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

Fred Hutchinson Cancer Center21 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Chronic Graft Versus Host Disease

Interventions

Immunosuppressive TherapyBIOLOGICAL

Discontinued IST

Immunosuppressive TherapyBIOLOGICAL

Continued IST

Survey AdministrationOTHER

Ancillary studies

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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

Locations (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, United States

Outcomes

Primary Outcomes

Feasibility of Enrolling Patients

Descriptive summary of number of patients enrolled on the study (signed consent)

Time frame: 22.9 months

Secondary Outcomes

Feasibility of Randomizing Patients

Descriptive summary of percentage of patients randomized.

Time frame: 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).