Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma"
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|ClinicalTrials.gov Identifier: NCT03729609|
Recruitment Status : Recruiting
First Posted : November 2, 2018
Last Update Posted : November 2, 2018
|Condition or disease||Intervention/treatment|
|Untreated CD30-Positive Hodgkin's Lymphoma||Drug: Brentuximab vedotin (Genetical Recombination)|
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.
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Drug Use Surveillance for ADCETRIS Intravenous Infusion "Untreated CD30-Positive Hodgkin's Lymphoma"|
|Actual Study Start Date :||November 1, 2018|
|Estimated Primary Completion Date :||May 31, 2022|
|Estimated Study Completion Date :||May 31, 2022|
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.
Drug: Brentuximab vedotin (Genetical Recombination)
Brentuximab vedotin Intravenous Infusion
Other Name: ADCETRIS Intravenous Infusion 50 mg
- Percentage of Participants with Grade 3 or Higher Neutropenia and Febrile Neutropenia [ Time Frame: Up to 2 weeks after the last dose (approximately 6 months) ]Severity grades will be 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.
- Tumor Response Rate Based on Investigator's Assessment [ Time Frame: Baseline, Up to 2 weeks after the last dose (approximately 6 months) ]Tumor response rate is 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03729609
|Contact: Takeda Study Registration Call Centerfirstname.lastname@example.org|
|Takeda Selected Site||Recruiting|
|Study Director:||Study Director||Takeda|