Clinical trial · Interventional
Brentuximab Vedotin Followed by ABVD in Patients With Previously Untreated Hodgkin Lymphoma
A Pilot Phase II Study To Assess The Efficacy Of Brentuximab Vedotin Administered Sequentially With ABVD Chemotherapy In Patients With Untreated Hodgkin Lymphoma.
NCT02275598CI-TRIAL-00015912unknownPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- 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 efficacy of two three-weekly 1.8 mg/kg Brentuximab vedotin administrations in untreated patients with Hodgkin Lymphoma (HL).
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 Lymphoma | Hodgkin Lymphoma | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ABVD | Drug | — | UNRESOLVED |
| Brentuximab vedotin | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- BV-ABVD
- description
- Treatment will consist of two three-weekly doses of Brentuximab vedotin, followed by standard treatment, ABVD (3 o 6 cycles q4w).
- interventionNames
- Drug: Brentuximab vedotin
- Drug: ABVD
Primary outcomes (1)
- measure
- Number of Participants with Complete Metabolic Response by FDG-PET
- timeFrame
- between day +8 and day +15 from second administration of Brentuximab
- description
- Complete Metabolic Response will be defined by Deauville score 1, 2, 3.
Secondary outcomes (3)
- measure
- Overall Response Rate (ORR)
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 8 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: * Previously-untreated patients with classical Hodgkin Lymphoma according to the World Health Organisation (WHO) classification * Histologically confirmed CD30+ HL * Stage IA, IIA, IIIA * Absence of bulky disease * FDG-PET at baseline * Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1 * Life expectancy \> 6 months. * Age 18-70 years. * Patients must be available for periodic blood sampling, study-related assessments, and management of toxicity at the treating institution. * Females of childbearing potential must have a negative pregnancy test result within three days of enrollment. All patients must agree to use effective contraceptive methods (one for male and two for female) during the course of the study and for 6 months following the end of full treatment (Brentuximab vedotin + ABVD +/- Radiotherapy). * Written informed consent. * Required baseline laboratory data: Absolute neutrophil count ≥ 1000/μl Platelet count ≥ 50.000/ μl Serum bilirubin ≤ 1.5 times ULN Serum creatinine ≤ 1.5 times ULN Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 times ULN Exclusion Criteria: * Peripheral neuropathy \> Grade 1 * Histologic diagnosis different from Hodgkin Lymphoma * Compressive symptoms * Patients previously treated with any anti-CD30 antibody * Known human immunodeficiency virus (HIV) positive * Known hepatitis B surface antigen-positive, or known or suspected infection active hepatitis C * Patients with signs or symptoms of progressive multifocal leukoencephalopathy (PML) * Patients with known cerebral/meningeal disease.
References
Publications (0)
Data not yet available
No reference posted for this study.