Clinical Trial: 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"

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: ADCETRIS IV Infusion − Special Drug Use Surveillance (All-case Surveillance) "Relapsed or Refractory CD30+ Hodgkin's Lymphoma or Anaplastic Large Cell Lymphoma&

Brief Summary: 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.

Detailed Summary:

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.


Sponsor: Takeda

Current Primary Outcome: 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.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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.


Original Secondary Outcome: Same as current

Information By: Takeda

Dates:
Date Received: April 17, 2014
Date Started: April 2014
Date Completion: June 2017
Last Updated: August 24, 2016
Last Verified: August 2016