Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation
Longitudinal Study of Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation (HCT)
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Arizona
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Scottsdale, Arizona, États-Unis, 85054
- Mayo Clinic
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California
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Stanford, California, États-Unis, 94305
- Stanford University
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Florida
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Tampa, Florida, États-Unis, 33612
- H. Lee Moffitt Cancer Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02115
- Dana Farber Cancer Institute
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55455
- University of Minnesota
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Missouri
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St. Louis, Missouri, États-Unis, 63110
- Washington University St. Louis
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New York
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Buffalo, New York, États-Unis, 14263
- Roswell Park Cancer Institute
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New York, New York, États-Unis, 10021
- Weill Cornell Medical College
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North Carolina
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Chapel Hill, North Carolina, États-Unis, 27599
- University of North Carolina at Chapel Hill
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Ohio
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Cleveland, Ohio, États-Unis, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, États-Unis, 43210
- The Ohio State University
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Tennessee
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Nashville, Tennessee, États-Unis, 37232
- Vanderbilt University
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Washington
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Seattle, Washington, États-Unis, 98109
- Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance
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Wisconsin
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Milwaukee, Wisconsin, États-Unis, 53226
- Medical College of Wisconsin
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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)
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Cohortes et interventions
Groupe / Cohorte |
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Controls
Never develop an immune mediated disorder
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Immune Mediated Disorder
Develop an immune mediated disorder
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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The prevalence of immune mediated disorders
Délai: Diagnosis of IMD and at 2 years
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The prevalence of:
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Diagnosis of IMD and at 2 years
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Banked blood and urine samples
Délai: At 2 years
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Summarized as the percentage of compliance for each center and for the study as a whole
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At 2 years
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Stephanie Lee, MD, MPH, Fred Hutchinson Cancer Center
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- RDCRN 6501
- U54CA163438 (Subvention/contrat des NIH des États-Unis)
- RDCRN-6501 (Autre identifiant: DMCC)
- 2342.00 (Autre identifiant: FHCRC)
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