EU Clinical Trial 2018-001039-29

A PHASE Ib/II, OPEN-LABEL, MULTICENTER, RANDOMIZED, CONTROLLED STUDY INVESTIGATING THE SAFETY, TOLERABILITY, PHARMACOKINETICS, AND EFFICACY OF MOSUNETUZUMAB (BTCT4465A) IN COMBINATION WITH CHOP OR CHP-POLATUZUMAB VEDOTIN IN PATIENTS WITH B-CELL NON-HODGKIN LYMPHOMA  Feb 26, 2019

Main objective of the trial: Phase Ib Mosunetuzumab + cyclophosphamide, doxorubicin, vincristine, prednisone (M-CHOP): •To evaluate safety, tolerability of M-CHOP in patients with relapsed or refractory (R/R) B-cell NHL including estimation of the maximum tolerated dose (MTD), determination of recommended Phase II dose (RP2D), and characterization of dose-limiting toxicities (DLTs) Mosunetuzumab + cyclophosphamide, doxorubicin, prednisone, polatuzumab vedotin (M-CHP-pola): •To evaluate the safety and tolerability of M CHP-pola in patients with relapsing/refractory (R/R) B-cell NHL, including estimation of the MTD, determination of RP2D, and characterization of DLTs Phase II To evaluate •Efficacy of M-CHP-pola compared with rituximab (R)-CHP-pola in patients with previously untreated diffuse large B-cell lymphoma (DLBCL)

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