Clinical trial · Interventional
A Phase 1 Study of Brentuximab Vedotin Combined With Multi-Agent Chemotherapy for Hodgkin Lymphoma
A Phase 1 Dose-Escalation Safety Study of Brentuximab Vedotin in Combination With Multi-Agent Chemotherapy as Frontline Therapy in Patients With Hodgkin Lymphoma
- 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)
The purpose of this study is to assess the safety profile of brentuximab vedotin in combination with multi-agent chemotherapy in treatment-naive Stage IIa or IIb-IV Hodgkin lymphoma. It is a phase 1, two-arm, open-label dose escalation study designed to define the maximum tolerated dose, pharmacokinetics, immunogenicity and anti-tumor activity of brentuximab vedotin in combination with frontline therapy.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disease, Hodgkin | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bleomycin | Drug | Bleomycin | ALIAS |
| brentuximab vedotin | Drug | Brentuximab Vedotin | ALIAS |
| dacarbazine | Drug | Dacarbazine | ALIAS |
| doxorubicin | Drug | Doxorubicin | ALIAS |
| vinblastine | Drug | Vinblastine | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- description
- brentuximab vedotin combined with ABVD (doxorubicin, bleomycin, vinblastine, dacarbazine)
- interventionNames
- Drug: brentuximab vedotin
- Drug: doxorubicin
- Drug: vinblastine
- Drug: dacarbazine
- Drug: bleomycin
- type
- EXPERIMENTAL
- label
- 2
- description
- brentuximab vedotin combined with AVD (doxorubicin, vinblastine, dacarbazine)
- interventionNames
- Drug: doxorubicin
- Drug: vinblastine
- Drug: dacarbazine
- Drug: brentuximab vedotin
Primary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 60 Years
Show eligibility criteria text
Inclusion Criteria: * Treatment-naive Hodgkin lymphoma, Stage IIa or IIb-IV * Measurable disease of at least 1.5 cm * Eastern Cooperative Oncology Group performance status \<3 Exclusion Criteria: * History of another primary malignancy that has not been in remission for at least 3 years * Known cerebral/meningeal disease
References
Publications (1)
- RESULTYounes A, Connors JM, Park SI, Fanale M, O'Meara MM, Hunder NN, Huebner D, Ansell SM. Brentuximab vedotin combined with ABVD or AVD for patients with newly diagnosed Hodgkin's lymphoma: a phase 1, open-label, dose-escalation study. Lancet Oncol. 2013 Dec;14(13):1348-56. doi: 10.1016/S1470-2045(13)70501-1. Epub 2013 Nov 15. PMID 24239220