Status:
COMPLETED
Reduced Intensity Double Umbilical Cord Blood Transplantation
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Non-Hodgkin's Lymphoma
Hodgkin's Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE2
Brief Summary
This trial will use two cord blood units for transplantation using a reduced intensity regimen rather than using intense doses of chemotherapy and radiation therapy. Two cord blood units (double cord ...
Detailed Description
Subjects will receive their transplants as in-patients. * IV-Catheter * one or two IV catheters will be placed on the day of hospital admission * Conditioning * Fludarabine IV six days before t...
Eligibility Criteria
Inclusion
- Hematologic malignancy for whom allogeneic stem cell transplantation is deemed clinically appropriate
- Appropriate candidate for reduced intensity regimen, according to the treating physician
- Lack of 6/6/ or 5/6 HLA-matched related, 8/8/ HLA-matched unrelated donor, or unrelated donor not available with a time frame necessary to perform a potentially curative stem cell transplant
- Able to comply with the requirements for care after allogeneic stem cell transplantation
Exclusion
- Cardiac disease: symptomatic congestive heart failure or evidence of left ventricular dysfunction
- Pulmonary disease: symptomatic chronic obstructive lung disease, symptomatic restrictive lung disease
- Renal disease
- Hepatic disease
- Neurologic disease: symptomatic leukoencephalopathy, active CNS malignancy or other neuropsychiatric abnormalities believed to preclude transplantation
- HIV-positive
- Uncontrolled infection
- Pregnant or breast-feeding
Key Trial Info
Start Date :
December 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2017
Estimated Enrollment :
33 Patients enrolled
Trial Details
Trial ID
NCT01408563
Start Date
December 1 2011
End Date
June 1 2017
Last Update
January 23 2019
Active Locations (3)
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1
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
2
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States, 02215
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215