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Monitoring of Erythroid Lineage Specific Chimerism Following Allogeneic Hematopoietic Transplantation for Thalassemia Major

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ClinicalTrials.gov Identifier: NCT00480506
Recruitment Status : Completed
First Posted : May 31, 2007
Last Update Posted : February 23, 2012
Sponsor:
Collaborator:
Tehran University of Medical Sciences
Information provided by (Responsible Party):
Catherine Wu, MD, Dana-Farber Cancer Institute

Study Description
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Brief Summary:
The purpose of this study is to collect peripheral blood and bone marrow aspirate samples from thalassemia patients in Tehran, in a collaborative effort to develop an erythroid lineage specific chimerism assay applicable to patients with thalassemia. Development of such an assay would be useful both for identification of the exact mutation causing the disease, as well as for providing a direct method to measure and monitor the kinetics of donor erythropoiesis in this patient population following transplant.

Condition or disease
Thalassemia Major

Detailed Description:
  • In the first phase of the study we will develop a panel of reagents designed to identify predominant thalassemia mutations in the Iranian population, as well as alternative highly variable erythroid specific polymorphisms. To determine how informative this panel is, these reagents will be applied to samples collected from patients homozygous for the disorder, and compared to patients with thalassemia trait and normal Iranian donors.
  • In the second phase, we propose to serially measure and compare erythroid lineage chimerism with overall genomic chimerism following transplant. Samples will be collected from participants before and at 1, 2, 3, 6 and 12 months following transplant and cryopreserved. Peripheral blood from the stem cell donor will also be collected and cryopreserved. Participants will undergo myeloablative or nonmyeloablative transplant.
Study Design
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Study Type : Observational
Estimated Enrollment : 40 participants
Time Perspective: Retrospective
Official Title: Monitoring of Erythroid Lineage Specific Chimerism Following Allogeneic Hematopoietic Transplantation for Thalassemia Major
Study Start Date : April 2004
Actual Primary Completion Date : October 2005
Actual Study Completion Date : October 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Groups and Cohorts
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Outcome Measures
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Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Thalassemia patients being treated at Shariati Hospital in Tehran.
Criteria

Inclusion Criteria:

  • Thalassemia patients being treated at Shariati Hospital in Tehran.
Contacts and Locations
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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): NCT00480506


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Iran, Islamic Republic of
Tehran University of Medical Sciences
Tehran, Iran, Islamic Republic of
Sponsors and Collaborators
Dana-Farber Cancer Institute
Tehran University of Medical Sciences
Investigators
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Principal Investigator: Catherine Wu, MD Dana-Farber Cancer Institute
More Information
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Responsible Party: Catherine Wu, MD, Principal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT00480506    
Other Study ID Numbers: 04-078
First Posted: May 31, 2007    Key Record Dates
Last Update Posted: February 23, 2012
Last Verified: February 2012
Keywords provided by Catherine Wu, MD, Dana-Farber Cancer Institute:
chimerism
allogenic hematopoietic transplantation
assay
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
 Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn