Safety and Efficacy Study of Loncastuximab Tesirine + Ibrutinib in Diffuse Large B-Cell or Mantle Cell Lymphoma

Part of paid clinical trials in Orange, California.

Sponsor
ADC Therapeutics S.A.
Study ID
NCT03684694
Phase
PHASE1/PHASE2
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

  • Loncastuximab Tesirine — DRUG
    Intravenous (IV) infusion.
  • Ibrutinib — DRUG
    Oral capsule.

Study Details

The purpose of this Phase 1/2 study is to evaluate the safety and efficacy of Loncastuximab Tesirine (ADCT-402) in combination with Ibrutinib in participants with Advanced Diffuse Large B-Cell Lymphoma or Mantle Cell Lymphoma.

Key Dates

Start date
Dec 1, 2018
Status verified
Jan 2024
Primary completion
Nov 8, 2022
Completion
Nov 8, 2022

Study Design

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

Arms

  • Experimental: Phase 1: Dose-Escalation of ADCT-402
    A standard 3+3 dose escalation design will be used. The dose-limiting toxicity (DLT) period will be the 21 days following the first dose of ibrutinib. The dose escalation cohort will receive loncastuximab tesirine for Cycle 1 and 2 (3 weeks each) with concurrent ibrutinib (concomitant therapy) daily. Participants may continue to receive ibrutinib therapy up to 1 year after Cycle 1 Day 1 (once every 4 weeks from Cycle 3 onwards). Loncastuximab tesirine will be administered intravenously (IV).
  • Experimental: Phase 2: MTD or RP2D of ADCT-402 in Non-GCB DLBCL
    Participants with non-germinal center B-cell diffuse large B-cell lymphoma (Non-GCB DLBCL) will receive the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of loncastuximab tesirine, as determined in Phase 1, once every 3 weeks for Cycle 1 and 2 and a daily dose of ibrutinib. Participants can continue treatment up to 1 year (once every 4 weeks from Cycle 3 onwards). Loncastuximab tesirine will be administered IV.
  • Experimental: Phase 2: MTD or RP2D of ADCT-402 in GCB DLBCL
    Participants with germinal center B-cell diffuse large B-cell lymphoma (GCB DLBCL) will receive the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of loncastuximab tesirine, as determined in Phase 1, once every 3 weeks for Cycle 1 and 2 and a daily dose of ibrutinib. Participants can continue treatment up to 1 year (once every 4 weeks from Cycle 3 onwards). Loncastuximab tesirine will be administered IV.
  • Experimental: Phase 2: MTD or RP2D of ADCT-402 in MCL
    Participants with mantle cell lymphoma (MCL) will receive the maximum tolerated dose (MTD) or recommended Phase 2 dose (RP2D) of loncastuximab tesirine, as determined in Phase 1, once every 3 weeks for Cycle 1 and 2 and a daily dose of ibrutinib. Participants can continue treatment up to 1 year (once every 4 weeks from Cycle 3 onwards). Loncastuximab tesirine will be administered IV.

Primary Outcome Measure

Phase 1: Number of Participants With Treatment-emergent Adverse Events (TEAEs) [ Time Frame: Day 1 until 30 days after last dose; max duration of treatment was 686 days for Phase 1 (up to approximately 716 days total) ]

Locations (12)

FacilityCityStateZIPSite coordinators
University of California Irvine Health Chao Family Comprehensive Cancer CenterOrangeCalifornia92868-
Redlands Community HospitalRedlandsCalifornia92373-
Miami Cancer InstituteMiamiFlorida33176-
University of MiamiMiamiFlorida33136-
The Blood and Marrow Transplant Group of GeorgiaAtlantaGeorgia30342-
Georgia Cancer Center at Augusta UniversityAugustaGeorgia30912-
Norton Cancer Institute, St. Matthews CampusLouisvilleKentucky40207-
The Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsBaltimoreMaryland21287-
University of Michigan Comprehensive Cancer CenterAnn ArborMichigan48109-
University of MinnesotaMinneapolisMinnesota55455-
Saint Vincent HealthcareBillingsMontana59101-
Case Western Reserve UniversityClevelandOhio44106-

Find similar trials in Orange, CA

By research site
University of California Irvine Health Chao Family Comprehensive Cancer Center· Orange, CARedlands Community Hospital· Redlands, CAMiami Cancer Institute· Miami, FLUniversity of Miami· Miami, FLThe Blood and Marrow Transplant Group of Georgia· Atlanta, GAGeorgia Cancer Center at Augusta University· Augusta, GA

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