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ACTIVE NOT RECRUITING
NCT05270057
PHASE1

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

Sponsor: Medical College of Wisconsin

View on ClinicalTrials.gov

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

Interventions

DRUG

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

DRUG

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.

DRUG

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.

DRUG

Rituximab

Level -2 through level 7: 375 mg/m\^2

DRUG

Vincristine

Level -2 through level 7: 0.4 mg/m\^2/day

DRUG

Prednisone

Level -2 through level 7: 60 mg/m\^2/twice daily (BID)

DRUG

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.

DRUG

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.

DRUG

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