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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%)

Must not have

Signs or symptoms of infection within 2 weeks prior to cycle 1, day 1

Patients with known uncontrolled central nervous system (CNS) involvement by lymphoma, including leptomeningeal involvement

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

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.

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.

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 below

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My lymphoma is CD30+ and has come back or didn't respond to treatment.

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I can take care of myself but might not be able to do heavy physical work.

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My condition worsened or didn't respond after my first treatment.

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My CD4 count is above 250 and my HIV viral load is undetectable.

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My kidneys are functioning well enough for treatment.

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I have a tumor that is larger than 1.5 cm, confirmed by CT or PET scan.

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I am on a stable HIV treatment plan.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have not had signs of infection in the last 2 weeks.

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My lymphoma has spread to my brain or spinal cord and is not under control.

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I haven't had chemotherapy or radiotherapy in the last 2 weeks.

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I do not have active tuberculosis.

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I have a significant liver condition, such as hepatitis or cirrhosis.

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I do not have severe nerve pain or damage.

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I have not had severe infections or been hospitalized for infection complications in the last 4 weeks.

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I have not received a live flu vaccine within the last 4 weeks.

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I haven't had a severe flare-up of my condition requiring strong treatments in the last year.

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I do not have any serious illnesses or social situations that would stop me from following the study's requirements.

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My rash covers less than 10% of my body.

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I haven't had major surgery in the last 28 days and don't expect to need one during the study.

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My condition is stable with mild creams.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Best overall response rate (ORR)

Complete response (CR) rate

Secondary study objectives

Duration of response

Overall survival

Progression-free survival

+1 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial 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

~330

Brentuximab Vedotin

2015

Completed Phase 3

~1080