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Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

This study has been completed.
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by:
Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier:
NCT01141959
First received: June 8, 2010
Last updated: January 3, 2012
Last verified: January 2012
History of Changes
  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:

U.S. FDA Resources

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)
  Eligibility

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.

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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Jeannine McCune, PharmD, Fred Hutchinson Cancer Research Center
ClinicalTrials.gov 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
cyclophosphamide
fludarabine
 mycophenolate mofetil
mycophenolic acid
biomarkers

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

ClinicalTrials.gov processed this record on May 19, 2013