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NCT01992653 (Clinical Trial / Polatuzumab Vedotin / DCDS4501A / RG-7596)

Study Title
A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin’s Lymphoma (NCT01992653)

Trial Description

This multicenter, open-label, dose-escalation study will evaluate the safety and anti-tumor activity of polatuzumab vedotin (DCDS4501A or RG-7596) in combination with rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone in participants with non-Hodgkin’s lymphoma. Cohort of participants will receive escalating doses of polatuzumab vedotin intravenously every 3 weeks in combination with standard doses of rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and oral prednisone.

Participants will be treated for a total of six or eight cycles in accordance with local institutional practice. Two parallel treatment arms will explore doses of polatuzumab vedotin in combination with rituximab-prednisone/prednisolone, cyclophosphamide, and doxorubicin (R-CHP) and obinutuzumab-prednisone/prednisolone, cyclophosphamide, and doxorubicin (G-CHP).

The maximum tolerated dose or MTD of polatuzumab vedotin in combination with R-CHP will be identified before it is combined with G-CHP. Once the MTD is determined, polatuzumab vedotin will be dosed at MTD -1 in combination with G-CHP to start the dose escalation of this combination.

Two parallel treatment arms will explore doses of polatuzumab vedotin in combination with R-CHP and G-CHP. The MTD of polatuzumab vedotin in combination with R-CHP will be identified before it is combined with G-CHP. Once the MTD is determined, polatuzumab vedotin will be dosed at MTD -1 in combination with G-CHP to start the dose escalation of this combination.

This trial is sponsored by Genentech. [1]

Study Data

Study Schematic

(Coming soon)

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Last Editorial review: July 13, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.

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