Blood Samples to Evaluate Biomarkers of Donor Chimerism

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.

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Key information

Conditions

Leukemia Bone Marrow Diseases Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Hodgkins Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoproliferative Disorders Myelodysplastic Syndrome Myelodysplastic Syndromes Neoplasms Neoplasms by Histologic Type Non-Hodgkins Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

Donor T-cell chimerism

Time frame: Day 28 post-transplant

Secondary outcomes

Exposure to fludarabine and mycophenolate mofetil and their breakdown products.

Time frame: Before and after transplant

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Important dates

Study start: 2008
Primary completion: 2012
Study completion: 2012
First posted: Oct 2, 2008
Registry last updated: Feb 15, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed