Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation

NCT ID: NCT01206309

Last Updated: 2016-10-07

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 911 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-03-31
• Study Completion Date: 2016-10-31

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.

Conditions

Graft vs Host Disease; Cutaneous Sclerosis; Bronchiolitis Obliterans

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Controls

Never develop an immune mediated disorder

No interventions assigned to this group

Immune Mediated Disorder

Develop an immune mediated disorder

No interventions assigned to this group

Eligibility 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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Fred Hutchinson Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Stephanie Lee, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Fred Hutchinson Cancer Center

Locations

Mayo Clinic

Scottsdale, Arizona, United States

Stanford University

Stanford, California, United States

H. Lee Moffitt Cancer Center

Tampa, Florida, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University St. Louis

St Louis, Missouri, United States

Roswell Park Cancer Institute

Buffalo, New York, United States

Weill Cornell Medical College

New York, New York, United States

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

The Ohio State University

Columbus, Ohio, United States

Vanderbilt University

Nashville, Tennessee, United States

Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance

Seattle, Washington, United States

Medical College of Wisconsin

Milwaukee, Wisconsin, United States

Countries

United States

References

Filipovich AH, Weisdorf D, Pavletic S, Socie G, Wingard JR, Lee SJ, Martin P, Chien J, Przepiorka D, Couriel D, Cowen EW, Dinndorf P, Farrell A, Hartzman R, Henslee-Downey J, Jacobsohn D, McDonald G, Mittleman B, Rizzo JD, Robinson M, Schubert M, Schultz K, Shulman H, Turner M, Vogelsang G, Flowers ME. National Institutes of Health consensus development project on criteria for clinical trials in chronic graft-versus-host disease: I. Diagnosis and staging working group report. Biol Blood Marrow Transplant. 2005 Dec;11(12):945-56. doi: 10.1016/j.bbmt.2005.09.004.

Reference Type: BACKGROUND

PMID: 16338616 (View on PubMed)

Other Identifiers

U54CA163438

Identifier Type: NIH

Identifier Source: secondary_id

View Link

RDCRN-6501

Identifier Type: OTHER

Identifier Source: secondary_id

2342.00

Identifier Type: OTHER

Identifier Source: secondary_id

RDCRN 6501

Identifier Type: -

Identifier Source: org_study_id