UPCC#17413: A Phase I/II Study Of Brentuximab Vedotin In Combination With Multi-Agent Chemotherapy As Front-Line Treatment In Patients With CD30 Positive Primary Mediastinal Large B-Cell Diffuse Large B-Cell And Grey Zone Lymphomas
This is a Phase I/II, multicenter, single-arm, non-randomized, open label study. All patients will receive combination of brentuximab vedotin, rituximab, cyclophosphamide, doxorubicin, and prednisone approximately every 3 weeks for a total of 6 cycles. The Phase I portion of the study will determine the safety and MTD of brentuximab vedotin when delivered in combination with R-CHP chemotherapy. The Phase II portion of the study will further evaluate the activity of brentuximab vedotin when administered in combination with multi-agent chemotherapy in patients with CD30 positive PMBL, DLBCL, and GZL. Safety assessments will include surveillance and recording of AEs, physical examination findings, and laboratory tests. Disease response will be assessed by the Investigator using the Revised Response Criteria for Malignant Lymphoma .
- Study Identifier: 818280
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