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
Qualifiers
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
Treatments tested in this trial
- Bendamustine Hydrochloride
- Brentuximab Vedotin
Treatment groups
23 Participants
are divided into 1 treatment groupSponsors and collaborators
University of California, Davis
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Seagen Inc.
Collaborator
Source ClinicalTrials.gov