A PHASE Ib STUDY EVALUATING THE SAFETY EFFICACY AND PHARMACOKINETICS OF VENETOCLAX IN COMBINATION WITH POLATUZUMAB VEDOTIN PLUS RITUXIMAB (R) AND CYCLOPHOSPHAMIDE DOXORUBICIN PREDNISONE (CHP) IN PATIENTS WITH UNTREATED BCL-2 IMMUNOHISTOCHEMISTRY (IHC) POSITIVE DIFFUSE LARGE B-CELL LYMPHOMA

Brief description of study

The purpose of this study is to test two different dosing schedules of an experimental drug called venetoclax. Venetoclax works by blocking a protein in the body called “BCL-2”. This protein helps cancer cells survive. Blocking this protein helps to kill and lower the number of cancer cells. This study is testing a drug called venetoclax in combination with polatuzumab vedotin, rituximab (R), cyclophosphamide, doxorubicin, and prednisone (CHP) in previously untreated patients with diffuse large B-cell lymphoma (DLBCL). Polatuzumab vedotin in combination with bendamustine and rituximab has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory DLBCL, not otherwise specified, after at least two prior therapies. Venetoclax is an experimental drug, which means the US Food and Drug Administration (FDA) has not approved venetoclax in combination with polatuzumab vedotin and R-CHP for the first-line treatment of previously untreated patients with DLBCL and this combination of drugs has not been tested in people prior to this study.


Clinical Study Identifier: s20-01092
ClinicalTrials.gov Identifier: NCT04790903
Principal Investigator: Catherine M Diefenbach.
Other Investigators: Maxim Kreditor, Vathveal Mathews, Bruce G Raphael, Kenneth B Hymes, Michael L. Grossbard, Cosmin Adrian Tegla, Jun Han Choi, Shella Saint Fleur-Lominy, David Kaminetzky, Tibor Moskovits.


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