Status:
TERMINATED
Pilot Trial of Targeted Immune-Depleting Chemotherapy and Reduced-Intensity Matched Unrelated Double Cord Blood Transplant for the Treatment of Leukemias, Lymphomas, and Pre-Malignant Blood Disorders
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Leukemia
Non-Hodgkins Lymphoma
Eligibility:
All Genders
18-69 years
Phase:
PHASE1
Brief Summary
Background: * Allogeneic stem cell transplantation (SCT) has been used to treat many kinds of cancer or pre-cancerous conditions that develop in blood or immune system cells. Umbilical cord blood tra...
Detailed Description
Background: The major limitations of umbilical cord blood transplantation (UCBT) in adults are graft rejection and delayed engraftment leading to increased infection-related morbidity and treatment r...
Eligibility Criteria
Inclusion
- ELIGIBILITY CRITERIA:
- Adults (18-69 years) with advanced or high-risk hematologic malignancies including AML, ALL, MDS, CLL, NHL, HL, CML, multiple myeloma, and MPD who lack a readily available HLA-matched sibling or greater than or equal to 7/8 HLA-matched unrelated donor. Patients must have life expectancy of at least 3 months, ECOG less than or equal to 2, and relatively normal major organ functions.
- Patients must have two partially HLA-matched UCB units. Units must be HLA-matched at HLA-A and B (intermediate resolution molecular typing) and DRB1 (high resolution molecular typing) 4-6/6 with the recipient and 4-6/6 with each other. Each unit must contain a minimum precryopreserved, nucleated cell dose of 1.5 x 10(7) per kilogram.
Exclusion
Key Trial Info
Start Date :
August 25 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 20 2013
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT00973804
Start Date
August 25 2009
End Date
May 20 2013
Last Update
December 17 2019
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892