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Monoclonal Antibodies

Brentuximab + Lenalidomide for T-Cell Lymphoma

Phase 2

Waitlist Available

Led By John Reneau, MD

Research Sponsored by John Reneau

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Biopsy-proven, measurable, stage IB-IVB relapsed or refractory cutaneous T-cell lymphoma after 2 lines of skin-directed therapy or one prior line of systemic therapy

AST (SGOT) and ALT (SGPT) =< 5 x ULN in patients with documented hepatic involvement by lymphoma

Must not have

Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antibiotics or hospitalization (relating to the completion of the course of antibiotics) within 4 weeks prior study therapy

Clinically significant history of liver disease, including viral or other hepatitis, current alcohol abuse, or cirrhosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

All Individual Drugs Already Approved

Approved for 10 Other Conditions

No Placebo-Only Group

Summary

This trial is studying brentuximab vedotin and lenalidomide to see how well they work in treating patients with stage IB-IVB T-cell lymphoma that have come back or do not respond to treatment.

Who is the study for?

This trial is for adults with stage IB-IVB T-cell lymphoma that has returned or isn't responding to treatment. Eligible participants must have tried at least one standard chemotherapy, be in good organ function, and not have certain medical conditions like severe allergies to monoclonal antibodies or active infections. Women of childbearing potential must follow strict pregnancy prevention measures.

What is being tested?

The effectiveness of combining brentuximab vedotin (a monoclonal antibody) with lenalidomide (a chemotherapy drug) is being tested. The goal is to see if this combination works better than previous treatments for patients with relapsed or refractory T-cell lymphoma.

What are the potential side effects?

Potential side effects include reactions related to the immune system such as inflammation in organs, blood disorders, fatigue, digestive issues, and increased risk of infection due to the immunosuppressive nature of the drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My skin lymphoma has returned or didn't respond after initial treatments.

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My liver enzymes are within acceptable limits for someone with lymphoma affecting the liver.

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My skin lymphoma has returned or didn't respond to treatment after 2 skin treatments or 1 body-wide treatment.

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My skin lymphoma has changed into a more aggressive form.

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I have T cell lymphoma, received chemotherapy, and my disease can be measured by scans.

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My T cell lymphoma came back after a stem cell transplant.

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I am able to care for myself and perform daily activities.

Exclusion Criteria

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

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I do not have any current infections or recent major infections that required IV antibiotics or hospitalization.

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I have a significant history of liver problems, including hepatitis, alcohol abuse, or cirrhosis.

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I haven't had any live-virus vaccines in the last 28 days and don't need any during the study.

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I have severe nerve damage in my hands or feet.

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I am currently on medication to suppress my immune system.

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My lymphoma has not spread to my brain or spinal cord.

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I have never had progressive multifocal leukoencephalopathy.

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I have never had an allogeneic stem cell transplant.

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I have issues that prevent me from properly swallowing pills or absorbing medication.

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My condition worsened within 30 days after my last brentuximab vedotin treatment.

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I have been treated with lenalidomide before.

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My heart condition limits my physical activity.

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

Overall response rate

Secondary study objectives

Incidence of adverse events according to National Cancer Institute Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0

Overall survival (OS)

Progression free survival (PFS)

Awards & Highlights

All Individual Drugs Already Approved

Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.

Approved for 10 Other Conditions

This treatment demonstrated efficacy for 10 other conditions.

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, lenalidomide)Experimental Treatment3 Interventions

Patients receive brentuximab vedotin IV over 30 minutes on day 1 and lenalidomide PO QD on day 1-21. Treatment repeats every 21 days for up to 16 courses in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenalidomide

FDA approved

Brentuximab vedotin

FDA approved

0 / 19Eligibility criteria met

Find a Location

Who is running the clinical trial?

John ReneauLead Sponsor

3 Previous Clinical Trials

67 Total Patients Enrolled

John Reneau, MD5.01 ReviewsPrincipal Investigator - Ohio State University Comprehensive Cancer Center

Ohio State University Comprehensive Cancer Center

2 Previous Clinical Trials

55 Total Patients Enrolled

5Patient Review

Reneau is not only skilled in their field, but they are also compassionate. They make it a priority to listen to your concerns and deliver bad news in the most comforting way possible. I have full confidence in their abilities and would recommend them to anyone.