NCT01964755

Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma

Phase II Study of Chemotherapy (Doxorubicin, Methotrexate and Leucovorin) in Combination With Antiviral-Based Therapy (Zidovudine + Hydroxyurea) for AIDS, Immunocompromised, or Immunocompetent Patients With Relapsed or CNS Positive Epstein Barr Virus Associated Lymphoma

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 6 (actual)
• Sponsor: University of Miami · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Epstein Barr Virus Associated Non Hodgkin's Lymphoma
• Epstein Barr Virus Associated Hodgkin's Lymphoma
• Post-Transplant Lymphoproliferative Disease

Interventions

Type	Name	Description
DRUG	Doxorubicin	Doxorubicin 20 mg/m2 intravenously will be administered on Day 1 in patients with systemic (non-primary CNS) lymphoma as per institutional guidelines
DRUG	Methotrexate	Methotrexate administered starting on Day 2, per study protocol.
DRUG	Leucovorin	Leucovorin administered first intravenously 24 hours after start of Methotrexate infusion, then orally every 6 hours for at least 10 doses, per study protocol.
BIOLOGICAL	Hydroxyurea	Hydroxyurea administered orally twice daily starting on Day 2, and continuing for a total of 10 doses, per study protocol
DRUG	Zidovudine	Zidovudine administered first intravenously on Day 2, and then orally twice daily for 10 doses, per study protocol.
DRUG	Rituximab	Rituximab is optional and will be administered to study participants, per study protocol.

Timeline

• Start date: 2009-04-21
• Primary completion: 2018-06-07
• Completion: 2018-06-07
• First posted: 2013-10-17
• Last updated: 2019-09-23
• Results posted: 2019-09-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study