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NCT Number: NCT01421667

A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma

This is an open-label, multicenter, phase 2 clinical trial to evaluate the efficacy and safety of brentuximab vedotin as a single agent in patients with CD30-positive non-Hodgkin lymphoma (NHL) (Part A). The study will also evaluate the safety and efficacy of brentuximab vedotin in combination with rituximab in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) (Part B) as well as further evaluate correlation of CD30 expression and response in DLBCL (Part C).

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Key information

Conditions

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

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

British Columbia Cancer Agency - Vancouver Centre, Vancouver, British Columbia, Canada

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Histologically-confirmed NHL (DLBCL only for Parts B and C)
  • Relapsed or refractory disease following at least 1 prior systemic therapy
  • Measurable disease of at least 1.5 cm as documented by CT
  • Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2

Exclusion criteria

  • History of another primary invasive malignancy that has not been in remission for at least 3 years
  • Current diagnosis of systemic or cutaneous anaplastic large cell lymphoma or mycosis fungoides
  • B cell lymphoma previously treated with only single-agent rituximab (for patients receiving brentuximab vedotin only) or corticosteroids as monotherapy
  • Known cerebral/meningeal disease

Treatment and study plan

Brentuximab Vedotin

Drug

1.8 mg/kg every 3 weeks by IV infusion

Other names: Adcetris; SGN-35

Rituximab

Drug

375 mg/m2 every 3 weeks by IV infusion

Primary outcomes

  1. Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy

    Time frame: Up to approximately 3 years

    Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

  2. Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab

    Time frame: Up to 3 years

    Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.

Secondary outcomes

  1. Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab

    Time frame: Up to approximately 3 years

    Percentage of participants treated with brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) or partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

  2. Complete Remission (CR) Rate by Investigator

    Time frame: Up to approximately 3 years

    Percentage of participants treated with brentuximab vedotin monotherapy or brentuximab vedotin plus rituximab who achieved a best response of complete remission (CR, disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

  3. Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis

    Time frame: Up to approximately 3 years

    Duration of complete remission (CR) or partial remission (PR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

  4. Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis

    Time frame: Up to approximately 3 years

    Duration of complete remission (CR), defined as time of initial response until disease progression or death. Response criteria per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

  5. Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis

    Time frame: Up to approximately 3 years

    Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause

  6. Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression

    Time frame: Up to 3 years

    Percentage of participants treated with brentuximab vedotin monotherapy who achieved a best response of complete remission (CR, disappearance of all evidence of disease), partial remission (PR, regression of greater than or equal to 50% of measurable disease and no new sites), or stable disease (SD, no new sites and no change in size of previous lesions) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma. Patients are grouped by CD30-positivity or CD30u (undetectable CD30).

  7. Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy

    Time frame: Up to 3 years

    Counts of participants who had treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on Study SGN35-012). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 4.03) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life-threatening/disabling, 5=fatal). Relatedness to study drug was assessed by the investigator (Yes/No). Participants with multiple occurrences of an adverse event within a category are counted once within the category.

  8. Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1)

    Time frame: 1 day

    End of infusion concentration of ADC following the first dose of brentuximab vedotin

  9. Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1)

    Time frame: 3 weeks

    Trough concentration of ADC from 0 to 21 days following the first dose of brentuximab vedotin

  10. Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1)

    Time frame: 3 weeks

    Maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin

  11. Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE)

    Time frame: 3 weeks

    Time of maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin

  12. Baseline Soluble CD30 Expression

    Time frame: Baseline

    Serum concentration of soluble CD30 before first dose of brentuximab vedotin

Sponsors and collaborators

Lead sponsor

Seagen Inc.

Industry

Registry information

Official study title

A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)

Important dates

Study start
2011
Primary completion
2015
Study completion
2015
First posted
Aug 23, 2011
Registry last updated
Nov 28, 2016

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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