Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03483675
Recruitment Status : Recruiting
First Posted : March 30, 2018
Last Update Posted : December 10, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

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.

Condition or disease Intervention/treatment Phase
Chronic Graft Versus Host Disease Hematopoietic Cell Transplantation Recipient Biological: Immunosuppressive Therapy Other: Survey Administration Phase 2

Detailed Description:

PRIMARY OBJECTIVES:

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomized Feasibility Study of Discontinuation Versus Continuation of Immunosuppressive Therapy (IST) in Patients With Chronic Graft Versus Host Disease (GVHD)
Actual Study Start Date : June 6, 2018
Estimated Primary Completion Date : July 2, 2020
Estimated Study Completion Date : October 2, 2021


Arm Intervention/treatment
Active Comparator: Arm I (discontinued IST)
Participants have their IST tapered and discontinued per the plan.
Biological: Immunosuppressive Therapy
Discontinued IST
Other Names:
  • Anti-Rejection Therapy
  • immunosuppression

Other: Survey Administration
Ancillary studies

Experimental: Arm II (continued IST)
Participants continue to receive a fixed dose IST for an additional 9 months with no taper.
Biological: Immunosuppressive Therapy
Continued IST
Other Names:
  • Anti-Rejection Therapy
  • immunosuppression

Other: Survey Administration
Ancillary studies




Primary Outcome Measures :
  1. Feasibility of enrolling patients, assessed by the number of patients enrolled on the study (signed consent) [ Time Frame: Up to 2 years ]
    Descriptive summary of number of patients enrolled on the study


Secondary Outcome Measures :
  1. Feasibility of randomizing patients, assessed by the percentage of patients randomized [ Time Frame: Up to 2 years ]
    Descriptive summary of percentage of patients randomized.

  2. Compliance with treatment assessed by rate of immunosuppressive therapy (IST) resumption (discontinuation arm) [standard of care]/increase IST dose (continuation arm) [investigational arm] [ Time Frame: Up to 12 months after randomization ]
    Rate of patients following study immunosuppressive therapy management based on study arm. Analyses will be descriptive. Descriptive summary for continuous variables will include sample size, mean, standard deviation (SD), median, minimum and maximum for both baseline and post-baseline measurements (if applicable). The summary statistics for categorical variables will include sample size, frequency and percentages. Fisher's exact test will be used to test the difference between two arms for categorical variables.

  3. Compliance with data collection for local and non-local patients. [ Time Frame: Up to 12 months after randomization ]
    Analyses will be descriptive. Descriptive summary for continuous variables will include sample size, mean, standard deviation (SD), median, minimum and maximum for both baseline and post-baseline measurements (if applicable). The summary statistics for categorical variables will include sample size, frequency and percentages. Fisher's exact test will be used to test the difference between two arms for categorical variables.

  4. New chronic graft versus host disease (GVHD) manifestations and/or worsening of existing manifestations [ Time Frame: Up to 12 months after randomization ]
    Analyses will be descriptive.

  5. Recurrent malignancy [ Time Frame: Up to 12 months after randomization ]
    Analyses will be descriptive.

  6. Incidence of grade >= 3 infections [ Time Frame: Up to 12 months after randomization ]
    Analyses will be descriptive.

  7. Incidence of grade >= 3 organ toxicity [ Time Frame: Up to 12 months after randomization ]
    Analyses will be descriptive.

  8. Enrollment rate of participants who are not local [ Time Frame: Up to 12 months after randomization ]
    Analyses will be descriptive.

  9. Quality of data of participants who are not local [ Time Frame: Up to 12 months after randomization ]
    Analyses will be descriptive.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03483675


Locations
Layout table for location information
United States, Washington
Fred Hutch/University of Washington Cancer Consortium Recruiting
Seattle, Washington, United States, 98109
Contact: Merav Bar    206-667-5854    mbar@uw.edu   
Principal Investigator: Merav Bar         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Investigators
Layout table for investigator information
Principal Investigator: Merav Bar Fred Hutch/University of Washington Cancer Consortium

Layout table for additonal information
Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT03483675     History of Changes
Other Study ID Numbers: 9962
NCI-2018-00323 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
9962 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
P30CA015704 ( U.S. NIH Grant/Contract )
First Posted: March 30, 2018    Key Record Dates
Last Update Posted: December 10, 2019
Last Verified: December 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Graft vs Host Disease
Immune System Diseases
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs