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

Fred Hutchinson Cancer Center (FHCC)

Status and phase: Completed; Phase 2

Conditions: Chronic Graft Versus Host Disease

Treatments: Biological: Immunosuppressive Therapy; Other: Survey Administration

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03483675

RG1001667 (Other Identifier)

NCI-2018-00323 (Registry Identifier)

P30CA015704 (U.S. NIH Grant/Contract)

9962 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 21 patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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21 participants in 2 patient groups

Arm I (discontinued IST)

Active Comparator group

Description:

Participants have their IST tapered and discontinued per the plan.

Treatment:

Biological: Immunosuppressive Therapy

Other: Survey Administration

Biological: Immunosuppressive Therapy

Arm II (continued IST)

Experimental group

Description:

Participants continue to receive a fixed dose IST for an additional 9 months with no taper.

Treatment:

Biological: Immunosuppressive Therapy

Other: Survey Administration

Biological: Immunosuppressive Therapy