Phase
Condition
Lymphoma, B-cell
Hematologic Cancer
Lymphoma
Treatment
Loncastuximab Tesirine
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Male or female participants aged 18 years or older
Pathologic diagnosis of relapsed (disease that has recurred following a response) orrefractory (disease that failed to respond to prior therapy) DLBCL not otherwisespecified, DLBCL arising from low grade lymphoma, and high-grade B-cell lymphoma (2016 World Health Organization classification) who have received at least onesystemic treatment regimen
Measurable disease as defined by the 2014 Lugano Classification
Normal hepatic function or hepatic impairment as defined by the National CancerInstitute Organ Dysfunction Working Group hepatic impairment classification:
Arm A Normal hepatic function: bilirubin and aspartate aminotransferase (AST) ≤upper limit of normal (ULN)
Arm B Moderate hepatic impairment: bilirubin > 1.5 × to 3 × ULN (any AST)
Arm C Severe hepatic impairment: bilirubin > 3 × ULN (any AST)
ECOG performance status 0 to 2 for participants with normal hepatic function. ECOG 0to 3 for participants with moderate or severe hepatic impairment
Adequate organ function
Women of childbearing potential (WOCBP)* must agree to use a highly effective methodof contraception from the time of giving informed consent until at least 10 monthsafter the last dose of study drug. Men with female partners who are of childbearingpotential must agree to use a condom when sexually active or practice totalabstinence from the time of the first dose until at least 7 months after the lastdose of study drug.
Exclusion
Exclusion Criteria:
Previous therapy with loncastuximab tesirine
Allogenic or autologous stem cell transplant within 60 days prior to start of studydrug (C1D1)
Human immunodeficiency virus (HIV) seropositive
Serologic evidence of chronic hepatitis B virus (HBV) infection and unable orunwilling to receive standard prophylactic antiviral therapy or with detectable HBVviral load
Serologic evidence of hepatitis C virus (HCV) infection without completion ofcurative 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
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 theSponsor
Study Design
Connect with a study center
Hospital Sírio-Libanês - Brasília
Brasília, 70200-730
BrazilActive - Recruiting
Hospital Mãe de Deus - Centro Integrado de Oncologia
Porto Alegre, 90110-270
BrazilActive - Recruiting
A Beneficência Portuguesa de São Paulo - Unidade Mirant
São Paulo, 01323-030
BrazilActive - Recruiting
Albert Einstein Israelite Hospital
São Paulo, 05652-900
BrazilActive - Recruiting
Hospital 9 de Julho
São Paulo, 01409-002
BrazilActive - Recruiting
Hospital Sírio-Libanês - São Paulo
São Paulo, 01308-050
BrazilActive - Recruiting
Kyungpook National University Chilgok Hospital
Daegu, Daegu Gwang'yeogsi 41944
Korea, Republic ofActive - Recruiting
Dong-A University Hospital
Busan, Gyeongsangnam-do 602-812
Korea, Republic ofActive - Recruiting
Korea University Anam Hospital
Seoul, Seongbuk District 02841
Korea, Republic ofSite Not Available
Severance Hospital
Seoul, Seoul Teugbyeolsi 03722
Korea, Republic ofActive - Recruiting
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi] 03080
Korea, Republic ofActive - Recruiting
Koo Foundation Sun Yat-Sen Cancer Center
Taipei, Taiwan 112
TaiwanActive - Recruiting
National Taiwan University Hospital
Taipei, 100
TaiwanActive - Recruiting
The Oncology Institute of Hope & Innovation - Lynwood
Lynwood, California 90262
United StatesActive - Recruiting
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