11
Participants
Start Date
January 26, 2023
Primary Completion Date
May 28, 2025
Study Completion Date
October 11, 2027
Etoposide
Dose level -2=50 mg/m\^2; dose level -1=50 mg/m\^2; dose level 1=50 mg/m\^2; dose level 2=60 mg/m\^2; dose level 3=72 mg/m\^2; dose level 4=86.4 mg/m\^2; dose level 5=103.7 mg/m\^2; dose level 6=124.4 mg/m\^2; dose level 7=149.3 mg/m\^2
Doxorubicin
Dose level -2=10 mg/m\^2; dose level -1; dose level -1=10 mg/m\^2; dose level 1=10 mg/m\^2; dose level 2=12 mg/m\^2; dose level 3=14.4 mg/m\^17.3 mg/m\^2; dose level 4=17.3 mg/m\^2; dose level 5=20.7 mg/m\^2; dose level 6=24.8 mg/m\^2; dose level 7=29.8 mg/m\^2.
Cyclophosphamide
Dose level -2=480 mg/m\^2; dose -1=600 mg/m\^2; dose level 1=750 mg/m\^2; level 2=900 mg/m\^2; level 3=1080 mg/m\^2; level 4=1296 mg/m\^2; level 5=1555 mg/m\^2; level 6=1866 mg/m\^2; level 7=2239 mg/m\^2.
Rituximab
Level -2 through level 7: 375 mg/m\^2
Vincristine
Level -2 through level 7: 0.4 mg/m\^2/day
Prednisone
Level -2 through level 7: 60 mg/m\^2/twice daily (BID)
Loncastuximab Tesirine 0.075 mg/kg by IV
Cohort 1: 0.075 mg/kg by IV. The dose-expansion phase will use the maximum-tolerated dose.
Loncastuximab tesirine 0.12 mg/kg by IV
Cohort 2: 0.12 mg/kg by IV. The dose-expansion phase will use the maximum-tolerated dose.
Loncastuximab tesirine 0.15 mg/kg by IV
Cohort 3: 0.15 mg/kg by IV The dose-expansion phase will use the maximum-tolerated dose.
Froedtert Hospital & the Medical College of Wisconsin, Milwaukee
University of Wisconsin School of Medicine and Public Health, Madison
University of Texas Southwestern, Dallas
Medical College of Wisconsin
OTHER