The purpose of the study is to evaluate the safety and effectiveness of siltuximab for participants being treated for large granular lymphocytic leukemia (LGLL).
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Siltuximab will be given on day 1 of each cycle. The dose will be 11 mg/kg given over 1 hour by intravenous infusion. Each cycle is three weeks (+-3 days).
Moffitt Cancer Center
Tampa, Florida, United States
Overall Response Rate
Overall response rate is defined as the rate of achieving best response of CR or PR, and will be summarized for participants who have received any dose of study drug
Time frame: Up to 30 months
Complete Response Rate (CR)
CR rate is defined as the percentage of patients achieving best response of CR.
Time frame: Up to 30 months
Time to Response (TTR)
TTR is defined as time from first dose of study drug to time of meeting criteria for CR or PR, whichever comes first.
Time frame: Up to 30 months
Duration of Response (DOR)
Duration of Response is defined as time from achieving either CR or PR, whichever comes first, to time of progression or starting another LGLL treatment, whichever comes first.
Time frame: Up to 30 months
Duration of Complete Response
Duration of CR is defined as time from achieving CR to time of progression or starting another LGLL treatment, whichever comes first.
Time frame: Up to 30 months
Time to Complete Response
Time to CR is defined as time from first dose of study drug to time of CR
Time frame: Up to 30 months
Duration of Complete Response with Normalization of PB LGL Count
Rate of CR with normalization of PB LGL count is defined as meeting criteria for CR AND a normal PB LGL count ( \<400/mm³ CD3+CD57+ cells or \<650/mm³ CD8+ T cells in PB).
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Up to 30 months
Progression Free Survival
PFS is defined as time from first dose of study drug to time of disease progression or starting another LGLL treatment, whichever comes first
Time frame: Up to 30 months