A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
NCT ID: NCT02631577
Last Updated: 2022-04-13
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1/PHASE2
38 participants
INTERVENTIONAL
2015-12-31
2020-10-07
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Atezolizumab-G-lena 15mg
Participants were administered obinutuzumab, Atezolizumab, and 15 mg of Lenalidomide.
Atezolizumab (MPDL3280A) [TECENTRIQ]
Atezolizumab will be administered at a flat dose of 840 mg on Days 1 and 15 of Cycles 2 to 6, given in 28-day cycles as induction treatment and 840 mg on Days 1 and 2 of each month, given as maintenance treatment.
Lenalidomide
Lenalidomide will be administered orally once daily on Days 1 to 21 of Cycles 1 to 6 (28-day cycles) during induction treatment and on Days 1 to 21 of each month during maintenance treatment. Lenalidomide will be administered at a dose of 15 or 20 mg (dose may be de-escalated to 10 mg) during induction treatment and at 10 mg during maintenance treatment. During the expansion phase, lenalidomide will be administered at the RP2D during induction treatment and at 10 mg during maintenance treatment.
Obinutuzumab
Obinutuzumab will be administered by intravenous infusion at an absolute (flat) dose of 1000 mg on Days 1, 8, and 15 of the first cycle and on Day 1 of each subsequent cycle during induction treatment, and on Day 1 of every other month (i.e., every 2 months) during maintenance treatment.
Atezolizumab-G-lena 20mg
Participants were administered obinutuzumab, Atezolizumab, and 20 mg of Lenalidomide.
Atezolizumab (MPDL3280A) [TECENTRIQ]
Atezolizumab will be administered at a flat dose of 840 mg on Days 1 and 15 of Cycles 2 to 6, given in 28-day cycles as induction treatment and 840 mg on Days 1 and 2 of each month, given as maintenance treatment.
Lenalidomide
Lenalidomide will be administered orally once daily on Days 1 to 21 of Cycles 1 to 6 (28-day cycles) during induction treatment and on Days 1 to 21 of each month during maintenance treatment. Lenalidomide will be administered at a dose of 15 or 20 mg (dose may be de-escalated to 10 mg) during induction treatment and at 10 mg during maintenance treatment. During the expansion phase, lenalidomide will be administered at the RP2D during induction treatment and at 10 mg during maintenance treatment.
Obinutuzumab
Obinutuzumab will be administered by intravenous infusion at an absolute (flat) dose of 1000 mg on Days 1, 8, and 15 of the first cycle and on Day 1 of each subsequent cycle during induction treatment, and on Day 1 of every other month (i.e., every 2 months) during maintenance treatment.
Interventions
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Atezolizumab (MPDL3280A) [TECENTRIQ]
Atezolizumab will be administered at a flat dose of 840 mg on Days 1 and 15 of Cycles 2 to 6, given in 28-day cycles as induction treatment and 840 mg on Days 1 and 2 of each month, given as maintenance treatment.
Lenalidomide
Lenalidomide will be administered orally once daily on Days 1 to 21 of Cycles 1 to 6 (28-day cycles) during induction treatment and on Days 1 to 21 of each month during maintenance treatment. Lenalidomide will be administered at a dose of 15 or 20 mg (dose may be de-escalated to 10 mg) during induction treatment and at 10 mg during maintenance treatment. During the expansion phase, lenalidomide will be administered at the RP2D during induction treatment and at 10 mg during maintenance treatment.
Obinutuzumab
Obinutuzumab will be administered by intravenous infusion at an absolute (flat) dose of 1000 mg on Days 1, 8, and 15 of the first cycle and on Day 1 of each subsequent cycle during induction treatment, and on Day 1 of every other month (i.e., every 2 months) during maintenance treatment.
Eligibility Criteria
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Inclusion Criteria
* 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
* History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL)
* 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
* 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 TE 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
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
University Miami
Miami, Florida, United States
Norton Medical Plaza II
Louisville, Kentucky, United States
Memorial Sloan-Kettering Cancer Center; Hematology/Oncology
New York, New York, United States
Levine Cancer Institute
Charlotte, North Carolina, United States
Chu Toulouse
Bron, , France
Hopital Henri Mondor; 51 Av Mal Lattre De Tassigny
Créteil, , France
Hopital du Bocage
Dijon, , France
Centre Jean Bernard
Le Mans, , France
Centre Hospitalier Le Mans
Le Mans, , France
CHRU de Lille - Hopital Claude Huriez
Lille, , France
CHU Montpellier - Saint ELOI
Montpellier, , France
CHU - Hôtel Dieu hematolgie clinique
Nantes, , France
Centre Hospitalier Lyon Sud; Hematolgie
Pierre-Bénite, , France
CHU de Rennes - Hopital de Pontchaillo
Rennes, , France
Centre Henri Becquerel
Rouen, , France
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2015-002467-42
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
BO29562
Identifier Type: -
Identifier Source: org_study_id
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