Phase
Condition
Non-hodgkin's Lymphoma
Lymphoma
Hematologic Cancer
Treatment
ABBV-525
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Dose Escalation (Part 1) Only: Participants with a documented diagnosis of one ofthe following third line or later of treatment (3L)+ mature B-cell malignancies,from the World Health Organization (WHO)-defined histologies as defined in theprotocol.
Dose Optimization (Part 2) Only: Participants with documented diagnosis of chroniclymphocytic leukemia (CLL) who are 3L+, +/- cysteine-to-serine point mutation atresidue 481 of BTK-domain active site (C481S with histology based on WHO criteria,with measurable disease requiring treatment as defined by the International Workshopon Chronic Lymphocytic Leukemia (iwCLL).
Dose Expansion (Part 3) Only: Participants with documented diagnosis of non-germinalcenter B cell (GCB) Diffuse large B-cell lymphoma (DLBCL) who are 3L+ chimericantigen receptor T-cells (CAR-T)/Hematopoietic cell transplant (HCT)relapsed/refractory (R/R) and/or ineligible with histology based on WHO criteria,with measurable disease requiring treatment.
Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)of 0 or 1.
Participant has a life expectancy >= 12 weeks.
Adequate hematological and hepatic function as defined in the protocol.
Must have archival or freshly collected tumor tissue for correlative studies beforestudy enrollment.
Participants with prior central nervous system (CNS) disease that has beeneffectively treated may be eligible.
Participants with resolved coronavirus disease 2019 (COVID-19) infection areeligible.
Exclusion
Exclusion Criteria:
Known active CNS disease, or primary CNS lymphoma.
Known bleeding disorders.
Known history of stroke or intracranial hemorrhage within 12 months prior to firstdose of study treatment.
Uncontrolled active systemic infection, or active cytomegalovirus infection.
Active hepatitis B or C infection.
Known history of human immunodeficiency virus (HIV).
Known active COVID-19 infection. Participant must not have signs/symptoms associatedwith COVID-19 infection or known exposure to a confirmed case of COVID-19 infectionduring screening. If participant has signs/symptoms suggestive of COVID-19infection, the participant must have a negative molecular (eg, polymerase chainreaction) test or 3 negative antigen test results at least 24 hours apart.
Study Design
Connect with a study center
Paratus Clinical Research Woden /ID# 247859
Phillip, Australian Capital Territory 2606
AustraliaSite Not Available
Monash University /ID# 246366
Clayton, Victoria 3168
AustraliaActive - Recruiting
Alfred Health /ID# 248592
Melbourne, Victoria 3004
AustraliaActive - Recruiting
The Alfred Hospital /ID# 248592
Melbourne, Victoria 3004
AustraliaActive - Recruiting
UZ Gent /ID# 246462
Gent, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
Universitair Ziekenhuis Leuven /ID# 246461
Leuven, Vlaams-Brabant 3000
BelgiumActive - Recruiting
CHRU Lille - Hopital Claude Huriez /ID# 252054
Lille, Nord 59037
FranceActive - Recruiting
CHU Toulouse /ID# 252193
Toulouse, Occitanie 31300
FranceSite Not Available
IUCT Oncopole /ID# 259409
Toulouse Cedex 9, Occitanie 31059
FranceActive - Recruiting
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 252062
Berlin, 13353
GermanyActive - Recruiting
University of Cologne /ID# 246646
Cologne, 50923
GermanySite Not Available
Shamir Medical Center (Assaf Harofeh) /ID# 257711
Be'er Yaakov, HaMerkaz 70300
IsraelSite Not Available
Shamir Medical Center /ID# 257711
Beer Ya'akov, HaMerkaz 70300
IsraelActive - Recruiting
The Chaim Sheba Medical Center /ID# 251442
Ramat Gan, Tel-Aviv 5265601
IsraelActive - Recruiting
Hadassah Medical Center-Hebrew University /ID# 251441
Jerusalem, Yerushalayim 91120
IsraelActive - Recruiting
Rabin Medical Center /ID# 257665
Haifa, 4941492
IsraelSite Not Available
Rabin Medical Center /ID# 257665
Petah Tikva, 4941492
IsraelActive - Recruiting
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 246537
L'Hospitalet de Llobregat, Barcelona 08907
SpainActive - Recruiting
Hospital Clinic de Barcelona /ID# 246543
Barcelona, 08036
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron /ID# 245475
Barcelona, 08035
SpainActive - Recruiting
Institut Catala d'Oncologia -Hospital Duran i Reynals /ID# 246537
Barcelona, 08907
SpainSite Not Available
Hospital Universitario 12 de Octubre /ID# 246538
Madrid, 28041
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal /ID# 246540
Madrid, 28034
SpainActive - Recruiting
Leeds Teaching Hospitals NHS Trust /ID# 245470
Leeds, West Yorkshire LS9 7TF
United KingdomActive - Recruiting
The Royal Marsden NHS Foundation Trust /ID# 250324
London, SW3 6JJ
United KingdomActive - Recruiting
The Christie Hospital /ID# 250325
Manchester, M20 4BX
United KingdomActive - Recruiting
University of California Los Angeles /ID# 246357
Los Angeles, California 90095
United StatesActive - Recruiting
Yale University School of Medicine /ID# 259081
New Haven, Connecticut 06510
United StatesActive - Recruiting
Mount Sinai Medical Center-Miami Beach /ID# 248251
Miami Beach, Florida 33140-2948
United StatesActive - Recruiting
Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113
Fort Wayne, Indiana 46804
United StatesActive - Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872
Indianapolis, Indiana 46202-5116
United StatesActive - Recruiting
Norton Healthcare /ID# 246362
Louisville, Kentucky 40207-4700
United StatesSite Not Available
Tulane Cancer Center Clinic /ID# 249586
New Orleans, Louisiana 70112
United StatesCompleted
Cancer & Hematology Centers /ID# 252359
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
START Midwest /ID# 252359
Grand Rapids, Michigan 49546
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459
New York, New York 10065-6007
United StatesActive - Recruiting
Levine Cancer Ins, Carolina Me /ID# 246363
Charlotte, North Carolina 28204
United StatesActive - Recruiting
Levine Cancer Institute /ID# 246363
Charlotte, North Carolina 28204
United StatesActive - Recruiting
University Of Cincinnati Medical Center /ID# 262288
Cincinnati, Ohio 45219
United StatesActive - Recruiting
University of Cincinnati /ID# 262288
Cincinnati, Ohio 45267-0585
United StatesActive - Recruiting
University of Texas MD Anderson Cancer Center /ID# 245463
Houston, Texas 77030
United StatesActive - Recruiting
University of Utah Health Hospital /ID# 259924
Salt Lake City, Utah 84132
United StatesActive - Recruiting
Northwest Medical Specialties - Tacoma /ID# 260376
Tacoma, Washington 98405
United StatesActive - Recruiting
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