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

Tracking Information

First Received Date ^ICMJE

June 8, 2010

Last Updated Date

January 3, 2012

Start Date ^ICMJE

May 2010

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Donor T-cell chimerism [ Time Frame: Day 28 post-transplant ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01141959 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

Official Title ^ICMJE

Blood Samples to Identify Biomarkers in Haploidentical Graft Recipients

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Case-Only
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples With DNA

Description:

plasma, DNA

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Leukemia
Hodgkin Disease
Non-Hodgkin Lymphoma
Myelodysplastic Syndrome
Multiple Myeloma

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2011

Primary Completion Date

December 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01141959

Other Study ID Numbers ^ICMJE

FHCRC-2373.00, IR-7093, R01HL091744-02S1

Has Data Monitoring Committee

Responsible Party

Jeannine McCune, PharmD, Fred Hutchinson Cancer Research Center

Study Sponsor ^ICMJE

Fred Hutchinson Cancer Research Center

Collaborators ^ICMJE

National Heart, Lung, and Blood Institute (NHLBI)

Investigators ^ICMJE

Principal Investigator:

Jeannine McCune, PharmD

Fred Hutchinson Cancer Research Center

Information Provided By

Fred Hutchinson Cancer Research Center

Verification Date

January 2012

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

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