Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, Davis
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Histologically or cytologically confirmed relapsed or refractory follicular CD30+ non-Hodgkin lymphoma (NHL) (included in this category are follicular grade I, II, IIIa). CD30 positivity > 1% (tumor cells or surrounding peripheral microenvironment)
Patients must have measurable disease by computed tomography (CT) or positron emission tomography (PET) scan, with one or more sites of disease >= 1.5 cm in longest dimension
Relapsed or refractory disease after at least 1 prior regimen, defined using the 2014 Lugano classification
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Disqualifiers
Herbal therapy (1 week washout required)
Treatment with any other investigational agent within 3 weeks prior to cycle 1, day 1.
Prior therapy with bendamustine or a bendamustine-containing regimens with progression within 6 months of receiving treatment
Intranasal, inhaled, topical or local steroid injections (e.g., intra-articular injection); steroids as premedication for hypersensitivity reactions; systemic corticosteroid at physiologic doses not to exceed 10 mg/day of prednisone or equivalent may be enrolled
Trial design
Design model
Single group
Treatments tested in this trial
Bendamustine Hydrochloride
DrugGiven IV
Brentuximab Vedotin
DrugGiven IV
Treatment groups
23 Participants
are divided into 1 treatment groupGroup A: Treatment (brentuximab vedotin, bendamustine)Experimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Complete 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 years2
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 yearsSecondary outcomes
1
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 years2
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 years3
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 years4
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 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Davis
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Seagen Inc.
Collaborator
Source ClinicalTrials.gov