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A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma

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ClinicalTrials.gov Identifier: NCT00848926
Recruitment Status : Completed
First Posted : February 20, 2009
Results First Posted : October 26, 2011
Last Update Posted : March 13, 2017
Sponsor:
Collaborator:
Millennium Pharmaceuticals, Inc.
Information provided by (Responsible Party):
Seagen Inc.

Study Description
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Brief Summary:
This is a single-arm, open-label, multicenter, pivotal clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory Hodgkin lymphoma.

Condition or disease Intervention/treatment Phase
Disease, Hodgkin Drug: brentuximab vedotin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
Study Start Date : February 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : May 2015

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Brentuximab vedotin Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by intravenous infusion
Other Names:
  • SGN-35
  • ADCETRIS


Outcome Measures
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Primary Outcome Measures :
  1. Objective Response Rate by Independent Review Group [ Time Frame: up to 12 months ]
    Percentage of participants 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.


Secondary Outcome Measures :
  1. Complete Remission Rate by Independent Review Group [ Time Frame: up to 12 months ]
    Percentage of participants who achieved a best response of CR (disappearance of all evidence of disease) per Cheson 2007 Revised Response Criteria for Malignant Lymphoma.

  2. Duration of Objective Response by Kaplan-Meier Analysis [ Time Frame: up to approximately 4 years ]
    Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.

  3. Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis [ Time Frame: up to approximately 4 years ]
    Duration of response from start of first objective tumor response (CR or PR) by independent review group to disease progression or death due to any cause in participants with CR.

  4. Progression-free Survival by Kaplan-Meier Analysis [ Time Frame: up to approximately 4 years ]
    Time from start of study treatment to disease progression per independent review group or death due to any cause.

  5. Overall Survival [ Time Frame: up to approximately 6 years ]
    Time from start of study treatment to date of death due to any cause.

  6. Adverse Events by Severity, Seriousness, and Relationship to Treatment [ Time Frame: up to 12 months ]
    Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose). Serious adverse events are reported from the time of informed consent. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE version 3.0) were used to assess severity (1=mild, 2=moderate, 3=severe, 4=life threatening/disabling, 5=death). 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.

  7. Hematology Laboratory Abnormalities >/= Grade 3 [ Time Frame: up to 12 months ]
    Counts of study participants with post-baseline hematology laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

  8. Chemistry Laboratory Abnormalities >/= Grade 3 [ Time Frame: up to 12 months ]
    Counts of study participants with post-baseline chemistry laboratory abnormalities of Grade 3 or greater per NCI CTCAE version 3.0. Participants with multiple occurrences of a laboratory abnormality within a category are counted once in that category.

  9. Area Under the Curve [ Time Frame: 3 weeks ]
    Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin

  10. Maximum Serum Concentration [ Time Frame: 3 weeks ]
    Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin

  11. Time of Maximum Serum Concentration [ Time Frame: 3 weeks ]
    Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin


Other Outcome Measures:
  1. B Symptom Resolution [ Time Frame: up to 12 months ]
    Percentage of participants with lymphoma-related symptoms (B symptoms: fever, night sweats, or weight loss >10%) at baseline who achieved resolution of all B symptoms at any time during the treatment period.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with relapsed or refractory Hodgkin lymphoma who have previously received autologous stem cell transplant.
  • Histologically confirmed CD30-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD30 expression via slides or tumor block.
  • Fluorodeoxyglucose-avid disease by positron emission tomography and measurable disease of at least 1.5 cm as documented by spiral computed tomography.
  • At US sites patients greater than or equal to 12 years of age may be enrolled. At non-US sites patients must be greater than or equal to 18 years of age.

Exclusion Criteria:

  • Previous treatment with brentuximab vedotin.
  • Previously received an allogeneic transplant.
  • Congestive heart failure, Class III or IV, by the New York Heart Association criteria.
  • History of another primary malignancy that has not been in remission for at least 3 years.
  • Known cerebral/meningeal disease.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00848926


Locations
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Sponsors and Collaborators
Seagen Inc.
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Abraham Fong, MD, PhD Seagen Inc.
More Information
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Publications of Results:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Seagen Inc.
ClinicalTrials.gov Identifier: NCT00848926    
Other Study ID Numbers: SG035-0003
2008-006034-10 ( EudraCT Number )
First Posted: February 20, 2009    Key Record Dates
Results First Posted: October 26, 2011
Last Update Posted: March 13, 2017
Last Verified: June 2015
Keywords provided by Seagen Inc.:
Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Disease, Hodgkin
Hematologic Diseases
 Lymphoma
monomethylauristatin E
Drug Therapy
Immunotherapy
Additional relevant MeSH terms:
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Lymphoma
Hodgkin Disease
Neoplasms by Histologic Type
Neoplasms
 Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases