Phase
Condition
Lymphoma, B-cell
Hematologic Cancer
Lymphoma
Treatment
Lenalidomide
Tafasitamab
Clinical Study ID
Ages 18-99 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Histologically-confirmed diagnosis of any of the following:
Diffuse large B-cell lymphoma not otherwise specified
T cell/histiocyte-rich large B-cell lymphoma
Epstein-Barr virus positive DLBCL of the elderly
Grade 3b follicular lymphoma
Composite lymphoma with a DLBCL component with a subsequent DLBCL relapse
Evidence of histological transformation from an earlier diagnosis of low gradelymphoma (ie, an indolent pathology such as follicular lymphoma, marginal zonelymphoma, chronic lymphocytic leukemia) into DLBCL, with a subsequent DLBCLrelapse
Willingness to undergo tumor biopsy requirements for the study, (or have archivallymph node or tissue block from the most recent biopsy, not to exceed 3 years priorto C1D1).
Willingness to undergo bone marrow biopsy/aspirate collections.
History of relapsed/progressive/recurrent disease according to the InternationalWorking Group response criteria after the most recent systemic therapy.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2.
Adequate hematologic, hepatic, and renal function,
Left ventricular ejection fraction (LVEF) ≥ 50%,
Willingness to avoid pregnancy or fathering children,
Exclusion
Exclusion Criteria:
- Any other histological type of lymphoma according to the WHO 2016 classification oflymphoid neoplasms, including:
primary mediastinal (thymic) large B-cell lymphoma,
Burkitt lymphoma,
Primary refractory diffuse large B-cell lymphoma (DLBCL),
History of double- or triple-hit DLBCL.
- Participants who, within 30 days prior to Cycle 1 Day 1, have:
Not discontinued CD20-targeted therapy, chemotherapy, radiotherapy,investigational anticancer therapy or other lymphoma-specific therapy
Undergone major surgery or suffered from significant traumatic injury
Received live vaccines or have an anticipated need for such vaccination whilereceiving study treatment
Required parenteral antimicrobial therapy for active, intercurrent infections
Have undergone ASCT within the period ≤ 3 months prior to signing consent.
Have undergone previous allogenic stem cell transplantation.
Inadequate recovery (> Grade 1) from prior treatment toxicity and/or complicationsfrom major surgery before Cycle 1 Day 1.
Have a history of deep venous thrombosis/embolism, threatening thromboembolism orknown thrombophilia or are at high risk for a thromboembolic event in the opinion ofthe investigator and who are not willing/able to take venous thromboembolic eventprophylaxis during the entire treatment period.
Prior history of malignancies other than DLBCL, unless disease-free for ≥ 5 yearsprior to screening.
Clinically significant cardiac disease, including unstable angina, acute myocardialinfarction, New York Heart Association Class II to IV congestive heart failure,uncontrolled arrhythmia, and/or cardiac conduction issues, within 6 months of Cycle 1 Day 1.
Any of the following positive tests:
Known seropositive for or history of active viral infection with HIV.
Known positive test result for hepatitis C (HCV antibody serology testing) anda positive test result for HCV RNA.
Known positive test results for chronic HBV infection (defined by HBsAgpositivity). Participants with occult or prior HBV infection (defined asnegative HBsAg and positive total HBcAb) may be included if HBV DNA wasundetectable
Study Design
Connect with a study center
Medical University Plovdiv
Plovdiv, 04000
BulgariaSite Not Available
Acibadem Cityclinica Mhat Tokuda
Sofia, 01407
BulgariaSite Not Available
Specialized Hospital For Active Treatment of Oncological Diseases - Sofia District Eood
Sofia, 01756
BulgariaSite Not Available
Umhat Alexandrovska Sofia
Sofia, 01431
BulgariaSite Not Available
Umhat Sv. Ivan Rilski Ead
Sofia, 01431
BulgariaSite Not Available
Clinical Hospital Dubrava
Zagreb, 10000
CroatiaSite Not Available
Clinical Hospital Merkur
Zagreb, 10000
CroatiaSite Not Available
University Hospital Centre Zagreb
Zagreb, 10000
CroatiaSite Not Available
Fakultni Nemocnice Olomouc
Olomouc, 779 00
CzechiaSite Not Available
Vseobecna Fakultni Nemocnice
Prague 2, 128 00
CzechiaSite Not Available
Aarhus University Hospital
Aarhus, 08200
DenmarkSite Not Available
Odense University Hospital
Odense, 05000
DenmarkSite Not Available
Helsinki University Central Hospital
Helsinki, FI-00029
FinlandSite Not Available
Kuopio University Hospital
Kuopio, 70210
FinlandSite Not Available
Oulu University Hospital
Oulu, 90420
FinlandSite Not Available
Tampere University Hospital
Tampere, 33520
FinlandSite Not Available
Turku University Hospital
Turku, 20520
FinlandSite Not Available
National Institute of Oncology
Budapest, 01122
HungarySite Not Available
Semmelweis Egyetem
Budapest, 01088
HungarySite Not Available
University of Debrecen
Debrecen, 04032
HungarySite Not Available
Markhot Ferenc Hospital
Eger, 03300
HungarySite Not Available
Markhot Ferenc Korhaz
Eger, 03300
HungarySite Not Available
Somogy Medyei Kaposi Mor Oktato Korhaz
Kaposvar, 07400
HungarySite Not Available
Bekes Megyei Kozponti Korhaz Pandy Kalman Tagkorhaza
Szeged, 06725
HungarySite Not Available
Bon Secours Hospital
Cork, T12 DV56
IrelandSite Not Available
Mater Misericordiae University Hospital
Dublin 7, D07AX57
IrelandSite Not Available
University Hospital Galway
Galway, H91 YR71
IrelandSite Not Available
Rambam Health Care Campus
Haifa, 31096
IsraelSite Not Available
Hadassah University Hospital
Jerusalem, 92210
IsraelSite Not Available
Shaare Zedek Mc
Jerusalem, 9103102
IsraelSite Not Available
Meir Medical Center
Kefar Sava, 44281
IsraelSite Not Available
Akershus University Hospital
Lorenskog, 01478
NorwaySite Not Available
Akershus University Hospital
Nordbyhagen, 01478
NorwaySite Not Available
Akershus University Hospital
Oslo, 1478
NorwaySite Not Available
Universitetssykehuset I Trondheim - St. Olavs Hospital
Trondheim, 07006
NorwaySite Not Available
Szpital Uniwersytecki Nr 2 Im Dr. Jana Biziela
Bydgoszcz, 85-168
PolandSite Not Available
Medical University of Gdansk
Gdansk, 80-211
PolandSite Not Available
Szpital Morski Im. Pck Sp. Z O.O
Gdynia, 81-519
PolandSite Not Available
University Public Hospital Nr 1
Lublin, 20-081
PolandSite Not Available
Oddzia Kliniczny Hematologii
Olsztyn, 10-228
PolandSite Not Available
Pratia Poznan
Skorzewo K. Poznania, 60-185
PolandSite Not Available
Pratia Poznan
Skórzewo, 60-185
PolandSite Not Available
Maria Sklodowska-Curie National Research Institute of Oncology
Warszawa, 02-0781
PolandSite Not Available
Uniwersytecki Szpital Kliniczny Im. Jana Mikulicza-Radeckiego
Wroclaw, 50-367
PolandSite Not Available
Coltea Clinical Hospital
Bucharest, 30167
RomaniaSite Not Available
Coltea Clinical Hospital
Bucureti, 30167
RomaniaSite Not Available
Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj-Napoca
Cluj-napoca, 400015
RomaniaSite Not Available
Institutul Regional de Oncologie Iasi
Iasi, 700483
RomaniaSite Not Available
Spitalul Clinic Judetean de Urgenta Targu Mures
Targu Mures, 540136
RomaniaSite Not Available
Clinic For Hematology, University Clinical Center Serbia
Belgrade, 11000
SerbiaSite Not Available
Clinical Center Kragujevac
Kragujevac, 34000
SerbiaSite Not Available
Clinic of Hematology Clinical Center of Vojvodina
Novi Sad, 21000
SerbiaSite Not Available
Institute For Pulmonary Diseases of Vojvodina
Sremska Kamenica, 21204
SerbiaSite Not Available
Ankara University Medical Faculty
Ankara, 06629
TurkeySite Not Available
Gazi University Hospital Gazi University Faculty of Medicine
Ankara, 06560
TurkeySite Not Available
Hacettepe University Cancer Institute Clinical Oncology Department
Ankara, 06230
TurkeySite Not Available
Ozel Liv Hospital Onkoloji Klinigi
Ankara, 06680
TurkeySite Not Available
Marmara Universitesi Pendik Egitim
Istanbul, 34899
TurkeySite Not Available
Vkf American Hospital
Istanbul, 34365
TurkeySite Not Available
Ege University Hospital
Izmir, 35040
TurkeySite Not Available
Ercyes University Medical School
Kayseri, 38039
TurkeySite Not Available
Tekrda-Nk Tp Fakltesi
Merkez, 59030
TurkeySite Not Available
Mersin University Medical Faculty
Mersin, 33000
TurkeySite Not Available
Hacettepe University Cancer Inst?Tute Clinical Oncology Department
Sihhiye, 06230
TurkeySite Not Available
Marmara Universitesi Pendik Egitim
Stanbul, 34899
TurkeySite Not Available
Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospital
Yenimahalle, 06200
TurkeyActive - Recruiting
Dr. Abdurrahman Yurtaslan Onkology Teaching and Research Hospitalerciyes Universitesi Tip Faklutesi
Yenimahalle, 06200
TurkeySite Not Available
Antrim Area Hospital Northern Health Social Care Trust
Antrim, BT41 2RL
United KingdomSite Not Available
Belfast Health and Social Care Trust, of Trust Headquarters
Belfast, BT9 7AB
United KingdomSite Not Available

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