NCT03729609

Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma"

Completed Results posted Last updated 21 August 2024

What this trial tests

trial testing Brentuximab vedotin (Genetical Recombination) in Untreated CD30-Positive Hodgkin's Lymphoma in 113 participants. Completed in 27 September 2023.

Timeline

1 November 2018

Primary endpoint
27 September 2023

27 September 2023

Quick facts

Lead sponsor	Takeda
Status	Completed
Study type	OBSERVATIONAL
Enrollment	113
Start date	1 November 2018
Primary completion	27 September 2023
Estimated completion	27 September 2023
Sites	1 location across Japan

Drugs / interventions tested

• Brentuximab vedotin (Genetical Recombination) — full drug profile →

Conditions studied

• Untreated CD30-Positive Hodgkin's Lymphoma — all drugs for Untreated CD30-Positive Hodgkin's Lymphoma →

Sponsor

Takeda — full company profile →

Who can join

Eligibility, any sex, with Untreated CD30-Positive Hodgkin's Lymphoma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Percentage of Participants With Grade 3 or Higher Neutropenia and Febrile Neutropenia Primary · Up to 2 weeks after the last dose (approximately 6 months)

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.

Neutropenia

Group	Value	95% CI
Brentuximab Vedotin 1.2 mg/kg (Body Weight)	65

Febrile Neutropenia

Group	Value	95% CI
Brentuximab Vedotin 1.2 mg/kg (Body Weight)	31

Tumor Response Rate Based on Investigator's Assessment Secondary · Baseline, Up to 2 weeks after the last dose (approximately 6 months)

Tumor response rate was defined as the percentage of participants with complete response (CR) or partial response (PR) as assessed by the Revised response criteria for malignant lymphoma by Cheson. CR is defined as the disappearance of all evidence of disease and PR is defined as regression of measurable disease and no new sites.

Group	Value	95% CI
Brentuximab Vedotin 1.2 mg/kg (Body Weight)	87

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 2 weeks after the last dose (approximately 6 months). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Brentuximab Vedotin 1.2 mg/kg (Body Weight)

Serious: 44/112 (39%)

Deaths: 1/112

Serious adverse events (2 terms)

Reaction	System	Brentuximab Vedotin 1.2 mg…
Febrile Neutropenia	Blood and lymphatic system disorders	—
Neutropenia	Investigations	—

Other adverse events (1 terms — click to expand)

Reaction	System	Brentuximab Vedotin 1.2 mg…
Neutropenia	Investigations	—

Most-reported serious reactions: Febrile Neutropenia, Neutropenia.

Data from ClinicalTrials.gov NCT03729609 adverse events section.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Postmarketing surveillance of brentuximab vedotin for previously untreated Hodgkin lymphoma in Japanese patients.
   Okazuka K, Shimizu T, Tawara R, Matsuo M, et al · · 2025 · PMID 40451861 · DOI 10.3960/jslrt.24078