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Trial record 1 of 1 for:    NCT00866047
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A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma

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ClinicalTrials.gov Identifier: NCT00866047
Recruitment Status : Completed
First Posted : March 20, 2009
Results First Posted : October 26, 2011
Last Update Posted : March 22, 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, clinical trial to evaluate the efficacy and safety of brentuximab vedotin (SGN-35) as a single agent in patients with relapsed or refractory ALCL.

Condition or disease Intervention/treatment Phase
Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin Drug: brentuximab vedotin Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2 Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Systemic Anaplastic Large Cell Lymphoma (ALCL)
Study Start Date : March 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Brentuximab vedotin
Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
 Drug: brentuximab vedotin
1.8 mg/kg every 3 weeks by IV 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 3 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 3 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 3 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 7 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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Information from the National Library of Medicine

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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 systemic ALCL who have previously received front line chemotherapy.
  • Documented anaplastic lymphoma kinase (ALK) status.
  • 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 and measurable disease of at least 1.5 cm as documented by both positron emission tomography and spiral computed tomography.
  • Received any previous autologous stem cell transplant at least 12 weeks (3 months) prior.
  • 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.
  • Patients with current diagnosis of primary cutaneous ALCL (patients who have transformed to systemic ALCL are eligible).
  • 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): NCT00866047


Locations
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United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294-3300
United States, California
Stanford University Medical Center
Palo Alto, California, United States, 94304
United States, Colorado
Rocky Mountain Cancer Centers
Denver, Colorado, United States, 80218
United States, Florida
University of Miami Sylvester Comprehensive Cancer Center
Miami, Florida, United States, 33136
United States, Illinois
Northwestern University
Chicago, Illinois, United States, 60611
United States, Michigan
Karmanos Cancer Institute / Wayne State University
Detroit, Michigan, United States, 48201
United States, Minnesota
Mayo Clinic Rochester
Rochester, Minnesota, United States, 55905
United States, Missouri
Washington University School of Medicine
St. Louis, Missouri, United States, 63110
United States, New York
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10021
Weill Cornell Medical College
New York, New York, United States, 10021
United States, Ohio
Nationwide Children's Hospital
Columbus, Ohio, United States, 43205
United States, Oregon
Oregon Health & Science University
Portland, Oregon, United States, 97239
United States, Texas
Baylor Sammons Cancer Center / Texas Oncology
Dallas, Texas, United States, 75246
MD Anderson Cancer Center / University of Texas
Houston, Texas, United States, 77030-4003
United States, Washington
University of Washington
Seattle, Washington, United States, 98109
Belgium
UZ Gasthuisberg
Leuven, Belgium, 3000
Canada, British Columbia
B.C Cancer Agency
Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
France
Institut Paoli Calmettes
Marseille, France, 13273
Hospital Saint Louis
Paris, France, 75475
Centre Henri Becquerel
Rouen, France, 76038
United Kingdom
Christie Hospital NHS
Manchester, United Kingdom, M20 4BX
Sponsors and Collaborators
Seagen Inc.
Millennium Pharmaceuticals, Inc.
Investigators
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Study Director: Dana Kennedy, PharmD Seagen Inc.
More Information
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Additional Information:

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: NCT00866047    
Other Study ID Numbers: SG035-0004
2008-006035-12 ( EudraCT Number )
First Posted: March 20, 2009    Key Record Dates
Results First Posted: October 26, 2011
Last Update Posted: March 22, 2017
Last Verified: December 2016
Keywords provided by Seagen Inc.:
Antigens, CD30
Antibody-Drug Conjugate
Antibodies, Monoclonal
Lymphoma, Non-Hodgkin
Lymphoma, Large-Cell, Anaplastic
 monomethyl auristatin E
Drug Therapy
Immunotherapy
Hematologic Diseases
Lymphoma
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, Large-Cell, Anaplastic
Lymphoma, Non-Hodgkin
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
 Immunoproliferative Disorders
Immune System Diseases
Lymphoma, T-Cell
Brentuximab Vedotin
Antineoplastic Agents, Immunological
Antineoplastic Agents