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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of two treatments: brentuximab vedotin (an antibody-drug conjugate) and lenalidomide (an immunomodulatory drug), to evaluate their effectiveness against T-cell lymphoma, a cancer affecting the immune system. The researchers aim to determine if these drugs can effectively treat the cancer, particularly in patients whose cancer has returned or didn’t respond to previous treatments. Individuals who have tried at least two skin treatments or one systemic (whole-body) treatment for their T-cell lymphoma and have measurable disease might be suitable candidates for this study. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

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

The trial requires that all cancer therapies, including radiation, topical steroids, and chemotherapy, be stopped at least one week or three half-lives before starting the study treatment. However, if you have been on corticosteroids for more than 60 days without changes, you may continue them. You can also continue medications for other conditions if there is evidence of T-cell lymphoma progression while on those medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the combination of brentuximab vedotin and lenalidomide has been tested in patients with certain types of lymphoma. Studies have found that this combination has a manageable safety profile, meaning that while side effects exist, most patients can tolerate them.

The FDA has already approved brentuximab vedotin for some types of lymphoma, indicating that its safety is well understood. Lenalidomide, a chemotherapy drug, stops cancer cells from growing and dividing. Previous studies have used this combination in patients who have undergone several treatments, and the safety results were acceptable.

In summary, the treatment is generally well-tolerated, although side effects can occur. Always discuss with your doctor what this might mean for you. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for T-cell lymphoma?

Researchers are excited about the combination of brentuximab vedotin and lenalidomide for T-cell lymphoma because it brings a fresh approach compared to standard treatments like chemotherapy and radiation. Brentuximab vedotin is an antibody-drug conjugate that specifically targets CD30-positive cancer cells, delivering a potent drug directly to the tumor while minimizing damage to healthy cells. Lenalidomide, on the other hand, enhances the immune system's ability to fight cancer. This combination not only targets the cancer cells directly but also boosts the body's natural defenses, offering a two-pronged attack that could improve outcomes for patients with this challenging type of lymphoma.

What evidence suggests that brentuximab vedotin and lenalidomide might be effective for T-cell lymphoma?

Research has shown that the drugs brentuximab vedotin and lenalidomide can each help treat certain types of T-cell lymphoma. Studies found that 57% of patients experienced a positive response, meaning their cancer improved with the treatment. On average, patients lived just over 10 months without their cancer worsening. This trial will administer a combination of brentuximab vedotin and lenalidomide, as strong evidence suggests that using these two drugs together could effectively treat T-cell lymphoma that has returned or is hard to treat. ^{1 2 6 7 8}

Who Is on the Research Team?

John Reneau, MD,PhD

Principal Investigator

Ohio State University Comprehensive Cancer Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. ashpublications.org ashpublications.org/blood/article/144/Supplement%201/4438/529456/Final-Results-of-a-Phase-II-Study-of-Brentuximab

Final Results of a Phase II Study of Brentuximab Vedotin and ... Brentuximab vedotin (BV) and lenalidomide (Len) demonstrate independent activity in peripheral T cell lymphoma (PTCL) and cutaneous T cell lymphoma (CTCL).

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39772655/

Brentuximab Vedotin Combination for Relapsed Diffuse ... BV + Len + R demonstrated a statistically significant survival benefit with a manageable safety profile in heavily pretreated patients with ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03302728

NCT03302728 | Brentuximab Vedotin and Lenalidomide in ... This study is investigating the combination of Brentuximab vedotin and lenalidomide in the treatment of relapsed/refractory peripheral T cell lymphoma or ...

4. fda.gov fda.gov/drugs/resources-information-approved-drugs/fda-approves-brentuximab-vedotin-lenalidomide-and-rituximab-relapsed-or-refractory-large-b-cell

FDA approves brentuximab vedotin with lenalidomide and ... FDA approves brentuximab vedotin with lenalidomide and rituximab for relapsed or refractory large B-cell lymphoma · Efficacy and Safety · Adverse ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT368928

Brentuximab vedotin in combination with lenalidomide and ... BV+len showed promising clinical activity in a Phase 1 trial with a 57% overall response rate (ORR), 10.2-month median progression-free survival, and 14.3-month ...

6. 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 ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2024.42.17_suppl.LBA7005

Brentuximab vedotin in combination with lenalidomide and ... BV, an anti-CD30 antibody-drug conjugate, has shown efficacy and safety when combined with lenalidomide (len) and with rituximab (R) in heavily ...

8. pfizer.com pfizer.com/news/press-release/press-release-detail/us-fda-approves-pfizers-adcetrisr-combination-regimen

U.S. FDA Approves Pfizer's ADCETRIS® Combination ... Approval is based on positive data from the Phase 3 ECHELON-3 trial, which demonstrated ADCETRIS regimen reduced the risk of death by 37%, ...