Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level
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ClinicalTrials.gov Identifier: NCT01396070 |
Recruitment Status
:
Completed
First Posted
: July 18, 2011
Results First Posted
: April 5, 2017
Last Update Posted
: April 5, 2017
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Tracking Information | ||||
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First Submitted Date ICMJE | July 14, 2011 | |||
First Posted Date ICMJE | July 18, 2011 | |||
Results First Submitted Date | December 28, 2016 | |||
Results First Posted Date | April 5, 2017 | |||
Last Update Posted Date | April 5, 2017 | |||
Study Start Date ICMJE | May 2011 | |||
Actual Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures ICMJE |
Overall Response Rate (ORR) [ Time Frame: 2 years ] Overall response rate of brentuximab vedotin in this study population.
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Original Primary Outcome Measures ICMJE |
Objective clinical response rate assessed by the standard response criteria used in MF (Mycosis fungoides) and SS (Sezary syndromel) [ Time Frame: 4 weeks ] | |||
Change History | Complete list of historical versions of study NCT01396070 on ClinicalTrials.gov Archive Site | |||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Not Provided | |||
Current Other Outcome Measures ICMJE | Not Provided | |||
Original Other Outcome Measures ICMJE | Not Provided | |||
Descriptive Information | ||||
Brief Title ICMJE | Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides With Variable CD30 Expression Level | |||
Official Title ICMJE | Exploratory Pilot Study of Brentuximab Vedotin (SGN-35) in Patients With Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level | |||
Brief Summary | The purpose of this study is to learn the effects of brentuximab vedotin (SGN-35), an investigational medication, on patients with cutaneous T cell lymphoma (CTCL), specifically mycosis fungoides (MF) and Sezary syndrome (SS). Despite a wide range of therapeutic options, the treatments are associated with short response duration, thus this condition is largely incurable. This investigational drug may offer less toxicity than standard treatments and have better tumor specific targeting. | |||
Detailed Description | This phase 2 exploratory study will evaluate the clinical response of brentuximab vedotin in MF and SS, where tumor cells express variable levels of CD30 target molecule. The primary objective is to explore the biologic activity of brentuximab vedotin in patients with MF and SS, the most common types of cutaneous T-cell lymphoma (CTCL), where expression of CD30 is variable. Brentuximab vedotin has significant biologic activity in Hodgkin's disease (HD) where only a small numbers of CD30 positive tumor cells are present, as well as in lymphomas with large numbers of CD30-expressing tumor cells such as systemic anaplastic large cell lymphoma (sALCL). The subject grouping by CD30 expression levels (low, intermediate, high) is for accrual purposes only, to ensure that a wide range of CD30 expression is studied. |
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Study Type ICMJE | Interventional | |||
Study Phase | Phase 2 | |||
Study Design ICMJE | Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Drug: Brentuximab vedotin
1.8 mg/kg by IV every 3 weeks for a maximum of 16 doses (8 cycles). Brentuximab vedotin is an antibody conjugate, consisting of the chimeric IgG1 anti-CD30 antibody cAC10; the microtubule disrupting agent monomethyl auristatin E (MMAE); a protease-cleavable linker that covalently attaches MMAE to cAC10. Other Names:
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Study Arms | Experimental: Brentuximab vedotin
Novel antibody-drug conjugate, 1.8 mg/kg intravenously every 3 weeks
Intervention: Drug: Brentuximab vedotin |
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Publications * | Kim YH, Tavallaee M, Sundram U, Salva KA, Wood GS, Li S, Rozati S, Nagpal S, Krathen M, Reddy S, Hoppe RT, Nguyen-Lin A, Weng WK, Armstrong R, Pulitzer M, Advani RH, Horwitz SM. Phase II Investigator-Initiated Study of Brentuximab Vedotin in Mycosis Fungoides and Sézary Syndrome With Variable CD30 Expression Level: A Multi-Institution Collaborative Project. J Clin Oncol. 2015 Nov 10;33(32):3750-8. doi: 10.1200/JCO.2014.60.3969. Epub 2015 Jul 20. | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status ICMJE | Completed | |||
Actual Enrollment ICMJE |
36 | |||
Original Estimated Enrollment ICMJE |
18 | |||
Actual Study Completion Date | May 2016 | |||
Actual Primary Completion Date | April 2015 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Senior) | |||
Accepts Healthy Volunteers | No | |||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries ICMJE | United States | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number ICMJE | NCT01396070 | |||
Other Study ID Numbers ICMJE | IRB-21324 LYMNHL0089 ( Other Identifier: OnCore ) SU-06212011-7946 ( Other Identifier: Stanford University ) |
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Has Data Monitoring Committee | Yes | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement |
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Responsible Party | Youn Kim, Stanford University | |||
Study Sponsor ICMJE | Youn Kim | |||
Collaborators ICMJE | Seattle Genetics, Inc. | |||
Investigators ICMJE |
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PRS Account | Stanford University | |||
Verification Date | February 2017 | |||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |