A Pivotal Open-Label Trial of Brentuximab Vedotin for Hodgkin Lymphoma
- Registration Number
- NCT00848926
- Lead Sponsor
- Seagen Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 102
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brentuximab vedotin brentuximab vedotin -
- Primary Outcome Measures
Name Time Method Objective Response Rate by Independent Review Group 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
Name Time Method Duration of Objective Response by Kaplan-Meier Analysis 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.
Duration of Objective Response in Participants With Complete Remission by Kaplan-Meier Analysis 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.
Overall Survival up to approximately 6 years Time from start of study treatment to date of death due to any cause.
Progression-free Survival by Kaplan-Meier Analysis up to approximately 4 years Time from start of study treatment to disease progression per independent review group or death due to any cause.
Hematology Laboratory Abnormalities >/= Grade 3 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.
Time of Maximum Serum Concentration 3 weeks Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Complete Remission Rate by Independent Review Group 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.
Adverse Events by Severity, Seriousness, and Relationship to Treatment 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.
Chemistry Laboratory Abnormalities >/= Grade 3 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.
Area Under the Curve 3 weeks Area under the serum concentration-time curve from time 0 to 21 days following the first dose of brentuximab vedotin
Maximum Serum Concentration 3 weeks Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Trial Locations
- Locations (27)
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
City of Hope National Medical Center
🇺🇸Duarte, California, United States
University of California at Los Angeles
🇺🇸Los Angeles, California, United States
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Rocky Mountain Cancer Center
🇺🇸Denver, Colorado, United States
Georgetown University
🇺🇸Washington, District of Columbia, United States
University of Miami
🇺🇸Miami, Florida, United States
Loyola University Medical Center Cardinal Bernardin Cancer Center
🇺🇸Maywood, Illinois, United States
Karmanos Cancer Institute
🇺🇸Detroit, Michigan, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
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