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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
36
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.
Stanford University School of Medicine
Stanford, California, United States
Overall Response Rate (ORR)
Overall response rate of brentuximab vedotin in this study population.
Time frame: 2 years
Overall Stable Disease Rate
Overall Stable Disease Rate (SD) in this study population. 3 subjects were not evaluable.
Time frame: 2 years
Overall Partial Response Rate
Overall Partial Response Rate (PR) in this study population. 3 subjects were not evaluable.
Time frame: 2 years
Overall Non-Evaluable Response
Overall Non-Evaluable Response of full patient population 3 subjects were not evaluable.
Time frame: 4 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.