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Blood Samples to Evaluate Biomarkers of Donor Chimerism

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT00764829
First received: September 30, 2008
Last updated: February 13, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition
Leukemia
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:

U.S. FDA Resources

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

Primary Outcome Measures:
  • Donor T-cell chimerism [ Time Frame: Day 28 post-transplant ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exposure to fludarabine and mycophenolate mofetil and their breakdown products. [ Time Frame: Before and after transplant ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

plasma,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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hematopoietic stem cell transplant patients receiving fludarabine and mycophenolate mofetil.

Criteria

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

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00764829

Locations
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)
Investigators
Principal Investigator: Jeannine S McCune, PharmD Fred Hutchinson Cancer Research Center
  More Information

No publications provided

Responsible Party: Jeannine S. McCune, PharmD, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT00764829     History of Changes
Other Study ID Numbers: FHCRC - 1980.00, R01HL091744, IR-5957
Study First Received: September 30, 2008
Last Updated: February 13, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hodgkin Disease
Leukemia
Lymphoma
Lymphoma, Non-Hodgkin
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions

ClinicalTrials.gov processed this record on May 19, 2013