drugset
drugset / Trial / NCT02722668

UCB Transplant for Hematological Diseases Using a Non Myeloablative Prep

NCT02722668 ↗

Phase 2 Completed 15 enrolled Masonic Cancer Center, University of Minnesota
Non-randomizedParallel-groupOpen-labelTreatment

Summary

This is a phase II trial using a non-myeloablative cyclophosphamide/ fludarabine/total body irradiation (TBI) preparative regimen with modifications based on factors including diagnosis, disease status, and prior treatment. Single or double unit selected according to current University of Minnesota umbilical cord blood graft selection algorithm.

Timeline

Start
2017-05-15
Primary completion
2023-02-22
Completion
2024-02-22

Drugs

EvaluationDrugModalityDoseRoute
Subject ATG Unknown 15 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 50 mg/kg Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background MMF Unknown 15 mg/kg Intravenous
Background MMF Unknown 3 g Intravenous
Background Sirolimus Small molecule 2.5 mg/m2 Oral
Background Sirolimus Small molecule 4 mg Oral
Background Umbilical cord blood cell infusion Cell therapy — —

Indications

Burkitt lymphoma Hodgkins lymphoma T-cell and NK-cell neoplasm T-cell non-Hodgkin lymphoma bone marrow failure syndrome chronic lymphocytic leukemia/small lymphocytic lymphoma chronic myeloid leukemia follicular lymphoma lymphoplasmacytic lymphoma mantle cell lymphoma marginal zone lymphoma mixed phenotype acute leukemia myelodysplastic syndrome plasma cell leukemia plasma cell myeloma prolymphocytic leukemia