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

PRIMARY OBJECTIVES:

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.

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