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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-06

Study Completion Date

2021-03-03

Brief Summary

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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.

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Detailed Description

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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

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Chronic Graft Versus Host Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Arm I (discontinued IST)

Participants have their IST tapered and discontinued per the plan.

Group Type ACTIVE_COMPARATOR

Immunosuppressive Therapy

Intervention Type BIOLOGICAL

Discontinued IST

Survey Administration

Intervention Type OTHER

Ancillary studies

Arm II (continued IST)

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

Group Type EXPERIMENTAL

Immunosuppressive Therapy

Intervention Type BIOLOGICAL

Continued IST

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Immunosuppressive Therapy

Discontinued IST

Intervention Type BIOLOGICAL

Immunosuppressive Therapy

Continued IST

Intervention Type BIOLOGICAL

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Anti-Rejection Therapy immunosuppression Anti-Rejection Therapy immunosuppression

Eligibility Criteria

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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