Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

Sponsor

Fred Hutchinson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01141959

Collaborator

National Heart, Lung, and Blood Institute (NHLBI) (NIH)

Enrollment

Location

Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Leukemia Hodgkin Disease Non-Hodgkin Lymphoma Myelodysplastic Syndrome Multiple Myeloma

Study Design

Study Type:

Observational

Actual Enrollment :

11 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

Study Start Date :

May 1, 2010

Actual Primary Completion Date :

Dec 1, 2011

Actual Study Completion Date :

Dec 1, 2011

Outcome Measures

Primary Outcome Measures

Donor T-cell chimerism [Day 28 post-transplant]

Secondary Outcome Measures

Exposure to cyclophosphamide, fludarabine, and mycophenolate mofetil and their breakdown products [1 week before through 3 weeks after transplant]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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