18 and older, any sex, with Epstein Barr Virus Associated Non Hodgkin's Lymphoma or Epstein Barr Virus Associated Hodgkin's Lymphoma. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Rate of Complete Response to Protocol TherapyPrimary· About 21 days
Complete Response (CR) rate in study participants to protocol therapy. Response will be assessed via CT Scan and bone marrow aspirate/biopsy, if applicable. Complete response criteria include:
* Complete disappearance of all detectable clinical and radiographic evidence of disease and disappearance of all disease-related symptoms if present before therapy, and normalization of those biochemical abnormalities definitely assignable to Non Hodgkin's Lymphoma (NHL);
* All lymph nodes and tumor masses disappeared or regressed to normal size (≤ 1.5 cm in their greatest transverse diameters for node
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
3
One-year Rate of Overall SurvivalSecondary· 12 months
Rate of overall survival of study participants at one year since initiation of protocol therapy. Overall survival (OS) will be measured from the date of initiation of study treatment until date of death from any cause. In the absence of death, the follow-up will be censored at date of last contact (censored observation). Kaplan-Meier estimate of overall survival at one-year.
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
83.3
27.3 – 97.5
One-Year Rate of Failure-Free Survival (FFS)Secondary· 12 months
Rate of failure-free survival of study participants one-year after start of protocol therapy. Failure-free survival (FFS) will be measured from the date of treatment initiation until date of documented disease progression, relapse after response, or death from any cause. For patients alive and free of relapse or progression, follow-up time will be censored at the last documented date of failure-free status. Kaplan-Meier estimate of failure-free survival at one-year.
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
37.5
1.1 – 80.8
Rate of Toxicity Related to Protocol TherapySecondary· Through Duration of Protocol Therapy, Up to six 21-day cycles (+/- 7 days)
Rate of adverse events, serious adverse events or other toxicities related to protocol therapy in study participants.
Patients w/Toxicity Definitely Treatment-Related
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
0
Gr. 4 Toxicity Probably/Possibly Treatment-Related
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
1
Gr. 3 Toxicity Probably/Possibly Treatment-Related
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
4
Gr. 2 Toxicity Probably/Possibly Treatment-Related
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
6
Gr. 1 Toxicity Probably/Possibly Treatment-Related
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
6
HIV Viral Load in Positive Subjects Before, During and After Protocol TherapySecondary· From Baseline Up to 1 Year Post-Therapy
Measurement of HIV Viral Load in positive subjects before, during and after protocol therapy to assess the effect of protocol therapy on immune reconstitution or exhaustion.
Before Therapy
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
333
During Therapy
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
NA
After Therapy
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
NA
T-Cell Subset Levels in Peripheral Blood in Positive Participants Before, During and After Protocol TherapySecondary· From Baseline Up to 1 Year Post-Therapy
Measurement of T-cell subset levels (CD4, CD8) in peripheral blood before, during and after protocol therapy to assess the effect of protocol therapy on immune re-constitution or exhaustion.
CD4 count, Before Therapy
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
328
± 164.05
CD4 count, During Therapy
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
285
± 124.58
CD4 count, After Therapy
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
323.5
± 178.90
CD8 count, Before Therapy
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
1246
± 668.86
CD8 count, During Therapy
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
1006
± 741.05
CD8 count, After Thaerapy
Group
Value
95% CI
Chemotherapy + Antiviral-Based Therapy
1006
± 741.05
Adverse events — posted to ClinicalTrials.gov
Time frame: 4 years.
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
NCT07444710 — Testing the Addition of an Anti-Cancer Drug, Glofitamab, to the Usual Chemotherapy Treatment (Alternating R-CHOP/R-DHAP)
· Phase 1
· not yet recruiting
NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E
· Phase 3
· not yet recruiting
NCT06738368 — Etoposide, Prednisone, Vincristine, Cyclophosphamide, and Doxorubicin (DA-EPOCH) With or Without Rituximab Plus Recombin
· Phase 2
· recruiting
NCT07493148 — Chidamide Combination With R-mini CHOP Followed by Chidamide+CD20 Maintenance in Elderly Newly Diagnosed MYC/BCL2+ DLBCL
· Phase 2
· recruiting
NCT07278856 — Ruxolitinib in Combination With CHOP Chemotherapy for the Treatment of Untreated Nodal T-Follicular Helper Cell Lymphoma
· Phase 1
· not yet recruiting
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Publications: Europe PMC API search by NCT ID, retrieved 9 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Miami
Last refreshed: 23 September 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01964755.