This phase II trial studies how well bendamustine hydrochloride, obinutuzumab, and dexamethasone work in treating older patients with diffuse large B-cell lymphoma. Drugs used in chemotherapy, such as bendamustine hydrochloride and dexamethasone, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Monoclonal antibodies, such as obinutuzumab, may find cancer cells and help kill them. Giving bendamustine hydrochloride, obinutuzumab, and dexamethasone may kill more cancer cells.
PRIMARY OBJECTIVES: I. Assess the overall response rate (ORR; complete responders \[CR\] + partial responders \[PR\]) using the Cheson et al parameters of this novel combination regimen. SECONDARY OBJECTIVES: I. Assess the feasibility of incorporating prospective geriatric assessments in patients \>= 70 years of age diagnosed with diffuse large B-cell lymphoma (DLBCL) and treated in a multi-center setting. II. Quality of life (QOL) based on Functional Assessment of Cancer Therapy-Lung (FACT-L) scale on all enrolled patients. III. Progression-free survival (PFS) at 2 and 3 years. IV. Overall survival (OS) at 2 and 3 years. OUTLINE: Patients receive bendamustine hydrochloride intravenously (IV) over 30 minutes on days 1 and 2, obinutuzumab IV over 4 hours on days 1 or 2, 8, and 15 (on both days 1 and 2 in course 1 only), dexamethasone orally (PO) daily on days 1-5. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up every 6 months for 40 months.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
2
University of Chicago Comprehensive Cancer Center
Chicago, Illinois, United States
ORR (PR + CR) Using the Cheson et al Parameters
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Time frame: Up to 8 months
Feasibility, Defined as Completing All Required Geriatric Assessments Where Applicable Per the Protocol in 80% or More of the Enrolled Eligible Patients
Time frame: Up to 40 months
Overall Survival
Survival analyses will be performed according to Kaplan and Meier methods. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better OS. OS will also be stratified for bulky versus non-bulky disease comparisons (defined as any site with more than 5 cm in largest diameter).
Time frame: From date of study entry (date of first treatment) until death from any cause, assessed at 2 years
Overall Survival (OS)
Survival analyses will be performed according to Kaplan and Meier methods. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better OS. OS will also be stratified for bulky versus non-bulky disease comparisons (defined as any site with more than 5 cm in largest diameter).
Time frame: From date of study entry (date of first treatment) until death from any cause, assessed at 3 years
Progression Free Survival
Kaplan-Meier analysis will be performed. Prognostic factors that predict favorable outcomes and responses will be evaluated in both univariate and multivariate analyses using Cox proportional hazards regression for possible indicator of better PFS.
Time frame: From date of study entry (date of first treatment) until progression, secondary malignancy, or death from any cause, assessed at 2 years
Incidence of Toxicity Graded According to the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4.0
Adverse events will be tabulated by type and grade.
Time frame: Up to 30 days following the last administration of study treatment
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