drugset / Trial / NCT02483000

Anti-CD20 Radioimmunotherapy Before Chemotherapy and Stem Cell Transplant in Treating Patients With High-Risk B-Cell Malignancies

NCT02483000

NaSingle-groupOpen-labelTreatment

Summary

This phase I/II trial studies the side effects and best dose of anti-cluster of differentiation (CD)20 radioimmunotherapy (RIT), and to see how well it works when given before chemotherapy and stem cell transplant in treating patients with B-cell malignancies that have not responded to treatment or have come back after responding to treatment. CD20 is a protein found on the cells of a type of cancer cell called B-cells. Anti-CD20 RIT attaches radioactive material to a drug that is designed to target CD20, which brings radioactive material to the cancer cells to kill the cells. This may kill more tumor cells while causing fewer side effects to healthy tissue. Adding anti-CD20 to standard chemotherapy and stem cell transplant may be more effective in treating patients with B-cell malignancies.

Timeline

Start
2017-02-01
Primary completion
2019-11-17
Completion
2020-09-02

Drugs

EvaluationDrugModalityDoseRoute
Subject Anti-CD20 B9E9 scFv-Streptavidin Fusion Protein Protein / enzyme biologic Intravenous
Background Cytarabine Small molecule Intravenous
Background Etoposide Small molecule Intravenous
Background Melphalan Small molecule Intravenous
Background carmustine Small molecule Intravenous