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

Chronic Graft Versus Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03483675
• Other study ID #: 9962
• Secondary ID: NCI-2018-0032399
• Status: Completed
• Phase: Phase 2
• Start date: June 6, 2018
• Est. completion date: March 3, 2021

Study information

• Verified date: June 2021
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: March 3, 2021
• Est. primary completion date: May 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Graft Versus Host Disease
• Graft vs Host Disease

Intervention

Biological:
• Immunosuppressive Therapy
Discontinued IST
• Immunosuppressive Therapy
Continued IST

Other:
• Survey Administration
Ancillary studies

Locations

Country	Name	City	State
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of Enrolling Patients	Descriptive summary of number of patients enrolled on the study (signed consent)	22.9 months
Secondary	Feasibility of Randomizing Patients	Descriptive summary of percentage of patients randomized.	22.9 months
Secondary	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
Secondary	Compliance With Data Collection	Count of surveys completed by physicians and patients	Up to 12 months after randomization
Secondary	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
Secondary	Recurrent Malignancy	Incidence of relapse of primary disease	Up to 12 months after randomization
Secondary	Incidence of Grade >= 3 Infections	Incidence of grade >= 3 infections	Up to 12 months after randomization
Secondary	Incidence of Grade >= 3 Organ Toxicity	Incidence of grade >= 3 organ toxicity	Up to 12 months after randomization
Secondary	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
Secondary	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