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

Hematopoietic and Lymphoid Cell Neoplasm Clinical Trial

— CATCH  

Official title:

Close Assessment and Testing for Chronic GVHD (The CATCH Study)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04188912
• Other study ID #: RG1005155
• Secondary ID: NCI-2019-0729310
• Status: Recruiting
• Start date: September 13, 2019
• Est. completion date: August 31, 2025

Study information

• Verified date: February 2024
• Source: Fred Hutchinson Cancer Center
• Contact: Marcie Hall
• Phone: 206-667-7010
• Email: amhall[@]fredhutch.org
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: August 31, 2025
• Est. primary completion date: August 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hematologic Neoplasms
• Hematopoietic and Lymphoid Cell Neoplasm

Intervention

Procedure:
• Biospecimen Collection
Undergo collection of blood, tears, saliva, buccal mucosa, feces, and tissue samples
• Optical Coherence Tomography
Undergo optical coherence tomography
• Spirometry
Undergo portable spirometry

Other:
• Survey Administration
Complete survey
• Digital Photography
Undergo digital photography
• Quality-of-Life Assessment
Ancillary studies
• Medical Chart Review
Review of medical charts

Locations

Country	Name	City	State
United States	National Cancer Institute	Bethesda	Maryland
United States	Roswell Park	Buffalo	New York
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Florida	Gainesville	Florida
United States	Vanderbilt	Nashville	Tennessee
United States	Fred Hutch/University of Washington Cancer Consortium	Seattle	Washington
United States	Moffitt Cancer Center	Tampa	Florida

Sponsors (3)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Center	National Cancer Institute (NCI), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of cytokines	Will compare the pg/ml levels and trajectories of proteins (IL-1b; IL-4; IL-5; IL-6; IL-8; IL-10; IL-13; IL-17a (pg/mL); TNF; G-CSF; IFNgamma; MCP-1; IL-12p40; GM-CSF; IL-2) between patients who do and do not develop chronic graft versus host disease (cGVHD). Blood will be analyzed separately from saliva and conjunctival washings.	Up to 3 years
Primary	Onset of cGVHD	Onset of cGVHD will be treated as a time-to-event endpoint, using Cox regression with monthly levels or slopes of the markers entered as time dependent covariates.	Up to 3 years
Primary	Percentage of cellular populations	Will compare the levels, proportions and trajectories of different cellular populations between those with and without cGVHD, and with different cGVHD organ involvement and symptoms. The following cell subtypes are of highest interest: Th17, FOXP3+ T regulatory cells, FOXP3- T regulatory type 1 (TR1) cells, T follicular helper cells, activated B cells, B regulatory cells, and monocytes but the list may evolve before actual testing.	Up to 3 years
Primary	Number of patients with tissue alterations in skin, mouth and eyes	Tissue alterations will be classified into Abnormal and Normal, and measured by biopsy and/or advanced bioimaging techniques. Histologic findings, ribonucleic acid (RNA) expression profiles, optical coherence tomography (OCT) findings and digital image interpretations will be compared between patients who do and do not develop cGVHD or who have different cGVHD clinical phenotypes and symptoms.	Up to 3 years