Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

Completed

• Conditions: Hodgkin Disease; Non-Hodgkin Lymphoma; Myelodysplastic Syndrome; Leukemia; Multiple Myeloma

• Registration Number: NCT01141959
• Lead Sponsor: Fred Hutchinson Cancer Center

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05
• Study First Submitted: 2010-06-08
• Study First Submitted QC: 2010-06-10
• Study First Posted: 2010-06-11
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2015-03
• Last Update Submitted: 2023-05-30
• Last Update Posted: 2023-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Donor T-cell chimerism	Day 28 post-transplant

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Fred Hutchinson Cancer Research Center; 🇺🇸 Seattle, Washington, United States