Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or refractory CD30-positive peripheral T cell lymphoma or Pediatric Hodgkin Lymphoma"

Special Drug Use Surveillance for Adcetris Intravenous Infusion 50 milligrams "Relapsed or refractory CD30-positive peripheral T cell lymphoma or Hodgkin Lymphoma (only pediatric patients)"

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1080224999

Enrollment

Registered

2019-12-24

Start date

2020-02-14

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

Peripheral T cell lymphoma and Pediatric Hodgkin lymphoma

Interventions

investigational material(s) Generic name etc : Brentuximab Vedotin INN of investigational material : Brentuximab Vedotin Therapeutic category code : 429 Other antitumor agents Dosage and Administratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Participants with relapsed or refractory lymphoma. 2. CD30-positive participants. 3. Participants who receive study drug after obtaining approval of CD30-positive PTCL indication of study drug.

Exclusion criteria

Exclusion criteria: 1. Participants with a history of severe hypersensitivity to Brentuximab Vedotin. 2. Participants taking bleomycin hydrochloride treatment.

Design outcomes

Primary

Measure	Time frame
1.Safety: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy Time Frame: Up to 12 Months An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported. 2.Safety: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy Time Frame: Up to 12 Months An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported. 3.Safety: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression Time Frame: Up to 12 Months An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported. 4.Safety: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression Time Frame: Up to 12 Months An adverse event (AE) is defined as any untoward medica	—

Measure

Time frame

1.Safety: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy Time Frame: Up to 12 Months An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported. 2.Safety: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy Time Frame: Up to 12 Months An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Adverse drug reaction refers to AE related to administered drug. Percentage of participants who had one or more serious or non-serious adverse drug reaction of peripheral motor neuropathy or peripheral sensory neuropathy which were classified as peripheral neuropathy was reported. 3.Safety: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression Time Frame: Up to 12 Months An adverse event (AE) is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. Percentage of participants who had one or more serious or non-serious adverse event of febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported. 4.Safety: Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression Time Frame: Up to 12 Months An adverse event (AE) is defined as any untoward medica

—

Secondary

Measure	Time frame
1.Efficacy: Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With Peripheral T-cell Lymphoma Not Otherwise Specified (PTCL-NOS), (Angioimmunoblastic T-cell Lymphoma) AITL, the Other PTCL, and Pediatric Participants With PTCL Time Frame: Up to 12 Months Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (when no positron emission tomography [PET] data are available), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by antitumor response criteria for adult PTCL. Reported data are divided into 2 populations; with or without PET data for each group. PET was used in cancer diagnosis and treatment. 2.Efficacy: Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With Adult T-cell Leukemia/lymphoma (ATLL) Time Frame: Up to 12 Months Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the antitumor response criteria. 3.Efficacy: Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL Time Frame: Up to 12 Months Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (for PTCL), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) version of antitumor response criteria. 4.Safety: Percentage of Participants Who Had One or More Adverse Event Time Frame: Up to 12 Months AE is defined as any unfavorable	—

Measure

Time frame

1.Efficacy: Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With Peripheral T-cell Lymphoma Not Otherwise Specified (PTCL-NOS), (Angioimmunoblastic T-cell Lymphoma) AITL, the Other PTCL, and Pediatric Participants With PTCL Time Frame: Up to 12 Months Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (when no positron emission tomography [PET] data are available), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by antitumor response criteria for adult PTCL. Reported data are divided into 2 populations; with or without PET data for each group. PET was used in cancer diagnosis and treatment. 2.Efficacy: Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With Adult T-cell Leukemia/lymphoma (ATLL) Time Frame: Up to 12 Months Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the antitumor response criteria. 3.Efficacy: Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL Time Frame: Up to 12 Months Best response is defined as the cumulative numbers of participants who achieve each level of best response including complete response (CR), complete response uncertain (CRu) (for PTCL), partial response (PR), Stable Disease (SD), and Progressive Disease (PD) after treatment. Best response was assessed by the Japanese Pediatric Leukemia/Lymphoma Study Group (JPLSG) version of antitumor response criteria. 4.Safety: Percentage of Participants Who Had One or More Adverse Event Time Frame: Up to 12 Months AE is defined as any unfavorable

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Countries

Japan

Outcome results

None listed

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