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NCT02179359 Clinical Trial

Hematopoietic Stem Cell Transplant for High Risk Hemoglobinopathies

Sickle Cell Disease Clinical Trial

Official title:
MT2014-10C: Allogeneic Hematopoietic Stem Cell Transplant for Patients With High Risk Hemoglobinopathies and Other Red Cell Transfusion Dependent Disorders

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT02179359
Other study ID # 2014OC034
Secondary ID MT2014-10C
Status Recruiting
Phase N/A
First received
Last updated
Start date September 2, 2014
Est. completion date August 2025

Study information
Verified date February 2024
Source Masonic Cancer Center, University of Minnesota
Contact Lisa Burke
Phone 612-273-8482
Email lburke3@Fairview.org
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This is a study to collect the outcomes of stem cell transplantation for patients with hematologic diseases other than cancer.

Recruitment information / eligibility
Status Recruiting
Enrollment 25
Est. completion date August 2025
Est. primary completion date January 2025
Accepts healthy volunteers No
Gender All
Age group N/A to 55 Years
Eligibility Inclusion Criteria: - Diagnosis of Sickle Cell Disease, Thalassemia, Diamond Blackfan Anemia or other non-malignant hematologic disorders for which a stem cell transplant is indicated - Acceptable stem cell source identified - Performance status of = 70% (Karnofsky),or = 70 (Lansky play score) - Creatinine <2.0 mg/dl for adults or glomerular filtration rate > 50 ml/min for children - Bilirubin, Aspartate Aminotransferase, Alkaline phosphatase <5 times the upper limit of institutional normal - Absence of decompensated congestive heart failure, or uncontrolled arrhythmia and left ventricular ejection fraction > 40% Exclusion Criteria: - active, uncontrolled infection - pregnant or breastfeeding - HIV positive

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Reduced Toxicity Ablative Regimen
Anti-thymocyte Globulin (ATG) Fludarabine Busulfan Stem Cell Infusion Day 0
• Reduced Intensity Preparative Regimen
Alemtuzumab Cyclophosphamide Fludarabine Total Body Irradiation (TBI) Stem Cell Infusion Day 0
• Myeloablative Preparative Regimen
Alemtuzumab Cyclophosphamide Busulfan Stem Cell Infusion Day 0

Locations
Country Name City State
United States University of Minnesota Medical Center, Fairview Minneapolis Minnesota

Sponsors (1)
Lead Sponsor Collaborator
Masonic Cancer Center, University of Minnesota

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary incidence of graft failure 42 days
Secondary overall survival 6 months, 1 and 2 years
Secondary disease free survival patient no longer needing red blood cell transfusion and/or a hemoglobin S level at that of the donor ( sickle cell disease only) 6 months, 1 and 2 years
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