NIPH Clinical Trials Search

Basic Information

Recruitment status
Health condition(s) or Problem(s) studied	Relapsed or refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma
Date of first enrollment	24/02/2014
Target sample size	140
Countries of recruitment
Study type	Observational
Intervention(s)	investigational material(s) Generic name etc : ADCETRIS IV Infusion 50 mg (brentuximab vedotin [recombinant]) INN of investigational material : Therapeutic category code : 429 Other antitumor agents Dosage and Administration for Investigational material : 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.

Outcome(s)

Primary Outcome

Frequency of adverse events Primary timeframeFrom the start of Cycle 1 to the end of Cycle 16 (3 weeks/cycle) or until discontinuation of treatment The frequency 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

Antitumor efficacy (best response) and overall survival Secondary timeframeFrom the start of Cycle 1 to the end of Cycle 16 (3 weeks/cycle) or until discontinuation of treatment (1) Based on findings from 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. (2) Time to death (regardless of cause of death) will be calculated using Kaplan-Meier method.

Key inclusion & exclusion criteria

Age minimum	Not applicable
Age maximum	Not applicable
Gender	Both
Include criteria	All patients treated with ADCETRIS IV Infusion
Exclude criteria