Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation

Study Overview
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Brief Summary
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The purpose of this research study is to better understand the onset and course of graft versus host disease (GVHD)and other immune-mediated disorders after stem cell transplant.

Detailed Description
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Allogeneic hematopoietic cell transplantation (HCT) is the only known curative option for many hematologic disorders. After transplantation, many patients develop immune mediated disorders that may be life-threatening such as graft versus host disease (GVHD). The morbidity and mortality associated with HCT-associated immune mediated disorders are major barriers to successful use of transplantation to cure rare hematologic malignancies such as leukemia, lymphoma, multiple myeloma, myelodysplastic/myeloproliferative syndromes amongst other diseases. With this study, the investigators will investigate the biologic basis for immune mediated disorders after allogeneic HCT, focusing on those developing cutaneous sclerosis, bronchiolitis obliterans syndrome, late acute GVHD and chronic GVHD. The study will enroll 1118 (1018 adults and 100 children) allogeneic HCT patients over a three year period. Subjects will be followed for two years and monitored closely for development of immune mediated disorders. This study will have 5 study visits at day 1, 100, 180, 365, and 730. During these visits, a physical assessment, medication review, blood and urine collection will occur. If a subject develops an immune mediated disordered, they will be monitored at 3 months, 6 months, 1 year and then annually from the date of diagnosis. During these study visits, a physical assessment, IMD status, and medication review as well as blood and urine collection will occur.

Official Title
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Longitudinal Study of Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation (HCT)

Conditions
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Graft vs Host Disease, Cutaneous Sclerosis, Bronchiolitis Obliterans

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned or completed first allogeneic stem cell transplant (any conditioning regimen, graft source, donor type and GVHD prophylaxis regimen) Signed, informed consent and, if applicable, child assent Exclusion Criteria: Inability to comply with study procedures Anticipated survival less than 6 months due to co-morbid disease Autoimmune disorder or inherited immunodeficiency before HCT Diagnosis of late acute or chronic GVHD prior to study enrollment Hematologic relapse or chemotherapy refractory disease at restaging within 1 month of HCT or at the time of enrollment (e.g., > 5% blasts for leukemia; poorly responsive lymphoma)
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Controls<br>Never develop an immune mediated disorder | |
| Immune Mediated Disorder<br>Develop an immune mediated disorder | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of immune mediated disorders | The prevalence of: Persistent, recurrent or late onset acute GVHD Cutaneous Sclerosis Bronchiolitis Obliterans Syndrome Chronic GVHD | Diagnosis of IMD and at 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Banked blood and urine samples | Summarized as the percentage of compliance for each center and for the study as a whole | At 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Graft vs Host Disease, Allogeneic Hematopoietic Cell Transplantation, Bone Marrow Transplantation, Peripheral Blood Stem Cell Transplantation, Umbilical Cord Blood Stem Cell Transplantation