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Completed

NCT Number: NCT04213209

Special Drug Use Surveillance for Brentuximab Vedotin Intravenous Infusion "Relapsed or Refractory CD30-positive Peripheral T Cell Lymphoma or Pediatric Hodgkin Lymphoma"

The purpose of this survey is to examine the safety of adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL) in the actual use of on concomitant Brentuximab Vedotin in routine clinical practice.

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Key information

About this study

The drug being tested in this survey is called Brentuximab Vedotin intravenous infusion 50 mg. This intravenous infusion is being tested to treat adult patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL) (excluding anaplastic large cell lymphoma (ALCL)) and pediatric patients with relapsed or refractory CD30-positive PTCL or Hodgkin lymphoma (HL).

This survey is an observational (non-interventional) study and will look at the safety of adult patients with relapsed or refractory CD30-positive PTCL (excluding ALCL) and pediatric patients with relapsed or refractory CD30-positive PTCL or HL in the routine clinical setting. The number of observed patients will be approximately 86 as total (80; Adult participants and 6; Pediatric participants).

This multi-center observational survey will be conducted in Japan.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants with relapsed or refractory lymphoma.
  • CD30-positive participants.
  • Participants who receive study drug after obtaining approval of CD30-positive PTCL indication of study drug.

Exclusion criteria

  • Participants with a history of severe hypersensitivity to Brentuximab Vedotin.
  • Participants taking bleomycin hydrochloride treatment.

Treatment and study plan

Brentuximab vedotin (Genetical Recombination)

Drug

Brentuximab Vedotin Intravenous Infusion

Other names: ADCETRIS Intravenous Infusion 50 mg

Primary outcomes

  1. 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. 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. 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. 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 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 febrile neutropenia, neutropenia, or neutrophil count decreased which were classified as myelosuppression was reported.

  5. Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder

    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 only interstitial lung disease which were classified as lung disorder was reported.

  6. Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Lung Disorder

    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 only interstitial lung disease which were classified as lung disorder was reported.

Secondary outcomes

  1. Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With PTCL-NOS, 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 the 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. Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With 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. 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. Percentage of Participants Who Had One or More Adverse Event

    Time frame: Up to 12 Months

    AE is defined as any unfavorable and unintended signs, symptoms or diseases temporally associated with the use of a medicinal product reported from the first dose of study drug to the last dose of study drug.

  5. Percentage of Participants Who Had One or More Adverse Drug Reaction

    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.

Sponsors and collaborators

Lead sponsor

Takeda

Industry

Registry information

Official study title

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)"

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Dec 30, 2019
Registry last updated
Sep 27, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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