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

Phase 2

Completed

Interventions: Biological: Immunosuppressive Therapy
Other: Survey Administration

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Arm II (continued IST)	Survey Administration	Participants continue to receive a fixed dose IST for an additional 9 months with no taper.
Arm I (discontinued IST)	Immunosuppressive Therapy	Participants have their IST tapered and discontinued per the plan.
Arm II (continued IST)	Immunosuppressive Therapy	Participants continue to receive a fixed dose IST for an additional 9 months with no taper.
Arm I (discontinued IST)	Survey Administration	Participants have their IST tapered and discontinued per the plan.

Primary Outcome Measures

Name	Time	Method
Feasibility of Enrolling Patients	22.9 months	Descriptive summary of number of patients enrolled on the study (signed consent)

Secondary Outcome Measures

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