A Study Evaluating the Safety and Efficacy of Atezolizumab in Combination With Obinutuzumab Plus Lenalidomide in Patients With Relapsed or Refractory Follicular Lymphoma
Status: | Active, not recruiting |
---|---|
Conditions: | Lymphoma |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 3/23/2019 |
Start Date: | December 31, 2015 |
End Date: | November 10, 2020 |
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
This study will evaluate the safety, efficacy, pharmacokinetics and immunogenicity of
induction treatment consisting of atezolizumab in combination with obinutuzumab plus
lenalidomide in patients with relapsed or refractory follicular lymphoma (FL), followed by
maintenance treatment with atezolizumab plus obinutzumab plus lenalidomide in patients who
achieve a complete response (CR), a partial response (PR), or stable disease at end of
induction.
induction treatment consisting of atezolizumab in combination with obinutuzumab plus
lenalidomide in patients with relapsed or refractory follicular lymphoma (FL), followed by
maintenance treatment with atezolizumab plus obinutzumab plus lenalidomide in patients who
achieve a complete response (CR), a partial response (PR), or stable disease at end of
induction.
Inclusion Criteria:
- 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 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
We found this trial at
6
sites
1275 York Avenue
New York, New York 10065
New York, New York 10065
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University of Alabama at Birmingham The University of Alabama at Birmingham (UAB) traces its roots...
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University of Miami A private research university with more than 15,000 students from around the...
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51 Avenue du Maréchal de Lattre de Tassigny
Creteil, 94010
Creteil, 94010
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