Brentuximab Vedotin (Recombinant) for IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"
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|ClinicalTrials.gov Identifier: NCT02139592|
Recruitment Status : Completed
First Posted : May 15, 2014
Results First Posted : May 6, 2019
Last Update Posted : July 13, 2020
|Condition or disease||Intervention/treatment|
|Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma||Drug: Brentuximab vedotin (recombinant)|
The present survey was designed to evaluate the safety of brentuximab vedotin (recombinant) for IV infusion (ADCETRIS IV Infusion 50 mg) in patients with relapsed/refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma in the routine clinical setting.
The usual adult dosage is 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) infused intravenously once every three weeks. The dose should be adjusted depending on the participant's condition. See the "PRECAUTIONS" section of the package insert.
|Study Type :||Observational|
|Actual Enrollment :||292 participants|
|Official Title:||Brentuximab Vedotin (ADCETRIS) IV Infusion - Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"|
|Actual Study Start Date :||April 17, 2014|
|Actual Primary Completion Date :||June 30, 2017|
|Actual Study Completion Date :||June 30, 2017|
brentuximab vedotin (recombinant) Intravenous infusion
Intravenous infusion of 1.8 mg/kg (body weight) of brentuximab vedotin (recombinant) administered once every three weeks
Drug: Brentuximab vedotin (recombinant)
Brentuximab vedotin (recombinant) for IV infusion
Other Name: ADCETRIS IV Infusion 50 mg
- Number of Participants Who Had One or More Adverse Events (AE) and Serious Adverse Events (SAE) [ Time Frame: Up to Week 48 or until discontinuation of treatment ]
- Percentage of Participants Who Achieve or Maintain Any Best Response [ Time Frame: Up to Week 48 or until discontinuation of treatment ]Best response is defined as the cumulative numbers of participants who achieve each level of best response including partial response (PR), complete response uncertain (CRu) (when no positron emission tomography [PET] data are available), and complete response (CR) after each cycle of treatment. Reported data are divided into 4 populations; Hodgkin's lymphoma (HL) participants with PET data, HL participants without PET data, anaplastic large cell lymphoma (ALCL) participants with PET data, and ALCL participants without PET data. PET is used in cancer diagnosis and treatment.
- Overall Survival (OS) [ Time Frame: Up to Week 48 or until discontinuation of treatment ]OS is defined as the period from the start of therapy in standard medical care to the time when death (regardless of the cause of death) is confirmed. Reported data as OS was point estimates of 1 year survival rate for HL and ALCL participants.
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): NCT02139592
|Study Director:||Study Director||Takeda|