Phase
Condition
Lymphoma
Lymphoma, B-cell
Treatment
N/AClinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Key Inclusion Criteria:
- Adults ≥ 18 years of age who are willing and able to provide written informed consent
- Have an ECOG performance status of ≤ 1. Subjects with an ECOG performance status of 2may be enrolled with Medical Monitor approval.
- Pathologically confirmed diagnosis of DLBCL, as defined by the 2016 World HealthOrganization classification including DLBCL NOS high-grade B-cell lymphoma with MYCand BCL2 and/or BCL6 rearrangements, Epstein-barr virus (EBV) positive DLBCL, and Tcell rich B cell lymphoma (TCRBCL). Subjects with DLBCL transformed from indolentlymphoma (except for Richter's transformation) are eligible.
- Subjects must have progressive disease following at least two (2) lines of priorsystemic therapy for DLBCL; prior treatment must have included an anthracycline andrituximab (or another CD20-targeted agent).
- Subjects must have failed or be ineligible for ASCT or CAR-T
- Have at least one bi-dimensionally measurable lesion per Lugano (2014)
- Willing to provide pre-treatment and on-treatment tumor biopsy tissue.
- Meet protocol-specified laboratory requirements
- Life expectancy > 3 months.
Exclusion
Key Exclusion Criteria:
- Primary CNS lymphoma or active secondary CNS involvement and/or lymphomatousmeningitis
- Chemotherapy, immunotherapy, major surgery, or investigational agent treatment within 28 days of D0 or 5 half-lives, whichever is shorter
- Radiotherapy within 14 days of day 0
- Autologous stem cell transplant (ASCT) within ˂100 days prior to D0
- Chimeric antigen receptor T cell (CAR-T) therapy within ˂28 days prior to D0
- Diagnosis of immunodeficiency disorder or history of active autoimmune disease thathas required systemic treatment in the past 2 years
- Uncontrolled significant active infections (controlled Hepatitis B, Hepatitis C, orHIV may be eligible)
- Prior history of malignancy other than eligible lymphoma sub-types, unless the subjecthas been free of the disease for ≥ 2 years prior to the start of study treatment
Study Design
Study Description
Connect with a study center
Royal Adelaide Hospital
Adelaide, South Australia 5000
AustraliaActive - Recruiting
Box Hill Hospital
Melbourne, Victoria 3128
AustraliaActive - Recruiting
Epworth Freemasons Hospital
Melbourne, Victoria 3002
AustraliaActive - Recruiting
Westmead Hospital
Westmead, 2145
AustraliaActive - Recruiting
Saskatoon Cancer Center
Saskatoon, Saskatchewan S7H 4H4
CanadaActive - Recruiting
Hôpital Avicenne
Bobigny, 93000
FranceActive - Recruiting
Centre d'Oncologie de Gentilly
Nancy, 54000
FranceActive - Recruiting
Hôpital Privé du Confluent
Nantes, 44277
FranceActive - Recruiting
Centre Antoine Lacassagne
Nice, 06189
FranceActive - Recruiting
Hôpital Necker
Paris, 75015
FranceActive - Recruiting
Hôpital Saint-Antoine
Paris, 75012
FranceActive - Recruiting
Hôpital de la Pitié-Salpêtrière
Paris, 75013
FranceActive - Recruiting
CHU Bordeaux- Hôpital Haut Lévêque
Pessac, 33600
FranceActive - Recruiting
Centre Hospitalier de Périgueux
Périgueux, 24019
FranceActive - Recruiting
Centre Hospitalier de Saint-Quentin
Saint-Quentin, 02321
FranceActive - Recruiting
Debreceni Egyetem Klinikai Központ
Debrecen, 4032
HungaryActive - Recruiting
SzSzBM Korhazak es Egyetemi Oktatokorhaz
Nyíregyháza, 4400
HungaryActive - Recruiting
North Shore Hospital
Auckland, Auckland Province 0622
New ZealandActive - Recruiting
Palmerston North Hospital
Palmerston North, Manawatu 4414
New ZealandActive - Recruiting
Szpitale Pomorskie Sp. z o. o.
Gdynia, 85-519
PolandActive - Recruiting
Wojewódzki Szpital Specjalistyczny w Legnicy
Legnica, 59-220
PolandActive - Recruiting
SP ZOZ MSWiA z Warmińsko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, 10-228
PolandActive - Recruiting
Centrum Medyczne Pratia Poznań
Skórzewo, 60-185
PolandActive - Recruiting
Narodowy Instytut Onkologii im. Marii, Skłodowskiej-Curie
Warszawa, 02-781
PolandActive - Recruiting
Bucharest Oncology Institute "Prof.Dr.Al. Trestioreanu"
Bucharest, 022328
RomaniaActive - Recruiting
The Oncology Institute "Prof. Dr. Ion Chiricuţă" I.O.C.H.
Cluj-Napoca, 400015
RomaniaActive - Recruiting
University Clinical Center of Serbia
Belgrade, 11000
SerbiaActive - Recruiting
University Clinical Center Kragujevac
Kragujevac, 34000
SerbiaActive - Recruiting
Oncology Institute of Vojvodina
Sremska Kamenica, 21204
SerbiaActive - Recruiting
Clinical Hospital Center Zemun
Zemun, 11080
SerbiaActive - Recruiting
Hospital Santa Creu i Sant Pau
Barcelona, 08041
SpainActive - Recruiting
Hospital Universitario de Burgos
Burgos, 09006
SpainActive - Recruiting
Hospital Universitario Virgen del Rocío
Sevilla, 41013
SpainActive - Recruiting
Compassionate Cancer Care Medical Group
Fountain Valley, California 92708
United StatesActive - Recruiting
Boca Raton Regional Hospital
Boca Raton, Florida 33486
United StatesSite Not Available
BRCR Medical Center Inc.
Hollywood, Florida 33021
United StatesSite Not Available
BRCR Medical Center Inc.
Plantation, Florida 33322
United StatesSite Not Available
Comprehensive Hematology and Oncology
Saint Petersburg, Florida 33709
United StatesSite Not Available
Blood and Marrow Transplant Group of Georgia
Atlanta, Georgia 30342
United StatesActive - Recruiting
Indiana University Health Melvin and Bren Simon Cancer Center
Indianapolis, Indiana 46202
United StatesActive - Recruiting
Tulane Cancer Center Office of Clinical Research
New Orleans, Louisiana 70112
United StatesActive - Recruiting
Oncology Hematology West, PC dba Nebraska Cancer Specialists
Omaha, Nebraska 68130
United StatesActive - Recruiting
Christus St. Vincent Regional Cancer Center
Santa Fe, New Mexico 87505
United StatesActive - Recruiting
Brody School of Medicine at East Carolina University
Greenville, North Carolina 27834
United StatesActive - Recruiting
Gabrail Cancer Center Research
Canton, Ohio 44718
United StatesSite Not Available
Toledo Clinic Cancer Center
Toledo, Ohio 43623
United StatesActive - Recruiting
University of Toledo Medical Center
Toledo, Ohio 43614
United StatesSite Not Available
Allegheny Health Network (AHN) West Penn Hospital
Pittsburgh, Pennsylvania 15224
United StatesActive - Recruiting
Reading Hospital - McGlinn Cancer Institute
West Reading, Pennsylvania 19611
United StatesActive - Recruiting
Prairie Lakes Health Care System
Watertown, South Dakota 57201
United StatesSite Not Available
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