Clinical trial NCT01902576: Chronic GVHD Response Measures Validation
Official title: Chronic GVHD Response Measures Validation
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Graft vs Host Disease
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
First posted: 2013-07-18
Enrollment: 383
Sex: ALL
Minimum age (years): 7
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients starting initial or subsequent therapy for chronic Graft vs Host Disease.

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.


Eligibility 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)

Primary outcomes:
measure: Develop and validate the Chronic GVHD-Activity Index (CGVHD-AI) as a measure of treatment response.
timeFrame: 18 months
Secondary outcomes:
measure: To develop and validate the Chronic GVHD Failure-Free Survival Score (CGVHD-FFS) as a predictor of failure-free survival.
timeFrame: 18 months
Other outcomes:
Locations:
city: Seattle
country: United States
facility: Fred Hutchinson Cancer Research Center
state: Washington
Study officials:
affiliation: Fred Hutchinson Cancer Center
name: Stephanie J Lee, MD MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.