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Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies
Sponsor: Medical College of Wisconsin
Summary
The overarching hypothesis for this study is that a safe and tolerable dose (i.e., the maximum tolerated dose) will be identified for loncastuximab tesirine in combination with dose-adjusted etoposide phosphate, prednisone, vincristine sulfate (Oncovin), cyclophosphamide, doxorubicin hydrochloride (hydroxydaunorubicin), and rituximab (DA-EPOCH-R) for patients with previously untreated aggressive B-cell lymphoid malignancies.
Official title: A Multicenter Phase 1, Open-Label Trial of Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
11
Start Date
2023-01-26
Completion Date
2027-10-11
Last Updated
2025-10-09
Healthy Volunteers
No
Conditions
Interventions
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.
Locations (3)
University of Texas Southwestern
Dallas, Texas, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, United States