Brentuximab Vedotin + CHP for T-Cell Lymphoma

Not currently recruiting at 116 trial locations

Overseen By Seagen Trial Information Support

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Seagen, a wholly owned subsidiary of Pfizer

Must not be taking: Brentuximab vedotin, Doxorubicin

Disqualifiers: sALCL, Other cancers, PML, 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: Unknown

Duration: 7 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if combining the drug brentuximab vedotin (an antibody-drug conjugate) with a chemotherapy mix called CHP (which includes cyclophosphamide, doxorubicin, and prednisone) can effectively treat certain types of peripheral T-cell lymphoma (PTCL). Researchers are also examining any side effects that might occur when these drugs are used together. The trial includes two groups: one with low levels of a protein called CD30 and another with no CD30. People newly diagnosed with specific types of PTCL, excluding systemic anaplastic large cell lymphoma, who have low CD30 levels, might be suitable for this trial. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in PTCL treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

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

Research has shown that brentuximab vedotin is usually well-tolerated. Studies in patients with Hodgkin lymphoma indicate it can cause side effects like low blood cell counts and nerve damage, but these are typically manageable. This drug is already approved for certain types of lymphoma, indicating that its safety is well understood.

Cyclophosphamide, a chemotherapy drug, can cause side effects such as nausea and hair loss. It may also affect fertility and increase the risk of other cancers. Despite these risks, its common use in cancer treatment suggests it is generally considered safe when used carefully.

Doxorubicin, another chemotherapy drug in this trial, can cause heart problems in some patients, especially at higher doses. However, its widespread use in cancer treatment indicates that its benefits often outweigh the risks.

Prednisone, a steroid, helps reduce inflammation and manage certain side effects. It's generally well-tolerated, but long-term use can lead to issues like weight gain, high blood sugar, and mood changes.

Overall, each of these drugs has a known safety profile, and they are used because their benefits in treating cancer often outweigh the side effects. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for T-cell lymphoma?

Researchers are excited about Brentuximab Vedotin for treating T-cell lymphoma because it works differently than standard chemotherapy options. Unlike traditional treatments that broadly attack cancer cells, Brentuximab Vedotin is an antibody-drug conjugate that specifically targets CD30, a protein often found on the surface of cancer cells. This targeted approach allows it to deliver a potent anti-cancer agent directly to the tumor, potentially increasing effectiveness and reducing side effects. Additionally, combining it with chemotherapy agents like Cyclophosphamide, Doxorubicin, and Prednisone could enhance its therapeutic impact, offering a promising new strategy for tackling this challenging cancer.

What evidence suggests that brentuximab vedotin + CHP could be an effective treatment for T-cell lymphoma?

Research has shown that brentuximab vedotin can help treat CD30-positive lymphomas, including some types of peripheral T-cell lymphoma (PTCL). In earlier studies, patients with these lymphomas, who had not responded to other treatments, experienced significant tumor shrinkage with brentuximab vedotin. In this trial, participants in the CD30-positive cohort will receive brentuximab vedotin combined with chemotherapy drugs—cyclophosphamide, doxorubicin, and prednisone (CHP)—which are already approved for certain PTCLs. This combination may improve treatment outcomes for CD30-positive PTCL, suggesting potential benefits for patients with these specific lymphomas. ^{6 7 8 9 10}

Who Is on the Research Team?

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Are You a Good Fit for This Trial?

This trial is for adults with specific types of peripheral T-cell lymphoma (PTCL) that express less than 10% CD30. Eligible participants include those newly diagnosed with PTCL, excluding systemic anaplastic large cell lymphoma, and have a performance status allowing daily activity. People who've had certain prior cancer treatments or have severe pre-existing conditions are excluded.

Inclusion Criteria

My scans show active cancer that's at least 1.5 cm big.

I have a slow-growing T-cell lymphoma in my digestive system.

I have been diagnosed with hepatosplenic T-cell lymphoma.

Exclusion Criteria

I have been treated with brentuximab vedotin or doxorubicin.

My heart function is below normal, or I have had heart issues or a heart attack in the last 6 months.

I have had cancer before, but it's been in remission for over 3 years or was a type with low risk of spreading.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive brentuximab vedotin with CHP for the treatment of PTCL

7 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

• Brentuximab Vedotin
• Cyclophosphamide
• Doxorubicin
• Prednisone

Trial Overview The study tests brentuximab vedotin combined with CHP chemotherapy (cyclophosphamide, doxorubicin, prednisone) in treating PTCL. It aims to determine the effectiveness and side effects of this combination therapy compared to standard treatments for patients whose tumors show low CD30 expression.

How Is the Trial Designed?

Group I: CD30-positive Cohort Experimental Treatment 4 Interventions

Participants with CD30 expression level ≥1% to \< 10%

Group II: CD30-negative Cohort Experimental Treatment 4 Interventions

Participants with CD30 expression level \< 1%

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?

Seagen, a wholly owned subsidiary of Pfizer

Lead Sponsor

Trials

20

Recruited

4,900+

Seagen Inc.

Lead 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

The ECHELON-2 trial demonstrated that the combination of brentuximab vedotin with cyclophosphamide, doxorubicin, and prednisone (A+CHP) significantly improved progression-free survival in patients with CD30-positive peripheral T-cell lymphomas, with a median of 48.2 months compared to 20.8 months for the standard CHOP regimen.

The safety profile of A+CHP was manageable, with similar rates of adverse events like febrile neutropenia and peripheral neuropathy compared to CHOP, indicating that A+CHP is a viable and effective front-line treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brentuximab vedotin with chemotherapy for CD30-positive peripheral T-cell lymphoma (ECHELON-2): a global, double-blind, randomised, phase 3 trial. Horwitz, S., O'Connor, OA., Pro, B., et al.[2022]

In a study of 1344 patients with peripheral T-cell lymphoma (PTCL), those treated with brentuximab vedotin plus cyclophosphamide, doxorubicin, and prednisone (A + CHP) had a lower rate of subsequent therapy compared to those treated with CHOP, indicating potentially better initial treatment efficacy.

The study highlighted that patients in the real-world setting were older and had more comorbidities than those in clinical trials, emphasizing the need for retrospective analyses to understand the impact of new treatments in diverse patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Retrospective Analysis With Propensity Score Matching of Peripheral T-Cell Lymphoma Treated Frontline With Brentuximab Vedotin and Chemotherapy. Burke, JM., Liu, N., Yu, KS., et al.[2023]

Brentuximab vedotin (BV) combined with cyclophosphamide, doxorubicin, and prednisone (BV-CHP) has shown improved outcomes in treating common nodal CD30+ peripheral T-cell lymphomas (PTCLs) compared to the traditional treatment regimen, indicating a significant advancement in therapy.

Further research is needed to determine the optimal level of CD30 expression for effective BV-CHP therapy and to assess its efficacy and safety in less common subtypes of CD30+ PTCLs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Brentuximab vedotin in the treatment of CD30+ PTCL. Barta, SK., Gong, JZ., Porcu, P.[2021]

Brentuximab vedotin (BV) has shown promising efficacy in treating refractory CD30+ non-Hodgkin lymphomas (NHL), as demonstrated in two cases where patients responded positively to BV-based regimens after failing multiple standard treatments.

Both patients, one with anaplastic large cell lymphoma and the other with diffuse large B-cell lymphoma, experienced significant responses to novel BV combinations, suggesting that these regimens are effective and have manageable side effects, warranting further clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Novel Brentuximab Vedotin Combination Therapies Show Promising Activity in Highly Refractory CD30+ Non-Hodgkin Lymphoma: A Case Series and Review of the Literature. Delacruz, W., Setlik, R., Hassantoufighi, A., et al.[2020]

Citations

1. 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 ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1002965

Brentuximab Vedotin (SGN-35) for Relapsed CD30- ... Brentuximab vedotin induced durable objective responses and resulted in tumor regression for most patients with relapsed or refractory CD30-positive lymphomas.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03113500

Study Details | NCT03113500 | Brentuximab Vedotin and ... Giving brentuximab vedotin and combination chemotherapy may work better in treating patients with CD30-positive peripheral T-cell lymphoma. Detailed Description.

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/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.

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

ADCETRIS® (brentuximab vedotin) Efficacy Data - Safety Info Brentuximab vedotin (ADCETRIS) is recommended by the NCCN Guidelines as a Category 2A treatment option for 1 year of post-auto-HSCT consolidation treatment.

7. 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 ...

8. 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 ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3627331/

Safety and efficacy of brentuximab vedotin in patients with ... In phase II studies, brentuximab vedotin induced overall response rates of 75% and 86% in relapsed or refractory Hodgkin lymphoma and anaplastic large cell ...

10. 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.