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drugset / Trial / NCT05270057

Loncastuximab Tesirine in Combination With DA-EPOCH-R in Patients With Previously Untreated Aggressive B-cell Lymphoid Malignancies

NCT05270057 ↗

Phase 1 Active not recruiting 11 enrolled Medical College of Wisconsin
Non-randomizedSequentialOpen-labelTreatment

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.

Timeline

Start
2023-01-26
Primary completion
2025-05-28
Completion
2027-10-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Loncastuximab Tesirine Other / unclassified 0.075 mg/kg Intravenous
Subject Loncastuximab Tesirine Other / unclassified 0.12 mg/kg Intravenous
Subject Loncastuximab Tesirine Other / unclassified 0.15 mg/kg Intravenous
Background Cyclophosphamide Other / unclassified 480 mg/m2 —
Background Cyclophosphamide Other / unclassified 600 mg/m2 —
Background Cyclophosphamide Other / unclassified 750 mg/m2 —
Background Cyclophosphamide Other / unclassified 900 mg/m2 —
Background Cyclophosphamide Other / unclassified 1080 mg/m2 —
Background Cyclophosphamide Other / unclassified 1296 mg/m2 —
Background Cyclophosphamide Other / unclassified 1555 mg/m2 —
Background Cyclophosphamide Other / unclassified 1866 mg/m2 —
Background Cyclophosphamide Other / unclassified 2239 mg/m2 —
Background Doxorubicin Other / unclassified 10 mg/m2 —
Background Doxorubicin Other / unclassified 12 mg/m2 —
Background Doxorubicin Other / unclassified 14.4 mg/m2 —
Background Doxorubicin Other / unclassified 17.3 mg/m2 —
Background Doxorubicin Other / unclassified 20.7 mg/m2 —
Background Doxorubicin Other / unclassified 24.8 mg/m2 —
Background Doxorubicin Other / unclassified 29.8 mg/m2 —
Background Etoposide Small molecule 50 mg/m2 —
Background Etoposide Small molecule 60 mg/m2 —
Background Etoposide Small molecule 72 mg/m2 —
Background Etoposide Small molecule 86.4 mg/m2 —
Background Etoposide Small molecule 103.7 mg/m2 —
Background Etoposide Small molecule 124.4 mg/m2 —
Background Etoposide Small molecule 149.3 mg/m2 —
Background Prednisone Other / unclassified 60 mg/m2 —
Background Rituximab Monoclonal antibody 375 mg/m2 —
Background Vincristine Small molecule 0.4 mg/m2 —

Indications

Burkitt lymphoma