Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation

This study is currently recruiting participants.
Verified September 2013 by Fred Hutchinson Cancer Research Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01206309
First received: September 20, 2010
Last updated: March 3, 2014
Last verified: September 2013
  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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01206309

Contacts
Contact: Kate Chilson (206) 667-6069 kchilson@fhcrc.org

Locations
United States, Arizona
Mayo Clinic Recruiting
Scottsdale, Arizona, United States, 85054
Contact: Mark Palazzo    480-342-2665    palazzo.mark@mayo.edu   
Principal Investigator: Nandita Khera, MD         
United States, California
Stanford University Recruiting
Stanford, California, United States, 94305
Contact: Khanh Huynh    650-721-2526    huynh27@stanford.edu   
Principal Investigator: Sally Arai, MD         
United States, Florida
H. Lee Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Michelle Burton, RN, BSN    813-745-1537    michelle.burton@moffitt.org   
Principal Investigator: Joseph Pidala, MD         
United States, Massachusetts
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Eileen Hansen    617-632-6715    EileenA_Hansen@DFCI.HARVARD.EDU   
Principal Investigator: Corey Cutler, MD         
United States, Minnesota
University of Minnesota Recruiting
Minneapolis, Minnesota, United States, 55455
Contact: Jenna Johnson    612-626-9712    joh03025@umn.edu   
Principal Investigator: Mukta Arora, MD, MS         
United States, Missouri
Washington University St. Louis Recruiting
St. Louis, Missouri, United States, 63110
Contact: Kevin Elliott    314-747-8086    kelliott@dom.wustl.edu   
Principal Investigator: Iskra Pusic, MD         
United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Contact: Dana Cipolla    716-845-5857    dana.cipolla@roswellpark.org   
Principal Investigator: George Chen, MD         
Weill Cornell Medical College Recruiting
New York, New York, United States, 10021
Contact: Alex Mazza    646-962-9335    alm2054@med.cornell.edu   
Principal Investigator: Sebastian Mayer, MD         
United States, North Carolina
University of North Carolina at Chapel Hill Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact: Carly Shatten    919-843-7843    carly_shatten@med.unc.edu   
Principal Investigator: William Wood, MD, MPH         
United States, Ohio
Cleveland Clinic Foundation Recruiting
Cleveland, Ohio, United States, 44195
Contact: Donna Abounader    216-444-0054    abounad2@ccf.org   
Principal Investigator: Hien Duong, MD         
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Katie Cortright    614-688-7562    Katie.Cortright@osumc.edu   
Principal Investigator: Samantha Jaglowski, MD, MPH         
United States, Tennessee
Vanderbilt University Recruiting
Nashville, Tennessee, United States, 37232
Contact: Chelsey Summers    615-875-6092    chelsey.n.rivers@vanderbilt.edu   
Principal Investigator: Madan Jagasia, MD         
United States, Washington
Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Recruiting
Seattle, Washington, United States, 98109
Contact: Marcie Hall    206-667-7010    amhall@fhcrc.org   
Principal Investigator: Stephanie Lee, MD, MPH         
United States, Wisconsin
Medical College of Wisconsin Recruiting
Milwaukee, Wisconsin, United States, 53226
Contact: Barbara Davies    414-805-8926    bdavies@mcw.edu   
Principal Investigator: Jeanne Palmer, MD         
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: March 3, 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:
Bronchitis
Bronchiolitis
Bronchiolitis Obliterans
Graft vs Host Disease
Sclerosis
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Infections
Immune System Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 15, 2014