Skip to content
Triangle logo TriangleGet started
← Study library

NCT04213209 · REGISTRY CONDITION SEARCH

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

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
Not reported
Status at capture
COMPLETED
Registry last update
2024-09-27

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.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

→

baseline

Baseline characteristics

→

outcome · POSTED

Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy

→

outcome · POSTED

Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Peripheral Neuropathy

→

outcome · POSTED

Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression

→

outcome · POSTED

Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

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

→

outcome · POSTED

Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With ATLL

→

outcome · POSTED

Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL

→

outcome · POSTED

Percentage of Participants Who Had One or More Adverse Event

→

outcome · POSTED

Percentage of Participants Who Had One or More Adverse Drug Reaction

→

adverse events

Adverse events

→

more info

Limitations, agreements, and source contact

→
Who could take part
eligibility 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: 1. Participants with a history of severe hypersensitivity to Brentuximab Vedotin. 2. Participants taking bleomycin hydrochloride treatment.
healthy Volunteers
false
sampling Method
PROBABILITY_SAMPLE
sex
ALL
std Ages
  1. CHILD
  2. ADULT
  3. OLDER_ADULT
study Population
Patients with relapsed or refractory CD30-positive PTCL (excluding ALCL) and pediatric patients with relapsed or refractory CD30-positive PTCL or HL as part of routine medical care.
Treatment arms and interventions
arm Groups
  1. description
    The usual dosage for intravenous administration is 1.8 milligrams per kilograms (mg/kg) (body weight) as Brentuximab Vedotin (genetic recombination) once every three weeks (up to 12 months). The dose may be reduced appropriately according to the participant's condition. Participants receive interventions as part of routine medical care.
    intervention Names
    1. Drug: Brentuximab Vedotin (Genetical Recombination)
    label
    Brentuximab Vedotin 1.8 mg/kg (body weight)
interventions
  1. arm Group Labels
    1. Brentuximab Vedotin 1.8 mg/kg (body weight)
    description
    Brentuximab Vedotin Intravenous Infusion
    name
    Brentuximab Vedotin (Genetical Recombination)
    other Names
    1. ADCETRIS Intravenous Infusion 50 mg
    type
    DRUG
Study design
observational Model
COHORT
time Perspective
PROSPECTIVE
Enrollment
count
95
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    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.
    measure
    Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Peripheral Neuropathy
    time Frame
    Up to 12 Months
  2. description
    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.
    measure
    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
  3. description
    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.
    measure
    Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Myelosuppression
    time Frame
    Up to 12 Months
  4. description
    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.
    measure
    Percentage of Participants Who Had One or More Serious or Non-serious Adverse Drug Reaction Classified as Myelosuppression
    time Frame
    Up to 12 Months
  5. description
    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.
    measure
    Percentage of Participants Who Had One or More Serious or Non-serious Adverse Event Classified as Lung Disorder
    time Frame
    Up to 12 Months
  6. description
    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.
    measure
    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
secondary Outcomes
  1. description
    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.
    measure
    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
  2. description
    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.
    measure
    Percentage of Participants Who Achieve or Maintain Any Best Response for Adult Participants With ATLL
    time Frame
    Up to 12 Months
  3. description
    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.
    measure
    Percentage of Participants Who Achieve or Maintain Any Best Response for Pediatric Participants With PTCL and HL
    time Frame
    Up to 12 Months
  4. description
    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.
    measure
    Percentage of Participants Who Had One or More Adverse Event
    time Frame
    Up to 12 Months
  5. description
    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.
    measure
    Percentage of Participants Who Had One or More Adverse Drug Reaction
    time Frame
    Up to 12 Months
Full study description
brief Summary
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.
detailed Description
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.
Source references
see Also Links
  1. label
    To obtain more information on the study, click here/on this link
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-eb2361882b0e50e2f971
      requested nct id
      NCT04213209
      primary nct id
      NCT04213209
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      payload sha256
      251f71a75988f395abaf28ca4e8518137dafa56d2ccba7777a9ed7a32fead915
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-eb2361882b0e50e2f971
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT04213209
      occurrences
      1. context exact
        NCT04213209
        end
        11
        exact text
        NCT04213209
        start
        0
      offset unit
      unicode_code_points
      query cond
      Peripheral T-Cell Non-Hodgkin Lymphoma
      query disease state id
      ds-peripheral-t-cell-non-hodgkin-lymphoma
      source file
      /Users/arunverma/Documents/ChatGPT/Cancer Statistics Website/research-data/2026-09-10/clinicaltrials-condition/round-0000/raw/cond-peripheral-t-cell-non-hodgkin-lymphoma-000.json
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      source json pointer
      /studies/12/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      9e6c1ecb4e02d2631b227bfff9e7b13ae07a747c88121077ea20614a18b85d78

    Preserved source evidence · Not medical advice