Chronic GVHD Response Measures Validation

NCT01902576 | Active Not Recruiting DMC

• 2 other identifiers: 2710.00RG1000980
• Study Type: observational
• Target: 383
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Graft vs Host Disease

Outcome Measures

Primary Outcomes (1)

• Develop and validate the Chronic GVHD-Activity Index (CGVHD-AI) as a measure of treatment response.

  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.

  18 months

Secondary Outcomes (1)

• To develop and validate the Chronic GVHD Failure-Free Survival Score (CGVHD-FFS) as a predictor of failure-free survival.

  18 months

Eligibility Criteria

• Age: 7 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Inability to comply with study procedures
• Complete resolution of chronic GVHD at the time of enrollment (patient must have some measurable chronic GVHD activity)

Sponsors & Collaborators

• Fred Hutchinson Cancer Center: lead

Study Sites (1)

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Location

Related Publications (1)

• Inamoto Y, Martin PJ, Onstad LE, Cheng GS, Williams KM, Pusic I, Ho VT, Arora M, Pidala J, Flowers MED, Gooley TA, Lawler RL, Hansen JA, Lee SJ. Relevance of Plasma Matrix Metalloproteinase-9 for Bronchiolitis Obliterans Syndrome after Allogeneic Hematopoietic Cell Transplantation. Transplant Cell Ther. 2021 Sep;27(9):759.e1-759.e8. doi: 10.1016/j.jtct.2021.06.006. Epub 2021 Jun 12.

  PMID: 34126278 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

MeSH Terms

Conditions

Graft vs Host Disease

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Stephanie J Lee, MD MPH

  Fred Hutchinson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2013
• First Posted: July 18, 2013
• Study Start: June 1, 2013
• Primary Completion: September 26, 2019
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 20, 2026

Record last verified: 2026-03

Locations

US (1)