Clinical trial NCT04188912: Close Assessment and Testing for Chronic Graft Versus Host Disease, CATCH Study
Official title: Close Assessment and Testing for Chronic GVHD (The CATCH Study)
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hematopoietic and Lymphoid Cell Neoplasm
Lead sponsor: Fred Hutchinson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
First posted: 2019-12-06
Enrollment: 267
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 scheduled for allogeneic hematopoietic cell transplantation (HCT) from any donor for any indication, with a risk of cGVHD of \> 25%

Brief summary: This trial observes and collects samples from patients before and after stem cell transplantation to learn more about how and why a complication called chronic graft-versus-host disease (GVHD) develops after stem cell transplantation. Performing close observation and various types of testing may enable doctors to notice symptoms or problems sooner than they would normally have been noticed and predict which patients will develop chronic GVHD.

Detailed description: OUTLINE:

Patients undergo collection of tears, saliva, buccal mucosa, and fecal samples before stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients also undergo collection of blood samples before stem cell transplant, at 1-2, 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients may undergo skin and mouth biopsy over 15-30 minutes before stem cell transplant, at 2-3 and 12 months after stem cell transplant, and at cGVHD onset. Patients undergo digital pictures of the eyes, mouth and skin, and optical coherence tomographybefore stem cell transplant, at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients without standard of care formal pulmonary function test undergo portable spirometry at 2-3, 4, 6, 8, 10, and 12 months after stem cell transplant, and at cGVHD onset. Patients also complete surveys and have their medical records reviewed.

After completion of study, patients are followed up periodically.

Eligibility criteria: Inclusion Criteria:

* Adults age 18 or older
* Scheduled for allogeneic HCT from any donor for any indication, with a risk of cGVHD of \> 25% (see below in exclusion criteria for treatment plans with a cGVHD risk \< 25%)
* Ability and willingness to comply with the intensive assessment schedule including evaluation every other month at a participating site
* Ability to communicate in English or Spanish, to allow completion of patient surveys and clear communication with the study team

Exclusion Criteria:

* Receipt of umbilical cord blood, bone marrow with post-transplant cyclophosphamide (peripheral blood with post-transplant cyclophosphamide is allowed), anti-thymocyte globulin, alemtuzumab, or ex-vivo T-cell depletion. These patients are excluded because they have a cGVHD risk of \< 25%
* Hematologic malignancy with active disease at the time of transplant. Minimal residual disease is allowed
* Hematopoietic cell transplant co-morbidity index \> 4 based on parameters known at time of enrollment
* Prior allogeneic transplant
* Prior autoimmune disease with ongoing symptoms
* History of noncompliance
* Inability to comply with study requirements due to geographic, logistic, social or any other factors

Primary outcomes:
measure: Levels of cytokines
timeFrame: Up to 3 years
measure: Onset of cGVHD
timeFrame: Up to 3 years
measure: Percentage of cellular populations
timeFrame: Up to 3 years
measure: Number of patients with tissue alterations in skin, mouth and eyes
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: Bethesda
country: United States
facility: National Cancer Institute
state: Maryland
city: Buffalo
country: United States
facility: Roswell Park
state: New York
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt
state: Tennessee
city: Seattle
country: United States
facility: Fred Hutch/University of Washington Cancer Consortium
state: Washington
Study officials:
affiliation: Fred Hutch/University of Washington Cancer Consortium
name: Stephanie Lee
role: PRINCIPAL_INVESTIGATOR
References: