Predicting the Quality of Response to Specific Treatments in Patients With cGVHD, PQRST Study

March 22, 2024 updated by: Fred Hutchinson Cancer Center

Predicting the Quality of Response to Specific Treatments (PQRST)

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 initial or second-line 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

OUTLINE:

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 4E6
        • Recruiting
        • Vancouver General Hospital/BC Cancer
        • Contact:
        • Principal Investigator:
          • Jennifer White
  • United States
    • Florida
      • Gainesville, Florida, United States, 32610
        • Active, not recruiting
        • University of Florida
      • Tampa, Florida, United States, 33612
        • Recruiting
        • Moffitt Cancer Center
        • Contact:
        • Principal Investigator:
          • Joseph Pidala
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Dana-Farber Harvard Cancer Center
        • Contact:
        • Principal Investigator:
          • Corey S. Cutler
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota/Masonic Cancer Center
        • Contact:
        • Principal Investigator:
          • Najla El-Jurdi
    • New York
      • Buffalo, New York, United States, 14263
        • Active, not recruiting
        • Roswell Park Cancer Institute
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Contact:
        • Principal Investigator:
          • Betty K. Hamilton
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Recruiting
        • UPMC Hillman Cancer Center
        • Contact:
        • Principal Investigator:
          • Annie Im
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Completed
        • Vanderbilt University/Ingram Cancer Center
    • Washington
      • Seattle, Washington, United States, 98109
        • Recruiting
        • Fred Hutch/University of Washington Cancer Consortium
        • Contact:
        • Principal Investigator:
          • Stephanie J. Lee

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic graft-versus-host disease (GVHD) who are starting first- or second-line therapy for GVHD

Description

Inclusion Criteria:

  • 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 initial or second-line treatment is started (may be concurrent with the enrollment visit), and later between 2-6 weeks, 3 months and 6 months after treatment is started or if a 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Observational (questionnaire, biospecimen, chart review)
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.
Other: Quality-of-Life Assessment
Ancillary studies
Other Names:
  • Quality of Life Assessment
Procedure: Biospecimen Collection
Undergo collection of blood sample
Other: Medical Chart Review
Review of medical chart
Other Names:
  • Chart Review
Other: Questionnaire Administration
Complete questionnaire

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical Response according to the 2014 criteria
Time Frame: Up 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 otherwise portable spirometry will be performed. Response will be assessed according to the recommendations of the 2014 NIH response measures publication or any applicable updates.
Up to 6 months
Time to next systemic treatment
Time Frame: 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
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.
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
Duration of treatment
Time Frame: Up 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.
Up to 3 months
Survival
Time Frame: 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
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
Non-relapse mortality
Time Frame: Up to 3 years
Non-relapse mortality is defined as death in remission, and relapse is considered a competing risk.
Up to 3 years
Patient-reported outcomes
Time Frame: Up 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.
Up to 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fred Hutchinson Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Stephanie J Lee, Fred Hutch/University of Washington Cancer Consortium

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 29, 2020

Primary Completion (Estimated)

August 2, 2025

Study Completion (Estimated)

August 2, 2025

Study Registration Dates

First Submitted

June 11, 2020

First Submitted That Met QC Criteria

June 11, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 26, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RG1006823
  • NCI-2020-01242 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • 10360 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium)
  • R01CA118953 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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