A Phase II Study of Loncastuximab Tesirine as Consolidation Strategy in Patients With LBCL in PR After CAR T-cell Therapy
Trial Parameters
Brief Summary
To learn if loncastuximab tesirine (called "lonca" in this informed consent form) can help to control large B-cell lymphoma that is relapsed or refractory after receiving CAR T-cell therapy. The safety and possible effects of the study therapy will also be studied.
Eligibility Criteria
Inclusion Criteria: Eligible subjects will be considered for inclusion in this study if they meet the following criteria: 1. Relapsed or refractory diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, transformed indolent B-cell lymphomas and high-grade B-cell lymphoma 2. Receive standard of care treatment with an FDA-approved anti-CD19 autologous CAR T-cell product, outside of a clinical trial 3. ≥ 18 years of age 4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2 5. Achievement of PR according to Lugano 2014 response criteria 30 days after CAR T-cell therapy 6. At least 30 days must have elapsed since CAR T-cell therapy infusion 7. No evidence of CD19 expression after CAR T-cell therapy infusion is required for enrolment 8. No additional anti-tumoral therapy, with the exclusion of palliative radiotherapy, must have been received after CAR T-cell therapy 9. Absolute neutrophil count (ANC) of ≥ 1.0×109/L without growth factor support for 3 days