A Study of MPDL3280A plus Obinutuzumab and Bendamustine or Obinutuzumab and CHOP in Patients with Follicular Lymphoma or DiffuseLarge B-Cell Lymphoma

Phase 1

• Conditions: Follicular lymphoma or diffuse large B-cell lymphoma; MedDRA version: 20.0Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10016904Term: Follicle centre lymphoma, follicular grade I, II, III NOSSystem Organ Class: 100000004864; MedDRA version: 20.0Level: LLTClassification code 10012820Term: Diffuse large B-cell lymphoma NOSSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-001364-19-IT
• Lead Sponsor: F. HOFFMANN - LA ROCHE LTD.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-03-07
• Last Update Posted: 17 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 91

Inclusion Criteria

• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status of 0,1, or 2
• For patient enrolled in safety run-in phase: Relapsed or refractory follicular lymphoma after treatment with at least one prior
chemoimmunotherapy regimen or previously untreated Grade 1, 2, or 3a follicular lymphoma that requires treatment (as per Groupe d'Etudes des
Lymphomes Folliculaires (GELF) criteria)
• For patient enrolled in expansion phase: Previously untreated Grade 1, 2, or 3a follicular lymphoma that requires treatment (as
per GELF criteria) or previously untreated advanced diffuse large B-cell lymphoma (DLBCL)
• Histologically documented CD20-positive lymphoma
• Fluorodeoxyglucose-avid lymphoma (i.e., positron emission tomography -positive lymphoma)
• Availability of a representative tumor specimen and the corresponding pathology report for retrospective central confirmation of
the diagnosis of FL or DLBCL
• For women who are not postmenopausal or surgically sterile: agreement to remain abstinent or use contraceptive methods that result in a failure rate of <1% per year during the treatment
period and for at least 18 months after the last dose of study treatment.
• For men: agreement to remain abstinent or use contraceptive measures and agreement to refrain from donating sperm
Are the trial subjects under 18? no
Number of subjects for this age range: 1
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 46
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 46

Exclusion Criteria

• Histological evidence of transformation of follicular lymphoma into high-grade B-cell non-Hodgkin's lymphoma
• Central nervous system lymphoma or leptomeningeal infiltration
• For patients with relapsed or refractory FL (enrolled in the safety run-in
phase: Prior allogeneic or autologous stem cell transplantation; Prior anthracycline therapy
• History of solid organ transplantation
• History of severe allergic or anaphylactic reaction to humanized or murine monoclonal antibodies
• Active bacterial, viral, fungal, or other infection
• History of progressive multifocal leukoencephalopathy
• Positive for hepatitis B surface antigen (HBsAg), total hepatitis B core antibody (HBcAb), or hepatitis C virus (HCV) antibody at screening
• Known history of HIV positive status
• History of autoimmune disease

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified