NCT03483675

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 21 (actual)
• Sponsor: Fred Hutchinson Cancer Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

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) 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.

Conditions

• Chronic Graft Versus Host Disease

Interventions

Type	Name	Description
BIOLOGICAL	Immunosuppressive Therapy	Discontinued IST
BIOLOGICAL	Immunosuppressive Therapy	Continued IST
OTHER	Survey Administration	Ancillary studies

Timeline

• Start date: 2018-06-06
• Primary completion: 2020-05-14
• Completion: 2021-03-03
• First posted: 2018-03-30
• Last updated: 2021-06-23
• Results posted: 2021-06-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study