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
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|Condition or disease||Intervention/treatment||Phase|
|Lymphoma, Large-Cell, Anaplastic Lymphoma, Non-Hodgkin||Drug: brentuximab vedotin||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||58 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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.
- 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.
- 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.
- 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.
- 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.
- Overall Survival [ Time Frame: 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 [ 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.
- 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.
- 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.
- 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
- Maximum Serum Concentration [ Time Frame: 3 weeks ]Maximum serum concentration from 0 to 21 days following the first dose of brentuximab vedotin
- 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
- 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.
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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|
- 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.
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
|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|
|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|
|Leuven, Belgium, 3000|
|Canada, British Columbia|
|B.C Cancer Agency|
|Vancouver, British Columbia, Canada, V5Z 4E6|
|Princess Margaret Hospital|
|Toronto, Ontario, Canada, M5G 2M9|
|Institut Paoli Calmettes|
|Marseille, France, 13273|
|Hospital Saint Louis|
|Paris, France, 75475|
|Centre Henri Becquerel|
|Rouen, France, 76038|
|Christie Hospital NHS|
|Manchester, United Kingdom, M20 4BX|
|Study Director:||Dana Kennedy, PharmD||Seagen Inc.|
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
|Responsible Party:||Seagen Inc.|
|Other Study ID Numbers:||
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|
Lymphoma, Large-Cell, Anaplastic
monomethyl auristatin E
Lymphoma, Large-Cell, Anaplastic
Neoplasms by Histologic Type
Immune System Diseases
Antineoplastic Agents, Immunological