Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01206309
First received: September 20, 2010
Last updated: July 28, 2014
Last verified: July 2014
  Purpose

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
Graft vs Host Disease
Cutaneous Sclerosis
Bronchiolitis Obliterans

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Longitudinal Study of Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation (HCT)

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • The prevalence of immune mediated disorders [ Time Frame: Diagnosis of IMD and at 2 years ] [ Designated as safety issue: No ]

    The prevalence of:

    • Persistent, recurrent or late onset acute GVHD
    • Cutaneous Sclerosis
    • Bronchiolitis Obliterans Syndrome
    • Chronic GVHD


Secondary Outcome Measures:
  • Banked blood and urine samples [ Time Frame: At 2 years ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 1118
Study Start Date: March 2011
Estimated Study Completion Date: September 2015
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Groups/Cohorts
Controls
Never develop an immune mediated disorder
Immune Mediated Disorder
Develop an immune mediated disorder

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.

  Eligibility

Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01206309

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

Publications:
Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01206309     History of Changes
Other Study ID Numbers: RDCRN 6501, U54CA163438, RDCRN-6501, 2342.00
Study First Received: September 20, 2010
Last Updated: July 28, 2014
Health Authority: United States: Federal Government

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
Bronchiolitis Obliterans
Graft vs Host Disease
Sclerosis
Bronchitis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on August 18, 2014