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Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01141959
First Posted: June 11, 2010
Last Update Posted: March 10, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center
  Purpose
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
Leukemia Hodgkin Disease Non-Hodgkin Lymphoma Myelodysplastic Syndrome Multiple Myeloma

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

Resource links provided by NLM:


Further study details as provided by Fred Hutchinson Cancer Research Center:

Primary Outcome Measures:
  • Donor T-cell chimerism [ Time Frame: Day 28 post-transplant ]

Secondary Outcome Measures:
  • Exposure to cyclophosphamide, fludarabine, and mycophenolate mofetil and their breakdown products [ Time Frame: 1 week before through 3 weeks after transplant ]

Biospecimen Retention:   Samples With DNA
plasma, DNA

Enrollment: 11
Study Start Date: May 2010
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hematopoeitic cell transplant patients with haploidentical donors receiving cyclophosphamide, fludarabine and mycophenolate mofetil.
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01141959


Locations
United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
National Heart, Lung, and Blood Institute (NHLBI)
Investigators
Principal Investigator: Jeannine McCune, PharmD Fred Hutchinson Cancer Research Center
  More Information

Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT01141959     History of Changes
Other Study ID Numbers: FHCRC-2373.00
IR-7093 ( Other Identifier: FHCRC )
R01HL091744-02S1 ( U.S. NIH Grant/Contract )
First Submitted: June 8, 2010
First Posted: June 11, 2010
Last Update Posted: March 10, 2015
Last Verified: March 2015

Keywords provided by Fred Hutchinson Cancer Research Center:
hematopoietic stem cell transplantation
cyclophosphamide
fludarabine
mycophenolate mofetil
mycophenolic acid
biomarkers

Additional relevant MeSH terms:
Multiple Myeloma
Myelodysplastic Syndromes
Preleukemia
Lymphoma, Non-Hodgkin
Hodgkin Disease
Neoplasms, Plasma Cell
Neoplasms by Histologic Type
Neoplasms
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Paraproteinemias
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Lymphoproliferative Disorders
Immunoproliferative Disorders
Immune System Diseases
Bone Marrow Diseases
Precancerous Conditions
Lymphoma
Lymphatic Diseases