Phase 2
N=82
A Study of Brentuximab Vedotin and CHP in Frontline Treatment of PTCL With Less Than 10% CD30 Expression
Peripheral T-cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT04569032 ↗Enrolled (actual)
82
Serious AEs
37.8%
Results posted
May 2025
Primary outcome: Primary: Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment — 61; 81 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- brentuximab vedotin (Drug); cyclophosphamide (Drug); doxorubicin (Drug); prednisone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Seagen, a wholly owned subsidiary of Pfizer
- Primary completion
- May 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) by Revised Response Criteria for Malignant Lymphoma Criteria (Cheson 2007) by Central CD30 Assessment |
61; 81 | — |
| SECONDARY Complete Response (CR) Rate Per BICR (Cheson 2007) by Central CD30 Assessment |
52; 71 | — |
| SECONDARY Progression Free Survival (PFS) Per BICR (Cheson 2007) by Central CD30 Assessment |
— | — |
| SECONDARY Overall Survival (OS) by Central CD30 Assessment |
— | — |
| SECONDARY Duration of Response (DOR) Per BICR (Cheson 2007) by Central CD30 Assessment |
— | — |
| SECONDARY ORR Per BICR by Modified Lugano Criteria (Cheson 2014) by Central CD30 Assessment |
57; 77 | — |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Treatment Related Adverse Events by Local CD30 Assessment |
32; 46; 15; 16; 25; 40 | — |
| SECONDARY Number of Participants With Treatment Emergent Laboratory Abnormalities as Per Worst Post Baseline Grading, by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) v4.03 by Local CD30 Assessment |
19; 34; 3; 1; 13; 23 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Newly diagnosed PTCL, excluding systemic anaplastic large cell lymphoma (sALCL), per the Revised European-American Lymphoma World Health Organization (WHO) 2016 classification
- The following non-sALCL PTCL subtypes are eligible:
- PTCL - not otherwise specified (PTCL-NOS)
- Angioimmunoblastic T-cell lymphoma (AITL)
- Adult T-cell leukemia/lymphoma (ATLL; acute and lymphoma types only, must be positive for human T cell leukemia virus 1)
- Enteropathy-associated T-cell lymphoma (EATL)
- Hepatosplenic T-cell lymphoma
- Monomorphic epitheliotropic intestinal T-cell lymphoma (MEITCL)
- Indolent T-cell lymphoproliferative disorder (T-LPD) of the gastrointestinal (GI) tract
- Follicular T-cell lymphoma
- Nodal peripheral T-cell lymphoma with T-follicular helper (TFH) phenotype
- CD30 expression 300 mg/m2 of doxorubicin.
- Any uncontrolled Grade 3 or higher (per the National Cancer Institute's Common Terminology Criteria for Adverse Events, NCI CTCAE Version 4.03) viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study drug. Routine antimicrobial prophylaxis is permitted.
Data sourced from ClinicalTrials.gov (NCT04569032). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.