NCT03483675

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2018

Completed
17 days until next milestone

First Posted

Study publicly available on registry

March 30, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

June 6, 2018

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2020

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 3, 2021

Completed
4 months until next milestone

Results Posted

Study results publicly available

June 23, 2021

Completed
Last Updated

June 23, 2021

Status Verified

June 1, 2021

Enrollment Period

1.9 years

First QC Date

March 13, 2018

Results QC Date

April 26, 2021

Last Update Submit

June 22, 2021

Conditions

Chronic Graft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

  • Feasibility of Enrolling Patients

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

    22.9 months

Secondary Outcomes (9)

  • Feasibility of Randomizing Patients

    22.9 months

  • Compliance With Treatment

    Up to 12 months after randomization

  • Compliance With Data Collection

    Up to 12 months after randomization

  • Graft Versus Host Disease Manifestations

    Up to 12 months after randomization

  • Recurrent Malignancy

    Up to 12 months after randomization

  • +4 more secondary outcomes

Study Arms (2)

Arm I (discontinued IST)

ACTIVE COMPARATOR

Participants have their IST tapered and discontinued per the plan.

Biological: Immunosuppressive TherapyOther: Survey Administration

Arm II (continued IST)

EXPERIMENTAL

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

Biological: Immunosuppressive TherapyOther: Survey Administration

Interventions

Immunosuppressive TherapyBIOLOGICAL

Discontinued IST

Also known as: Anti-Rejection Therapy, immunosuppression
Arm I (discontinued IST)
Survey AdministrationOTHER

Ancillary studies

Arm I (discontinued IST)Arm II (continued IST)

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Inability to comply with study procedures
  • Pregancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fred Hutch/University of Washington Cancer Consortium

Seattle, Washington, 98109, United States

Location

MeSH Terms

Conditions

Bronchiolitis Obliterans Syndrome

Interventions

Immunosuppression Therapy

Condition Hierarchy (Ancestors)

Organizing PneumoniaBronchiolitis ObliteransBronchiolitisBronchitisBronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesGraft vs Host DiseaseImmune System Diseases

Intervention Hierarchy (Ancestors)

ImmunotherapyImmunomodulationBiological TherapyTherapeuticsImmunologic TechniquesInvestigative Techniques

Results Point of Contact

Title
Kate Chilson
Organization
FHCRC
kchilson@fredhutch.org
206-667-6069

Study Officials

  • Stephanie Lee

    Fred Hutch/University of Washington Cancer Consortium

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor and Associate Director

Study Record Dates

First Submitted

March 13, 2018

First Posted

March 30, 2018

Study Start

June 6, 2018

Primary Completion

May 14, 2020

Study Completion

March 3, 2021

Last Updated

June 23, 2021

Results First Posted

June 23, 2021

Record last verified: 2021-06

Locations

US(1)