Spots Global Cancer Trial Database for A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL)
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Trial Identification
Brief Title: A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax in Combination With Polatuzumab Vedotin Plus Rituximab (R) and Cyclophosphamide, Doxorubicin, Prednisone (CHP) in Participants With Untreated BCL-2 Immunohistochemistry (IHC)-Positive Diffuse Large B-Cell Lymphoma (DLBCL)
Official Title: 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
Study ID: NCT04790903
Conditions
Study Description
Brief Summary: This Phase Ib, open-label, multicenter study evaluates the safety, efficacy, and pharmacokinetics of venetoclax in combination with Pola + R-CHP in previously untreated participants with BCL-2 IHC-positive DLBCL. Approximately 50 participants will be enrolled in this study in five consecutive cohorts each consisting of approximately 10 participants.
Detailed Description:
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
NYU Langone Hospitals, NYU Langone Rusk Ambulatory Surgical Pharmacy, New York, New York, United States
Memorial Sloan-Kettering Cancer Center, New York, New York, United States
SARAH CANNON RESEARCH INST.; Tennessee Oncology, PLLC, Nashville, Tennessee, United States
Centre Hospitalier Régional Universitaire de Lille (CHRU) - Hôpital Claude Huriez, Lille, , France
CHU Montpellier - Saint ELOI, Montpellier, , France
CHU de Nantes; Cancéro-dermatologie, Nantes, , France
Hôpital Saint-Louis, Paris, , France
Centre Hospitalier Lyon Sud; Service d'Oncologie Médicale, Pierre Benite, , France
CHU Rennes - Hopital Pontchaillou, Rennes cedex 09, , France
Centre Henri Becquerel, Rouen, , France
Istituto Nazionale Tumori Irccs Fondazione g. Pascale;s.c. Ematologia Oncologica, Napoli, Campania, Italy
Azienda Ospedaliero-Universitaria Policlinico S. Orsola Malpighi; Dip. Scienze Mediche e Chirurgiche, Bologna, Emilia-Romagna, Italy
Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori - IRST; Farmacia Oncologica, Meldola, Emilia-Romagna, Italy
Ospedale Santa Maria Delle Croci, Ravenna, Emilia-Romagna, Italy
Azienda Ospedaliero Universitaria Pisana-Ospedale Santa Chia, Pisa, Piemonte, Italy
Clinica Universidad de Navarra, Pamplona, Navarra, Spain
Hospital de la Santa Creu i Sant Pau; Servicio de Dermatologia, Barcelona, , Spain
Hospital Universitari Vall d'Hebron, Barcelona, , Spain
Hospital General Univ. Gregorio Maranon, Madrid, , Spain
Hospital Universitario La Fe; Servicio de Farmacia, Valencia, , Spain
Contact Details
Name: Clinical Trials
Affiliation: Hoffmann-La Roche
Role: STUDY_DIRECTOR
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