- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01141959
Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients
May 30, 2023 updated by: Fred Hutchinson Cancer Center
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.
Study Overview
Status
Completed
Study Type
Observational
Enrollment (Actual)
11
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Washington
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Seattle, Washington, United States, 98109
- Fred Hutchinson Cancer Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
Hematopoeitic cell transplant patients with haploidentical donors receiving cyclophosphamide, fludarabine and mycophenolate mofetil.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Donor T-cell chimerism
Time Frame: Day 28 post-transplant
|
Day 28 post-transplant
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Exposure to cyclophosphamide, fludarabine, and mycophenolate mofetil and their breakdown products
Time Frame: 1 week before through 3 weeks after transplant
|
1 week before through 3 weeks after transplant
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Jeannine McCune, PharmD, Fred Hutchinson Cancer Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2010
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
June 8, 2010
First Submitted That Met QC Criteria
June 10, 2010
First Posted (Estimated)
June 11, 2010
Study Record Updates
Last Update Posted (Actual)
May 31, 2023
Last Update Submitted That Met QC Criteria
May 30, 2023
Last Verified
March 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Neoplasms
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Neoplasms, Plasma Cell
- Lymphoma
- Myelodysplastic Syndromes
- Multiple Myeloma
- Hodgkin Disease
Other Study ID Numbers
- FHCRC-2373.00
- IR-7093 (Other Identifier: FHCRC)
- R01HL091744-02S1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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