Safety and Antitumor Activity Study of Loncastuximab Tesirine and Durvalumab in Diffuse Large B-Cell, Mantle Cell, or Follicular Lymphoma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
ADC Therapeutics S.A.
Study ID
NCT03685344
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of this phase 1 study is to evaluate the safety and anti-tumor activity of Loncastuximab Tesirine (ADCT-402) and Durvalumab in participants with Advanced Diffuse Large B-Cell Lymphoma, Mantle Cell Lymphoma, or Follicular Lymphoma

Key Dates

Start date
Feb 4, 2019
Status verified
Sep 2021
Primary completion
Oct 27, 2020
Completion
Oct 27, 2020

Study Design

Enrollment
13 participants (actual)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: ADCT-402
    Dose escalation phase: Ascending doses of Loncastuximab tesirine will be administered using a traditional 3+3 design. Dose level 1: 90 µg/kg, every 3 weeks (Q3W). Dose level 2: 120 µg/kg, Q3W. Dose level 3: 150 µg/kg, Q3W. Loncastuximab tesirine will be given for 2 doses, 3 weeks apart. Dose expansion phase: Loncastuximab tesirine will be administered at the recommended dose determined in the dose escalation phase. Durvalumab will also be administered at a dose of 1500 mg once every 4 weeks (Q4W) throughout the dose escalation phase and dose expansion phase.

Primary Outcome Measure

Number of Participants With a Treatment-emergent Adverse Event (TEAE) [ Time Frame: Day 1 to 30 days after the last dose of study drugs (maximum treatment duration at study termination was 336 days) ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35294-
UCH-MHS Memorial Hospital CenteralColorado SpringsColorado80909-
University of Florida Health Shands Cancer HospitalGainesvilleFlorida32603-
University of Miami - Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08901-
Icahm School of Medicine at Mount SinaiNew YorkNew York10029-
Baylor University Medical CenterDallasTexas75246-
Joe Arrington Cancer Research and Treatment CenterLubbockTexas79410-
Baylor Scott & White Medical Center - TempleTempleTexas76508-

Find similar trials in Birmingham, AL

By research site
University of Alabama at Birmingham· Birmingham, ALUCH-MHS Memorial Hospital Centeral· Colorado Springs, COUniversity of Florida Health Shands Cancer Hospital· Gainesville, FLUniversity of Miami - Sylvester Comprehensive Cancer Center· Miami, FLRutgers Cancer Institute of New Jersey· New Brunswick, NJIcahm School of Medicine at Mount Sinai· New York, NY

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