drugset / Trial / NCT01964755

Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma

NCT01964755

Phase 2 Terminated 6 enrolled University of Miami
NaSingle-groupOpen-labelTreatment

Summary

By combining a variety of agents that potentiate Zidovudine (ZDV), the investigators hope to induce remission in this generally fatal disease. Most therapies for aggressive B cell lymphomas are based upon intensive chemotherapeutic regimens, expensive modalities (bone marrow transplant, Rituximab), or experimental approaches (gene therapy, cytotoxic T cell infusion) that are difficult to implement in heavily pre-treated patients. Therapy for relapsed aggressive B cell lymphomas is very poor. Even curable lymphomas such as Burkitt Lymphoma (BL) and Hodgkin lymphoma are extremely difficult to treat in relapse and/or after stem cell transplant failure. The investigators propose a novel therapeutic approach that exploits the presence of Epstein-Barr virus (EBV) in lymphomas; antiviral mediated suppression of NF-kB and disruption of viral latency.

Timeline

Start
2009-04-21
Primary completion
2018-06-07
Completion
2018-06-07

Drugs

EvaluationDrugModalityDoseRoute
Subject Doxorubicin Other / unclassified 20 mg/m2 Intravenous
Subject Hydroxyurea Other / unclassified 1000 mg Oral
Subject Leucovorin Small molecule 25 mg Intravenous
Subject Methotrexate Small molecule 3.5 g/kg Intravenous
Subject Rituximab Monoclonal antibody 375 mg/m2 Intravenous
Subject Zidovudine Small molecule 1200 mg Intravenous