Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study (NCT04431479) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study
United States, Canada211 participantsStarted 2020-06-29
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This study is listed as 'active, not recruiting' — does that mean enrollment is closed, and if so, are there similar observational studies on chronic GVHD treatment response that I could still be considered for?
2Since this study is measuring how well patients respond to specific treatments using the 2014 NIH criteria for chronic GVHD, can you explain which of my current or planned treatments would be evaluated, and how that assessment might influence decisions about my care?
3The study tracks 'time to next systemic treatment' and 'duration of treatment' as key outcomes — what does that tell us about what researchers are still trying to understand about chronic GVHD, and does that uncertainty affect the treatment plan you'd recommend for me?
4Because this study also measures non-relapse mortality and survival, does participating in or being tracked by an observational study like this carry any direct risk to me, or does it mainly involve data collection from my existing care?
5Given that patient-reported outcomes are part of what this study measures, how would my quality-of-life experience be documented, and would my feedback actually influence treatment decisions during my care or only contribute to future research?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Clinical Response according to the 2014 criteria
Timeframe: Up to 6 months
2
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
3
Duration of treatment
Timeframe: Up to 3 months
4
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