Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01141959

Enrollment

Registered

2010-06-11

Start date

2010-05-31

Completion date

2011-12-31

Last updated

2023-05-31

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

Conditions

Hodgkin Disease, Leukemia, Multiple Myeloma, Myelodysplastic Syndrome, Non-Hodgkin Lymphoma

Keywords

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

Brief summary

The investigators are interested in identifying patient-specific factors related to donor chimerism in patients who receive nonmyeloablative hematopoietic stem cell transplants from haploidentical donors. We will look how patients' bodies break down and immediately respond to cyclophosphamide, fludarabine and mycophenolate mofetil.

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

* Scheduled to receive nonmyeloablative conditioning which includes fludarabine * Scheduled to receive a haploidentical graft * Scheduled to receive postgrafting immunosuppression which includes oral mycophenolate mofetil (MMF) or enteric-coated mycophenolic acid * Age \>18 years at the time of enrollment

Exclusion criteria

* Diagnosed with an immunodeficiency disorder, including HIV

Design outcomes

Primary

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

Secondary

Measure	Time frame
Exposure to cyclophosphamide, fludarabine, and mycophenolate mofetil and their breakdown products	1 week before through 3 weeks after transplant

Countries

United States

Outcome results