Monitoring of Erythroid Lineage Specific Chimerism Following Allogeneic Hematopoietic Transplantation for Thalassemia Major - Full Text View

Sponsors and Collaborators:	Dana-Farber Cancer Institute Tehran University of Medical Sciences
Information provided by:	Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier:	NCT00480506

Purpose

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
Thalassemia Major

Genetics Home Reference related topics: beta thalassemia

MedlinePlus related topics: Thalassemia

U.S. FDA Resources

Study Type:	Observational
Study Design:	Retrospective
Official Title:	Monitoring of Erythroid Lineage Specific Chimerism Following Allogeneic Hematopoietic Transplantation for Thalassemia Major

Further study details as provided by Dana-Farber Cancer Institute:

Estimated Enrollment:	40
Study Start Date:	April 2004
Study Completion Date:	October 2005
Primary Completion Date:	October 2005 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Thalassemia patients being treated at Shariati Hospital in Tehran.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00480506

Locations

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

Principal Investigator:

Catherine Wu, MD

Dana-Farber Cancer Institute

More Information

Study ID Numbers:	04-078
Study First Received:	May 30, 2007
Last Updated:	December 20, 2007
ClinicalTrials.gov Identifier:	NCT00480506
Health Authority:	United States: Institutional Review Board

Keywords provided by Dana-Farber Cancer Institute:

chimerism
allogenic hematopoietic transplantation
assay

Study placed in the following topic categories:

Anemia, Hemolytic, Congenital
Thalassemia minor
Genetic Diseases, Inborn
Hematologic Diseases
Hemoglobinopathies
Beta-Thalassemia

Beta-thalassemia
Anemia
Anemia, Hemolytic
Hemoglobinopathy
Thalassemia

ClinicalTrials.gov processed this record on January 16, 2009