This phase II trial investigates how well brentuximab vedotin and bendamustine work in treating patients with follicular lymphoma that has come back (relapsed) or does not respond to treatment (refractory). Brentuximab vedotin is a monoclonal antibody, brentuximab, linked to a toxic agent called vedotin. Brentuximab attaches to CD30 positive cancer cells in a targeted way and delivers vedotin to kill them. Chemotherapy drugs, such as bendamustine, 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. This trial is being done to determine if the combination of brentuximab vedotin plus bendamustine is safe and to determine the effectiveness of the combination.
PRIMARY OBJECTIVE: I. Obtain a preliminary estimate of the anti-tumor activity of brentuximab vedotin plus bendamustine hydrochloride (bendamustine) in patients with relapsed/refractory (R/R) CD30+ follicular lymphoma as determined by the complete response rate (CR) and best overall response rate (ORR) as defined per Lugano criteria. SECONDARY OBJECTIVES: To obtain the duration of response (DOR). To obtain the time to response (TTR). To obtain the progression-free survival (PFS) among subjects with relapsed or refractory CD30-positive follicular lymphoma (FL) receiving brentuximab vedotin and bendamustine. To obtain data on overall survival (OS). To evaluate the safety and tolerability. OUTLINE: Patients receive brentuximab vedotin intravenously (IV) over 30 minutes on day 1 and bendamustine IV over 60 minutes on days 1 and 2 of each cycle. Treatment repeats every 21 days for 6 cycles in the absence of disease progression or unacceptable toxicity. Patients who respond to combination treatment and do not experience excessive toxicity may continue to receive additional single-agent brentuximab vedotin IV over 30 minutes on day 1 (once every 21 days) for up to 10 cycles in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed up for 30 days, and then every 3 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
23
Given IV
Given IV
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States
RECRUITINGComplete response (CR) rate
Will be assessed per 2014 Lugano criteria and Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) criteria. Will be summarized with 95% confidence intervals.
Time frame: Up to 2 years
Best overall response rate (ORR)
Will be assessed by complete response + partial response per 2014 Lugano criteria and LYRIC criteria.
Time frame: Up to 2 years
Duration of response
Will be summarized descriptively using the Kaplan-Meier estimate.
Time frame: From time of initial response assessment demonstrating at least partial response until disease response assessment that demonstrates progressive disease, assessed up to 2 years
Time to response
Will be summarized descriptively using the Kaplan-Meier estimate.
Time frame: From registration to first disease response assessment that demonstrates at least partial response, assessed up to 2 years
Progression-free survival
Disease relapse/progression will be defined according to the 2014 International Harmonization Project (IHP) criteria. Will be summarized descriptively using the Kaplan-Meier estimate.
Time frame: From registration until death, relapse/progression, receipt of anti-lymphoma therapy, or last follow-up, whichever comes first, assessed up to 2 years
Overall survival
Will be summarized descriptively using the Kaplan-Meier estimate.
Time frame: From registration to death due to any cause, assessed up to 2 years
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