Spots Global Cancer Trial Database for A Study of Polatuzumab Vedotin in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Participants With B-Cell Non-Hodgkin's Lymphoma
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Trial Identification
Brief 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
Official Title: A Phase Ib/II Study Evaluating the Safety, Tolerability and Anti-Tumor Activity of Polatuzumab Vedotin (DCDS4501A) in Combination With Rituximab or Obinutuzumab, Cyclophosphamide, Doxorubicin, and Prednisone in Patients With B-Cell Non-Hodgkin's Lymphoma
Study ID: NCT01992653
Conditions
Study Description
Brief Summary: This multicenter, open-label, dose-escalation study will evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of polatuzumab vedotin in combination with rituximab or obinutuzumab, cyclophosphamide, doxorubicin, and prednisone (CHP chemotherapy) in participants with non-Hodgkin's lymphoma (NHL). Participants will receive escalating doses of polatuzumab vedotin intravenously (IV) every 3 weeks in combination with standard doses of rituximab plus CHP chemotherapy (R-CHP) or obinutuzumab plus CHP chemotherapy (G-CHP). 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 R-CHP or G-CHP. The maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of polatuzumab vedotin in combination with R-CHP will be identified before it is combined with G-CHP. Once the MTD or RP2D is determined, polatuzumab vedotin will be dosed at MTD or RP2D -1 in combination with G-CHP to start the dose escalation of this combination.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
The University of Alabama at Birmingham, Birmingham, Alabama, United States
Banner MD Anderson Cancer Center, Greeley, Colorado, United States
Washington University; Pediatrics, Saint Louis, Missouri, United States
Northwest Cancer Specialists, Portland, Oregon, United States
Oregon Health and Science University, Portland, Oregon, United States
Willamette Valley Clinical Studies; Cancer Institute, Springfield, Oregon, United States
Blue Ridge Cancer Care, Roanoke, Virginia, United States
Hopital Henri Mondor, Unite Hemopathies lymphoides, Creteil, , France
Hopital Claude Huriez - CHU Lille; Service des maladies du sang, Lille, , France
Centre Hospitalier Lyon Sud; Hematolgie, Pierre Benite, , France
Centre Henri Becquerel; Hematologie, Rouen, , France
Contact Details
Name: Clinical Trials
Affiliation: Genentech, Inc.
Role: STUDY_DIRECTOR
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