Blood Samples to Evaluate Biomarkers of Donor Chimerism

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00764829

Enrollment

Registered

2008-10-02

Start date

2008-09-30

Completion date

2012-02-29

Last updated

2012-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hodgkins Disease, Leukemia, Myelodysplastic Syndrome, Non-hodgkins Lymphoma

Keywords

hematopoietic stem cell transplantation, fludarabine, mycophenolate mofetil, mycophenolic acid, biomarkers

Brief summary

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Donor T-cell chimerism	Day 28 post-transplant

Secondary

Measure	Time frame
Exposure to fludarabine and mycophenolate mofetil and their breakdown products.	Before and after transplant

Countries

United States

Outcome results