Clareo Health | A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL)
A Study of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Participants With Relapsed or Refractory (R/R) Follicular Lymphoma (FL) or Rituximab in Combination With Idasanutlin and Venetoclax in Participants With R/R Diffuse Large B-Cell Lymphoma (DLBCL)
Saves the questions and what to expect into your notes, next to the visit they belong to.
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Lead
Hoffmann-La Roche
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
You may not be if
Histologically documented CD20-positive lymphoma
Fluorodeoxyglucose (FDG)-avid lymphoma (that is \[i.e.\], PET-positive lymphoma)
At least one bi-dimensionally measurable lesion (greater than \[\>\] 1.5 centimeters \[cm\] in its largest dimension by CT scan or magnetic resonance imaging \[MRI\])
Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of the diagnosis of FL or DLBCL
Known CD20-negative status at relapse or progression
Prior allogeneic stem-cell transplantation (SCT)
Completion of autologous SCT within 100 days prior to Day 1 of Cycle 1
Prior standard or investigational anti-cancer therapy as specified: Radioimmunoconjugate within 12 weeks prior to Day 1 of Cycle 1; Monoclonal antibody or antibody-drug conjugate within 4 weeks prior to Day 1 of Cycle 1; Radiotherapy, chemotherapy, hormonal therapy, or targeted small-molecule therapy within 2 weeks prior to Day 1 of Cycle 1
Clinically significant toxicity (other than alopecia) from prior therapy that has not resolved to Grade less than or equal to (\</=) 2 (according to National Cancer Institute Common Terminology Criteria for Adverse Events \[NCI CTCAE\] version 4.0) prior to Day 1 of Cycle 1
Grade 3b FL
History of transformation of indolent disease to DLBCL (expansion-phase only)
Central nervous system lymphoma or leptomeningeal infiltration
Treatment with systemic corticosteroids \>20 mg/day, prednisone or equivalent
Clinical conditions requiring treatment with oral or parenteral anticoagulants or antiplatelet agents unless treatment can be discontinued 7 days (or 5 half-lives) prior to initiation of study treatment (except used as flushes for indwelling catheters)
History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies
Known hypersensitivity or allergy to murine products or any component of the obinutuzumab, rituximab, idasanutlin, or venetoclax formulation
Current or history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection: positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or HCV antibody at screening
History of progressive multifocal leukoencephalopathy (PML)
History of other malignancy that could affect compliance with the protocol or interpretation of results
Evidence of any significant, uncontrolled concomitant disease that could affect compliance with the protocol or interpretation of results
Non-malignant medical illnesses that are uncontrolled or whose control may be jeopardized by study treatment, such as severe hereditary coagulation disorders or insulin-dependent diabetes mellitus that is not optimally controlled with medical management (example, presence of ketoacidosis)
Major surgical procedure other than for diagnosis within 28 days prior to Day 1 of Cycle 1, or anticipation of a major surgical procedure during the study
Inadequate hematologic function (unless due to underlying lymphoma), defined as follows: Hemoglobin less than (\<) 9 grams per decilitre (g/dL), absolute neutrophil count (ANC) \<1.5\*10\^9 cells per liter (cells/L), platelet count \<75\*10\^9 cells/L
Any of the following abnormal laboratory values (unless due to underlying lymphoma): International normalized ratio (INR) or prothrombin time (PT) \>1.5\*upper limit of normal (ULN) in the absence of therapeutic anticoagulation; partial thromboplastin time (PTT) or activated partial thromboplastin time (aPTT) \>1.5\*ULN in the absence of a lupus anticoagulant
