ADCETRIS IV Infusion - Special drug use surveillance (all-case surveillance) "Relapsed or refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma"

Status

Unknown

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080222405

Enrollment

140

Registered

2014-02-24

Start date

2014-02-24

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsed or refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma

Interventions

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

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients treated with ADCETRIS IV Infusion

Exclusion criteria

Exclusion criteria:

Design outcomes

Primary

Measure	Time frame
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.	—

Measure

Time frame

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

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

ADCETRIS IV Infusion - Special drug use surveillance (all-case surveillance) "Relapsed or refractory CD30+ Hodgkin's lymphoma or anaplastic large cell lymphoma"

Conditions

Related papers

Interventions

Sponsors

Eligibility

Inclusion criteria

Exclusion criteria

Design outcomes

Primary

Secondary

Outcome results