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Title:
A Phase 1b/2 Open-Label, Dose Escalation and Expansion Study of Orally Administered VRx3996 and Valganciclovir in Subjects with Epstein-Barr Virus-Associated Lymphoid Malignancies
Protocol Number:
J1811
Phase:
Phase I/II
Physician:
Richard Ambinder
Sites:
Johns Hopkins Kimmel Cancer Center in Baltimore
Purpose:
A two part, Phase 1b/2 study to define a recommended Phase 2 dose of VRx-3996 in combination with valganciclovir (Phase 1b) and to evaluate the efficacy of this combination in relapsed/refractory EBV+ lymphomas and lymphoproliferative diseases (Phase 2).
Eligibility:
Age 18+. Must have EBV positive lymphoma or lymphoproliferative disease that did not respond to, or that relapsed after at least one previous treatment. Must have adequate blood counts and organ function. Must not have primary central nervous system lymphoma.
Treatment:
Subjects will receive VRx-3996 and Valganciclovir twice a day until their disease progresses, they experience unacceptable toxicity, the investigator considers additional study drug to no longer be in the subject’s best interest, the subject no longer wishes to participate, or the study closes.
Population:
Adult
Last Update
12/14/2019 05:03 AM