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A Study to Evaluate the Tolerability, Safety, Pharmacokinetics, and Antitumor Activity of Loncastuximab Tesirine in Combination With Rituximab, Cyclophosphamide, Doxorubicin, Vincristine, and Prednisone (R-CHOP) in Participants With Previously Untreated Diffuse Large B-cell Lymphoma (LOTIS-8)

NCT04974996 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2022-03-29

No results posted yet for this study

Summary

The primary objective of this study is to characterize the safety and tolerability of loncastuximab tesirine in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) chemotherapy, and identify the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) for the combination therapy.

Conditions

  • Diffuse Large B-Cell Lymphoma

Interventions

DRUG

Loncastuximab tesirine

Intravenous (IV) infusion

DRUG

Prednisone

Orally via tablet or capsule

DRUG

Rituximab

Intravenous (IV) infusion

DRUG

Cyclophosphamide

Intravenous (IV) infusion

DRUG

Doxorubicin

Intravenous (IV) infusion

DRUG

Vincristine

Intravenous (IV) infusion

Sponsors & Collaborators

  • ADC Therapeutics S.A.

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-02-01
Primary Completion
2024-03-11
Completion
2027-05-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04974996 on ClinicalTrials.gov