Brentuximab Vedotin + CHP for T-Cell Lymphoma

Recruiting at 57 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

82 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial will study brentuximab vedotin with CHP to find out if the drugs work for people who have certain types of peripheral T-cell lymphoma (PTCL). It will also find out what side effects occur when brentuximab vedotin and CHP are used together. A side effect is anything the drugs do besides treating cancer. CHP is a type of chemotherapy that uses three drugs (cyclophosphamide, doxorubicin, and prednisone). CHP is approved by the FDA to treat certain types of PTCL.

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.

What data supports the effectiveness of the drug Brentuximab Vedotin plus CHP for T-cell lymphoma?

The ECHELON-2 trial showed that Brentuximab Vedotin combined with cyclophosphamide, doxorubicin, and prednisone (A+CHP) improved outcomes compared to the standard treatment for CD30-positive peripheral T-cell lymphomas. This combination was found to be practice-changing for common nodal CD30+ PTCLs, indicating its effectiveness. ^{1 2 3 4 5}

What makes the drug Brentuximab Vedotin + CHP unique for treating T-cell lymphoma?

Brentuximab Vedotin + CHP is unique because it specifically targets CD30-positive T-cell lymphomas, offering improved outcomes compared to traditional treatments like CHOP. It has become the new standard for first-line treatment in certain types of T-cell lymphomas, providing a new option for patients with these challenging conditions. ^{1 3 4 6 7}

Research Team

Pfizer CT.gov Call Center

Principal Investigator

Pfizer

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Retrospective Analysis With Propensity Score Matching of Peripheral T-Cell Lymphoma Treated Frontline With Brentuximab Vedotin and Chemotherapy. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Cost-effectiveness of brentuximab vedotin plus chemotherapy for previously untreated CD30-positive peripheral T-cell lymphoma in Canada. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Brentuximab vedotin in the treatment of CD30+ PTCL. [2021]

4. England 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. [2022]

5. United States 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. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Systemic ALCL Treated in Routine Clinical Practice: Outcomes Following First-Line Chemotherapy from a Multicentre Cohort. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Durable Response to Brentuximab Vedotin Plus Cyclophosphamide, Doxorubicin, and Prednisone (BV-CHP) in a Patient with CD30-Positive PTCL Arising as a Post-Transplant Lymphoproliferative Disorder (PTLD). [2022]