Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01206309

Collaborator

National Cancer Institute (NCI) (NIH)

911

Enrollment

Locations

67.1

Duration (Months)

65.1

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

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	Intervention/Treatment	Phase
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

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 :

Mar 1, 2011

Actual Primary Completion Date :

Oct 1, 2016

Actual Study Completion Date :

Oct 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Controls Never develop an immune mediated disorder
Immune Mediated Disorder Develop an immune mediated disorder

Outcome Measures

Primary Outcome Measures

The prevalence of immune mediated disorders [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

Banked blood and urine samples [At 2 years]
Summarized as the percentage of compliance for each center and for the study as a whole

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Mayo Clinic	Scottsdale	Arizona	United States	85054
2	Stanford University	Stanford	California	United States	94305
3	H. Lee Moffitt Cancer Center	Tampa	Florida	United States	33612
4	Dana Farber Cancer Institute	Boston	Massachusetts	United States	02115
5	University of Minnesota	Minneapolis	Minnesota	United States	55455
6	Washington University St. Louis	St. Louis	Missouri	United States	63110
7	Roswell Park Cancer Institute	Buffalo	New York	United States	14263
8	Weill Cornell Medical College	New York	New York	United States	10021
9	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599
10	Cleveland Clinic Foundation	Cleveland	Ohio	United States	44195
11	The Ohio State University	Columbus	Ohio	United States	43210
12	Vanderbilt University	Nashville	Tennessee	United States	37232
13	Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance	Seattle	Washington	United States	98109
14	Medical College of Wisconsin	Milwaukee	Wisconsin	United States	53226