Actively Recruiting
Phase II Study of Brentuximab Vedotin Plus Bendamustine for Relapsed or Refractory Follicular Lymphoma
Led by Joseph Tuscano · Updated on 2025-04-24
23
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
J
Joseph Tuscano
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying a combination of two drugs, brentuximab vedotin and bendamustine, to treat adults with follicular lymphoma that has returned or does not respond to previous treatments. Brentuximab vedotin targets and kills CD30-positive cancer cells, while bendamustine works by stopping cancer cell growth in different ways. This phase II trial aims to assess the safety and effectiveness of this drug combination in patients with relapsed or refractory follicular lymphoma. Participants receive brentuximab vedotin through an intravenous infusion over 30 minutes on the first day and bendamustine through an intravenous infusion over 60 minutes on the first and second days of each 21-day treatment cycle. This combination treatment is given for up to 6 cycles unless the disease worsens or side effects become unacceptable. Patients who respond well and tolerate the treatment may continue with brentuximab vedotin alone for up to 10 additional cycles, also every 21 days. During the trial, patients undergo regular assessments including imaging scans to measure tumor response based on standard criteria. Researchers monitor for complete and overall response rates up to two years, as well as duration and time to response, progression-free survival, and overall survival. Safety and tolerability are evaluated throughout treatment. After finishing treatment, patients are followed up for 30 days and then every three months for two years to track long-term outcomes and side effects.
CONDITIONS
Brief Title
Brentuximab Vedotin and Bendamustine for the Treatment of Relapsed or Refractory Follicular Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically or cytologically confirmed relapsed or refractory follicular CD30-positive non-Hodgkin lymphoma grades I, II, or IIIa
- CD30 positivity greater than 1% on tumor cells or surrounding environment
- Measurable disease with at least one site 1.5 cm or larger by CT or PET scan
- Relapsed or refractory disease after at least one prior treatment regimen
- ECOG performance status of 2 or less (Karnofsky score 60% or higher)
- Life expectancy longer than 3 months
- Leukocyte count of 2,500/mcL or higher
- Absolute neutrophil count of 1,000/mcL or higher
- Platelet count of 50,000/mcL or higher
- Hemoglobin level of 8 g/dL or higher
- Total bilirubin less than or equal to 1.5 times the normal upper limit (with exceptions for Gilbert disease)
- AST and ALT levels less than or equal to 3 times normal upper limit (up to 5 times if liver involved)
- Alkaline phosphatase less than or equal to 2.5 times normal upper limit (up to 5 times if liver or bone involved)
- Creatinine clearance of 30 mL/min/1.73 m2 or higher
- INR and aPTT less than or equal to 1.5 times normal (unless on stable anticoagulation)
- Agreement to use effective contraception during and for 5 months after treatment
- Ability to understand and sign informed consent
- HIV-positive patients allowed if on stable treatment with controlled viral load and adequate CD4 count
You will not qualify if you...
- Chemotherapy or radiotherapy within 2 weeks before study start (6 weeks for some drugs), or not recovered from earlier side effects
- Herbal therapy within 1 week before study
- Investigational agents within 3 weeks before study
- Prior bendamustine treatment with progression within 6 months
- Immunosuppressive medications within 14 days before first dose, with some exceptions for low-dose or local steroids
- Uncontrolled central nervous system lymphoma involvement
- History of allergic reactions to bendamustine, brentuximab vedotin, or similar antibodies
- Significant liver disease including active hepatitis or cirrhosis, with some exceptions for resolved infections
- Neuropathy grade higher than 1
- Certain skin conditions only if well controlled and limited in extent
- Active tuberculosis
- Severe infections or symptoms of infection within weeks before treatment
- Recent antibiotic use unless for prevention
- Major surgery within 28 days before study or planned during study
- Live attenuated influenza vaccine within 4 weeks before or during study
- Uncontrolled illnesses that could affect study compliance such as heart failure, unstable angina, arrhythmia, or psychiatric/social issues
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1 year, depending on response and tolerance
Participants receive brentuximab vedotin intravenously over 30 minutes on day 1 and bendamustine intravenously over 60 minutes on days 1 and 2 of each cycle. Treatment repeats every 21 days for 6 cycles unless disease progresses or toxicity occurs. Responding participants without excessive toxicity may continue brentuximab vedotin alone every 21 days for up to 10 additional cycles.
Every 21 days for 6 cycles, then every 21 days for up to 10 additional cycles if eligible
Duration - Up to 2 years after treatment completion
After completing study treatment, participants are followed up for safety and disease status with visits 30 days after treatment completion, then every 3 months for 2 years.
1 visit 30 days after treatment, then visits every 3 months for 2 years
Trial Site Locations
Total: 1 location
1
University of California Davis Comprehensive Cancer Center
Sacramento, California, United States, 95817
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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