ClinicalTrials.gov
ClinicalTrials.gov Menu

Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01206309
Recruitment Status : Completed
First Posted : September 21, 2010
Last Update Posted : October 7, 2016
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

September 20, 2010
September 21, 2010
October 7, 2016
March 2011
October 2016   (Final data collection date for primary outcome measure)
The prevalence of immune mediated disorders [ Time Frame: Diagnosis of IMD and at 2 years ]

The prevalence of:

  • Persistent, recurrent or late onset acute GVHD
  • Cutaneous Sclerosis
  • Bronchiolitis Obliterans Syndrome
  • Chronic GVHD
The prevalence of immune mediated disorders [ Time Frame: The time of diagnosis and at two years ]

The prevalence of:

  • Persistent, recurrent or late onset acute GVHD
  • Cutaneous Sclerosis
  • Bronchiolitis Obliterans Syndrome
  • Chronic GVHD
Complete list of historical versions of study NCT01206309 on ClinicalTrials.gov Archive Site
Banked blood and urine samples [ Time Frame: At 2 years ]
Summarized as the percentage of compliance for each center and for the study as a whole
Banked blood and urine samples [ Time Frame: At the end of the study ]
Summarized as the percentage of compliance for each center and for the study as a whole
Not Provided
Not Provided
 
Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation
Longitudinal Study of Immune Mediated Disorders After Allogeneic Hematopoietic Cell Transplantation (HCT)
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
blood and urine specimens
Probability Sample
Patients who are preparing for or have recently received an allogeneic hematopoietic cell transplant
  • Graft vs Host Disease
  • Cutaneous Sclerosis
  • Bronchiolitis Obliterans
Not Provided
  • Controls
    Never develop an immune mediated disorder
  • Immune Mediated Disorder
    Develop an immune mediated disorder
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
911
1118
October 2016
October 2016   (Final data collection date for primary outcome measure)

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)
Sexes Eligible for Study: All
Child, Adult, Older Adult
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01206309
RDCRN 6501
U54CA163438 ( U.S. NIH Grant/Contract )
RDCRN-6501 ( Other Identifier: DMCC )
2342.00 ( Other Identifier: FHCRC )
Yes
Not Provided
Not Provided
Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
National Cancer Institute (NCI)
Principal Investigator: Stephanie Lee, MD, MPH Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
October 2016