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Blood Samples to Evaluate Biomarkers of Donor Chimerism

This study has been completed.
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Fred Hutchinson Cancer Research Center Identifier:
First received: September 30, 2008
Last updated: February 13, 2012
Last verified: February 2012
We are interested in patient-specific factors that may affect the balance of recipient cells and donor cells in patients who receive stem cell transplants. We will look at the way the patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these two drugs affect the patient's body.

Hodgkins Disease
Non-hodgkins Lymphoma
Myelodysplastic Syndrome

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Blood Samples to Evaluate Biomarkers of Donor Chimerism

Resource links provided by NLM:

Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Donor T-cell chimerism [ Time Frame: Day 28 post-transplant ]

Secondary Outcome Measures:
  • Exposure to fludarabine and mycophenolate mofetil and their breakdown products. [ Time Frame: Before and after transplant ]

Biospecimen Retention:   Samples With DNA

Estimated Enrollment: 80
Study Start Date: September 2008
Study Completion Date: February 2012
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hematopoietic stem cell transplant patients receiving fludarabine and mycophenolate mofetil.

Inclusion Criteria:

  • Diagnosed with a hematologic disease or malignancy
  • Scheduled to receive nonablative conditioning with fludarabine and total body irradiation
  • Donor is well-matched by high resolution DNA techniques.
  • Scheduled to receive postgrafting immunosuppression of oral MMF (CellCept) and an oral calcineurin inhibitor.
  • Age >18 years at the time of enrollment.

Exclusion criteria:

-Diagnosed with an immunodeficiency disorder

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Please refer to this study by its identifier: NCT00764829

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jeannine S McCune, PharmD Fred Hutchinson Cancer Research Center
  More Information

Responsible Party: Jeannine S. McCune, PharmD, Fred Hutchinson Cancer Research Center Identifier: NCT00764829     History of Changes
Other Study ID Numbers: FHCRC - 1980.00
R01HL091744 ( US NIH Grant/Contract Award Number )
IR-5957 ( Other Identifier: FHCRC )
Study First Received: September 30, 2008
Last Updated: February 13, 2012

Keywords provided by Fred Hutchinson Cancer Research Center:
hematopoietic stem cell transplantation
mycophenolate mofetil
mycophenolic acid

Additional relevant MeSH terms:
Myelodysplastic Syndromes
Lymphoma, Non-Hodgkin
Hodgkin Disease
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases processed this record on April 28, 2017