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NCT01716806 · REGISTRY CONDITION SEARCH

A Study of Brentuximab Vedotin With Hodgkin Lymphoma (HL) and CD30-expressing Peripheral T-cell Lymphoma (PTCL)

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
COMPLETED
Registry last update
2024-06-11

This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.

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) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)

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outcome · POSTED

ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)

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outcome · POSTED

ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F)

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outcome · POSTED

Number of Participants With Adverse Events

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outcome · POSTED

Number of Participants With Laboratory Abnormalities

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outcome · POSTED

Complete Response Rate

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outcome · POSTED

Duration of Complete Response

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outcome · POSTED

Duration of Objective Response

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outcome · POSTED

Progression-free Survival

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outcome · POSTED

Disease Control Rate

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outcome · POSTED

ORR According to Lugano Criteria Per BICR (Parts E and F)

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outcome · POSTED

B Symptom Resolution Rate

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outcome · POSTED

Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)

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outcome · POSTED

Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only)

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outcome · POSTED

Overall Survival (Parts E and F Only)

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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: * Parts A, B, C, and D: 60 years of age or older * Treatment-naive patients with histopathological diagnosis of classical Hodgkin lymphoma (Parts A, B, C, D, and E) * Treatment-naive patients with CD30-expressing PTCL (Part F) * Ineligible for or have declined initial conventional combination chemotherapy for HL (Parts A, B, C, and D) * Unsuitable or unfit for initial conventional combination chemotherapy for HL (Part E) or CD30-expressing PTCL due to the presence of comorbidity-factors, as documented by: * A CIRS score of 10 or greater * Requiring assistance with or dependence on other for any instrumental activities of daily living (IADLs) * Measurable disease of at least 1.5 cm as documented by radiographic technique * Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3 (Parts, A, B, C, E, and F) or less than or equal to 2 (Part D) Exclusion Criteria: * Symptomatic neurologic disease compromising IADLs or requiring medication * History of progressive multifocal leukoencephalopathy * Grade 3 or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of brentuximab vedotin * Concurrent use of other investigational agents * Chemotherapy, radiotherapy, biologics, and/or other treatment with immunotherapy not completed 4 weeks prior to first dose of study drug * History of another malignancy within 1 year before first dose of study drug (Parts E and F only) * Part D only: * Received any prior immune-oncology therapy * History of known or suspected autoimmune disease * Prior allogeneic stem cell transplant * History of cerebral vascular event within 6 months of first dose of study drug * Active interstitial lung disease that is symptomatic or may interfere with the detection or management of suspected drug-related pulmonary toxicology * Known history of pancreatitis * Parts D, E, and F only: * Known cerebral/meningeal disease related to the underlying malignancy * Systemic treatment with corticosteroids or other immunosuppressive medications within 1 week of enrollment
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
    Part A: Brentuximab Vedotin in HL Patients
    type
    EXPERIMENTAL
  2. intervention Names
    1. Drug: brentuximab vedotin
    2. Drug: dacarbazine
    label
    Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
    type
    EXPERIMENTAL
  3. intervention Names
    1. Drug: brentuximab vedotin
    2. Drug: bendamustine
    label
    Part C: Brentuximab Vedotin + Bendamustine in HL Patients
    type
    EXPERIMENTAL
  4. intervention Names
    1. Drug: brentuximab vedotin
    2. Drug: nivolumab
    label
    Part D: Brentuximab Vedotin + Nivolumab in HL Patients
    type
    EXPERIMENTAL
  5. intervention Names
    1. Drug: brentuximab vedotin
    label
    Part E: Brentuximab Vedotin in HL Patients
    type
    EXPERIMENTAL
  6. intervention Names
    1. Drug: brentuximab vedotin
    label
    Part F: Brentuximab Vedotin in PTCL Patients
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. Part A: Brentuximab Vedotin in HL Patients
    2. Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
    3. Part C: Brentuximab Vedotin + Bendamustine in HL Patients
    4. Part D: Brentuximab Vedotin + Nivolumab in HL Patients
    5. Part E: Brentuximab Vedotin in HL Patients
    6. Part F: Brentuximab Vedotin in PTCL Patients
    description
    1.8 mg/kg every 3 weeks by IV infusion
    name
    brentuximab vedotin
    other Names
    1. Adcetris; SGN-35
    type
    DRUG
  2. arm Group Labels
    1. Part C: Brentuximab Vedotin + Bendamustine in HL Patients
    description
    70 mg/m\^2 by IV infusion on Days 1 and 2 of 3-week cycle
    name
    bendamustine
    type
    DRUG
  3. arm Group Labels
    1. Part B: Brentuximab Vedotin + Dacarbazine in HL Patients
    description
    375 mg/m\^2 every 3 weeks by IV infusion
    name
    dacarbazine
    type
    DRUG
  4. arm Group Labels
    1. Part D: Brentuximab Vedotin + Nivolumab in HL Patients
    description
    3 mg/kg every 3 weeks by IV infusion
    name
    nivolumab
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
PARALLEL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
131
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    Objective response rate (ORR) per investigator was defined as the percentage of subjects with complete response (CR) or partial response (PR) through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts A, B, and C the response was assessed using the Revised Response Criteria for Malignant Lymphoma (Cheson 2007).
    measure
    Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)
    time Frame
    Up to 81 months
  2. description
    Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Part D, the response was assessed using the Lugano Classification Revised Staging System for nodal non-Hodgkin and cHL (Lugano criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC).
    measure
    ORR According to the Lugano Classification Revised Staging System for Nodal Non-Hodgkin and Hodgkin Lymphomas (Lugano Criteria) and the Lymphoma Response to Immunomodulatory Therapy Criteria (LYRIC) (Part D)
    time Frame
    Up to 60 months
  3. description
    Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment. For Parts E and F, the response was assessed per blinded independent central review (BICR) using the modified Lugano criteria.
    measure
    ORR According to Modified Lugano Criteria Per Blinded Independent Central Review (BICR) (Parts E and F)
    time Frame
    Up to 31 months
secondary Outcomes
  1. description
    A treatment-emergent AE (TEAE) is defined as a newly occurring or worsening AE after the first dose of any study drug component. Treatment-related AEs are defined as treatment-emergent AEs that are determined by the investigator to be related to the treatment on study. TEAEs were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
    measure
    Number of Participants With Adverse Events
    time Frame
    Up to 122 months
  2. description
    Laboratory values were graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE version 4.03). The CTCAE displays Grades 1 through 5, where Grade 1: Mild, Grade 2: Moderate, Grade 3: Severe or medically significant but not immediately life-threatening, Grade 4: Life-threatening consequences, Grade 5: Death related to AE.
    measure
    Number of Participants With Laboratory Abnormalities
    time Frame
    Up to 30 months
  3. description
    Complete response rate is defined as the percentage of patients with CR
    measure
    Complete Response Rate
    time Frame
    Up to 81 months
  4. description
    Duration of CR per investigator was defined as the time from start of the first documentation of CR to the first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
    measure
    Duration of Complete Response
    time Frame
    Up to 81 months
  5. description
    Duration of response per investigator was defined as the time from start of the first documentation of objective tumor response (CR or PR) to the first documentation of tumor progression (PD) based on radiographic evidence of progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
    measure
    Duration of Objective Response
    time Frame
    Up to 81 months
  6. description
    Progression-free survival (PFS) per investigator was defined as the time from start of study treatment to first documentation of tumor progression or to death due to any cause, whichever came first. For Parts E and F, the assessment was per BICR.
    measure
    Progression-free Survival
    time Frame
    Up to 83 months
  7. description
    Disease control rate (DCR) per investigator was defined as the percentage of subjects with CR, PR, or SD, per investigator assessment of best clinical response per Cheson 2007. For Parts E and F, the assessment was per BICR.
    measure
    Disease Control Rate
    time Frame
    Up to 81 months
  8. description
    Objective response rate (ORR) per investigator was defined as the percentage of subjects with CR or PR through the end of study or prior to the start of new anti-cancer treatment (including stem cell transplant, and excluding consolidative radiotherapy) other than the study treatment.
    measure
    ORR According to Lugano Criteria Per BICR (Parts E and F)
    time Frame
    Up to 31 months
  9. description
    B symptom resolution rate per investigator was defined as the percentage of subjects with lymphoma-related B symptoms at baseline who achieved resolution of all B symptoms at any time during the treatment period.
    measure
    B Symptom Resolution Rate
    time Frame
    Up to 42 weeks
  10. measure
    Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)
    time Frame
    Up to 30 months
  11. measure
    Number of Participants With Nivolumab Antitherapeutic Antibodies (ATA) (Part D Only)
    time Frame
    Up to 30 months
  12. description
    Overall survival (OS) per investigator was defined as the time from date of enrollment to date of death due to any cause.
    measure
    Overall Survival (Parts E and F Only)
    time Frame
    Up to 44 months
Full study description
brief Summary
This trial will study brentuximab vedotin to find out whether it is an effective treatment for Hodgkin lymphoma (HL) and peripheral T-cell lymphoma (PTCL). Participants in this study will be older or will have other conditions that make them unable to have standard chemotherapy treatment. The study will look at brentuximab vedotin alone and combined with other drugs.
detailed Description
This study is designed to evaluate the efficacy and tolerability of brentuximab vedotin as monotherapy and in combination with other agents as frontline therapy. There are 6 parts of the study. The population to be studied includes treatment-naïve patients with classical Hodgkin lymphoma (HL) or treatment-naïve patients with CD30-expressing peripheral T-cell lymphoma (PTCL).
Source references
references
  1. citation
    Friedberg JW, Bordoni R, Patel-Donnelly D, Larson T, Goldschmidt J, Boccia R, Cline VJM, Mamidipalli A, Liu J, Akyol A, Yasenchak CA. Brentuximab vedotin with dacarbazine or nivolumab as frontline cHL therapy for older patients ineligible for chemotherapy. Blood. 2024 Feb 29;143(9):786-795. doi: 10.1182/blood.2022019536.
    pmid
    37946283
    type
    DERIVED
  2. citation
    Friedberg JW, Forero-Torres A, Bordoni RE, Cline VJM, Patel Donnelly D, Flynn PJ, Olsen G, Chen R, Fong A, Wang Y, Yasenchak CA. Frontline brentuximab vedotin in combination with dacarbazine or bendamustine in patients aged >/=60 years with HL. Blood. 2017 Dec 28;130(26):2829-2837. doi: 10.1182/blood-2017-06-787200. Epub 2017 Oct 16.
    pmid
    29038340
    type
    DERIVED
  3. citation
    Forero-Torres A, Holkova B, Goldschmidt J, Chen R, Olsen G, Boccia RV, Bordoni RE, Friedberg JW, Sharman JP, Palanca-Wessels MC, Wang Y, Yasenchak CA. Phase 2 study of frontline brentuximab vedotin monotherapy in Hodgkin lymphoma patients aged 60 years and older. Blood. 2015 Dec 24;126(26):2798-804. doi: 10.1182/blood-2015-06-644336. Epub 2015 Sep 16.
    pmid
    26377597
    type
    DERIVED
  4. citation
    Gopal AK, Bartlett NL, Forero-Torres A, Younes A, Chen R, Friedberg JW, Matous JV, Shustov AR, Smith SE, Zain J, O'Meara MM, Fanale MA. Brentuximab vedotin in patients aged 60 years or older with relapsed or refractory CD30-positive lymphomas: a retrospective evaluation of safety and efficacy. Leuk Lymphoma. 2014 Oct;55(10):2328-34. doi: 10.3109/10428194.2013.876496. Epub 2014 Feb 24.
    pmid
    24359243
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice