At a glance
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A Phase II Study of Reduced Intensity Double Umbilical Cord Blood Transplantation Using Fludarabine, Melphalan, and Low Dose Total Body Radiation
In Brief
A Phase 2 clinical trial evaluating Fludarabine, Melphalan, and 2 other interventions for Non-Hodgkin's Lymphoma and 4 related conditions. Completed, enrolled 33 participants across 3 sites.
Detailed 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 blood) are being used, as the numbers of blood cells in one unit are too few to allow successful growth of these cells. Because the risk of infection, particularly virus infection, is high after double cord blood transplant, this study seeks to reduce the rise of virus infection by using a reduced intensity regimen without a medicine called antithymocyte globulin (ATG), as used in prior cord blood transplants. Subjects will receive two chemotherapy drugs, melphalan and fludarabine, and low dose of total body radiation (one treatment) instead of the ATG. The number of patients with virus infections in this study will be compared to our prior experience using the ATG.
Study Details
Timeline
Interventions
30 mg/m2/day IV x 6 days
100 mg/m2/day IV x 1 day
200 cGy on Day 0
2 cord blood units IV