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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
Sponsor:
Information provided by (Responsible Party):
Takeda

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety of brentuximab vedotin (recombinant) for intravenous (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, as well as to collect efficacy information for reference.

Condition or disease Intervention/treatment
Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma Drug: Brentuximab vedotin (recombinant)

Detailed Description:

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 Design
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Study Type : Observational
Actual Enrollment : 292 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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.

  2. 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.


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Relapsed or refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma
Criteria

Inclusion Criteria:

  • All patients treated with brentuximab vedotin IV Infusion

Exclusion Criteria:

  • None
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Japan
Osaka, Japan
Sponsors and Collaborators
Takeda
Investigators
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Study Director: Study Director Takeda
  Study Documents (Full-Text)

Documents provided by Takeda:
Study Protocol  [PDF] June 2, 2017
Statistical Analysis Plan  [PDF] January 27, 2017

More Information
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Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02139592    
Other Study ID Numbers: 291-011
JapicCTI-142455 ( Registry Identifier: JapicCTI )
First Posted: May 15, 2014    Key Record Dates
Results First Posted: May 6, 2019
Last Update Posted: July 13, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Takeda:
Pharmacological therapy
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Non-Hodgkin
Hodgkin Disease
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell