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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Seattle Genetics, Inc.
ClinicalTrials.gov Identifier:
NCT01421667
First received: August 19, 2011
Last updated: October 14, 2016
Last verified: June 2015

August 19, 2011
October 14, 2016
August 2011
June 2015   (final data collection date for primary outcome measure)
  • Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Monotherapy [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
    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.
  • Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Plus Rituximab [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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.
Objective response rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01421667 on ClinicalTrials.gov Archive Site
  • Objective Response Rate (ORR) by Investigator With Brentuximab Vedotin Plus Rituximab [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
    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.
  • Complete Remission (CR) Rate by Investigator [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
    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.
  • Duration of Objective Response With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
    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.
  • Duration of Complete Remission With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
    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.
  • Progression-Free Survival With Brentuximab Vedotin Monotherapy by Kaplan-Meier Analysis [ Time Frame: Up to approximately 3 years ] [ Designated as safety issue: No ]
    Progression-free survival, defined as time from start of study treatment to disease progression per investigator or death due to any cause
  • Correlation Between Antitumor Activity of Brentuximab Vedotin Monotherapy and CD30 Expression [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    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).
  • Adverse Events by Severity, Seriousness, and Relationship to Treatment With Brentuximab Vedotin Monotherapy [ Time Frame: Up to 3 years ] [ Designated as safety issue: Yes ]
    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.
  • Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Concentration at End of Infusion (Ceoi) (Cycle 1) [ Time Frame: 1 day ] [ Designated as safety issue: No ]
    End of infusion concentration of ADC following the first dose of brentuximab vedotin
  • Brentuximab Vedotin Antibody-Drug Conjugate (ADC) Trough Concentration (Ctrough) (Cycle 1) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Trough concentration of ADC from 0 to 21 days following the first dose of brentuximab vedotin
  • Maximum Concentration (Cmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) (Cycle 1) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin
  • Time to Maximum Concentration (Tmax) of Brentuximab Vedotin Monomethyl Auristatin E (MMAE) [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]
    Time of maximum serum concentration of MMAE from 0 to 21 days following the first dose of brentuximab vedotin
  • Baseline Soluble CD30 Expression [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Serum concentration of soluble CD30 before first dose of brentuximab vedotin
  • Complete remission (CR) rate [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Incidence of laboratory abnormalities [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: Yes ]
  • Correlation between CD30 expression and antitumor activity [ Time Frame: Through 1 month following last dose ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]
  • Progression-free survival [ Time Frame: Until disease progression or study closure ] [ Designated as safety issue: No ]
  • Area under the plasma concentration versus time curve (AUC) [ Time Frame: Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Peak plasma concentration (Cmax) [ Time Frame: Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Plasma concentration at end of infusion (Ceoi) [ Time Frame: Cycle 1: pre-dose, end of infusion and 24, 48, 168, and 336 hours post-dose. Cycles 2 and later: pre-dose and end of infusion ] [ Designated as safety issue: No ]
  • Pharmacodynamic (PD) biomarkers [ Time Frame: Pre-dose at each cycle ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
A Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma
A Phase 2 Study of Brentuximab Vedotin in Relapsed or Refractory Non-Hodgkin Lymphoma (NHL)
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).
Not Provided
Interventional
Phase 2
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Lymphoma, B-Cell
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, Non-Hodgkin
  • Lymphoma, T-Cell
  • Drug: brentuximab vedotin
    1.8 mg/kg every 3 weeks by IV infusion
    Other Name: Adcetris; SGN-35
  • Drug: rituximab
    375 mg/m2 every 3 weeks by IV infusion
  • Experimental: Brentuximab vedotin+rituximab
    Interventions:
    • Drug: brentuximab vedotin
    • Drug: rituximab
  • Experimental: Brentuximab vedotin
    Intervention: Drug: brentuximab vedotin

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
176
June 2015
June 2015   (final data collection date for primary outcome measure)

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
Both
6 Years and older   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT01421667
SGN35-012
No
Not Provided
Not Provided
Seattle Genetics, Inc.
Seattle Genetics, Inc.
Not Provided
Study Director: Corinna Palanca-Wessels, MD, PhD Seattle Genetics, Inc.
Seattle Genetics, Inc.
June 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP