Clinical trial · Observational
Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma"
Drug Use Surveillance for ADCETRIS Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma"
NCT03729609CI-TRIAL-00080020completedResults postedClinicalTrials.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 survey is to monitor and identify the occurrence of neutropenia and febrile neutropenia in untreated CD30-positive Hodgkin's lymphoma participants on concomitant brentuximab vedotin and doxorubicin hydrochloride, vinblastine sulfate, and dacarbazine (AVD) in routine clinical practice.
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 |
|---|---|---|---|
| Untreated CD30-Positive Hodgkin's Lymphoma | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brentuximab vedotin (Genetical Recombination) | Drug | Brentuximab Vedotin | ALIAS |
Design
Arms and outcomes
Arms (1)
- label
- Brentuximab vedotin 1.2 mg/kg (body weight)
- description
- Brentuximab vedotin 1.2 milligrams per kilograms (mg/kg) (body weight), intravenous infusion, once every two weeks (up to 12 times). The dose should be adjusted depend on the participant's condition. Participants received interventions as part of routine medical care.
- interventionNames
- Drug: Brentuximab vedotin (Genetical Recombination)
Primary outcomes (1)
- measure
- Percentage of Participants With Grade 3 or Higher Neutropenia and Febrile Neutropenia
- timeFrame
- Up to 2 weeks after the last dose (approximately 6 months)
- description
- Severity grades was evaluated as per National Cancer Institute Common Terminology Criteria for Adverse Event (NCI CTCAE). Grade 1 scales as Mild; Grade 2 scales as Moderate; Grade 3 scales as severe or medically significant but not immediately life-threatening; Grade 4 scales as life-threatening consequences; and Grade 5 scales as death related to AE.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
Inclusion Criteria: 1. Untreated participants 2. CD30-positive participants 3. Participants on concomitant Brentuximab vedotin and AVD Exclusion Criteria: 1\. Participants contraindicated for Brentuximab vedotin
References
Publications (0)
Data not yet available
No reference posted for this study.