A Phase 2 Open-label Study of Loncastuximab Tesirine in Combination With Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Patients With Diffuse Large B-cell Lymphoma (DLBCL) (LOTIS-9)

Who is this study for? Patients with Diffuse Large B-cell Lymphoma
What treatments are being studied? Loncastuximab Tesirine+Rituximab
Status: Terminated
Location: See all (41) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

The main objective of the trial is to assess the efficacy and tolerability of Lonca-R in unfit and frail participants with previously untreated DLBCL.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 65
Healthy Volunteers: f
View:

• Pathologic diagnosis of DLBCL, as defined by the 2016 World Health Organization (WHO) classification (including participants with DLBCL transformed from indolent lymphoma), or HGBCL, or Grade 3b FL.

• Measurable disease as defined by the 2014 Lugano Classification.

• Stages I-IV.

• ECOG PS 0-2; ECOG PS 3 allowed if decline in status is deemed related to lymphoma \& felt to be potentially reversible by the treating physician.

• Adequate organ function as defined by screening laboratory values within the following parameters:

‣ Absolute neutrophil count (ANC) ≥1.0 x 10\^3/µL (off growth factors at least 72 hours).

⁃ Platelet count ≥75 x 10\^3/µL without transfusion in the past 7 days.

⁃ Alanine aminotransferase (ALT), aspartate aminotransferase (AST), and gamma glutamyl transferase (GGT) ≤2.5 x the upper limit of normal (ULN).

⁃ Total bilirubin ≤1.5 x ULN (participants with known Gilbert's syndrome may have a total bilirubin up to ≤3 x ULN).

⁃ Calculated creatinine clearance \>30 mL/min by the Cockcroft and Gault equation.

∙ Note: A laboratory assessment may be repeated a maximum of two times during the screening period to confirm eligibility.

• Women of childbearing potential (WOCBP) must agree to use a highly effective method of contraception from the time of giving informed consent until at least 12 months after the last dose of study treatment. Men with female partners who are of childbearing potential must agree to use a condom when sexually active or practice total abstinence from the time of the first dose until at least 7 months after the participant receives his last dose of study treatment.

• Unfit as defined by the simplified geriatric assessment (sGA). Includes all of the following:

‣ Aged ≥80 years

⁃ ADL score of 6

⁃ IADL score of 8

⁃ CIRS-G: no score of 3-4 and \<5 scores of 2

• Frail as defined by sGA:

‣ Aged ≥80 years

⁃ ADL score of \<6 and/or

⁃ IADL score of \<8 and/or

⁃ CIRS-G: ≥1 score of 3-4 and/or \>5 scores of 2 OR

• Aged ≥65 - \<80 with at least one of the following cardiac comorbidities that make anthracycline-containing regimens inadvisable as determined by the investigator.

‣ Left ventricular ejection fraction (LVEF) ≥30 to \<50%

⁃ History of myocardial infarction within 6 months prior to screening

⁃ Ischemic heart disease

⁃ History of stroke within 12 months prior to screening

Locations
United States
Arkansas
Winthrop P. Rockefeller Cancer Institute
Little Rock
Arizona
University of Arizona Cancer Center
Tucson
Colorado
Rocky Mountain Cancer Centers - Aurora
Aurora
Illinois
USOR - Illinois Cancer Specialists - Niles
Niles
Kentucky
Leonard Lawson Cancer Center
Pikeville
North Carolina
Novant Health Cancer Specialists - Charlotte
Charlotte
Nevada
Cancer Care Specialists - Nevada
Reno
New York
New York Cancer & Blood Specialists - New Hyde Park
Babylon
New York Cancer & Blood Specialists - Babylon Medical Oncology
Port Jefferson
Ohio
USOR - Oncology Hematology Care - Kenwood
Cincinnati
University Hospitals Cleveland Medical Center
Cleveland
Ohio Health - Research and Innovation Institute
Columbus
Oregon
Willamette Valley Cancer Institute and Research Center - Eugene
Eugene
Pennsylvania
Reading Hospital - Tower Health
Reading
South Carolina
Prisma Health Cancer Institute
Greenville
South Dakota
Avera Cancer Institute
Sioux Falls
Texas
Texas Oncology - Austin Midtown
Austin
Texas Oncology - Medical City Dallas
Dallas
USOR - Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas
USOR - Texas Oncology - Presbyterian Cancer Center Dallas
Dallas
University of Texas MD Anderson Cancer Center
Houston
USOR - Texas Oncology - San Antonio
San Antonio
Texas Oncology Northeast Texas - Tyler
Tyler
Virginia
Blue Ridge Cancer Care - Blacksburg
Blacksburg
USOR - Virginia Cancer Specialists - Gainesville Office
Gainesville
Virginia Cancer Institute - West End
Richmond
USOR - Virginia Oncology Associates
Virginia Beach
Washington
Kadlec Clinic - Hematology and Oncology
Richland
USOR - Northwest Cancer Specialists, P.C. dba Compass Oncology - Vancouver Cancer Center
Vancouver
Other Locations
Italy
Ospedaliera Santi Antonio E Biagio E Cesare Arrigo-SC Ematologia
Alessandria
Azienda Socio Sanitaria Territoriale (ASST) degli Spedali Civili di Brescia
Brescia
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan
Puerto Rico
Hospital Español Auxilio Mutuo
San Juan
Spain
Hospital del Mar - Parc de Salut Mar
Barcelona
Institut Català d'Oncologia - Hospital Duran i Reynals (ICO L'Hospitalet)
Barcelona
Hospital San Pedro de Alcantara
Cáceres
Hospital Universitario Fundación Jiménez Díaz
Madrid
Hospital Universitario Ramón y Cajal
Madrid
Clinica Universidad de Navarra - Pamplona
Pamplona
Hospital Universitario Marqués de Valdecilla
Santander
Hospital Arnau de Vilanova
Valencia
Time Frame
Start Date: 2022-06-21
Completion Date: 2024-01-22
Participants
Target number of participants: 41
Treatments
Experimental: Cohort A : Loncastuximab Tesirine + Rituximab (Lonca-R)
Participants who are unfit (per sGA) will receive Lonca-R for 3 cycles. Participants who achieve a complete response (CR) will receive Lonca-R for 1 additional cycle. Participants who achieve a partial response (PR) will receive Lonca-R for 3 additional cycles.~Lonca-R will be administered as rituximab 375 mg/m\^2 on Day 1 of Cycle 1 and loncastuximab tesirine 150 µg/kg on Day 2 of Cycle 1. During Cycle 2, Lonca-R will be administered as rituximab\* 375 mg/m\^2 and loncastuximab tesirine 150 µg/kg on Day 1. For cycles 3 and beyond, Lonca-R will be administered as rituximab 375 mg/m\^2 and loncastuximab tesirine 75 µg/kg on Day 1.~\*subcutaneous rituximab 1400mg/dose may be used during Cycle 2 and beyond
Experimental: Cohort B : Loncastuximab Tesirine + Rituximab (Lonca-R)
Participants who are frail (per sGA) or participants with cardiac comorbidities will receive Lonca-R for 3 cycles. Participants who achieve a CR will receive Lonca-R for 1 additional cycle. Participants who achieve a PR will receive Lonca-R for 3 additional cycles for a total of up to 6 cycles. Only participants enrolled in Cohort B, who achieve stable disease (SD) and deriving clinical benefit per the treating physician, may also receive Lonca-R for an additional 3 cycles.~Lonca-R will be administered as rituximab 375 mg/m\^2 on Day 1 of Cycle 1 and loncastuximab tesirine 150 µg/kg on Day 2 of Cycle 1. During Cycle 2, Lonca-R will be administered as rituximab\* 375 mg/m\^2 and loncastuximab tesirine 150 µg/kg on Day 1. For cycles 3 and beyond, Lonca-R will be administered as rituximab 375 mg/m\^2 and loncastuximab tesirine 75 µg/kg on Day 1.~\*subcutaneous rituximab 1400mg/dose may be used during Cycle 2 and beyond
Sponsors
Leads: ADC Therapeutics S.A.

This content was sourced from clinicaltrials.gov

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