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Protocol Details

Close Assessment and Testing for Chronic Graft-vs-Host Disease (CATCH Study)

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

20-C-0167

Sponsoring Institute

National Cancer Institute (NCI)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 18 Years
Max Age: N/A

Referral Letter Required

No

Population Exclusion(s)

Fetuses;
Pregnant Women;
Adults who are or may become unable to consent;
Children

Keywords

Hematologic Malignancies;
Allogeneic hematopoietic cell transplantation;
iatrogenic disease;
IMMUNODEFICIENCY DISEASES;
donor cells;
Natural History

Recruitment Keyword(s)

None

Condition(s)

Graft vs Host Disease

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Cancer Institute

Background:

Allogeneic hematopoietic cell transplantation (HCT) can cure blood cancers and bone marrow and immunodeficiency diseases. However, its success is limited. Many people who receive HCT develop a debilitating complication called chronic graft-versus-host disease (cGVHD). Researchers want to know if they can use different tests and close observation to predict who will develop cGVHD.

Objective:

To learn more about how and why cGVHD develops after allogenic HCT.

Eligibility:

People ages 18 or older scheduled for allogeneic HCT

Design:

Participants will have 1 study visit before transplant. Then they will have a visit 2 to 3 months after transplant. Starting 4 months after transplant, they will have study visits every other month. (months 4, 6, 8, 10, and 12). They will also have blood draw visits 1 and 2 months after transplant. They may have 1 more visit if they develop severe GVHD.

Visits will include:

Physical exams

Symptom and medication reviews

Blood tests

Breathing tests. Participants will breathe into a device. The device will measure how much air is blown out, and how fast.

Questionnaires about symptoms and quality of life

Saliva and tear collection

3D images of the skin, eyes, and mouth

Oral swabs and stool samples. Participants will collect stool samples at home.

Biopsies of the skin and the inside of the mouth. These will be optional.

Researchers will continue to review participants medical records until the study ends. This is so they can collect long-term outcome and GVHD information.

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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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Steven Z. Pavletic, M.D.
National Cancer Institute (NCI)
NIHBC 10 - CRC BG RM 4-3130
10 CENTER DR
BETHESDA MD 20892
(240) 760-6174
sp326h@nih.gov

Ashley E. Carpenter
National Cancer Institute (NCI)
National Institutes of Health
BG 82 RM 120A
9030 OLD GEORGETOWN RD
BETHESDA MD 20814
(240) 760-6009
carpentera@mail.nih.gov

NCI Referral Office
National Institute of Health Clinical Center (CC), 9000 Rockville Pike, Bethesda, Maryland 20892, United States: NCI Clinical Trials Referral Office
1-888-NCI-1937

Clinical Trials Number:

NCT04188912

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