Your session is about to expire
← Back to Search
Alkylating agents
Brentuximab + Bendamustine for Follicular Lymphoma
Phase 2
Recruiting
Led By Joseph M Tuscano
Research Sponsored by Joseph Tuscano
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Eastern Cooperative Oncology Group (ECOG) performance status =< 2 (Karnofsky >= 60%)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 2 years
Awards & highlights
Study Summary
This trial is investigating whether a combination of two drugs is effective in treating patients with a certain type of lymphoma.
Who is the study for?
This trial is for adults with relapsed or refractory follicular lymphoma, a type of non-Hodgkin lymphoma. Participants must have had at least one prior treatment, measurable disease via scans, and be generally healthy with proper organ function. They should not be pregnant and agree to use contraception. Those with recent infections, certain allergies, severe liver disease, uncontrolled illnesses or who've recently used similar drugs are excluded.Check my eligibility
What is being tested?
The trial tests the combination of brentuximab vedotin (a monoclonal antibody linked to a toxin) and bendamustine (a chemotherapy drug) in patients whose follicular lymphoma has returned or resisted treatment. The goal is to see if this combo is safe and effective in stopping cancer growth by targeting cancer cells directly while preventing them from dividing or spreading.See study design
What are the potential side effects?
Potential side effects include reactions related to the immune system such as infusion reactions; blood cell count changes leading to increased infection risk; fatigue; digestive issues like nausea; liver enzyme changes; nerve damage that could cause numbness or tingling; rash; and potential harm to an unborn baby.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lymphoma is CD30+ and has come back or didn't respond to treatment.
Select...
I can take care of myself but might not be able to do heavy physical work.
Select...
My condition worsened or didn't respond after my first treatment.
Select...
My CD4 count is above 250 and my HIV viral load is undetectable.
Select...
My kidneys are functioning well enough for treatment.
Select...
I have a tumor that is larger than 1.5 cm, confirmed by CT or PET scan.
Select...
I am on a stable HIV treatment plan.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Best overall response rate (ORR)
Complete response (CR) rate
Secondary outcome measures
Duration of response
Overall survival
Progression-free survival
+1 moreTrial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (brentuximab vedotin, bendamustine)Experimental Treatment2 Interventions
Patients receive brentuximab vedotin IV over 30 minutes on day 1 and bendamustine IV over 60 minutes on days 1 and 2. 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 brentuximab vedotin IV over 30 minutes on day 1. Treatment repeats every 21 days for up to 10 cycles in the absence of disease progression or unacceptable toxicity.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Bendamustine Hydrochloride
2011
Completed Phase 2
~230
Brentuximab Vedotin
2015
Completed Phase 4
~1100
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,658 Previous Clinical Trials
40,924,618 Total Patients Enrolled
Joseph TuscanoLead Sponsor
7 Previous Clinical Trials
159 Total Patients Enrolled
Seagen Inc.Industry Sponsor
207 Previous Clinical Trials
69,134 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a known allergy or sensitivity to products made from Chinese hamster ovary cells or other human antibodies made in a laboratory.I have not had signs of infection in the last 2 weeks.I have taken a one-time low dose of medication to suppress my immune system.I am using inhaled corticosteroids or fludrocortisone for low blood pressure or adrenal gland issues.You have had allergic reactions to similar medications or substances that are being used in the study.My lymphoma has spread to my brain or spinal cord and is not under control.My condition worsened within 6 months after receiving bendamustine.My lymphoma is CD30+ and has come back or didn't respond to treatment.I can take care of myself but might not be able to do heavy physical work.My condition worsened or didn't respond after my first treatment.I haven't had chemotherapy or radiotherapy in the last 2 weeks.I have taken antibiotics in the last 2 weeks, but only as a preventive measure.My CD4 count is above 250 and my HIV viral load is undetectable.I am HIV positive but my condition is under control.You have had an allergic reaction to bendamustine or brentuximab vedotin or any ingredients in the medications.I haven't taken any immune-weakening drugs in the last 14 days.I am only using low-dose steroids or steroids for allergies, skin, joint issues, or asthma.I do not have active tuberculosis.My kidneys are functioning well enough for treatment.I have a significant liver condition, such as hepatitis or cirrhosis.I have skin conditions like eczema or psoriasis without severe symptoms.I tested positive for hepatitis C but do not currently have the virus in my blood.I do not have severe nerve pain or damage.I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.I agree to use birth control during and for 5 months after the study due to risks to a fetus.I have not received a live flu vaccine within the last 4 weeks.I haven't had a severe flare-up of my condition requiring strong treatments in the last year.My blood clotting tests are within normal limits, or I am on a stable dose of blood thinners.I do not have any serious illnesses or social situations that would stop me from following the study's requirements.My rash covers less than 10% of my body.I have a tumor that is larger than 1.5 cm, confirmed by CT or PET scan.You are expected to live for at least 3 more months.You have had severe allergic reactions in the past to certain types of medications called chimeric or humanized antibodies or fusion proteins.I haven't had major surgery in the last 28 days and don't expect to need one during the study.My condition is stable with mild creams.I do not need daily antibiotics or antifungals to prevent infections.I am on a stable HIV treatment plan.I have stopped any herbal treatments for at least a week.I am on bisphosphonate therapy for reasons other than high calcium levels.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (brentuximab vedotin, bendamustine)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary aim of this research project?
"This 2 year trial will primarily focus on the Best overall response rate (ORR) as its primary outcome. Secondary objectives include evaluating Progression-free survival, Overall survival and Time to response using Kaplan-Meier estimates according to International Harmonization Project criteria."
Answered by AI
What primary indications is Bendamustine Hydrochloride commonly prescribed for?
"Bendamustine Hydrochloride is commonly prescribed to treat multiple myeloma. Other conditions which may benefit from this medication include b-large cell anaplastic lymphoma (kiel classification) refractory, waldenstrom macroglobulinemia, and treatment resistant mantle cell lymphoma."
Answered by AI
How perilous is Bendamustine Hydrochloride for humans?
"The safety of Bendamustine Hydrochloride received a score of 2 as it is at the Phase 2 trial stage, thus there are some data indicating its security but no evidence that suggests effectiveness."
Answered by AI
How many participants are receiving treatment in this trial?
"Affirmative. The details from clinicaltrials.gov demonstrate that the current search for participants began on December 4th 2020, with a most recent update occurring on December 17th 2021. In total, 23 patients should be recruited at 1 medical centre."
Answered by AI
Is enrollment in this clinical trial still open?
"Affirmative. Clinicaltrials.gov has data that attests to this medical trial's active recruitment of participants, which began on December 4th 2020 and was last edited on December 17th 2021. The clinical trial is looking for 23 patients at a single site."
Answered by AI
Are there any additional investigations involving Bendamustine Hydrochloride?
"As of the present, 134 trials studying Bendamustine Hydrochloride are underway. Of those, 27 have reached Phase 3. Montvale in New jersey has several clinical sites researching this drug; however, 6615 other locations around the world are also conducting research on it."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger