drugset / Trial / NCT01408563

Reduced Intensity Double Umbilical Cord Blood Transplantation

NCT01408563

Phase 2 Completed 33 enrolled Massachusetts General Hospital
NaSingle-groupOpen-labelTreatment

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.

Timeline

Start
2011-12
Primary completion
2017-06
Completion
2017-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Fludarabine Small molecule 30 mg/m2 Intravenous
Subject Influenza Virus Vaccine Vaccine 2 unknown Intravenous
Subject Melphalan Small molecule 100 mg/m2 Intravenous