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Chemotherapy for Relapsed Epstein Barr Virus Associated Lymphoma

NCT01964755 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 6

Last updated 2019-09-23

Study results available
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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

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.

Sponsors & Collaborators

  • University of Miami

    lead OTHER

Principal Investigators

  • Juan Carlos Ramos, MD · University of Miami

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-04-21
Primary Completion
2018-06-07
Completion
2018-06-07
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01964755 on ClinicalTrials.gov