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)



Status:Recruiting
Conditions:Lymphoma
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/4/2019
Start Date:June 15, 2017
End Date:October 27, 2022
Contact:Reference Study ID Number: BH39147 www.roche.com/about_roche/roche_worldwide.htm
Email:global-roche-genentech-trials@gene.com
Phone:888-662-6728 (U.S. and Canada)

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A Phase Ib/II Study Evaluating the Safety and Efficacy of Obinutuzumab in Combination With Idasanutlin and Venetoclax in Patients With Relapsed or Refractory Follicular Lymphoma and Obinutuzumab or Rituximab in Combination With Idasanutlin and Venetoclax in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

This Phase Ib/II, open-label, multicenter, non-randomized, dose-escalation study will
evaluate the safety, efficacy, and pharmacokinetics of obinutuzumab in combination with
idasanutlin and venetoclax in participants with R/R FL and obinutuzumab or rituximab in
combination with idasanutlin and venetoclax in participants with R/R DLBCL. The study will
include an initial dose-escalation phase followed by an expansion phase. The dose-escalation
phase is designed to determine the recommended phase II doses (RP2Ds) and regimen for
idasanutlin and venetoclax in combination with obinutuzumab for FL participants and in
combination with rituximab for DLBCL participants.


Inclusion Criteria:

- Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2

- B-cell lymphoma classified as either of the following: R/R FL after treatment with at
least one prior chemoimmunotherapy regimen that included an anti-cluster of
differentiation 20 (CD20) monoclonal antibody; R/R DLBCL after treatment with at least
one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody in
participants who are not eligible for second line combination chemotherapy and
autologous stem-cell transplantation, have failed second line combination
chemotherapy, or experienced disease progression following autologous stem-cell
transplantation

- 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

Exclusion Criteria:

- 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 ( 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

- Life expectancy <3 months
We found this trial at
9
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Aurora, Colorado 80045
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1 Gustave L Levy Pl # 271
New York, New York 10029
 (212) 241-6500
Mount Sinai Med Ctr Founded in 1852, The Mount Sinai Hospital is a 1,171-bed, tertiary-care...
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401 College Street
Richmond, Virginia 23298
(804) 828-0450
Virginia Commonwealth University Massey Cancer Center Founded in 1974, VCU Massey Cancer Center is a...
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5841 S Maryland Ave
Chicago, Illinois 60637
(773) 702-1000
University of Chicago Medical Center The University of Chicago Medicine has been at the forefront...
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Louisville, Kentucky 40207
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320 E North Ave
Pittsburgh, Pennsylvania 15212
(412) 359-3131
Allegheny General Hospital At Allegheny General Hospital, our physicians and healthcare staff have earned an...
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Randwick, New South Wales 2031
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Sayre, Pennsylvania 18840
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Seattle, Washington 98104
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