EUCTR2015-002467-42-FR
Active, not recruiting
Phase 1
A phase Ib/II study evaluating the safety and efficacy of Atezolizumab in combination with obinutuzumab plus lenalidomide in patients with relapsed or refractory follicular lymphoma
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Follicular lymphoma
- Sponsor
- F. Hoffmann-La Roche Ltd
- Enrollment
- 38
- Status
- Active, not recruiting
- Last Updated
- 5 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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