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

Primary Purpose

Chronic Graft Versus Host Disease

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Immunosuppressive Therapy
Immunosuppressive Therapy
Survey Administration
Sponsored by
Fred Hutchinson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Graft Versus Host Disease

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Fred Hutch/University of Washington Cancer Consortium

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Arm I (discontinued IST)

Arm II (continued IST)

Arm Description

Participants have their IST tapered and discontinued per the plan.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Feasibility of Randomizing Patients
Descriptive summary of percentage of patients randomized.
Compliance With Treatment
Rate of patients following study immunosuppressive therapy management based on study arm (standard taper or continuation of low dose).
Compliance With Data Collection
Count of surveys completed by physicians and patients
Graft Versus Host Disease Manifestations
New chronic graft versus host disease (GVHD) manifestations and/or worsening of existing manifestations
Recurrent Malignancy
Incidence of relapse of primary disease
Incidence of Grade >= 3 Infections
Incidence of grade >= 3 infections
Incidence of Grade >= 3 Organ Toxicity
Incidence of grade >= 3 organ toxicity
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.
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.

Full Information

First Posted
March 13, 2018
Last Updated
June 22, 2021
Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT03483675
Brief Title
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

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
June 6, 2018 (Actual)
Primary Completion Date
May 14, 2020 (Actual)
Study Completion Date
March 3, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Fred Hutchinson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Graft Versus Host Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm I (discontinued IST)
Arm Type
Active Comparator
Arm Description
Participants have their IST tapered and discontinued per the plan.
Arm Title
Arm II (continued IST)
Arm Type
Experimental
Arm Description
Participants continue to receive a fixed dose IST for an additional 9 months with no taper.
Intervention Type
Biological
Intervention Name(s)
Immunosuppressive Therapy
Other Intervention Name(s)
Anti-Rejection Therapy, immunosuppression
Intervention Description
Discontinued IST
Intervention Type
Biological
Intervention Name(s)
Immunosuppressive Therapy
Other Intervention Name(s)
Anti-Rejection Therapy, immunosuppression
Intervention Description
Continued IST
Intervention Type
Other
Intervention Name(s)
Survey Administration
Intervention Description
Ancillary studies
Primary Outcome Measure Information:
Title
Feasibility of Enrolling Patients
Description
Descriptive summary of number of patients enrolled on the study (signed consent)
Time Frame
22.9 months
Secondary Outcome Measure Information:
Title
Feasibility of Randomizing Patients
Description
Descriptive summary of percentage of patients randomized.
Time Frame
22.9 months
Title
Compliance With Treatment
Description
Rate of patients following study immunosuppressive therapy management based on study arm (standard taper or continuation of low dose).
Time Frame
Up to 12 months after randomization
Title
Compliance With Data Collection
Description
Count of surveys completed by physicians and patients
Time Frame
Up to 12 months after randomization
Title
Graft Versus Host Disease Manifestations
Description
New chronic graft versus host disease (GVHD) manifestations and/or worsening of existing manifestations
Time Frame
Up to 12 months after randomization
Title
Recurrent Malignancy
Description
Incidence of relapse of primary disease
Time Frame
Up to 12 months after randomization
Title
Incidence of Grade >= 3 Infections
Description
Incidence of grade >= 3 infections
Time Frame
Up to 12 months after randomization
Title
Incidence of Grade >= 3 Organ Toxicity
Description
Incidence of grade >= 3 organ toxicity
Time Frame
Up to 12 months after randomization
Title
Enrollment Rate of Participants Who Are Not Local
Description
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.
Time Frame
Up to 12 months after randomization
Title
Quality of Data of Participants Who Are Not Local
Description
Participants who are local defined as those who had all or some study visits completed at the cancer center.
Time Frame
Up to 12 months after randomization

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephanie Lee
Organizational Affiliation
Fred Hutch/University of Washington Cancer Consortium
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fred Hutch/University of Washington Cancer Consortium
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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