Study to Evaluate the Efficacy and Safety of Loncastuximab Tesirine in Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma

Completed · Phase 2

Conditions studied: Diffuse Large B-Cell Lymphoma Refractory, Diffuse Large B-cell Lymphoma Recurrent

In brief

The purpose of this Phase 2 study is to evaluate the clinical efficacy and safety of Loncastuximab Tesirine (ADCT-402) in patients with relapsed or refractory Diffuse Large B-Cell Lymphoma.

Key facts

Study ID

NCT03589469

Run by

ADC Therapeutics S.A.

People needed

145

Starts

2018-08-01

Expected to finish

2022-08-09

Last updated by the study team

2023-08-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female patient aged 18 years or older.
• Pathologic diagnosis of DLBCL, as defined by the 2016 WHO classification, to include: DLBCL not otherwise specified; primary mediastinal large B-cell lymphoma; and high-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements
• Relapsed or refractory disease following two or more multi-agent systemic treatment regimens
• Patients who have received previous CD19-directed therapy must have a biopsy that shows CD19 protein expression after completion of the CD19-directed therapy.
• Measurable disease as defined by the 2014 Lugano Classification
• Availability of formalin-fixed paraffin-embedded (FFPE) tumor tissue block or minimum 10 freshly cut unstained slides if block is not available
• ECOG performance status 0-2
• Adequate organ function
• Negative beta-human chorionic gonadotropin (β-HCG) pregnancy test within 7 days prior to start of study drug (C1D1) for women of childbearing potential
• Women of childbearing potential must agree to use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the last dose of loncastuximab tesirine. Men with female partners who are of childbearing potential must agree that they will use a highly effective method of contraception from the time of giving informed consent until at least 16 weeks after the patient receives his last dose of loncastuximab tesirine.

You may not qualify if…

• Previous treatment with loncastuximab tesirine
• Known history of hypersensitivity to or positive serum human ADA to a CD19 antibody
• Pathologic diagnosis of Burkitt lymphoma
• 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
• Autologous stem cell transplant (ASCT) within 30 days prior to start of study drug (C1D1)
• Allogeneic stem cell transplant (AlloSCT) within 60 days prior to start of study drug (C1D1)
• Active graft-versus-host disease
• Post-transplant lymphoproliferative disorders
• Active autoimmune disease, including motor neuropathy considered of autoimmune origin and other central nervous system (CNS) autoimmune disease
• Known seropositive and requiring anti-viral therapy for human immunodeficiency (HIV) virus, hepatitis B virus (HBV), or hepatitis C virus (HCV).
• History of Stevens-Johnson syndrome or toxic epidermal necrolysis
• Lymphoma with active CNS 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)
• Breastfeeding or pregnant
• Significant medical comorbidities
• Major surgery, radiotherapy, chemotherapy or other anti-neoplastic therapy within 14 days prior to start of study drug (C1D1), except shorter if approved by the Sponsor
• Use of any other experimental medication within 14 days prior to start of study drug (C1D1)
• Planned live vaccine administration after starting study drug (C1D1)
• Failure to recover to Grade ≤1 (Common Terminology Criteria for Adverse Events version 4.0 [CTCAE v4.0]) from acute non-hematologic toxicity (Grade ≤2 neuropathy or alopecia) due to previous therapy prior to screening
• Congenital long QT syndrome or a corrected QTcF interval of >480 ms at screening (unless secondary to pacemaker or bundle branch block)
• Any other significant medical illness, abnormality, or condition that would, in the Investigator's judgment, make the patient inappropriate for study participation or put the patient at risk

Where it is running

• City of Hope (City of Hope National Medical Center, City of Hope Medical Center) — Duarte, California, United States
• Compassionate Care Research Group, Inc., at Compassionate Care Medical Group, Inc. — Fountain Valley, California, United States
• UC San Diego Moores Cancer Center — La Jolla, California, United States
• University of California, San Francisco Medical Center — San Francisco, California, United States
• The Oncology Institute of Hope and Innovation — Whittier, California, United States
• University of Miami Hospital and Clinics — Miami, Florida, United States
• Miami Cancer Institute — Miami, Florida, United States
• Winship Cancer Institute of Emory University — Atlanta, Georgia, United States
• Northside Hospital — Atlanta, Georgia, United States
• Northwest Georgia Oncology Centers, PC-Drug Shipment, Lab and Study Supplies Only — Marietta, Georgia, United States
• Medical Oncology & Hematology Associates — Des Moines, Iowa, United States
• Ochsner Clinic Foundation — New Orleans, Louisiana, United States
• Washington University School of Medicine — St Louis, Missouri, United States
• University of Nebraska Medical Center/ Nebraska Medicine — Omaha, Nebraska, United States
• North Shore Hematology Oncology Associates DBA NY Cancer and Blood Specialists — East Setauket, New York, United States
• University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
• Sidney Kimmel Cancer Center at Thomas Jefferson University — Philadelphia, Pennsylvania, United States
• Hollings Cancer Center — Charleston, South Carolina, United States
• GHD Cancer Institute — Greenville, South Carolina, United States
• Baylor University Medical Center — Dallas, Texas, United States
• Baylor Scott & White Medical Center - Temple — Temple, Texas, United States
• Virginia Cancer Specialists, PC — Fairfax, Virginia, United States
• Vista Oncology Inc. PS — Olympia, Washington, United States
• Froedtert Hospital & the Medical College of Wisconsin — Milwaukee, Wisconsin, United States
• A.O. SS Antonio e Biagio e Cesare Arrigo — Alessandria, AL, Italy

Full record on ClinicalTrials.gov

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