Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Chronic GVHD Response Measures Validation

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Fred Hutchinson Cancer Research Center
Sponsor:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01902576
First received: July 16, 2013
Last updated: June 24, 2014
Last verified: June 2014
  Purpose

The purpose of this study is to develop and validate endpoint measures that can accurately determine whether patients are responding to treatment for chronic Graft-versus-Host Disease (GVHD). Hopefully, this will also lead to being better able to predict which patients will respond to what therapies.


Condition
Graft vs Host Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Chronic GVHD Response Measures Validation

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Develop and validate the Chronic GVHD-Activity Index (CGVHD-AI) as a measure of treatment response. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    This measure is intended to capture impairments caused by chronic GVHD. We expect that change in the CGVHD-AI could be used to measure treatment response because it will correlate with clinically significant changes reported by physicians and patients. The CGVHD-AI would be most appropriate for use in clinical trials where the goal is symptom relief and decreased disease activity.


Secondary Outcome Measures:
  • To develop and validate the Chronic GVHD Failure-Free Survival Score (CGVHD-FFS) as a predictor of failure-free survival. [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    This measure is intended for use as an intermediate endpoint that predicts subsequent failure-free survival, defined as absence of death, relapse and requirement for new therapy, i.e., events that constitute treatment failures in clinical trials. The CGVHD-FFS would be most appropriate for phase II and III trials testing agents intended to change the underlying biology of the syndrome, for example by inducing immunologic tolerance.


Biospecimen Retention:   Samples With DNA

Whole blood samples (30mL) processed for peripheral blood mononuclear cells (PBMC), plasma, and granulocytes.


Estimated Enrollment: 368
Study Start Date: June 2013
Estimated Primary Completion Date: June 2018 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   7 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients starting initial or subsequent therapy for chronic Graft vs Host Disease.

Criteria

Inclusion Criteria:

  • Age 7 years or older
  • Prior first allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis.
  • Diagnosis of chronic GVHD according to the criteria of the diagnosis and scoring group of the NIH consensus conference (Patient must have at least one diagnostic manifestation of chronic GVHD or one distinctive manifestation with pathological confirmation of the diagnosis. Concurrent acute GVHD manifestations will be allowed as long as at least one classic chronic manifestation is present.)
  • Initiation of a new systemic treatment for chronic GVHD in the past 4 weeks or anticipated within the next 4 weeks. Systemic treatment is defined as any medication or intervention that has intended systemic effects, including extracorporeal photopheresis, regardless of prior lines of therapy or prior treatment with the agent(s). If a patient is restarting a treatment to which they were previously exposed, they must have been off of it for at least 4 weeks before restarting.
  • No evidence of persistent or progressive malignancy at the time of enrollment
  • Evaluation at the transplant center at the time of study enrollment, and agreement to be re-evaluated at the transplant center up to four subsequent times: at 3 months, 6 months, and 18 months after enrollment and once if another treatment is added for chronic GVHD.
  • Signed, informed consent

Exclusion Criteria:

  • Inability to comply with study procedures
  • Complete resolution of chronic GVHD at the time of enrollment (patient must have some measurable chronic GVHD activity)
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01902576

Contacts
Contact: Evangelyn Nkwopara, MS (206) 667-6830 enkwopar@fhcrc.org

Locations
United States, Washington
Fred Hutchinson Cancer Research Center Recruiting
Seattle, Washington, United States, 98109
Contact: Evangelyn Nkwopara, MS    206-667-6830    enkwopar@fhcrc.org   
Principal Investigator: Stephanie J Lee, MD MPH         
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Investigators
Principal Investigator: Stephanie J Lee, MD MPH Fred Hutchinson Cancer Research Center
  More Information

No publications provided

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01902576     History of Changes
Other Study ID Numbers: 2710.00
Study First Received: July 16, 2013
Last Updated: June 24, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Graft vs Host Disease
Immune System Diseases

ClinicalTrials.gov processed this record on November 25, 2014