Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

This study has been completed.
Sponsor:
Collaborator:
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

June 8, 2010
January 3, 2012
May 2010
December 2011   (final data collection date for primary outcome measure)
Donor T-cell chimerism [ Time Frame: Day 28 post-transplant ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01141959 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients
Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

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.

Not Provided
Observational
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

plasma, DNA

Non-Probability Sample

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

  • Leukemia
  • Hodgkin Disease
  • Non-Hodgkin Lymphoma
  • Myelodysplastic Syndrome
  • Multiple Myeloma
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
11
December 2011
December 2011   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01141959
FHCRC-2373.00, IR-7093, R01HL091744-02S1
No
Jeannine McCune, PharmD, Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
National Heart, Lung, and Blood Institute (NHLBI)
Principal Investigator: Jeannine McCune, PharmD Fred Hutchinson Cancer Research Center
Fred Hutchinson Cancer Research Center
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP