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

  • STATUS
    Recruiting
  • End date
    Jun 1, 2024
  • participants needed
    200
  • sponsor
    Fred Hutchinson Cancer Center
Updated on 4 October 2022
graft versus host disease
cell transplantation

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.

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.

Details
Condition Hematopoietic and Lymphoid Cell Neoplasm
Treatment quality-of-life assessment, medical chart review, spirometry, Optical Coherence Tomography, survey administration, biospecimen collection, Digital Photography
Clinical Study IdentifierNCT04188912
SponsorFred Hutchinson Cancer Center
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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