Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study
At a glance
Conditions
NCT04431479
Where you'd take part
This study runs at 10 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Cleveland Clinic Foundation
Cleveland, Ohiono site contact published
Dana-Farber Harvard Cancer Center
Boston, Massachusettsno site contact published
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washingtonno site contact published
Moffitt Cancer Center
Tampa, Floridano site contact published
Roswell Park Cancer Institute
Buffalo, New Yorkno site contact published
University of Florida
Gainesville, Floridano site contact published
University of Minnesota/Masonic Cancer Center
Minneapolis, Minnesotano site contact published
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvaniano site contact published
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Stephanie J. Lee · PRINCIPAL_INVESTIGATOR · Fred Hutch/University of Washington Cancer Consortium
Who to contact
This trial hasn't published a contact. View it on ClinicalTrials.gov
Want this trial checked against your situation?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Inclusion
Exclusion
What this trial measures
- Clinical Response according to the 2014 criteriaUp to 6 months
At the assessments, the 9 provider-reported National Institute of Health (NIH) organ severity scores (skin, eye, mouth, esophagus, upper gastrointestinal \[GI\], lower GI, liver, lung, and joint manifestations) will be collected reflecting disease activity in the past week. All scored items are single 4-7 point Likert scales. Based on past work, we anticipate it will take approximately 8 minutes to conduct the physical exam and record the relevant results. Pulmonary function testing results will be collected if available. Response will be assessed according to the recommendations of the 2014 NIH response measures publication or any applicable updates.
- Time to next systemic treatmentFrom 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
Any addition of another systemic cGVHD treatment for medical reasons will be considered a failure, whether added because of a new or worsening manifestation of cGVHD, used as a "steroid sparing agent," or substituted due to toxicity.
- Duration of treatmentUp to 3 months
Duration of treatment is defined as the time until discontinuation of therapeutic systemic immunosuppression (adrenal replacement and topical/local therapies are allowed) without resumption for at least 3 months.
- SurvivalFrom 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
- Non-relapse mortalityUp to 3 years
Non-relapse mortality is defined as death in remission, and relapse is considered a competing risk.
- Patient-reported outcomesUp to 3 years
Will be assessed using Lee symptom scale and Patient Reported Outcomes Measurement Information System (PROMIS). The summary score of the Lee Symptom Scale and the PROMIS Global will be calculated according to the instructions of the developers. For analyses assessing change in quality of life, improvement or worsening of the Summary symptom score by 6 points or more or the PROMIS Physical or Mental Functioning scales by 5 points or more compared to baseline will be considered a clinically significant change.