Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease
Graft vs Host Disease; Cutaneous Sclerosis; Bronchiolitis Obliterans

Detailed Description:

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 Design

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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

Groups and Cohorts

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Group/Cohort
Controls; Never develop an immune mediated disorder
Immune Mediated Disorder; Develop an immune mediated disorder

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. 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

Secondary Outcome Measures :

1. 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

blood and urine specimens

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Study Population

Patients who are preparing for or have recently received an allogeneic hematopoietic cell transplant

Criteria

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)

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

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

Sponsors and Collaborators

Fred Hutchinson Cancer Research Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Stephanie Lee, MD, MPH	Fred Hutchinson Cancer Research Center

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56.

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
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