Brentuximab + Lenalidomide for T-Cell Lymphoma

Overseen By Lily Yang

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: John Reneau

Must be taking: Steroids

Must not be taking: Immunosuppressants, others

Disqualifiers: CNS involvement, HIV, Hepatitis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Breakthrough Therapy This drug has been fast-tracked for approval by the FDA given its high promise

Compensation: Varies

Number of Visits: 19

Duration: 48 weeks

26 Participants Needed

Trial Summary

What is the purpose of this trial?

This phase II trial studies how well brentuximab vedotin and lenalidomide work in treating patients with stage IB-IVB T-cell lymphoma that have come back or do not respond to treatment. Monoclonal antibodies, such as brentuximab vedotin, may interfere with the ability of cancer cells to grow and spread. Drugs used in chemotherapy, such as lenalidomide, 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. Giving brentuximab vedotin and lenalidomide may work better in treating patients with T-cell lymphoma.

Research Team

John Reneau, MD,PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Eligibility Criteria

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.

Inclusion Criteria

Calculated creatinine clearance >= 60 ml/min (by the Cockcroft-Gault equation)

I can understand and willingly sign a consent form.

I have a type of skin lymphoma that is not mycosis fungoides.

Exclusion Criteria

History of severe allergic reactions to humanized monoclonal antibodies

I have had cancer before, but it was either early stage, treated over 2 years ago, or under surveillance without treatment.

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brentuximab vedotin intravenously on day 1 and lenalidomide orally on days 1-21, repeating every 21 days for up to 16 courses

48 weeks

16 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 years

Every 3 months

Treatment Details

Interventions

• Brentuximab Vedotin
• Lenalidomide

Trial Overview 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.

Participant Groups

Group I: Treatment (brentuximab vedotin, lenalidomide) Experimental Treatment 3 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.

Brentuximab Vedotin is already approved in United States, European Union for the following indications:

Approved in United States as Adcetris for:

• Hodgkin lymphoma
• Systemic anaplastic large cell lymphoma
• Primary cutaneous anaplastic large cell lymphoma
• CD30-expressing mycosis fungoides
• Peripheral T-cell lymphoma

Approved in European Union as Adcetris for:

• Hodgkin lymphoma
• Systemic anaplastic large cell lymphoma
• Cutaneous T-cell lymphoma

Who Is Running the Clinical Trial?

John Reneau

Lead Sponsor

Trials

4

Recruited

90+