drugset / Trial / NCT01490723

Zevalin-Containing Nonmyeloablative Conditioning for Stem Cell Transplantation (SCT)

NCT01490723

NaSingle-groupOpen-labelTreatment

Summary

The goal of this clinical research study is to learn if adding Zevalin (ibritumomab tiuxetan) to low-intensity chemotherapy (the combination of rituximab, bendamustine, and fludarabine), followed by an allogeneic stem cell transplant, can help to control lymphoma. The safety of this combination will also be studied. Two (2) forms of ibritumomab tiuxetan will be used in this study. 90Y-ibritumomab tiuxetan is designed to attach to lymphoma cells and destroy the cells using a radioactive particle that is attached to it. 111In-ibritumomab tiuxetan is like 90Y- ibritumomab tiuxetan, but the radioactive particle that is attached to it does not kill lymphoma cells. The radioactive particle makes the drug able to be seen inside your body. It is being used in this study to predict how fast the study drug will travel in the body and how long the drug stays in the body. Rituximab is designed to attach to lymphoma cells, which may cause them to die. Bendamustine is designed to damage and destroy the DNA (genetic material) of cancer cells. Fludarabine is designed to make cancer cells less able to repair damaged DNA. This may increase the likelihood of the cells dying.

Timeline

Start
2013-01
Primary completion
2019-04-24
Completion
2019-04-24

Drugs

EvaluationDrugModalityDoseRoute
Subject 111In-ibritumomab tiuxetan Unknown 5 unknown Intravenous
Subject 90Y-ibritumomab tiuxetan Other / unclassified Intravenous
Background Bendamustine Small molecule 130 mg/m2 Intravenous
Background Fludarabine Small molecule 30 mg/m2 Intravenous
Background G-CSF Unknown 5 ug/kg Subcutaneous
Background Methotrexate Small molecule 5 mg/m2 Intravenous
Background Mycophenolate Sodium Unknown 15 mg/kg Intravenous
Background Rituximab Monoclonal antibody 250 mg/m2 Intravenous
Background Tacrolimus Small molecule 0.015 mg/kg Intravenous
Background Tacrolimus Small molecule 0.03 mg/kg Intravenous
Background Thymoglobulin Protein / enzyme biologic 1 mg/kg Intravenous

Indications