A Phase Ib Study of VK-2019 in Patients With Relapsed or Refractory EBV+ Diffuse Large B-cell Lymphomas (DLBCL)
Trial Parameters
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
Brief Summary
This is a Phase Ib in adult patients with relapsed or refractory EBV-positive DLBCL using daily oral dosing of VK-2019 in three dose escalation cohorts: 600 mg/day, 1200 mg/day, 1800 mg/day for 28 days (cycle), until progression or toxicity.
Eligibility Criteria
4.1 Inclusion Criteria 1. Informed consent obtained prior to any protocol mandated assessment. 2. Age ≥ 18 years. 3. Patient must have relapsed or refractory EBV-positive DLBCL after a minimum of 2 prior regimens of systemic therapy. 4. Patient must have exhausted all available standard of care treatment options that could potentially provide clinical benefit. 5. Toxicities related to prior therapy must have returned to Grade 1 or less, or if chronic must be stable. Peripheral neuropathy must be Grade 2 or less 6. Prior anti-cancer treatment must have been completed greater than 2 weeks prior to study day 1. 7. Patients must have measurable disease, as defined by IWG 2007 criteria. 8. ECOG performance status score of ≤2 9. Adequate organ function as defined by the following criteria: 1. Absolute neutrophil count \> 1,500/microl (stable off any growth factor within 1 week of study drug administration) 2. Hemoglobin \> 9 g/dL (transfusion to achieve this level is permitted) 3. Platelet c