A Brentuximab Vedotin Trial for Patients Who Have Previously Participated in a Brentuximab Vedotin Study
- Conditions
- Disease, HodgkinLymphoma, Large-Cell, AnaplasticLymphoma, Non-Hodgkin
- Interventions
- Registration Number
- NCT00947856
- Lead Sponsor
- Seagen Inc.
- Brief Summary
This is a multicenter, open-label study to evaluate the safety and efficacy of treatment with brentuximab vedotin (SGN-35) in patients who have previously participated in an brentuximab vedotin study.
- Detailed Description
This is a multicenter, open-label study to evaluate single-agent brentuximab vedotin (SGN-35) treatment in patients who previously participated in a brentuximab vedotin study, including Studies SGN35-005 (NCT01100502), SGN35-007 (NCT01026233), and SGN35-008 (NCT01026415). Patients treated on this study (SGN35-006) could re-enroll on study if eligible. The study consisted of 2 arms, as follows:
* Retreatment arm: Patients with CD30-positive hematologic malignancies who experienced a complete remission (CR) or partial remission (PR) with previous brentuximab vedotin treatment on a clinical study and subsequently experienced disease progression or relapse. The purpose of this arm was to assess safety and efficacy of retreatment with brentuximab vedotin.
* Extension treatment arm: Patients with either CD30-positive hematologic or nonhematologic malignancies who completed treatment in a prior brentuximab vedotin study without unacceptable toxicity and experienced clinical benefit as assessed by the investigator. The purpose of this arm was to enable patients who participated in certain prior brentuximab vedotin trials to receive extension treatment and to assess patient safety and survival in the extension treatment setting.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 110
- Participated in a previous brentuximab vedotin study.
- CD30-positive hematologic malignancy.
- At a minimum, experienced clinical benefit in the prior brentuximab vedotin study. For retreatment, patients must have previously achieved either complete or partial remission with brentuximab vedotin and experienced disease progression after discontinuing the prior brentuximab vedotin study.
Withdrew consent to participate in any prior brentuximab vedotin study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BV Retreatment brentuximab vedotin Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (retreatment after relapse) BV Extension brentuximab vedotin Brentuximab vedotin 1.2 or 1.8 mg/kg every 3 weeks by IV infusion (continued treatment)
- Primary Outcome Measures
Name Time Method Objective Response Rate by Investigator Up to approximately 38 months Percentage of participants in the retreatment arm 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 up to 39 months Counts of participants who had adverse events or treatment-emergent adverse events (TEAE, defined as newly occurring or worsening after first dose on SGN35-006). 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.
Laboratory Abnormalities >/= Grade 3 Up to 39 months Counts of study participants with post-baseline 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.
- Secondary Outcome Measures
Name Time Method Duration of Objective Response by Kaplan-Meier Analysis Up to 38 months Duration of objective response (CR + PR) on retreatment, defined as time of initial response until disease progression or death
Progression-free Survival by Kaplan-Meier Analysis Up to approximately 29 months Progression-free survival, defined as time from start of study treatment in the retreatment arm to disease progression per investigator or death due to any cause
Overall Survival Up to approximately 41 months Overall survival for both extension and retreatment arms, defined as time from start of study treatment to date of death due to any cause
Incidence of Antitherapeutic Antibodies Up to 39 months Counts of participants with anti-brentuximab vedotin antibodies at any time during extension treatment on Study SGN35-006 or number of retreatment experiences with anti-brentuximab vedotin antibodies at any time during retreatment
Trial Locations
- Locations (17)
Loyola University Medical Center - Cardinal Bernadin Cancer Center
🇺🇸Maywood, Illinois, United States
The John Theurer Cancer Center, Hackensack University Medical Center
🇺🇸Hackensack, New Jersey, United States
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
MD Anderson Cancer Center /The University of Texas
🇺🇸Houston, Texas, United States
Hopital Saint-Louis/Service d'Hematologie
🇫🇷Paris, Cedex 10, France
City of Hope National Medical Center
🇺🇸Duarte, California, United States
Stanford Cancer Center
🇺🇸Stanford, California, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Columbia University Medical Center
🇺🇸New York, New York, United States
NYU Clinical Cancer Center
🇺🇸New York, New York, United States
Seattle Cancer Care Alliance / University of Washington Medical Center
🇺🇸Seattle, Washington, United States
Charles A. Sammons Cancer Center
🇺🇸Dallas, Texas, United States
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Colorado Blood Cancer Institute
🇺🇸Denver, Colorado, United States
University of Miami Miller School of Medicine / Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
St. Francis Medical Group Oncology & Hematology Specialists
🇺🇸Indianapolis, Indiana, United States
Karmanos Cancer Institute / Wayne State University
🇺🇸Detroit, Michigan, United States