Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation
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ClinicalTrials.gov Identifier: NCT01206309 |
Recruitment Status
:
Completed
First Posted
: September 21, 2010
Last Update Posted
: October 7, 2016
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Condition or disease |
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Graft vs Host Disease Cutaneous Sclerosis Bronchiolitis Obliterans |
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.
Study Type : | Observational |
Actual Enrollment : | 911 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Longitudinal Study of Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation (HCT) |
Study Start Date : | March 2011 |
Actual Primary Completion Date : | October 2016 |
Actual Study Completion Date : | October 2016 |

Group/Cohort |
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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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- The prevalence of immune mediated disorders [ Time Frame: Diagnosis of IMD and at 2 years ]
The prevalence of:
- Persistent, recurrent or late onset acute GVHD
- Cutaneous Sclerosis
- Bronchiolitis Obliterans Syndrome
- Chronic GVHD
- Banked blood and urine samples [ Time Frame: At 2 years ]Summarized as the percentage of compliance for each center and for the study as a whole
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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)

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01206309
United States, Arizona | |
Mayo Clinic | |
Scottsdale, Arizona, United States, 85054 | |
United States, California | |
Stanford University | |
Stanford, California, United States, 94305 | |
United States, Florida | |
H. Lee Moffitt Cancer Center | |
Tampa, Florida, United States, 33612 | |
United States, Massachusetts | |
Dana Farber Cancer Institute | |
Boston, Massachusetts, United States, 02115 | |
United States, Minnesota | |
University of Minnesota | |
Minneapolis, Minnesota, United States, 55455 | |
United States, Missouri | |
Washington University St. Louis | |
St. Louis, Missouri, United States, 63110 | |
United States, New York | |
Roswell Park Cancer Institute | |
Buffalo, New York, United States, 14263 | |
Weill Cornell Medical College | |
New York, New York, United States, 10021 | |
United States, North Carolina | |
University of North Carolina at Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599 | |
United States, Ohio | |
Cleveland Clinic Foundation | |
Cleveland, Ohio, United States, 44195 | |
The Ohio State University | |
Columbus, Ohio, United States, 43210 | |
United States, Tennessee | |
Vanderbilt University | |
Nashville, Tennessee, United States, 37232 | |
United States, Washington | |
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance | |
Seattle, Washington, United States, 98109 | |
United States, Wisconsin | |
Medical College of Wisconsin | |
Milwaukee, Wisconsin, United States, 53226 |
Principal Investigator: | Stephanie Lee, MD, MPH | Fred Hutchinson Cancer Research Center |
Publications:
Responsible Party: | Fred Hutchinson Cancer Research Center |
ClinicalTrials.gov Identifier: | NCT01206309 History of Changes |
Other Study ID Numbers: |
RDCRN 6501 U54CA163438 ( U.S. NIH Grant/Contract ) RDCRN-6501 ( Other Identifier: DMCC ) 2342.00 ( Other Identifier: FHCRC ) |
First Posted: | September 21, 2010 Key Record Dates |
Last Update Posted: | October 7, 2016 |
Last Verified: | October 2016 |
Keywords provided by Fred Hutchinson Cancer Research Center:
Graft vs Host Disease Allogeneic Hematopoietic Cell Transplantation Bone Marrow Transplantation Peripheral Blood Stem Cell Transplantation Umbilical Cord Blood Stem Cell Transplantation |
Additional relevant MeSH terms:
Bronchiolitis Graft vs Host Disease Bronchiolitis Obliterans Bronchitis Bronchial Diseases |
Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Tract Infections Immune System Diseases |