SGN-35 for Skin Lymphomas

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: M.D. Anderson Cancer Center

Must not be taking: Corticosteroids, others

Disqualifiers: Infections, 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

Compensation: Varies

Number of Visits: 2

Duration: 6-12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests SGN-35, a medication targeting specific skin lymphomas, including ALCL, LyP, and MF. The goal is to determine if SGN-35 can effectively manage these conditions while remaining safe for patients. This trial suits individuals with a confirmed diagnosis of CD30+ lymphomas who have experienced disease progression after previous treatments. Participants must have active or recurrent skin lesions or systemic involvement from their lymphoma. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.

Will I have to stop taking my current medications?

The trial requires a washout period (time without taking certain medications) from previous treatments: at least 4 weeks for local radiation or systemic anticancer therapy, over 2 weeks for oral methotrexate or topical therapies, and at least 12 weeks for immunotherapy. Some medications, like corticosteroids, are restricted, but small doses for certain conditions are allowed.

Is there any evidence suggesting that SGN-35 is likely to be safe for humans?

Research has shown that brentuximab vedotin (also known as SGN-35) is approved for treating certain skin lymphomas, specifically CD30-expressing cutaneous T-cell lymphoma (CTCL), after other treatments have been tried. This approval indicates that the drug's safety for these conditions is well understood.

Studies have found that brentuximab vedotin is generally well-tolerated, though some patients have experienced side effects. These may include low blood cell counts, nerve damage, or fatigue. Not everyone will experience these side effects, and they can range from mild to severe.

For those considering joining a trial with SGN-35, its existing approval for similar conditions may offer reassurance about its safety. However, discussing any concerns with a healthcare provider remains important. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for skin lymphomas?

SGN-35 is unique because it targets CD30, a protein found on the surface of certain cancer cells, including those in skin lymphomas. Unlike traditional treatments such as chemotherapy and radiation, which can affect a broad range of cells, SGN-35 (also known as brentuximab vedotin) is an antibody-drug conjugate that delivers a potent anti-cancer drug directly to the cancer cells, minimizing damage to healthy cells. Researchers are excited about this approach because it offers the potential for more effective treatment with fewer side effects, providing a promising alternative to the existing therapies.

What evidence suggests that SGN-35 might be an effective treatment for skin lymphomas?

Research has shown that SGN-35, also known as brentuximab vedotin, may help treat certain skin lymphomas such as ALCL, LyP, and MF. In one study, 67% of patients responded to the treatment, with success rates of 63% for MF and 84% for CD30 LPD. Brentuximab vedotin also demonstrated a higher rate of lasting responses, with effects persisting for at least four months, compared to other treatments. Patients using this drug experienced longer periods without disease progression. These results suggest that SGN-35 could be an effective option for managing certain skin lymphomas. ^{1 3 4 6 7}

Who Is on the Research Team?

Auris O Huen, MD

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

Adults with certain skin lymphomas (ALCL, LyP, or MF) that are CD30 positive and have not responded to previous treatments like radiation therapy or chemotherapy. They must be in good enough health for systemic therapy as judged by the doctor, not pregnant, willing to use contraception, and able to follow study procedures.

Inclusion Criteria

I can take care of myself but might not be able to do heavy physical work.

I can attend all required study visits for tests and treatment management.

I am not pregnant and agree to use birth control during the study.

Exclusion Criteria

I do not have any serious health conditions that would interfere with treatment.

I have dementia or changes in my mental status.

I do not have severe infections.

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 of each 21-day cycle, for up to 8 cycles, with possible extension based on response

6-12 months

1 visit per cycle (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including physical exams, questionnaires, and imaging

3-4 weeks

1 visit (in-person)

Long-term Follow-up

Long-term follow-up on disease status and any study-related nerve damage, with visits every 12-16 weeks for the first 2 years, then every 6 months up to 5 years

5 years

What Are the Treatments Tested in This Trial?

Interventions

• SGN-35

Trial Overview The trial is testing SGN-35 (brentuximab vedotin) for its effectiveness in controlling three types of skin lymphomas: ALCL, LyP, and MF. It also aims to evaluate the safety profile of this drug in patients who have these conditions.

How Is the Trial Designed?

Group I: SGN-35 Experimental Treatment 1 Intervention

1.8 mg/kg intravenously Day 1 of 21-day cycle.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Seagen Inc.

Industry Sponsor

Trials

212

Recruited

73,800+

Founded

1997

Headquarters

Bothell, USA

Known For

Antibody-Drug Conjugates

Top Products

Adcetris (brentuximab vedotin), Tukysa (tucatinib), Padcev (enfortumab vedotin-ejfv), Tivdak (tisotumab vedotin-tftv)

Dr. Roger Dansey

Seagen Inc.

Chief Medical Officer since 2018

MD from University of Witwatersrand

David R. Epstein

Seagen Inc.

Chief Executive Officer since 2022

BSc in Pharmacy from Rutgers University, MBA from Columbia University

Published Research Related to This Trial

In a Phase 1 study involving 24 patients with refractory Hodgkin lymphoma or CD30(+) non-Hodgkin lymphoma, SGN-30 was found to be safe with mild adverse effects, and the maximum tolerated dose was not reached.

The treatment showed modest clinical activity, with one patient achieving a complete response and six others maintaining stable disease for 6 to 16 months, indicating potential effectiveness in targeting CD30(+) malignancies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 multidose study of SGN-30 immunotherapy in patients with refractory or recurrent CD30+ hematologic malignancies. Bartlett, NL., Younes, A., Carabasi, MH., et al.[2021]

SGN-30, a chimeric antibody targeting CD30, shows promising efficacy, particularly in patients with primary cutaneous CD30-positive lymphoproliferative disease and in those with relapsed or refractory systemic anaplastic large-cell lymphoma.

The drug is well tolerated even in patients with a history of stem cell transplantation, and it may work synergistically with chemotherapy, although the optimal dosing schedule is still to be determined.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

SGN-30: a basis for the effective treatment of CD30 positive hematopoietic malignancies. Pinter-Brown, LC.[2019]

In a Phase II study involving 79 patients with refractory/recurrent Hodgkin lymphoma (HL) and anaplastic large cell lymphoma (ALCL), SGN-30 showed modest clinical activity, particularly in ALCL, where 2 patients achieved complete responses and 5 had partial responses.

The treatment was found to be safe, with most adverse events being mild or moderate, indicating that SGN-30 can be administered weekly without significant safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II study of SGN-30 (anti-CD30 mAb) in Hodgkin lymphoma or systemic anaplastic large cell lymphoma. Forero-Torres, A., Leonard, JP., Younes, A., et al.[2022]

SGN-35, an antibody-drug conjugate targeting CD30, effectively releases the potent drug MMAE inside CD30(+) cancer cells, achieving high intracellular concentrations that contribute to its therapeutic effects.

MMAE not only kills CD30(+) cells but can also diffuse to and exert cytotoxic effects on neighboring CD30(-) cells, enhancing the overall antitumor activity of SGN-35 in mixed tumor environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Intracellular activation of SGN-35, a potent anti-CD30 antibody-drug conjugate. Okeley, NM., Miyamoto, JB., Zhang, X., et al.[2021]

In a study of 118 patients with cutaneous T-cell lymphomas (CTCL), including mycosis fungoides (MF) and Sézary syndrome (SS), the overall survival for MF patients was 17.7 years, while SS patients had a median survival of 3.5 years, indicating significant differences in outcomes based on the type of CTCL.

The most common treatments for MF included low-dose methotrexate and interferon-alpha, while SS patients often received bexarotene and extracorporeal photopheresis, highlighting the need for more innovative therapies to be integrated into earlier treatment lines.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Analysis of 118 Patients With Cutaneous T-Cell Lymphomas: A Single-Center Experience. Polgárová, K., Polívka, J., Kodet, O., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/36017748/

Brentuximab vedotin in the treatment of cutaneous T-cell ... The overall response rate (ORR) was 67% (63% in MF, 71% in SS and 84% in CD30 LPD). Ten of 14 patients with folliculotropic MF (FMF) achieved complete or ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S2152265023021468

Real-World Treatment Patterns and Clinical Outcomes With ... This retrospective chart review describes patient characteristics, treatment patterns, clinical outcomes, and healthcare resource use (HRU) in patients with ...

3. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1155/dth/7123954

Clinical Experience With Brentuximab Vedotin in Treating ... The results showed that the BV group had an objective response rate at least 4 months (ORR4) (54.7% versus 12.5%) and PFS (16.7 months versus ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34879742/

Cost-effectiveness of brentuximab vedotin for the treatment ... Results were robust in sensitivity and scenario analyses. Conclusion: BV is a highly cost-effective treatment for advanced cutaneous T-cell lymphoma. Keywords: ...

5. ahdbonline.com ahdbonline.com/issues/2017/february-2017-vol-10-special-issue-payers-perspectives-in-oncology-ash-2016-highlights/brentuximab-vedotin-improves-responses-lasting-4-months-in-cutaneous-t-cell-lymphoma

Brentuximab Vedotin Improves Responses Lasting 4 ... Approximately 5 times as many patients who were randomized to receive brentuximab vedotin achieved an ORR lasting ≥4 months compared with those who received ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT01578499

NCT01578499 | A Phase 3 Trial of Brentuximab Vedotin ... This study will look at the overall response of people who took brentuximab vedotin compared to people who took methotrexate or bexarotene as standard care.

7. takedaoncology.com takedaoncology.com/news/news-releases/back-view-printer-friendly-version-takeda-and-seattle-genetics-announce-positive-data-from-phase-3-alcanza-clinical-trial-of-adcetris-brentuximab-vedotin-for-cd30-expressing-cutaneous-t-cell-lymphoma/

Takeda and Seattle Genetics Announce Positive Data from ... Takeda and Seattle Genetics Announce Positive Data from Phase 3 ALCANZA Clinical Trial of ADCETRIS® (Brentuximab Vedotin) for CD30-Expressing Cutaneous T-Cell ...