A Study of Loncastuximab Tesirine and Rituximab (Lonca-R) in Previously Untreated Unfit/Frail Participants With Diffuse Large B-cell Lymphoma (DLBCL)

Stopped early · Phase 2

Conditions studied: Diffuse Large B-cell Lymphoma

In brief

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.

Key facts

Study ID

NCT05144009

Run by

ADC Therapeutics S.A.

People needed

41

Starts

2022-06-21

Expected to finish

2024-01-22

Last updated by the study team

2025-01-30

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.
• Inclusion Criteria specific for Cohort A:
• 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
• Inclusion Criteria specific for Cohort B:
• 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.

You may not qualify if…

• Known history of hypersensitivity to or positive serum human anti-drug antibody to a cluster of differentiation 19 (CD19) antibody.
• Previous therapy for DLBCL, HGBCL, or Grade 3b FL (with exception of corticosteroid course for symptom management of less than 14 days).
• Previous therapy with loncastuximab tesirine and rituximab for any indication.
• Known history of hypersensitivity to any component of study treatment (loncastuximab tesirine and rituximab)
• Human immunodeficiency virus (HIV) seropositive with any of the following:
• CD4+ T-cell (CD4+) counts <350 cells/µL
• Acquired immunodeficiency syndrome (AIDS) - defining opportunistic infection within 12 months prior to screening
• Not on anti-retroviral therapy, or on anti-retroviral therapy for <4 weeks at the time of screening
• HIV viral load ≥400 copies/mL
• Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load.
• Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load.
• History of Stevens-Johnson syndrome or toxic epidermal necrolysis.
• Lymphoma with active central nervous system involvement at the time of screening, including leptomeningeal disease.
• Clinically significant third space fluid accumulation (i.e., ascites requiring drainage or pleural effusion that is either requiring drainage or associated with shortness of breath).
• Major surgery, radiotherapy, chemotherapy, or other anti-neoplastic therapy within 14 days prior to start of study drug (Cycle 1 Day 1 [C1D1]), except shorter if approved by the Sponsor.
• Use of any other experimental medication within 14 days prior to start of study drug (C1D1).
• Received live vaccine within 4 weeks of C1D1.
• Congenital long QT syndrome or a corrected Fridericia correction of the QT measure (QTcF) interval of >480 ms at screening (unless secondary to pacemaker or bundle branch block).
• Active second primary malignancy other than non-melanoma skin cancers, non-metastatic prostate cancer, in situ cervical cancer, ductal or lobular carcinoma in situ of the breast, or other malignancy that the Sponsor's Medical monitor and Investigator agree, and document should not be exclusionary.
• Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the participant inappropriate for study participation or put the participant at risk.

Where it is running

• University of Arizona Cancer Center — Tucson, Arizona, United States
• Winthrop P. Rockefeller Cancer Institute — Little Rock, Arkansas, United States
• Rocky Mountain Cancer Centers - Aurora — Aurora, Colorado, United States
• USOR - Illinois Cancer Specialists - Niles — Niles, Illinois, United States
• Leonard Lawson Cancer Center — Pikeville, Kentucky, United States
• Cancer Care Specialists - Nevada — Reno, Nevada, United States
• New York Cancer & Blood Specialists - New Hyde Park — Babylon, New York, United States
• New York Cancer & Blood Specialists - Babylon Medical Oncology — Port Jefferson, New York, United States
• Novant Health Cancer Specialists - Charlotte — Charlotte, North Carolina, United States
• USOR - Oncology Hematology Care - Kenwood — Cincinnati, Ohio, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Ohio Health - Research and Innovation Institute — Columbus, Ohio, United States
• Willamette Valley Cancer Institute and Research Center - Eugene — Eugene, Oregon, United States
• Reading Hospital - Tower Health — Reading, Pennsylvania, United States
• Prisma Health Cancer Institute — Greenville, South Carolina, United States
• Avera Cancer Institute — Sioux Falls, South Dakota, United States
• Texas Oncology - Austin Midtown — Austin, Texas, United States
• Texas Oncology - Medical City Dallas — Dallas, Texas, United States
• USOR - Texas Oncology - Presbyterian Cancer Center Dallas — Dallas, Texas, United States
• USOR - Texas Oncology - Baylor Charles A. Sammons Cancer Center — Dallas, Texas, United States
• University of Texas MD Anderson Cancer Center — Houston, Texas, United States
• USOR - Texas Oncology - San Antonio — San Antonio, Texas, United States
• Texas Oncology Northeast Texas - Tyler — Tyler, Texas, United States
• Blue Ridge Cancer Care - Blacksburg — Blacksburg, Virginia, United States
• USOR - Virginia Cancer Specialists - Gainesville Office — Gainesville, Virginia, United States

Full record on ClinicalTrials.gov

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