This study is currently recruiting participants.
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)
Investigational Device(s)
Intervention(s)
Supporting Site
National Cancer Institute
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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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.
-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.
Principal Investigator
Referral Contact
For more information: