Clinical trial · Interventional
A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)
A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hodgkin Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
| Peripheral T Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bendamustine | Drug | Bendamustine | ALIAS |
| brentuximab vedotin | Drug | Brentuximab Vedotin | ALIAS |
| dacarbazine | Drug | Dacarbazine | ALIAS |
| nivolumab | Drug | Nivolumab | ALIAS |
Design
Arms and outcomes
Arms (6)
- type
- EXPERIMENTAL
- label
- Part A: Brentuximab Vedotin in HL Patients
- interventionNames
- Drug: brentuximab vedotin
- type
- EXPERIMENTAL
- label
- Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
- interventionNames
- Drug: brentuximab vedotin
- Drug: dacarbazine
- type
- EXPERIMENTAL
- label
- Part C: Brentuximab Vedotin + Bendamustine in HL Patients
- interventionNames
- Drug: brentuximab vedotin
- Drug: bendamustine
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Parts A, B, C, and D: 60 years of age or older * Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E) * Treatment-naive patients with CD30-expressing PTCL (Part F) * Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D) * Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by: * A CIRS score of 10 or greater * Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs) * Measurable disease of at least 1.5 cm as documented by radiographic technique * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D) Exclusion Criteria: * Symptomatic neurologic disease compromising IADLs or requiring medication * History of progressive multifocal leukoencephalopathy * Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin * Concurrent use of other investigational agents * Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug * History of another malignancy within 1 year before first dose of study drug (Parts E and F only) * Part D only: * Received any prior immune-oncology therapy * History of known or suspected autoimmune disease * Prior allogeneic stem cell transplant * History of cerebral vascular event within 6 months of first dose of study drug * Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology * Known history of pancreatitis * Parts D, E, and F only: * Known cerebral/meningeal disease related to the underlying malignancy * Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment
References
Publications (4)
- DERIVEDFriedberg JW, Bordoni R, Patel-Donnelly D, Larson T, Goldschmidt J, Boccia R, Cline VJM, Mamidipalli A, Liu J, Akyol A, Yasenchak CA. Brentuximab vedotin with dacarbazine or nivolumab as frontline cHL therapy for older patients ineligible for chemotherapy. Blood. 2024 Feb 29;143(9):786-795. doi: 10.1182/blood.2022019536. PMID 37946283
- DERIVEDFriedberg JW, Forero-Torres A, Bordoni RE, Cline VJM, Patel Donnelly D, Flynn PJ, Olsen G, Chen R, Fong A, Wang Y, Yasenchak CA. Frontline brentuximab vedotin in combination with dacarbazine or bendamustine in patients aged >/=60 years with HL. Blood. 2017 Dec 28;130(26):2829-2837. doi: 10.1182/blood-2017-06-787200. Epub 2017 Oct 16. PMID 29038340
- DERIVEDForero-Torres A, Holkova B, Goldschmidt J, Chen R, Olsen G, Boccia RV, Bordoni RE, Friedberg JW, Sharman JP, Palanca-Wessels MC, Wang Y, Yasenchak CA. Phase 2 study of frontline brentuximab vedotin monotherapy in Hodgkin lymphoma patients aged 60 years and older. Blood. 2015 Dec 24;126(26):2798-804. doi: 10.1182/blood-2015-06-644336. Epub 2015 Sep 16. PMID 26377597
- DERIVEDGopal AK, Bartlett NL, Forero-Torres A, Younes A, Chen R, Friedberg JW, Matous JV, Shustov AR, Smith SE, Zain J, O'Meara MM, Fanale MA. Brentuximab vedotin in patients aged 60 years or older with relapsed or refractory CD30-positive lymphomas: a retrospective evaluation of safety and efficacy. Leuk Lymphoma. 2014 Oct;55(10):2328-34. doi: 10.3109/10428194.2013.876496. Epub 2014 Feb 24. PMID 24359243