Clinical trial · Interventional
Study of Brentuximab Vedotin Combined With Bendamustine in Patients With Hodgkin Lymphoma
A Phase 1/2 Single-arm, Open-label Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin in Combination With Bendamustine in Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
- 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 safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.
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 |
|---|---|---|---|
| Hodgkin Disease | Hodgkin Lymphoma | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bendamustine | Drug | Bendamustine | ALIAS |
| brentuximab vedotin | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Brentuximab Vedotin + Bendamustine
- description
- Brentuximab vedotin 1.8 mg/kg every 3 weeks for up to 16 cycles by IV infusion and bendamustine 90 mg/m2 on Days 1 and 2 every 3 weeks by IV infusion for up to 6 cycles
- interventionNames
- Drug: brentuximab vedotin
- Drug: bendamustine
Primary outcomes (2)
- measure
- Complete Remission Rate
- timeFrame
- Up to 4.6 months
- description
- Complete remission rate among all subjects (Phase 1 and 2 combined) treated at the dose level selected for Phase 2. Complete remission (CR) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma is a disappearance of all evidence of disease.
- measure
- Incidence of Adverse Events (AEs)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histopathological diagnosis of classical Hodgkin lymphoma * Failed standard front-line therapy * Measurable disease of at least 1.5 cm as documented by radiographic technique * Eastern Cooperative Oncology Group performance status less than or equal to 2 Exclusion Criteria: * Received prior salvage therapy, including radiotherapy * Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug * Concurrent use of other investigational agents
References
Publications (1)
- DERIVEDLaCasce AS, Bociek RG, Sawas A, Caimi P, Agura E, Matous J, Ansell SM, Crosswell HE, Islas-Ohlmayer M, Behler C, Cheung E, Forero-Torres A, Vose J, O'Connor OA, Josephson N, Wang Y, Advani R. Brentuximab vedotin plus bendamustine: a highly active first salvage regimen for relapsed or refractory Hodgkin lymphoma. Blood. 2018 Jul 5;132(1):40-48. doi: 10.1182/blood-2017-11-815183. Epub 2018 Apr 27. PMID 29703778