enrollment Rate of Participants Who Are Not Local | Enrollment rate of participants who are not local. Participants who are local defined as those who had all or some study visits completed at the cancer center. | Up to 12 months after randomization | 
| Quality of Data of Participants Who Are Not Local | Participants who are local defined as those who had all or some study visits completed at the cancer center. | Up to 12 months after randomization |