Clinical trial NCT04431479: Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study
Official title: Predicting the Quality of Response to Specific Treatments (PQRST)
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Chronic Graft Versus Host Disease
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-06-16
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic graft-versus-host disease (GVHD) who are starting a new therapy for GVHD

Brief summary: This trial collects clinical data and blood samples to predict the quality of response to specific treatments in patients with chronic graft-versus-host disease (cGVHD) who are about to start a new therapy. Collecting and analyzing clinical data and blood samples from patients with cGVHD before and after treatment initiation may help doctors identify changes that may predict treatment response.

Detailed description: OUTLINE: This is an observational study.

Patients complete questionnaires over 10 minutes about physical symptoms, activity level, and emotional well-being and have their medical records reviewed at baseline, 1, 3, and 6 months after starting index treatment, and at start of a new systemic treatment. Patients also undergo collection of blood samples over 1-2 minutes at baseline and at 1 month after starting index treatment, or at a treatment change visit if new therapy has not started.

Eligibility criteria: Inclusion Criteria:

* Adults age 18 or older
* Prior allogeneic stem cell transplant, with any graft source, donor type, and GVHD prophylaxis
* No evidence of persistent or progressive malignancy at the time of enrollment
* Agrees to be evaluated at the transplant center before a new line of treatment is started (may be concurrent with the enrollment visit), and later between 2-6 weeks, 3 months and 6 months after index treatment is started or if an additional new therapy is started before 6 months
* Signed, informed consent

Exclusion Criteria:

* Inability to comply with study procedures
* Uncontrolled psychiatric disorder
* Anticipated survival \< 6 months

Primary outcomes:
measure: Clinical Response according to the 2014 criteria
timeFrame: Up to 6 months
measure: Time to next systemic treatment
timeFrame: From the start of the index medication until the addition of another systemic chronic graft versus host disease (cGVHD) treatment with death and treated recurrent malignancy considered competing events, assessed up to 3 years
measure: Duration of treatment
timeFrame: Up to 3 months
measure: Survival
timeFrame: From the start of the index medication to death with patients lost to follow up or alive at the conclusion of the study censored, assessed up to 3 years
measure: Non-relapse mortality
timeFrame: Up to 3 years
measure: Patient-reported outcomes
timeFrame: Up to 3 years
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
city: Tampa
country: United States
facility: Moffitt Cancer Center
state: Florida
city: Boston
country: United States
facility: Dana-Farber Harvard Cancer Center
state: Massachusetts
city: Minneapolis
country: United States
facility: University of Minnesota/Masonic Cancer Center
state: Minnesota
city: Buffalo
country: United States
facility: Roswell Park Cancer Institute
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Pittsburgh
country: United States
facility: UPMC Hillman Cancer Center
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University/Ingram Cancer Center
state: Tennessee
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
city: Vancouver
country: Canada
facility: Vancouver General Hospital/BC Cancer
state: British Columbia
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Stephanie J. Lee
role: PRINCIPAL_INVESTIGATOR
References: