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NCT03947255 · REGISTRY CONDITION SEARCH

A Study of Retreatment With Brentuximab Vedotin in Subjects With Classic Hodgkin Lymphoma or CD30-expressing Peripheral T Cell Lymphoma

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

Phase
PHASE2
Status at capture
TERMINATED
Registry last update
2023-10-13

This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.

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

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baseline

Baseline characteristics

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outcome · POSTED

Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria

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outcome · POSTED

Number of Participants With Adverse Events

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outcome · POSTED

Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria

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outcome · POSTED

Number of Participants With Laboratory Abnormalities

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outcome · POSTED

Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria

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outcome · POSTED

Overall Survival (OS)

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outcome · POSTED

Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria

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outcome · POSTED

ORR Per Investigator Assessment According to Modified Lugano Response Criteria

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outcome · POSTED

DOR Per Investigator Assessment According to Modified Lugano Response Criteria

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outcome · POSTED

Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria

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outcome · POSTED

Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria

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outcome · POSTED

ORR Per BICR According to Lugano Response Criteria

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Histologically confirmed cHL, sALCL, or other CD30-expressing PTCL * Previously treated with brentuximab vedotin containing regimen, with evidence of objective response, and subsequent disease progression or relapse after discontinuing treatment * Documentation of disease relapse or progression ≥6 months after the last dose of brentuximab vedotin * Fluorodeoxyglucose positron emission tomography- (FDG-PET) avid and bidimensional measurable disease of at least 1.5 cm in longest axis as documented by radiographic technique * Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to 2 * Must not be pregnant and, if of childbearing or fathering potential, must agree to use 2 effective contraception methods during study and for 6 months following last dose of study drug Exclusion Criteria: * Previously discontinued brentuximab vedotin due to any Grade 3 or higher toxicity * Existing Grade 2 or higher peripheral neuropathy * Previously refractory to treatment with brentuximab vedotin * History of a cerebral vascular event, unstable angina, or myocardial infarction within 6 months prior to first dose * History of another malignancy within 3 years before first dose of study drug or any evidence of residual disease from previously diagnosed malignancy * Acute or chronic graft-versus-host-disease (GvHD) or receiving immunosuppressive therapy as treatment for or prophylaxis agent against GvHD * Active cerebral/meningeal disease * History of progressive multifocal leukoencephalopathy (PML) * Active uncontrolled Grade 3 (per NCI CTCAE v5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to first dose of study drug * Chemotherapy, radiotherapy, biologics, and/or other antitumor treatment with immunotherapy that is not completed 4 weeks prior to first dose of study drug, unless underlying disease has progressed on treatment
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. intervention Names
    1. Drug: brentuximab vedotin
    label
    Brentuximab vedotin
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Brentuximab vedotin
    description
    1.8 mg/kg given intravenously (IV)
    name
    brentuximab vedotin
    other Names
    1. ADCETRIS
    2. SGN-35
    type
    DRUG
Study design
allocation
NA
intervention Model
SINGLE_GROUP
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
12
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Objective Response Rate (ORR) is defined as the percentage of participants with complete response (CR) or partial response (PR) according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on BICR
    measure
    Objective Response Rate (ORR) Per BICR According to Modified Lugano Response Criteria
    time Frame
    Up to 18.3 months
  2. description
    An AE is any untoward medical occurrence in a patient or clinical investigational participant administered a medicinal product and which does not necessarily have a causal relationship with this treatment. Treatment emergent AEs (TEAEs) are defined as events that are new or worsened on or after receiving the first dose of study treatment and up through 30 days after the last dose of study treatment.
    measure
    Number of Participants With Adverse Events
    time Frame
    Up to 36 months
  3. description
    Laboratory data was summarized by the worst post-baseline grade, by NCI CTCAE v5.0 or higher for each parameter.
    measure
    Number of Participants With Laboratory Abnormalities
    time Frame
    Up to 36 months
secondary Outcomes
  1. description
    Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.
    measure
    Duration of Response (DOR) Per BICR According to Modified Lugano Response Criteria
    time Frame
    Up to 17.1 months
  2. description
    PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.
    measure
    Progression-free Survival (PFS) Per BICR According to Modified Lugano Response Criteria
    time Frame
    up to 18.3 months
  3. description
    OS is defined as the time from date of enrollment to date of death due to any cause.
    measure
    Overall Survival (OS)
    time Frame
    Up to 35.8 months
  4. description
    CR rate is defined as the percentage of participants with CR according to the modified Lugano Criteria for Response Assessment (Cheson 2014)
    measure
    Rate of Complete Response (CR) Per BICR According to Modified Lugano Response Criteria
    time Frame
    Up to 18.3 months
  5. description
    Objective Response Rate (ORR) is defined as the percentage of participants with CR or PR according to the modified Lugano Criteria for Response Assessment (Cheson 2014) based on investigator assessment
    measure
    ORR Per Investigator Assessment According to Modified Lugano Response Criteria
    time Frame
    Up to 18.3 months
  6. description
    Duration of response is defined as the time from start of the first documentation of objective tumor response (CR or PR), according to the Modified Lugano Criteria for Response Assessment (Cheson 2007), to the first documentation of objective tumor progression or to death due to any cause, whichever comes first.
    measure
    DOR Per Investigator Assessment According to Modified Lugano Response Criteria
    time Frame
    Up to 17.1 months
  7. description
    PFS is defined as the time from start of study treatment to first documentation of objective tumor progression according to the Modified Lugano Criteria for Response Assessment (Cheson 2007) or to death due to any cause, whichever comes first.
    measure
    Progression-free Survival Per Investigator Assessment According to Modified Lugano Response Criteria
    time Frame
    Up to 18.3 months
  8. description
    CR rate is defined as the percentage of participants with CR according to the Modified Lugano Criteria for Response Assessment (Cheson 2014).
    measure
    Rate of Complete Response Per Investigator Assessment According to Modified Lugano Response Criteria
    time Frame
    Up to 18.3 months
  9. description
    ORR is defined as the percentage of participants with CR or PR, assessed according to Lugano Criteria for Response Assessment (Cheson 2014)
    measure
    ORR Per BICR According to Lugano Response Criteria
    time Frame
    Up to 18.3 months
Full study description
brief Summary
This study will look at whether brentuximab vedotin works and is safe in the re-treatment setting. To be in this study, patients must have already received brentuximab vedotin as treatment and have cancer that progressed (got worse) after stopping treatment.
detailed Description
This is a study to determine the safety and efficacy of brentuximab vedotin in subjects with classic Hodgkin lymphoma (cHL) and systemic anaplastic large cell lymphoma (sALCL) or other CD30-expressing peripheral T cell lymphoma (PTCL) who experienced complete response (CR) or partial response (PR) with a brentuximab vedotin-containing regimen and subsequently experienced disease progression or relapse.
Source references
Source notices and limitations
    Discovery and provenance
    1. release id
      ctgov-registry-1336d216cbd1bbff780dac70
      edge id
      nct-edge-e42e9f7d4053e275d024
      requested nct id
      NCT03947255
      primary nct id
      NCT03947255
      source kind
      ctgov_condition_query
      source record id
      Source null
      source file sha256
      e270600534699a676fe83226e7a7b0f73aeb00c1d0a05cfc115c748864ad8173
      payload sha256
      9409567e6c461255a9c358a92ea6b4c7dbc8968813d4d03fe2ef90304ec4028f
      payload
      clinical indication matching status
      condition_index_match_asserted_by_registry_not_reviewed
      end exclusive
      true
      id
      nct-edge-e42e9f7d4053e275d024
      link basis
      returned_by_explicit_condition_and_posted_results_filter_query
      nct id
      NCT03947255
      occurrences
      1. context exact
        NCT03947255
        end
        11
        exact text
        NCT03947255
        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/112/protocolSection/identificationModule/nctId
      source kind
      ctgov_condition_query
      source record id
      Source null
      source string basis
      parsed_JSON_string_unmodified
      source string sha256
      04a4fe54797f7ec9ad6c9cd5d5e3ce46de12d3890eaef346bd74a888adec6dd9

    Preserved source evidence · Not medical advice