Trial Outcomes & Findings for Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma" (NCT NCT03729609)

Last Updated: 2024-08-21

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

113 participants

Primary outcome timeframe

Up to 2 weeks after the last dose (approximately 6 months)

Results posted on

2024-08-21

Participant Flow

Participants took part in the survey at 51 investigative sites in Japan, from 1 November 2018 to 27 September 2023.

Participants with a historical diagnosis of untreated CD30-Positive Hodgkin's lymphoma were enrolled. Participants received Brentuximab Vedotin Intravenous Infusion as part of a routine medical care.

Participant milestones

Participant milestones
Measure	Brentuximab Vedotin 1.2 mg/kg (Body Weight) 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.
Overall Study STARTED	113
Overall Study COMPLETED	112
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Brentuximab Vedotin 1.2 mg/kg (Body Weight) 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.
Overall Study Protocol Violation	1

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Brentuximab Vedotin 1.2 mg/kg (Body Weight) n=112 Participants 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.
Age, Continuous	57.1 Years STANDARD_DEVIATION 19.41 • n=112 Participants
Sex: Female, Male Female	48 Participants n=112 Participants
Sex: Female, Male Male	64 Participants n=112 Participants
Region of Enrollment Japan	112 Participants n=112 Participants
Duration of Diagnosis of Hodgkin's Lymphoma	2.3 Months STANDARD_DEVIATION 6.34 • n=111 Participants • The number analyzed is the number of participants with data available for analysis.
Eastern Cooperative Oncology Group Performance Status Scale = 0	62 Participants n=112 Participants
Eastern Cooperative Oncology Group Performance Status Scale = 1	37 Participants n=112 Participants
Eastern Cooperative Oncology Group Performance Status Scale = 2	11 Participants n=112 Participants
Eastern Cooperative Oncology Group Performance Status Scale = 3	2 Participants n=112 Participants
Eastern Cooperative Oncology Group Performance Status Scale = 4	0 Participants n=112 Participants
Healthcare Category Outpatient	2 Participants n=112 Participants
Healthcare Category Inpatient	110 Participants n=112 Participants
Medical Complications Had No Medical Complications	49 Participants n=112 Participants
Medical Complications Had Medical Complications	63 Participants n=112 Participants
Renal Impairment Had No Renal Impairment	109 Participants n=112 Participants
Renal Impairment Had Renal Impairment	3 Participants n=112 Participants
Hepatic Impairment Had No Hepatic Impairment	109 Participants n=112 Participants
Hepatic Impairment Had Hepatic Impairment	3 Participants n=112 Participants
Medical History Had No Medical History	65 Participants n=112 Participants
Medical History Had Medical History	47 Participants n=112 Participants
Weight	58.26 Kilograms (kg) STANDARD_DEVIATION 12.450 • n=112 Participants
BMI	22.20 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.561 • n=112 Participants

PRIMARY outcome

Timeframe: Up to 2 weeks after the last dose (approximately 6 months)

Population: Safety Analysis Set, The safety analysis set was defined as all participants who completed the survey.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.2 mg/kg (Body Weight) n=112 Participants 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.
Percentage of Participants With Grade 3 or Higher Neutropenia and Febrile Neutropenia Neutropenia	65 Participants
Percentage of Participants With Grade 3 or Higher Neutropenia and Febrile Neutropenia Febrile Neutropenia	31 Participants

SECONDARY outcome

Timeframe: Baseline, Up to 2 weeks after the last dose (approximately 6 months)

Population: Efficacy analysis set: all participants who received at least one dose of protocol treatment without major protocol deviation. The number analyzed was the number of participants with data available for analysis.

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.

Outcome measures

Outcome measures
Measure	Brentuximab Vedotin 1.2 mg/kg (Body Weight) n=98 Participants 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.
Tumor Response Rate Based on Investigator's Assessment	87 Participants

Adverse Events

Brentuximab Vedotin 1.2 mg/kg (Body Weight)

Serious events: 44 serious events

Other events: 52 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Brentuximab Vedotin 1.2 mg/kg (Body Weight) n=112 participants at risk 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.
Blood and lymphatic system disorders Febrile Neutropenia	27.7% 31/112 • Up to 2 weeks after the last dose (approximately 6 months) At each visit the investigator had to document any occurrence of Neutropenia and Febrile Neutropenia with Grade 3 or higher events as AEs, irrespective of the relation to the survey treatment. Only Neutropenia and Febrile Neutropenia with Grade 3 or higher events were planned to be collected and assessed in this study. The other AEs were out of the scope for the data collection plan.
Investigations Neutropenia	11.6% 13/112 • Up to 2 weeks after the last dose (approximately 6 months) At each visit the investigator had to document any occurrence of Neutropenia and Febrile Neutropenia with Grade 3 or higher events as AEs, irrespective of the relation to the survey treatment. Only Neutropenia and Febrile Neutropenia with Grade 3 or higher events were planned to be collected and assessed in this study. The other AEs were out of the scope for the data collection plan.

Other adverse events

Other adverse events
Measure	Brentuximab Vedotin 1.2 mg/kg (Body Weight) n=112 participants at risk 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.
Investigations Neutropenia	46.4% 52/112 • Up to 2 weeks after the last dose (approximately 6 months) At each visit the investigator had to document any occurrence of Neutropenia and Febrile Neutropenia with Grade 3 or higher events as AEs, irrespective of the relation to the survey treatment. Only Neutropenia and Febrile Neutropenia with Grade 3 or higher events were planned to be collected and assessed in this study. The other AEs were out of the scope for the data collection plan.

Additional Information

Study Director

Takeda

Phone: +1-877-825-3327

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee The first study related publication will be a multi-center publication submitted within 24 months after conclusion or termination of a study at all sites. After such multi site publication, all proposed site publications and presentations will be submitted to sponsor for review 60 days in advance of publication. Site will remove Sponsor confidential information unrelated to study results. Sponsor can delay a proposed publication for another 60 days to preserve intellectual property.
Publication restrictions are in place

Restriction type: OTHER