Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation

Completed

• Conditions: Bronchiolitis Obliterans; Cutaneous Sclerosis; Graft vs Host Disease

• Registration Number: NCT01206309
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

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 Timeline

• Study First Submitted: 2010-09-20
• Study First Submitted QC: 2010-09-20
• Study First Posted: 2010-09-21
• Study Start: 2011-03
• Status Verified: 2016-10
• Primary Completion: 2016-10
• Study Completion: 2016-10
• Last Update Submitted: 2016-10-06
• Last Update Posted: 2016-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 911

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

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

Trial Locations

Locations (14)

Cleveland Clinic Foundation; 🇺🇸 Cleveland, Ohio, United States

Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance; 🇺🇸 Seattle, Washington, United States

University of Minnesota; 🇺🇸 Minneapolis, Minnesota, United States

The Ohio State University; 🇺🇸 Columbus, Ohio, United States

Roswell Park Cancer Institute; 🇺🇸 Buffalo, New York, United States

H. Lee Moffitt Cancer Center; 🇺🇸 Tampa, Florida, United States

Mayo Clinic; 🇺🇸 Scottsdale, Arizona, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Washington University St. Louis; 🇺🇸 St. Louis, Missouri, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Stanford University; 🇺🇸 Stanford, California, United States

Vanderbilt University; 🇺🇸 Nashville, Tennessee, United States

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States