A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL
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Keep this study
Lead
Hoffmann-La Roche
With
AbbVie
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At least one bi-dimensionally measurable lymphoma lesion on CT scan defined as \> 1.5 cm in its longest dimension, which is also FDG avid by screening PET scan.
Confirmed availability of archival or freshly biopsied tumor tissue prior to study enrollment
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1 or 2
Adequate hematologic function
For female participants of childbearing potential, agreement to use highly effective forms of contraception
Dose-Escalation Portion of the Study:
Participants must have histologically confirmed B-cell NHL, except MCL or SLL
Participants must have never received previous R-CHOP treatment
Any relapsed/refractory participants that are enrolled during the dose escalation should have received only a single previous treatment regimen
Expansion Portion of the Study:
Participants must have previously untreated CD20-positive DLBCL and IPI score must be 2-5
You may not be if
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies or known sensitivity or allergy to murine products
Contraindication to receive any of the individual components of CHOP, rituximab or obinutuzumab
Prior anthracycline therapy
Participants with ongoing corticosteroid use \>30 mg per day of prednisone or equivalent
CNS lymphoma or primary mediastinal DLBCL
Vaccination with live vaccines within 28 days prior to randomization
Chemotherapy or other investigational therapy within 28 days prior to the start of Cycle 1
History of other malignancy that could affect compliance with the protocol or interpretation of results
Evidence of significant, uncontrolled concomitant disease
Significant cardiovascular disease or significant pulmonary disease
Left ventricular ejection fraction less than (\<) 50% as defined by multiple-gated acquisition (MUGA)
Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior to Cycle 1 Day 1
Received the following agents within 7 days prior to the first dose of venetoclax: steroid therapy for anti-neoplastic intent; strong and moderate cytochrome P450 (CYP) 3A4 inhibitors or inducers; grapefruit/grapefruit products, seville oranges or star fruit within 3 days prior to the first dose of venetoclax
Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis
Recent major surgery
Women who are pregnant or lactating
Dose-Escalation Portion of the Study:
Participants with confirmed mantle cell lymphoma (MCL) or small lymphocytic lymphoma (SLL)
Expansion Portion of the Study:
Participants with transformed lymphoma (participants with discordant bone marrow involvement (i.e., low grade histology in bone marrow) may be considered after discussion with the Medical Monitor)
Prior therapy for NHL
Clareo Health | A Study Evaluating the Safety, Efficacy and Pharmacokinetics of Venetoclax Combined With Chemotherapy in Participants With B-Cell Non-Hodgkin's Lymphoma (NHL) and DLBCL
