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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hematopoietic and Lymphoid Cell Neoplasm
• Intervention / Treatment: Other: Quality-of-Life Assessment; Other: Survey Administration; Other: Medical Chart Review; Procedure: Biospecimen Collection; Procedure: Optical Coherence Tomography; Procedure: Spirometry; Other: Digital Photography

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Marcie Hall; Phone Number: 206-667-7010; Email: amhall@fredhutch.org

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32610
      • Active, not recruiting
      • University of Florida
    • Tampa, Florida, United States, 33612
      • Active, not recruiting
      • Moffitt Cancer Center
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Cancer Institute
      • Contact: Steven Pavletic; Phone Number: 240-760-6174; Email: pavletis@mail.nih.gov
      • Principal Investigator: Steven Pavletic
  • New York
    • Buffalo, New York, United States, 14263
      • Active, not recruiting
      • Roswell Park
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Active, not recruiting
      • Cleveland Clinic
  • Tennessee
    • Nashville, Tennessee, United States, 37212
      • Terminated
      • Vanderbilt
  • Washington
    • Seattle, Washington, United States, 98109
      • Recruiting
      • Fred Hutch/University of Washington Cancer Consortium
      • Contact: Marcie Hall; Phone Number: 206-667-7010; Email: amhall@fredhutch.org
      • Principal Investigator: Stephanie Lee

Participation Criteria

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 scheduled for allogeneic hematopoietic cell transplantation (HCT) from any donor for any indication, with a risk of cGVHD of > 25%

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Observational (sample collection, survey, imaging, spirometry); 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.

Other: Quality-of-Life Assessment; Ancillary studies; Other Names: Quality of Life Assessment; Other: Survey Administration; Complete survey; Other: Medical Chart Review; Review of medical charts; Other Names: Chart Review; Procedure: Biospecimen Collection; Undergo collection of blood, tears, saliva, buccal mucosa, feces, and tissue samples; Procedure: Optical Coherence Tomography; Undergo optical coherence tomography; Other Names: OCT; Procedure: Spirometry; Undergo portable spirometry; Other: Digital Photography; Undergo digital photography

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

• Sponsor: Fred Hutchinson Cancer Center
• Collaborators: National Cancer Institute (NCI); National Institutes of Health (NIH)
• Investigators: Principal Investigator: Stephanie Lee, Fred Hutch/University of Washington Cancer Consortium

Study record dates

Study Major Dates

• Study Start (Actual): September 13, 2019
• Primary Completion (Estimated): August 31, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: December 2, 2019
• First Submitted That Met QC Criteria: December 3, 2019
• First Posted (Actual): December 6, 2019

Study Record Updates

• Last Update Posted (Actual): April 12, 2024
• Last Update Submitted That Met QC Criteria: April 10, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Hematologic Diseases; Hematologic Neoplasms
• Other Study ID Numbers: RG1005155; 10134 (Other Identifier: Fred Hutch/University of Washington Cancer Consortium); NCI-2019-07293 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); U01CA236229 (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