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NCT Number: NCT01716806

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

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.

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Key information

Conditions

Hodgkin Disease Hematologic Diseases Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoma, Non-Hodgkin Lymphoma, T-Cell Lymphoma, T-Cell, Peripheral Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Peripheral T Cell Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

University of Alberta / Cross Cancer Institute, Edmonton, Alberta, Canada

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About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Brentuximab Vedotin

Drug

1.8 mg/kg every 3 weeks by IV infusion

Other names: Adcetris; SGN-35

Bendamustine

Drug

70 mg/m^2 by IV infusion on Days 1 and 2 of 3-week cycle

Dacarbazine

Drug

375 mg/m^2 every 3 weeks by IV infusion

Nivolumab

Drug

3 mg/kg every 3 weeks by IV infusion

Primary outcomes

  1. Objective Response Rate (ORR) According to the Revised Response Criteria for Malignant Lymphoma (Parts A, B, and C)

    Time frame: Up to 81 months

    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).

  2. 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

    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).

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

    Time frame: Up to 31 months

    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.

Secondary outcomes

  1. Number of Participants With Adverse Events

    Time frame: Up to 122 months

    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.

  2. Number of Participants With Laboratory Abnormalities

    Time frame: Up to 30 months

    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.

  3. Complete Response Rate

    Time frame: Up to 81 months

    Complete response rate is defined as the percentage of patients with CR

  4. Duration of Complete Response

    Time frame: Up to 81 months

    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.

  5. Duration of Objective Response

    Time frame: Up to 81 months

    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.

  6. Progression-free Survival

    Time frame: Up to 83 months

    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.

  7. Disease Control Rate

    Time frame: Up to 81 months

    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.

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

    Time frame: Up to 31 months

    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.

  9. B Symptom Resolution Rate

    Time frame: Up to 42 weeks

    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.

  10. Number of Participants With Brentuximab Vedotin Antitherapeutic Antibodies (ATA)

    Time frame: Up to 30 months

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

    Time frame: Up to 30 months

  12. Overall Survival (Parts E and F Only)

    Time frame: Up to 44 months

    Overall survival (OS) per investigator was defined as the time from date of enrollment to date of death due to any cause.

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Collaborators

  • Bristol-Myers Squibb

Registry information

Official study title

A Phase 2 Open-label Study of Brentuximab Vedotin in Front-line Therapy of Hodgkin Lymphoma (HL) an dCD30-expressing Peripheral T-cell Lymphoma (PTCL) in Older Patients or Patients With Significant Comorbidities Ineligible for Standard Chemotherapy

Important dates

Study start
2012
Primary completion
2023
Study completion
2023
First posted
Oct 30, 2012
Registry last updated
Jun 11, 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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