Untreated CD30-Positive Hodgkin's Lymphoma
Conditions
Brief summary
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.
Detailed description
The drug being tested in this survey is called brentuximab vedotin intravenous infusion 50 mg. This intravenous infusion is being tested to treat people with untreated CD30-positive Hodgkin's lymphoma. This survey is an observational (non-interventional) study and will look at the occurrence of neutropenia and febrile neutropenia in untreated CD30-positive Hodgkin's lymphoma patients on concomitant brentuximab vedotin and AVD in the routine clinical setting. The planned number of observed patients will be approximately 100. This multi-center observational trial will be conducted in Japan.
Interventions
Brentuximab vedotin Intravenous Infusion
Sponsors
Takeda
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Grade 3 or Higher Neutropenia and Febrile Neutropenia | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Tumor Response Rate Based on Investigator's Assessment | 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. |
Countries
Japan
Participant flow
Recruitment details
Participants took part in the survey at 51 investigative sites in Japan, from 1 November 2018 to 27 September 2023.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 112 |
| Total | 112 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Protocol Violation | 1 |
Baseline characteristics
| Characteristic | Brentuximab Vedotin 1.2 mg/kg (Body Weight) | — |
|---|---|---|
| Age, Continuous | 57.1 Years STANDARD_DEVIATION 19.41 | — |
| BMI | 22.20 Kilogram (kg)/meter (m)^2 STANDARD_DEVIATION 3.561 | — |
| Duration of Diagnosis of Hodgkin's Lymphoma | 2.3 Months STANDARD_DEVIATION 6.34 | — |
| Eastern Cooperative Oncology Group Performance Status Scale = 0 | 62 Participants | — |
| Eastern Cooperative Oncology Group Performance Status Scale = 1 | 37 Participants | — |
| Eastern Cooperative Oncology Group Performance Status Scale = 2 | 11 Participants | — |
| Eastern Cooperative Oncology Group Performance Status Scale = 3 | 2 Participants | — |
| Eastern Cooperative Oncology Group Performance Status Scale = 4 | 0 Participants | — |
| Healthcare Category Inpatient | 110 Participants | — |
| Healthcare Category Outpatient | 2 Participants | — |
| Hepatic Impairment Had Hepatic Impairment | 3 Participants | — |
| Hepatic Impairment Had No Hepatic Impairment | 109 Participants | — |
| Medical Complications Had Medical Complications | 63 Participants | — |
| Medical Complications Had No Medical Complications | 49 Participants | — |
| Medical History Had Medical History | 47 Participants | — |
| Medical History Had No Medical History | 65 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Japan | 112 Participants | — |
| Renal Impairment Had No Renal Impairment | 109 Participants | — |
| Renal Impairment Had Renal Impairment | 3 Participants | — |
| Sex: Female, Male Female | 48 Participants | — |
| Sex: Female, Male Male | 64 Participants | — |
| Weight | 58.26 Kilograms (kg) STANDARD_DEVIATION 12.45 | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 112 |
| other Total, other adverse events | 52 / 112 |
| serious Total, serious adverse events | 44 / 112 |
Outcome results
Primary
Percentage of Participants With Grade 3 or Higher Neutropenia and Febrile Neutropenia
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.
Time frame: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Brentuximab Vedotin 1.2 mg/kg (Body Weight) | Percentage of Participants With Grade 3 or Higher Neutropenia and Febrile Neutropenia | Neutropenia | 65 Participants |
| Brentuximab Vedotin 1.2 mg/kg (Body Weight) | Percentage of Participants With Grade 3 or Higher Neutropenia and Febrile Neutropenia | Febrile Neutropenia | 31 Participants |
Secondary
Tumor Response Rate Based on Investigator's Assessment
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.
Time frame: 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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Brentuximab Vedotin 1.2 mg/kg (Body Weight) | Tumor Response Rate Based on Investigator's Assessment | 87 Participants |