A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination with Obinutuzumab plus Lenalidomide in Patients with Relapsed or Refractory Follicular Lymphoma
- Conditions
- Follicular lymphomaMedDRA version: 19.0Level: LLTClassification code 10016904Term: Follicle centre lymphoma, follicular grade I, II, III NOSSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2015-002467-42-FR
- Lead Sponsor
- F. Hoffmann-La Roche Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 38
• Age >=18 years
• Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2
• Relapsed or refractory FL after treatment with at least one prior chemoimmunotherapy regimen that included an anti-CD20 monoclonal antibody and for which no other more appropriate treatment option exists as determined by the investigator
• Histologically documented CD20-positive lymphoma as determined by the local laboratory
• Fluorodeoxyglucose-avid lymphoma (i.e., PET-positive lymphoma)
• At least one bi-dimensionally measurable lesion (>1.5 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
• Agreement to comply with all local requirements of the lenalidomide risk minimization plan
• For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use two adequate methods of contraception, including at least one method with a failure rate of <1% per year, for at least 28 days prior to Day 1 of Cycle 1, during the treatment period (including periods of treatment interruption), and for at least 18 months after the last dose of study treatment
• For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures and agreement to refrain from donating sperm for at least 3 months after the last dose of study treatment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 23
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 23
• Grade 3b follicular lymphoma
• History of transformation of indolent disease to DLBCL
• Known history of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonia or evidence of active pneumonitis at screening.
• Known CD20-negative status at relapse or progression
• Central nervous system lymphoma or leptomeningeal infiltration
• Prior allogeneic stem-cell transplantation (SCT)
• Completion of autologous SCT within 100 days prior to Day (D) 1 of Cycle (C) 1
• Prior standard or investigational anti-cancer therapy as specified in protocol
• History of resistance to lenalidomide or response duration of <1 year
• Treatment with systemic immunosuppressive medications
• History of solid organ transplantation
• Clinically significant toxicity from prior therapy that has not resolved to Grade = 2 (according to the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE], v4.0) prior to Day 1 of Cycle 1
• History of erythema multiforme, Grade = 3 rash, or blistering following prior treatment with immunomodulatory derivatives such as thalidomide and lenalidomide
• Active bacterial, viral, fungal, or other infection or IV antibiotics within 4 weeks of Day 1 of Cycle 1
• 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 progressive multifocal leukoencephalopathy
• History of autoimmune disease
• Contraindication to treatment for thromboembolism prophylaxis
• Grade = 2 neuropathy
• History of other malignancy that could affect compliance with the protocol or interpretation of results
• Evidence of any significant, uncontrolled concomitant disease
• Inadequate hematologic function (unless due to underlying lymphoma)
• Abnormal laboratory values (unless due to underlying lymphoma)
• Pregnant or lactating or intending to become pregnant during the study
• History of severe allergic or anaphylactic reaction to humanized, chimeric or murine monoclonal antibodies
• Vaccination with a live virus vaccine within 28 days prior to Day 1 of Cycle 1
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method