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NCT Number: NCT03483675

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

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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Key information

Conditions

Chronic Graft Versus Host Disease Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Respiratory Tract Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Immunosuppressive Therapy

Biological

Discontinued IST

Other names: Anti-Rejection Therapy, immunosuppression

Survey Administration

Other

Ancillary studies

Primary outcomes

  1. Feasibility of Enrolling Patients

    Time frame: 22.9 months

    Descriptive summary of number of patients enrolled on the study (signed consent)

Secondary outcomes

  1. Feasibility of Randomizing Patients

    Time frame: 22.9 months

    Descriptive summary of percentage of patients randomized.

  2. Compliance With Treatment

    Time frame: 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).

  3. Compliance With Data Collection

    Time frame: Up to 12 months after randomization

    Count of surveys completed by physicians and patients

  4. Graft Versus Host Disease Manifestations

    Time frame: Up to 12 months after randomization

    New chronic graft versus host disease (GVHD) manifestations and/or worsening of existing manifestations

  5. Recurrent Malignancy

    Time frame: Up to 12 months after randomization

    Incidence of relapse of primary disease

  6. Incidence of Grade >= 3 Infections

    Time frame: Up to 12 months after randomization

    Incidence of grade >= 3 infections

  7. Incidence of Grade >= 3 Organ Toxicity

    Time frame: Up to 12 months after randomization

    Incidence of grade >= 3 organ toxicity

  8. Enrollment Rate of Participants Who Are Not Local

    Time frame: 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.

  9. Quality of Data of Participants Who Are Not Local

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Randomized Feasibility Study of Discontinuation Versus Continuation of Immunosuppressive Therapy (IST) in Patients With Chronic Graft Versus Host Disease (GVHD)

Important dates

Study start
2018
Primary completion
2020
Study completion
2021
First posted
Mar 30, 2018
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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