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Longitudinal Study of Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation (HCT)


N/A
N/A
N/A
Open (Enrolling)
Both
Graft vs Host Disease, Cutaneous Sclerosis, Bronchiolitis Obliterans

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Trial Information

Longitudinal Study of Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation (HCT)


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.


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)

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

The prevalence of immune mediated disorders

Outcome Description:

The prevalence of: Persistent, recurrent or late onset acute GVHD Cutaneous Sclerosis Bronchiolitis Obliterans Syndrome Chronic GVHD

Outcome Time Frame:

Diagnosis of IMD and at 2 years

Safety Issue:

No

Principal Investigator

Stephanie Lee, MD, MPH

Investigator Role:

Principal Investigator

Investigator Affiliation:

Fred Hutchinson Cancer Research Center

Authority:

United States: Federal Government

Study ID:

RDCRN 6501

NCT ID:

NCT01206309

Start Date:

March 2011

Completion Date:

September 2015

Related Keywords:

  • Graft Vs Host Disease
  • Cutaneous Sclerosis
  • Bronchiolitis Obliterans
  • Graft vs Host Disease
  • Allogeneic Hematopoietic Cell Transplantation
  • Bone Marrow Transplantation
  • Peripheral Blood Stem Cell Transplantation
  • Umbilical Cord Blood Stem Cell Transplantation
  • Bronchiolitis
  • Bronchiolitis Obliterans
  • Graft vs Host Disease
  • Sclerosis

Name

Location

Cleveland Clinic FoundationCleveland, Ohio  44195
Roswell Park Cancer InstituteBuffalo, New York  14263
Medical College of WisconsinMilwaukee, Wisconsin  53226
Stanford UniversityStanford, California  94305
University of MinnesotaMinneapolis, Minnesota  55455
Vanderbilt UniversityNashville, Tennessee  37232-6305
H. Lee Moffitt Cancer CenterTampa, Florida  33612
Dana Farber Cancer InstituteBoston, Massachusetts  02115
Mayo ClinicScottsdale, Arizona  
University of North Carolina at Chapel HillChapel Hill, North Carolina  27599
Fred Hutchinson Cancer Research Center/Seattle Cancer Care AllianceSeattle, Washington  98109
Weill Cornell Medical CollegeNew York, New York  10021
Washington University St. LouisSt. Louis, Missouri  63110