Early Detection of Graft-Versus-Host Disease in Patients Undergoing a Donor Bone Marrow Transplant

This study has been withdrawn prior to enrollment.
(No Patients enrolled)
Sponsor:
Collaborator:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00898612
First received: May 9, 2009
Last updated: March 6, 2014
Last verified: March 2014
  Purpose

RATIONALE: Studying samples of blood in the laboratory from patients who have undergone a donor bone marrow transplant may help doctors learn more about changes that occur in DNA and identify biomarkers related to graft-versus-host disease. It may also help doctors predict how patients will respond to a donor bone marrow transplant.

PURPOSE: This laboratory study is looking at early detection of graft-versus-host disease in patients undergoing a donor bone marrow transplant.


Condition
Lymphoma

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Using the Transcriptome for Early Detection of Graft Versus Host Disease in Allogeneic Bone Marrow Transplantation

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Identification of changes in the transcriptome or proteome expression prior to clinical manifestations of graft-versus-host disease (GVHD) in patient blood samples [ Time Frame: Patients beyond period of risk for developing acute GVHD ] [ Designated as safety issue: No ]
    Once a minimum of 20 patients have been enrolled and clinically are beyond their period of risk of developing acute GVHD, samples from at least 5 patients who have developed acute GVHD are compared to samples from at least 5 patients who have had no detectable clinical GVHD. If no differences are detected, additional patients/samples will be enrolled/analyzed.


Secondary Outcome Measures:
  • Characterization of changes in the expression patterns which are predictive of clinically significant GVHD [ Time Frame: Patient beyond period of risk for developing acute GVHD ] [ Designated as safety issue: No ]
  • Development of reliable tests to predict GVHD in time for early intervention [ Time Frame: Patient beyond period of risk for developing acute GVHD ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2008
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Detailed Description:

OBJECTIVES:

Primary

  • Identify detectable changes in the transcriptomic or proteomic expression prior to clinical manifestations of graft-versus-host disease (GVHD) in blood samples from at-risk patients who have undergone allogeneic bone marrow transplantation.

Secondary

  • Characterize changes in the transcriptome or proteome expression pattern which are predictive of clinically significant GVHD in these patients.
  • Develop reliable tests which enable early intervention for these patients.

OUTLINE: Blood samples are collected prior to and just after typical onset of clinical graft-vs-host disease (GVHD) on days 1, 7-10, 20-23, 30-33, and 60 after allogeneic bone marrow transplantation. RNA is quantified and assessed by microarray analysis to identify changes to transcriptome or proteome expression and markers predictive of the onset of clinical GVHD. Samples are also stored for future analysis.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients undergoing allogeneic bone marrow transplantation at participating institutions.

Criteria

DISEASE CHARACTERISTICS:

  • Any patient undergoing an allogeneic bone marrow transplantation at one of the participating Mayo Clinic sites

PATIENT CHARACTERISTICS:

  • Body weight ≥ 15 kg
  • Not pregnant
  • Not a prisoner

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00898612

Locations
United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States, 85259-5499
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Roberta Adams, MD Mayo Clinic Hospital
  More Information

Additional Information:
No publications provided

Responsible Party: Roberta H. Adams, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier: NCT00898612     History of Changes
Other Study ID Numbers: CDR0000588925, P30CA015083, 878-05, 878-05
Study First Received: May 9, 2009
Last Updated: March 6, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
stage III adult Burkitt lymphoma
stage III adult diffuse large cell lymphoma
stage III adult diffuse mixed cell lymphoma
stage III adult diffuse small cleaved cell lymphoma
stage III adult Hodgkin lymphoma
stage III adult immunoblastic large cell lymphoma
stage III adult lymphoblastic lymphoma
stage III grade 1 follicular lymphoma
stage III grade 2 follicular lymphoma
stage III grade 3 follicular lymphoma
stage III mantle cell lymphoma
stage III marginal zone lymphoma
stage III small lymphocytic lymphoma
stage IV adult Burkitt lymphoma
stage IV adult diffuse large cell lymphoma
stage IV adult diffuse mixed cell lymphoma
stage IV adult diffuse small cleaved cell lymphoma
stage IV adult Hodgkin lymphoma
stage IV adult immunoblastic large cell lymphoma
stage IV adult lymphoblastic lymphoma
stage IV grade 1 follicular lymphoma
stage IV grade 2 follicular lymphoma
stage IV grade 3 follicular lymphoma
stage IV mantle cell lymphoma
stage IV marginal zone lymphoma
stage IV small lymphocytic lymphoma
recurrent adult Burkitt lymphoma
recurrent adult diffuse large cell lymphoma
recurrent adult diffuse mixed cell lymphoma
recurrent adult diffuse small cleaved cell lymphoma

Additional relevant MeSH terms:
Graft vs Host Disease
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Immunoblastic
Immune System Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders

ClinicalTrials.gov processed this record on July 22, 2014