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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Graft Versus Host Disease
• Intervention / Treatment: Other: Survey Administration; Biological: Immunosuppressive Therapy; Biological: Immunosuppressive Therapy

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.

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98109
      • Fred Hutch/University of Washington Cancer Consortium

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Arm I (discontinued IST); Participants have their IST tapered and discontinued per the plan.	Other: Survey Administration; Ancillary studies; Biological: Immunosuppressive Therapy; Discontinued IST; Other Names: Anti-Rejection Therapy; immunosuppression; Biological: Immunosuppressive Therapy; Continued IST; Other Names: Anti-Rejection Therapy; immunosuppression
Experimental: Arm II (continued IST); Participants continue to receive a fixed dose IST for an additional 9 months with no taper.	Other: Survey Administration; Ancillary studies; Biological: Immunosuppressive Therapy; Discontinued IST; Other Names: Anti-Rejection Therapy; immunosuppression; Biological: Immunosuppressive Therapy; Continued IST; Other Names: Anti-Rejection Therapy; immunosuppression

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility of Enrolling Patients	Descriptive summary of number of patients enrolled on the study (signed consent)	22.9 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI)

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2018
• Primary Completion (Actual): May 14, 2020
• Study Completion (Actual): March 3, 2021

Study Registration Dates

• First Submitted: March 13, 2018
• First Submitted That Met QC Criteria: March 23, 2018
• First Posted (Actual): March 30, 2018

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Graft vs Host Disease; Physiological Effects of Drugs; Immunologic Factors; Immunosuppressive Agents
• Other Study ID Numbers: 9962 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); P30CA015704 (U.S. NIH Grant/Contract); NCI-2018-00323 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); RG1001667 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No