Open-label of Loncastuximab Tesirine (ADCT-402) in Relapsed/Refractory Marginal Zone Lymphoma

Part of paid clinical trials in Duarte, California.

Sponsor
University of Miami
Study ID
NCT05296070
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Marginal Zone Lymphoma

Eligibility Criteria

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

Interventions

  • Loncastuximab tesirine 150 µg/Kg — DRUG
    Participants will be treated with loncastuximab tesirine at a dose of 150 µg/Kg given as an intravenous infusion (given as per treatment guidelines for 30 minutes or longer) on Day 1 (+/- 3 days) of each 21 day cycle for Cycle 1 - 2.
  • Loncastuximab tesirine 75µg/Kg — DRUG
    Participants will be treated with loncastuximab tesirine at a dose of 75 µg/Kg given as an intravenous infusion (given as per treatment guidelines for 30 minutes or longer) on Day 1 (+/- 3 days) of each 21 day cycle for Cycle 3 - 6.

Study Details

The purpose of this research study is to see if loncastuximab tesirine has any benefits at dose levels researchers found acceptable in earlier studies in patients with related forms of immune cell cancers. The researchers want to find out the effects (good and bad) that loncastuximab tesirine has on the participant and the participant's condition.

Key Dates

Start date
Jun 21, 2022
Status verified
Sep 2025
Primary completion
Jun 30, 2028
Completion
Jun 30, 2029

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Loncastuximab tesirine Cycles 1-6
    Patients will be treated with loncastuximab tesirine for a total of 6 cycles on Day 1 (+/-3) of each 21 day (3 week) cycle. The total duration of treatment is approximately 18 weeks (4.5 months)

Primary Outcome Measure

Complete Response (CR) rate of Loncastuximab tesirine in relapsed/refractory at 6 months [ Time Frame: 6 months. ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010
Johana Carmona, DO, PhD
[email protected]
626-218-0942
Geoffrey Shouse, DO, PhD (PRINCIPAL_INVESTIGATOR)
University of MiamiMiamiFlorida33136
Lutecia Pereira, PhD
[email protected]
305-243-6160
Izidore Lossos, MD (PRINCIPAL_INVESTIGATOR)
Emory UniversityAtlantaGeorgia30322
Jean L Koff, MD
[email protected]
404-778-0519
Jean L Koff, MD (PRINCIPAL_INVESTIGATOR)
Vanderbilt UniversityNashvilleTennessee37232
Olalekan Oluwole, MD
[email protected]
615-936-8422
Olalekan Oluwole, MD (PRINCIPAL_INVESTIGATOR)

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City of Hope National Medical Center· Duarte, CAUniversity of Miami· Miami, FLEmory University· Atlanta, GAVanderbilt University· Nashville, TN

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