SGN-35 in CD30-positive Lymphoproliferative Disorders (ALCL), Mycosis Fungoides (MF), and Extensive Lymphomatoid Papulosis (LyP)
|ClinicalTrials.gov Identifier: NCT01352520|
Recruitment Status : Active, not recruiting
First Posted : May 12, 2011
Last Update Posted : July 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|CD-30 Positive Anaplastic Large T-cell Cutaneous Lymphoma Lymphoma, Primary Cutaneous Anaplastic Large Cell Lymphomatoid Papulosis Mycosis Fungoides Skin Lymphoma Cutaneous Lymphomas Lymphoma Hematologic Disorder||Drug: SGN-35||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||84 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Brentuximab Vedotin (SGN-35) at Dose of 1.8 mg/kg IV Every 3 Weeks in Patients With CD30-positive Lymphoproliferative Disorders (Cutaneous Anaplastic Large T-cell Lymphoma (ALCL), Mycosis Fungoides, and Extensive Lymphomatoid Papulosis (LyP)|
|Actual Study Start Date :||June 2011|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||January 2021|
1.8 mg/kg intravenously Day 1 of 21-day cycle.
1.8 mg/kg administered by outpatient IV infusion given over approximately 30 minutes on Day 1 of each 21-day cycle.
Other Name: Brentuximab vedotin
- Response Rate [ Time Frame: 12 months ]Response rate is percentage of participants with skin lesions that express CD30+ receiving SGN-35 in primary cutaneous ALCL, MF, and extensive lymphomatoid papulosis whose best response during the observation period is a Partial Response (PR), regression of measurable disease, or Complete Response (CR), complete disappearance of all clinical evidence of disease, (i.e. at least moderate improvement). Objective tumor response (PR, CR, PR+CR) based on Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
- Time to Progression [ Time Frame: Assessments through 8 treatment cycles (21 day cycle, approximately 6 months) with possible expansion to 16 cycles, up to 2 years. ]Time to progression calculated as the time (days) from date of first dose of study drug to date of first observed progression or death date if the death was due to disease progression whichever comes first.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01352520
|United States, Texas|
|University of Texas MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Ronald P. Rapini, MD||M.D. Anderson Cancer Center|