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Trial record 1 of 1 for:    291-011
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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"

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02139592
First Posted: May 15, 2014
Last Update Posted: July 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Takeda
  Purpose
The purpose of this study is 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, as well as to collect efficacy information for reference.

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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: ADCETRIS IV Infusion − Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma"

Resource links provided by NLM:


Further study details as provided by Takeda:

Primary Outcome Measures:
  • Frequency of adverse events [ Time Frame: From the start of this drug uoto 48 weeks or until discontinuation of treatment ]
    The frequencies of all adverse events observed during the observation period will be tabulated by type and seriousness. Adverse events are defined as unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product, regardless of relationship to the medicinal product.


Secondary Outcome Measures:
  • Antitumor efficacy (best response) [ Time Frame: From the start of this drug up to 48 weeks or until discontinuation of treatment ]
    Based on findings of neck, chest, abdominal, and pelvic computed tomography and positron emission tomography, and in accordance with evaluation criteria for antitumor efficacy, the antitumor efficacy (best response) of ADCETRIS will be assessed as one of the following: complete response, unconfirmed complete response (when no PET data are available), partial response, stable disease, or progressive disease.

  • Overall survival [ Time Frame: From the start of this drug up to 48 weeks or until discontinuation of treatment ]
    Time to death (regardless of cause of death) will be caluculated using Kaplan-Meier method.


Estimated Enrollment: 140
Actual Study Start Date: April 17, 2014
Study Completion Date: June 30, 2017
Primary Completion Date: June 30, 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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 patient's condition. See the "PRECAUTIONS" section of the package insert.

  Eligibility

Information from the National Library of Medicine

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

Inclusion Criteria:

  • All patients treated with ADCETRIS IV Infusion

Exclusion Criteria:

  Contacts and Locations
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
Japan
Osaka, Japan
Sponsors and Collaborators
Takeda
Investigators
Study Chair: Postmarketing Group Manager Takeda
  More Information

Responsible Party: Takeda
ClinicalTrials.gov Identifier: NCT02139592     History of Changes
Other Study ID Numbers: 291-011
JapicCTI-142455 ( Registry Identifier: JapicCTI )
First Submitted: April 17, 2014
First Posted: May 15, 2014
Last Update Posted: July 7, 2017
Last Verified: July 2017

Keywords provided by Takeda:
Pharmacological therapy

Additional relevant MeSH terms:
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
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs