A Phase 2 Open Label Trial of Brentuximab Vedotin (SGN-35) for Systemic Anaplastic Large Cell Lymphoma
- Conditions
- Lymphoma, Large-Cell, AnaplasticLymphoma, Non-Hodgkin
- Interventions
- Registration Number
- NCT00866047
- Lead Sponsor
- Seagen Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 58
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Brentuximab vedotin brentuximab vedotin Brentuximab vedotin 1.8 mg/kg every 3 weeks by intravenous (IV) infusion
- 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 in Participants With Complete Remission by Kaplan-Meier Analysis 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.
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.
Duration of Objective Response by Kaplan-Meier Analysis 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.
Progression-free Survival by Kaplan-Meier Analysis up to approximately 3 years Time from start of study treatment to disease progression per independent review group or death due to any cause.
Overall Survival up to approximately 7 years Time from start of study treatment to date of death due to any cause.
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.
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.
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
Time of Maximum Serum Concentration 3 weeks Time of maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
Trial Locations
- Locations (22)
Nationwide Children's Hospital
🇺🇸Columbus, Ohio, United States
Princess Margaret Hospital
🇨🇦Toronto, Ontario, Canada
Stanford University Medical Center
🇺🇸Palo Alto, California, United States
Memorial Sloan Kettering Cancer Center
🇺🇸New York, New York, United States
Hospital Saint Louis
🇫🇷Paris, France
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
Institut Paoli Calmettes
🇫🇷Marseille, France
Centre Henri Becquerel
🇫🇷Rouen, France
Christie Hospital NHS
🇬🇧Manchester, United Kingdom
University of Miami Sylvester Comprehensive Cancer Center
🇺🇸Miami, Florida, United States
Washington University School of Medicine
🇺🇸St. Louis, Missouri, United States
Mayo Clinic Rochester
🇺🇸Rochester, Minnesota, United States
Karmanos Cancer Institute / Wayne State University
🇺🇸Detroit, Michigan, United States
Baylor Sammons Cancer Center / Texas Oncology
🇺🇸Dallas, Texas, United States
MD Anderson Cancer Center / University of Texas
🇺🇸Houston, Texas, United States
University of Washington
🇺🇸Seattle, Washington, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Oregon Health & Science University
🇺🇸Portland, Oregon, United States
UZ Gasthuisberg
🇧🇪Leuven, Belgium
Weill Cornell Medical College
🇺🇸New York, New York, United States
Rocky Mountain Cancer Centers
🇺🇸Denver, Colorado, United States
B.C Cancer Agency
🇨🇦Vancouver, British Columbia, Canada