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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01206309
Other study ID # RDCRN 6501
Secondary ID U54CA163438RDCRN
Status Completed
Phase N/A
First received September 20, 2010
Last updated October 6, 2016
Start date March 2011
Est. completion date October 2016

Study information

Verified date October 2016
Source Fred Hutchinson Cancer Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 911
Est. completion date October 2016
Est. primary completion date October 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Observational Model: Cohort, Time Perspective: Prospective


Locations

Country Name City State
United States Dana Farber Cancer Institute Boston Massachusetts
United States Roswell Park Cancer Institute Buffalo 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 Medical College of Wisconsin Milwaukee Wisconsin
United States University of Minnesota Minneapolis Minnesota
United States Vanderbilt University Nashville Tennessee
United States Weill Cornell Medical College New York New York
United States Mayo Clinic Scottsdale Arizona
United States Fred Hutchinson Cancer Research Center/Seattle Cancer Care Alliance Seattle Washington
United States Washington University St. Louis St. Louis Missouri
United States Stanford University Stanford California
United States H. Lee Moffitt Cancer Center Tampa Florida

Sponsors (2)

Lead Sponsor Collaborator
Fred Hutchinson Cancer Research Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary The prevalence of immune mediated disorders The prevalence of:
Persistent, recurrent or late onset acute GVHD
Cutaneous Sclerosis
Bronchiolitis Obliterans Syndrome
Chronic GVHD
Diagnosis of IMD and at 2 years No
Secondary Banked blood and urine samples Summarized as the percentage of compliance for each center and for the study as a whole At 2 years No
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