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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
50
Participants will self-administer Venetoclax, as described in the Arm Descriptions.
Participants will receive Polatuzumab Vedotin at a dose of 1.8 mg/kg by intravenous (IV) infusion on Day 1 of Cycles 1-6.
Participants will receive Rituximab at a dose of 375 mg/m\^2 by IV infusion on Day 1 of Cycles 1-6.
Participants will receive Cyclophosphamide at a dose of 750 mg/m\^2 by IV infusion or bolus on Day 1 of Cycles 1-6.
Participants will receive Doxorubicin at a dose of 50 mg/m\^2 by IV infusion or bolus on Day 1 of Cycles 1-6.
Participants will receive Prednisone orally (PO) at a dose of 100 mg/day on Days 1-5 of Cycles 1-6.
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-Bénite, France
CHU Rennes - Hopital Pontchaillou
Rennes, France
Centre Henri Becquerel
Rouen, France
...and 10 more locations
Percentage of Participants with Dose-Limiting Toxicities (DLTs)
Time frame: Cycle 1 Day 1 up to but not including Cycle 3 Day 1 (Cycle length = 21 days)
Percentage of Participants with Adverse Events (AEs)
Time frame: Up to 4 years
Complete Response (CR) rate at the end of treatment
Assessed by the investigator on PET and computed tomography (PET/CT) scans according to the Lugano Response Criteria for Malignant Lymphoma (Cheson et al. 2014)
Time frame: Up to 4 years
Objective Response Rate (ORR) at the end of treatment
Defined as the proportion of patients with a CR or a partial response (PR), as determined by the investigator on PET/CT scans according to the Lugano 2014 Response Criteria
Time frame: Up to 4 years
Duration of Response (DOR)
Defined as the time from the first occurrence of a documented objective response (a PR or a CR) to disease progression, relapse, or death from any cause (whichever occurs first), as determined by the investigator according to the Lugano 2014 Response Criteria
Time frame: Up to 4 years
Progression-Free Survival (PFS)
Defined as the time from the date of first study treatment to the first occurrence of disease progression or relapse, as assessed by the investigator, according to the Lugano 2014 Response Criteria, or death from any cause, whichever occurs earlier
Time frame: Up to 4 years
Plasma Concentrations of Venetoclax at specified timepoints
Time frame: Up to 4 years
Plasma Concentrations of Polatuzumab Vedotin analytes at specified timepoints
Time frame: Up to 4 years
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