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Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

This study has been completed.
Information provided by:
Fred Hutchinson Cancer Research Center Identifier:
First received: June 8, 2010
Last updated: January 3, 2012
Last verified: January 2012

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.

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Exposure to cyclophosphamide, fludarabine, and mycophenolate mofetil and their breakdown products [ Time Frame: 1 week before through 3 weeks after transplant ] [ Designated as safety issue: No ]

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)

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Hematopoeitic cell transplant patients with haploidentical donors receiving cyclophosphamide, fludarabine and mycophenolate mofetil.


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
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Please refer to this study by its identifier: NCT01141959

United States, Washington
Fred Hutchinson Cancer Research Center
Seattle, Washington, United States, 98109
Sponsors and Collaborators
Fred Hutchinson Cancer Research Center
Principal Investigator: Jeannine McCune, PharmD Fred Hutchinson Cancer Research Center
  More Information

No publications provided

Responsible Party: Jeannine McCune, PharmD, Fred Hutchinson Cancer Research Center Identifier: NCT01141959     History of Changes
Other Study ID Numbers: FHCRC-2373.00, IR-7093, R01HL091744-02S1
Study First Received: June 8, 2010
Last Updated: January 3, 2012
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Hodgkin Disease
Lymphoma, Non-Hodgkin
Multiple Myeloma
Myelodysplastic Syndromes
Neoplasms, Plasma Cell
Blood Protein Disorders
Bone Marrow Diseases
Cardiovascular Diseases
Hematologic Diseases
Hemorrhagic Disorders
Hemostatic Disorders
Immune System Diseases
Immunoproliferative Disorders
Lymphatic Diseases
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Precancerous Conditions
Vascular Diseases processed this record on November 19, 2014