Phase
Condition
Non-hodgkin's Lymphoma
Lymphoma, B-cell
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)/small lymphocytic lymphoma (SLL) with histology based onWHO criteria, with measurable disease requiring treatment as defined by theInternational Workshop on Chronic Lymphocytic Leukemia (iwCLL).
Dose Expansion (Part 3) Only: Participants with documented diagnosis of one of the 3L+ mature B-cell malignancies based on WHO criteria listed in the protocol, withmeasurable disease requiring treatment.
Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)of 0, 1, or 2.
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 and/or chronic hepatitis B or C infection and/or the criteria listed in theprotocol.
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 (e.g., 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
Liverpool Hospital /ID# 260191
Liverpool, New South Wales 2170
AustraliaSite Not Available
Liverpool Hospital /ID# 260191
Liverpool 2159851, New South Wales 2155400 2170
AustraliaActive - Recruiting
Orange Health Service /ID# 260473
Orange 2154219, New South Wales 2155400 2800
AustraliaActive - Recruiting
Monash Health - Monash Medical Centre /ID# 246366
Clayton, Victoria 3168
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
AustraliaSite Not Available
Monash Health - Monash Medical Centre /ID# 246366
Clayton 2171400, Victoria 2145234 3168
AustraliaActive - Recruiting
The Alfred Hospital /ID# 248592
Melbourne 2158177, Victoria 2145234 3004
AustraliaActive - Recruiting
UZ Gent /ID# 246462
Gent, Oost-Vlaanderen 9000
BelgiumSite Not Available
UZ Gent /ID# 246462
Ghent 2797656, Oost-Vlaanderen 9000
BelgiumActive - Recruiting
Universitair Ziekenhuis Leuven /ID# 246461
Leuven, Vlaams-Brabant 3000
BelgiumSite Not Available
Universitair Ziekenhuis Leuven /ID# 246461
Leuven 2792482, Vlaams-Brabant 3000
BelgiumActive - Recruiting
CHRU Lille - Hopital Claude Huriez /ID# 252054
Lille, Nord 59037
FranceSite Not Available
CHRU Lille - Hopital Claude Huriez /ID# 252054
Lille 2998324, Nord 59037
FranceActive - Recruiting
CHU Toulouse /ID# 252193
Toulouse, Occitanie 31300
FranceSite Not Available
IUCT Oncopole /ID# 259409
Toulouse Cedex 9, Occitanie 31059
FranceSite Not Available
IUCT Oncopole /ID# 259409
Toulouse 2972315, Occitanie 11071623 31059
FranceActive - Recruiting
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 252062
Berlin, 13353
GermanyActive - Recruiting
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 252062
Berlin, 13353
GermanySite Not Available
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 252062
Berlin 2950159, 13353
GermanyCompleted
University of Cologne /ID# 246646
Cologne, 50923
GermanySite Not Available
Shamir Medical Center /ID# 257711
Beer Ya'akov, Central District 294904 70300
IsraelActive - Recruiting
Shamir Medical Center (Assaf Harofeh) /ID# 257711
Be'er Yaakov, HaMerkaz 70300
IsraelSite Not Available
Hadassah Medical Center-Hebrew University /ID# 251441
Jerusalem 281184, Jerusalem 293198 91120
IsraelActive - Recruiting
The Chaim Sheba Medical Center /ID# 251442
Ramat Gan 293788, Tel Aviv 293396 5265601
IsraelActive - Recruiting
The Chaim Sheba Medical Center /ID# 251442
Ramat Gan, Tel-Aviv 5265601
IsraelSite Not Available
Hadassah Medical Center-Hebrew University /ID# 251441
Jerusalem, Yerushalayim 91120
IsraelSite Not Available
Rabin Medical Center /ID# 257665
Haifa, 4941492
IsraelSite Not Available
Rabin Medical Center /ID# 257665
Petah Tikva, 4941492
IsraelSite Not Available
Rabin Medical Center /ID# 257665
Petah Tikva 293918, 4941492
IsraelActive - Recruiting
Rabin Medical Center. /ID# 257665
Petah Tikva 293918, 4941492
IsraelActive - Recruiting
Asan Medical Center /ID# 266341
Seoul, Seoul Teugbyeolsi 05505
Korea, Republic ofSite Not Available
Asan Medical Center /ID# 266341
Seoul 1835848, Seoul Teugbyeolsi 05505
South KoreaActive - Recruiting
Samsung Medical Center /ID# 266415
Seoul 1835848, Seoul Teugbyeolsi 06351
South KoreaActive - Recruiting
Seoul National University Hospital /ID# 266340
Seoul 1835848, Seoul Teugbyeolsi 03080
South KoreaActive - Recruiting
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 246537
L'Hospitalet de Llobregat, Barcelona 08907
SpainSite Not Available
Institut Català d'Oncologia (ICO) - L'Hospitalet /ID# 246537
L'Hospitalet de Llobregat 3120619, Barcelona 08907
SpainActive - Recruiting
Hospital Clinic de Barcelona /ID# 246543
Barcelona, 08036
SpainSite Not Available
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 Clinic de Barcelona /ID# 246543
Barcelona 3128760, 08036
SpainActive - Recruiting
Hospital Universitario Vall de Hebron /ID# 245475
Barcelona 3128760, 08035
SpainActive - Recruiting
Hospital Universitario 12 de Octubre /ID# 246538
Madrid, 28041
SpainSite Not Available
Hospital Universitario Ramon y Cajal /ID# 246540
Madrid, 28034
SpainActive - Recruiting
Hospital Universitario 12 de Octubre /ID# 246538
Madrid 3117735, 28041
SpainActive - Recruiting
Hospital Universitario Ramon y Cajal /ID# 246540
Madrid 3117735, 28034
SpainCompleted
National Taiwan University Hospital /ID# 266343
Taipei City, Taipei 7280290 100
TaiwanSite Not Available
China Medical University Hospital /ID# 266414
Taichung 1668399, 40447
TaiwanActive - Recruiting
National Taiwan University Hospital /ID# 266343
Taipei 1668341, 100
TaiwanActive - Recruiting
Leeds Teaching Hospitals NHS Trust /ID# 245470
Leeds, West Yorkshire LS9 7TF
United KingdomSite Not Available
Leeds Teaching Hospitals NHS Trust /ID# 245470
Leeds 2644688, West Yorkshire LS9 7TF
United KingdomActive - Recruiting
The Royal Marsden NHS Foundation Trust /ID# 250324
London, SW3 6JJ
United KingdomSite Not Available
The Royal Marsden NHS Foundation Trust /ID# 250324
London 2643743, SW3 6JJ
United KingdomActive - Recruiting
The Christie Hospital /ID# 250325
Manchester, M20 4BX
United KingdomSite Not Available
The Christie Hospital /ID# 250325
Manchester 2643123, M20 4BX
United KingdomActive - Recruiting
University of California Los Angeles /ID# 246357
Los Angeles, California 90095
United StatesSite Not Available
University of California Los Angeles /ID# 246357
Los Angeles 5368361, California 5332921 90095
United StatesActive - Recruiting
University of California Los Angeles Medical Center /ID# 246357
Los Angeles 5368361, California 5332921 90095
United StatesActive - Recruiting
Yale University School of Medicine /ID# 259081
New Haven, Connecticut 06510
United StatesSite Not Available
Yale University School of Medicine /ID# 259081
New Haven 4839366, Connecticut 4831725 06510
United StatesActive - Recruiting
Mount Sinai Medical Center-Miami Beach /ID# 248251
Miami Beach, Florida 33140-2948
United StatesSite Not Available
Mount Sinai Medical Center-Miami Beach /ID# 248251
Miami Beach 4164143, Florida 4155751 33140-2948
United StatesCompleted
Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113
Fort Wayne, Indiana 46804
United StatesSite Not Available
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872
Indianapolis, Indiana 46202-5116
United StatesSite Not Available
Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113
Fort Wayne 4920423, Indiana 4921868 46804
United StatesActive - Recruiting
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872
Indianapolis 4259418, Indiana 4921868 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 StatesSite Not Available
Tulane Cancer Center Clinic /ID# 249586
New Orleans 4335045, Louisiana 4331987 70112
United StatesCompleted
Cancer & Hematology Centers /ID# 252359
Grand Rapids, Michigan 49503
United StatesActive - Recruiting
START Midwest /ID# 252359
Grand Rapids, Michigan 49546
United StatesSite Not Available
START Midwest /ID# 252359
Grand Rapids 4994358, Michigan 5001836 49546
United StatesActive - Recruiting
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459
New York, New York 10065-6007
United StatesSite Not Available
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459
New York 5128581, New York 5128638 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 StatesSite Not Available
Atrium Health Levine Cancer Institute /ID# 246363
Charlotte 4460243, North Carolina 4482348 28204
United StatesActive - Recruiting
Levine Cancer Institute /ID# 246363
Charlotte 4460243, North Carolina 4482348 28204
United StatesActive - Recruiting
University Of Cincinnati Medical Center /ID# 262288
Cincinnati, Ohio 45219
United StatesSite Not Available
University of Cincinnati /ID# 262288
Cincinnati, Ohio 45267-0585
United StatesActive - Recruiting
University Of Cincinnati Medical Center /ID# 262288
Cincinnati 4508722, Ohio 5165418 45219
United StatesCompleted
University of Texas MD Anderson Cancer Center /ID# 245463
Houston, Texas 77030
United StatesSite Not Available
University of Texas MD Anderson Cancer Center /ID# 245463
Houston 4699066, Texas 4736286 77030
United StatesActive - Recruiting
University of Utah Health Hospital /ID# 259924
Salt Lake City, Utah 84132
United StatesSite Not Available
University of Utah Health Hospital /ID# 259924
Salt Lake City 5780993, Utah 5549030 84132
United StatesActive - Recruiting
Northwest Medical Specialties - Tacoma /ID# 260376
Tacoma, Washington 98405
United StatesSite Not Available
Northwest Medical Specialties - Tacoma /ID# 260376
Tacoma 5812944, Washington 5815135 98405
United StatesActive - Recruiting

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