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

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.

Study Overview

• Status: Completed
• Conditions: 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 Type: Observational
• Enrollment (Anticipated): 40

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Tehran, Iran, Islamic Republic of
    • Tehran University of Medical Sciences
• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Dana-Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Thalassemia patients being treated at Shariati Hospital in Tehran.

Description

Inclusion Criteria:

• Thalassemia patients being treated at Shariati Hospital in Tehran.

Study Plan

How is the study designed?

Design Details

• Time Perspectives: Retrospective

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Tehran University of Medical Sciences
• Investigators: Principal Investigator: Catherine Wu, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start: April 1, 2004
• Primary Completion (Actual): October 1, 2005
• Study Completion (Actual): October 1, 2005

Study Registration Dates

• First Submitted: May 30, 2007
• First Submitted That Met QC Criteria: May 30, 2007
• First Posted (Estimate): May 31, 2007

Study Record Updates

• Last Update Posted (Estimate): February 23, 2012
• Last Update Submitted That Met QC Criteria: February 22, 2012
• Last Verified: February 1, 2012

More Information

Terms related to this study

• Keywords: assay; chimerism; allogenic hematopoietic transplantation
• Additional Relevant MeSH Terms: Hematologic Diseases; Genetic Diseases, Inborn; Anemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Hemoglobinopathies; Thalassemia; beta-Thalassemia
• Other Study ID Numbers: 04-078