Clinical trial NCT03483675: Discontinuation or Continuation of Immunosuppressive Therapy in Participants With Chronic Graft Versus Host Disease
Official title: Randomized Feasibility Study of Discontinuation Versus Continuation of Immunosuppressive Therapy (IST) in Patients With Chronic Graft Versus Host Disease (GVHD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Graft Versus Host Disease
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2018-03-30
Enrollment: 21
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility of Enrolling Patients
timeFrame: 22.9 months
Secondary outcomes:
measure: Feasibility of Randomizing Patients
timeFrame: 22.9 months
measure: Compliance With Treatment
timeFrame: Up to 12 months after randomization
measure: Compliance With Data Collection
timeFrame: Up to 12 months after randomization
measure: Graft Versus Host Disease Manifestations
timeFrame: Up to 12 months after randomization
measure: Recurrent Malignancy
timeFrame: Up to 12 months after randomization
measure: Incidence of Grade >= 3 Infections
timeFrame: Up to 12 months after randomization
measure: Incidence of Grade >= 3 Organ Toxicity
timeFrame: Up to 12 months after randomization
measure: Enrollment Rate of Participants Who Are Not Local
timeFrame: Up to 12 months after randomization
measure: Quality of Data of Participants Who Are Not Local
timeFrame: Up to 12 months after randomization
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Stephanie Lee
role: PRINCIPAL_INVESTIGATOR
References: