Close Assessment and Testing for Chronic Graft Versus Host Disease, CATCH Study

Fred Hutchinson Cancer Center (FHCC)

Status

Completed

Conditions

Hematopoietic and Lymphoid Cell Neoplasm

Treatments

Procedure: Biospecimen Collection

Procedure: Optical Coherence Tomography

Other: Medical Chart Review

Procedure: Spirometry

Other: Survey Administration

Other: Quality-of-Life Assessment

Other: Digital Photography

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT04188912

NCI-2019-07293 (Registry Identifier)

U01CA236229 (U.S. NIH Grant/Contract)

10134

RG1005155

Details and patient eligibility

About

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.

Full 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.

Enrollment

267 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

267 participants in 1 patient group

Observational (sample collection, survey, imaging, spirometry)

Description:

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 tomography before 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.