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

Primary Purpose

Disease, Hodgkin

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
brentuximab vedotin
Sponsored by
Seagen Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Disease, Hodgkin focused on measuring Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Disease, Hodgkin, Hematologic Diseases, Lymphoma, monomethylauristatin E, Drug Therapy, Immunotherapy

Eligibility Criteria

12 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • City of Hope National Medical Center
  • University of California at Los Angeles
  • Stanford University Medical Center
  • Rocky Mountain Cancer Center
  • Georgetown University
  • University of Miami
  • Loyola University Medical Center Cardinal Bernardin Cancer Center
  • Karmanos Cancer Institute
  • Mayo Clinic Rochester
  • Washington University School of Medicine
  • Weill Cornell Medical College
  • Memorial Sloan Kettering Cancer Center
  • University of Rochester Medical Center
  • Ohio State University
  • Oregon Health & Science University
  • Baylor Sammons Cancer Center
  • University of Texas MD Anderson Cancer Center
  • University of Washington
  • UZ Gasthuisberg
  • Cliniques Universitaires UCL de Mont-Goddine
  • B.C Cancer Agency
  • Princess Margaret Hospital
  • Institut Paoli Calmettes
  • Hospital Saint Louis
  • Centre Henri Becquerel
  • Instituto di Ematologia ed Oncologia Medica

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Brentuximab vedotin

Arm Description

Outcomes

Primary Outcome Measures

Objective Response Rate by Independent Review Group
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

Complete Remission Rate by Independent Review Group
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.
Duration of Objective Response by Kaplan-Meier Analysis
Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.
Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
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.
Progression-free Survival by Kaplan-Meier Analysis
Time from start of study treatment to disease progression per independent review group or death due to any cause.
Overall Survival
Time from start of study treatment to date of death due to any cause.
Adverse Events by Severity, Seriousness, and Relationship to Treatment
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.
Hematology Laboratory Abnormalities >/= Grade 3
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.
Chemistry Laboratory Abnormalities >/= Grade 3
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.
Area Under the Curve
Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin
Maximum Serum Concentration
Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Time of Maximum Serum Concentration
Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin

Full Information

First Posted
February 18, 2009
Last Updated
March 9, 2017
Sponsor
Seagen Inc.
Collaborators
Millennium Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00848926
Brief Title
A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
Official Title
A Pivotal Study of SGN-35 in Treatment of Patients With Relapsed or Refractory Hodgkin Lymphoma (HL)
Study Type
Interventional

2. Study Status

Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
August 2010 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Seagen Inc.
Collaborators
Millennium Pharmaceuticals, Inc.

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Disease, Hodgkin
Keywords
Antigens, CD30, Antibody-Drug Conjugate, Antibodies, Monoclonal, Disease, Hodgkin, Hematologic Diseases, Lymphoma, monomethylauristatin E, Drug Therapy, Immunotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
102 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Brentuximab vedotin
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
brentuximab vedotin
Other Intervention Name(s)
SGN-35, ADCETRIS
Intervention Description
1.8 mg/kg every 3 weeks by intravenous infusion
Primary Outcome Measure Information:
Title
Objective Response Rate by Independent Review Group
Description
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.
Time Frame
up to 12 months
Secondary Outcome Measure Information:
Title
Complete Remission Rate by Independent Review Group
Description
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.
Time Frame
up to 12 months
Title
Duration of Objective Response by Kaplan-Meier Analysis
Description
Duration of objective response (CR + PR) by independent review group, defined as time of initial response until disease progression or death.
Time Frame
up to approximately 4 years
Title
Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis
Description
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.
Time Frame
up to approximately 4 years
Title
Progression-free Survival by Kaplan-Meier Analysis
Description
Time from start of study treatment to disease progression per independent review group or death due to any cause.
Time Frame
up to approximately 4 years
Title
Overall Survival
Description
Time from start of study treatment to date of death due to any cause.
Time Frame
up to approximately 6 years
Title
Adverse Events by Severity, Seriousness, and Relationship to Treatment
Description
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.
Time Frame
up to 12 months
Title
Hematology Laboratory Abnormalities >/= Grade 3
Description
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.
Time Frame
up to 12 months
Title
Chemistry Laboratory Abnormalities >/= Grade 3
Description
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.
Time Frame
up to 12 months
Title
Area Under the Curve
Description
Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin
Time Frame
3 weeks
Title
Maximum Serum Concentration
Description
Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Time Frame
3 weeks
Title
Time of Maximum Serum Concentration
Description
Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Time Frame
3 weeks
Other Pre-specified Outcome Measures:
Title
B Symptom Resolution
Description
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.
Time Frame
up to 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Abraham Fong, MD, PhD
Organizational Affiliation
Seagen Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-3300
Country
United States
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010-3000
Country
United States
Facility Name
University of California at Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University Medical Center
City
Palo Alto
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Rocky Mountain Cancer Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80218
Country
United States
Facility Name
Georgetown University
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Loyola University Medical Center Cardinal Bernardin Cancer Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Karmanos Cancer Institute
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Mayo Clinic Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Washington University School of Medicine
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Baylor Sammons Cancer Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75246
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
UZ Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cliniques Universitaires UCL de Mont-Goddine
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Facility Name
B.C Cancer Agency
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 4E6
Country
Canada
Facility Name
Princess Margaret Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
Institut Paoli Calmettes
City
Marseille
ZIP/Postal Code
13273
Country
France
Facility Name
Hospital Saint Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Instituto di Ematologia ed Oncologia Medica
City
Bologna
ZIP/Postal Code
40138
Country
Italy

12. IPD Sharing Statement

Citations:
PubMed Identifier
22454421
Citation
Younes A, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Ramchandren R, Bartlett NL, Cheson BD, de Vos S, Forero-Torres A, Moskowitz CH, Connors JM, Engert A, Larsen EK, Kennedy DA, Sievers EL, Chen R. Results of a pivotal phase II study of brentuximab vedotin for patients with relapsed or refractory Hodgkin's lymphoma. J Clin Oncol. 2012 Jun 20;30(18):2183-9. doi: 10.1200/JCO.2011.38.0410. Epub 2012 Mar 26.
Results Reference
result
PubMed Identifier
27432875
Citation
Chen R, Gopal AK, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Huebner D, Fong A, Younes A. Five-year survival and durability results of brentuximab vedotin in patients with relapsed or refractory Hodgkin lymphoma. Blood. 2016 Sep 22;128(12):1562-6. doi: 10.1182/blood-2016-02-699850. Epub 2016 Jul 18.
Results Reference
derived
PubMed Identifier
25533035
Citation
Gopal AK, Chen R, Smith SE, Ansell SM, Rosenblatt JD, Savage KJ, Connors JM, Engert A, Larsen EK, Chi X, Sievers EL, Younes A. Durable remissions in a pivotal phase 2 study of brentuximab vedotin in relapsed or refractory Hodgkin lymphoma. Blood. 2015 Feb 19;125(8):1236-43. doi: 10.1182/blood-2014-08-595801. Epub 2014 Dec 22.
Results Reference
derived

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

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