Brentuximab Vedotin for T-Cell Lymphoma

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a drug called Brentuximab Vedotin for individuals with mature T-cell lymphoma that hasn't responded well to previous chemotherapy. The drug targets and kills cancer cells with low levels of a molecule called CD30, often present on these cancer cells. Patients who have tried at least one chemotherapy treatment and whose lymphoma remains unresponsive might be suitable candidates. The main goal is to evaluate the drug's effectiveness and learn more about its side effects. As a Phase 2 trial, this research focuses on assessing the treatment's efficacy in an initial, smaller group of participants.

Do I need to stop my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot have had chemotherapy or investigational agents within 2 weeks before starting the study treatment.

Is there any evidence suggesting that Brentuximab Vedotin is likely to be safe for humans?

Research has shown that Brentuximab Vedotin is generally well-tolerated in people with certain types of cancer. Studies have found that it has a manageable safety profile, with most side effects not being severe. Serious side effects, such as pneumonia and fever, occur in about 4% of patients. Some individuals also experienced vomiting, nausea, liver issues, and nerve problems, though these were less common.

The FDA has already approved Brentuximab Vedotin for other cancers, indicating prior safety studies. However, since this trial tests it for a new condition, ongoing monitoring of its effects remains important. Participants should discuss any concerns with their doctors and report any unusual symptoms during the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Brentuximab vedotin is unique because it specifically targets a protein called CD30, which is often found on the surface of T-cell lymphoma cells. Unlike traditional chemotherapy that attacks rapidly dividing cells indiscriminately, brentuximab vedotin delivers a potent anti-cancer drug directly to the cancer cells, minimizing damage to healthy cells. This targeted approach not only aims to improve effectiveness but also potentially reduces side effects compared to conventional treatments. Researchers are excited about this treatment because it offers a more precise attack on the cancer cells, which could lead to better outcomes for patients with T-cell lymphoma.

What evidence suggests that Brentuximab Vedotin might be an effective treatment for T-cell lymphoma?

Research has shown that Brentuximab Vedotin, the treatment under study in this trial, can benefit individuals with certain types of lymphoma. In one study involving 58 patients, 86% responded to the treatment, and 57% achieved complete remission, meaning their cancer was undetectable after treatment. Brentuximab Vedotin targets a protein called CD30 found on some cancer cells, including those in T-cell lymphoma. The treatment uses an antibody to locate and attach to cancer cells, combined with a chemotherapy agent that kills them. This makes Brentuximab Vedotin a promising option, particularly for patients whose cancer has low levels of CD30. ^{6 7 8 9}

Who Is on the 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

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/22614995/

Brentuximab vedotin (SGN-35) in patients with relapsed or ...

Results: Of 58 patients treated in the study, 50 patients (86%) achieved an objective response, 33 patients (57%) achieved a complete remission ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5746164/

Five-year results of brentuximab vedotin in patients with ...

An estimated 91% of patients who experienced peripheral neuropathy with brentuximab vedotin reported resolution or improvement of symptoms. Abstract. This ...

3.

adcetrispro.com

adcetrispro.com/relapsed-refractory-dlbcl/efficacy

Efficacy Data for Certain Patients with R/R DLBCL

First phase III randomized study to demonstrate a survival benefit in patients with R/R DLBCL after ≥2 prior lines of systemic therapy.

4.

ascopubs.org

ascopubs.org/doi/10.1200/JCO.2024.42.16_suppl.7069

Results from the phase 2 SGN35-032 study.

There were 2 (3%) treatment-related deaths: 1 pt died of decreased appetite and 1 pt died of general physical health deterioration. Conclusions: ...

5.

adcetrispro.com

adcetrispro.com/classical-hodgkin-lymphoma-post-auto-hsct-consolidation/safety

ADCETRIS® (brentuximab vedotin) Safety Info

The most common serious adverse reactions were pneumonia (4%), pyrexia (4%), vomiting (3%), nausea (2%), hepatotoxicity (2%), and peripheral sensory neuropathy ...

6.

ema.europa.eu

ema.europa.eu/en/documents/product-information/adcetris-epar-product-information_en.pdf

Adcetris, INN-brentuximab vedotin - EMA

The safety data in patients with relapsed or refractory HL who had not received an autologous stem cell transplant and were treated with the recommended dose of ...

7.

adcetris.com

adcetris.com/

ADCETRIS® (brentuximab vedotin) - Official Patient Website

FDA-approved for adults with relapsed or refractory diffuse large B-cell lymphoma after 2 prior treatments and who are not candidates for stem cell ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC3499340/

Brentuximab vedotin - PMC

Several trials have shown durable antitumor activity with a manageable safety profile in patients with relapsed/refractory Hodgkin lymphoma, systemic anaplastic ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT01026233

Cardiac Safety Study of Brentuximab Vedotin (SGN-35)

Study record managers: refer to the Data ... Safety and efficacy of brentuximab vedotin for Hodgkin lymphoma recurring after allogeneic stem cell transplantation.