Brentuximab Vedotin for T-Cell Lymphoma

Recruiting at 3 trial locations

Overseen By Deepa Jagadeesh, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Deepa Jagadeesh

Must not be taking: Chemotherapy, Investigational agents

Disqualifiers: ALCL, CNS involvement, Pregnancy, 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

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: Up to 13 months

23 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will include patients with mature T-cell lymphoma (MTCL) that has been treated with at least one type of chemotherapy, but is not responding or coming back after the previous treatment. This clinical trial uses a drug called Brentuximab Vedotin. The Food and Drug Administration (FDA) has approved Brentuximab Vedotin for sale in the United States for certain diseases. Brentuximab is still being studied in clinical trials like this one to learn more about what its side effects are and whether or not it is effective in the disease or condition being studied. Brentuximab Vedotin is a type of drug called an antibody drug conjugate (ADC). ADCs usually have 2 parts; a part that targets cancer cells (the antibody) and a cell killing part (the chemotherapy). Antibodies are proteins that are part of your immune system. They can stick to and attack specific targets on cells. The antibody part of Brentuximab Vedotin sticks to a target called CD30. CD30 is an important molecule on some cancer cells (including non Hodgkin lymphoma) and some normal cells of the immune system. The cell killing part of Brentuximab Vedotin is a chemotherapy called monomethyl auristatin E (MMAE). It can kill cells that the antibody part of Brentuximab Vedotin sticks to. Brentuximab Vedotin has also been shown to kill cancer cells with levels of CD30 that cannot be seen by traditional methods. This study is being done to test if the study drug has an effect on Mature T cell Lymphoma with such low levels of a target called CD30 and how your disease respond to the study drug.

Research Team

Deepa Jagadeesh

Principal Investigator

Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center

Paolo F. Caimi

Principal Investigator

University Hospitals Cleveland Medical Center, Case Comprehensive Cancer Center

Eligibility Criteria

This trial is for adults with certain types of T-cell lymphoma that have low levels of CD30 and haven't responded to or relapsed after at least one chemotherapy treatment. Participants must be in relatively good health, not pregnant, willing to use contraception, and able to understand the study. They can't join if they've had certain other cancers recently, active infections including hepatitis B or C, heart problems, a history of HIV or PML disease.

Inclusion Criteria

I can care for myself but may not be able to do heavy physical work, or I'm mostly in bed due to my lymphoma.

Subjects must have the ability to understand and the willingness to sign a written informed consent document

My T cell lymphoma has returned or didn't respond to treatment and has low CD30.

Exclusion Criteria

My condition is anaplastic large cell lymphoma, regardless of ALK status.

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

Pregnancy or breast feeding women

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Brentuximab Vedotin 1.8 mg/kg intravenously once every 3 weeks

Up to 13 months

Every 3 weeks (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

Three years after end of treatment

Treatment Details

Interventions

• Brentuximab Vedotin

Trial Overview The trial tests Brentuximab Vedotin on mature T-cell lymphomas with low CD30 levels. It's an antibody drug conjugate combining an antibody targeting cancer cells and a cell-killing chemo agent. The goal is to see how effective it is against this specific type of lymphoma when previous treatments failed.

Participant Groups

Group I: Brentuximab vedotin Experimental Treatment 1 Intervention

Brentuximab vedotin 1.8 mg/kg intravenously (IV) once every 3 weeks

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?

Deepa Jagadeesh

Lead Sponsor

Trials

3

Recruited

40+