Status:
COMPLETED
Umbilical Cord Blood Stem Cell Transplantation in Adults With Advanced Blood Disorders or Cancer
Lead Sponsor:
Duke University
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Hematologic Neoplasms
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
Umbilical cord blood is an important source of stem cells and can be used to treat blood and immune system disorders and certain types of cancer. Stem cell transplants of umbilical cord blood have bee...
Detailed Description
The use of umbilical cord blood stem cells to treat blood disorders and cancer is an important medical advance; currently, more than 45 disorders can be treated with this method. While bone marrow tra...
Eligibility Criteria
Inclusion
- Diagnosis reviewed at transplant center and confirmed to fit the criterion for high risk blood disease or cancer, as defined for the study
- Estimated life expectancy of at least 6 weeks following study entry
- Cancer and Leukemia Group B (CALGB) performance status less than or equal to 2
- White blood cell count, platelet, hematocrit, tuberculosis, aspartate aminotransferase (AST), alanine aminotransferase (ALT), alkaline phosphatase, creatinine, and HIV test results reviewed by transplant center
- Multiple gated acquisition (MUGA), echocardiogram, cardiac MRI, and/or pulmonary function tests (PFT) performed and reviewed by transplant center (for individuals with an ejection fraction and diffusing capacity \[DLCO\] of 40-50%, the appropriate cardiology or pulmonary consultations should be considered if the individual has severe heart or lung disease at the initiation of therapy)
- Sufficient number of umbilical cord blood units available for transplantation
- If female, willing to use contraception throughout the study
Exclusion
- Undergoing Interleukin-2 (IL-2) therapy within 8 weeks of study entry
- Diagnosed with a medical or psychiatric illness that may interfere with study participation
- Pregnant
Key Trial Info
Start Date :
January 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2008
Estimated Enrollment :
34 Patients enrolled
Trial Details
Trial ID
NCT00312429
Start Date
January 1 2002
End Date
May 1 2008
Last Update
April 3 2012
Active Locations (1)
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1
Duke University
Durham, North Carolina, United States, 27710