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)

Part of paid clinical trials in Cleveland, Ohio.

Sponsor
ADC Therapeutics S.A.
Study ID
NCT04974996
Phase
PHASE1
Status
Withdrawn

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Loncastuximab tesirine — DRUG
    Intravenous (IV) infusion
  • Prednisone — DRUG
    Orally via tablet or capsule
  • Rituximab — DRUG
    Intravenous (IV) infusion
  • Cyclophosphamide — DRUG
    Intravenous (IV) infusion
  • Doxorubicin — DRUG
    Intravenous (IV) infusion
  • Vincristine — DRUG
    Intravenous (IV) infusion

Study Details

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.

Key Dates

Start date
Feb 1, 2022
Status verified
Mar 2022
Primary completion
Mar 11, 2024
Completion
May 5, 2027

Study Design

Enrollment
0 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Part 1: Dose Escalation
    Participants will receive escalating doses of loncastuximab tesirine (initial dose of 60 μg/kg and highest dose possibly tested of 150 µg/kg) in combination with R-CHOP (rituximab 375 mg/m\^2, cyclophosphamide 750 mg/m\^2, doxorubicin 50 mg/m\^2, vincristine 1.4 mg/m\^2, and prednisone 100 mg/day) according to a standard 3+3 dose escalation design. The dose escalation part will be completed once the maximum tolerated dose (MTD)/recommended dose for expansion (RDE) has been identified.
  • Experimental: Part 2: Dose Expansion
    Participants will receive the maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE) of loncastuximab tesirine in combination with rituximab, cyclophosphamide, doxorubicin, vincristine, and prednisone (R-CHOP) as determined in Part 1.

Primary Outcome Measure

Number of Participants Who Experience Dose Limiting Toxicities (DLTs) in Part 1 [ Time Frame: Day 1 to Day 21 of Cycle 1, where a cycle is 21 days ]

Locations (1)

FacilityCityStateZIPSite coordinators
University Hospitals Cleveland Medical CenterClevelandOhio44106-

Find similar trials in Cleveland, OH

By research site
University Hospitals Cleveland Medical Center· Cleveland, OH

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