Trial Title:
Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
NCT ID:
NCT05618028
Condition:
Diffuse Large B-Cell Lymphoma
Chronic Lymphocytic Leukemia
B Cell Malignancies
Non-Hodgkin's Lymphoma
Conditions: Official terms:
Lymphoma
Neoplasms
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large B-Cell, Diffuse
Conditions: Keywords:
Diffuse Large B-Cell Lymphoma
B-cell Malignancies
Chronic Lymphocytic Leukemia
Non-Hodgkin's Lymphoma
ABBV-525
Cancer
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABBV-525
Description:
Oral; Tablet
Arm group label:
ABBV-525 Dose Escalation
Arm group label:
ABBV-525 Dose Expansion
Arm group label:
ABBV-525 Dose Optimization
Summary:
B-cell malignancies are a group of cancers of B lymphocytes, a type of white blood cell
responsible for fighting infections. The purpose of this study is to assess safety,
tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy.
ABBV-525 is an investigational drug being developed for the treatment of B-Cell
Malignancies. Study doctors put the participants in groups called treatment arms.
Participants will receive ABBV-525 at different doses. Approximately 100 adult
participants will be enrolled in the study across sites worldwide.
In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525.
In part 2 (dose optimization), participants will receive one of two oral doses of
ABBV-525, until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose
expansion), participants will receive the RP2D oral dose of ABBV-525. The estimated
duration of the study is up to 64 months.
There may be higher treatment burden for participants in this trial compared to their
standard of care. Participants will attend regular visits during the study at a hospital
or clinic and may require frequent medical assessments, blood tests, and scans.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Dose Escalation (Part 1) Only: Participants with a documented diagnosis of one of
the following third line or later of treatment (3L)+ mature B-cell malignancies,
from the World Health Organization (WHO)-defined histologies as defined in the
protocol.
- Dose Optimization (Part 2) Only: Participants with documented diagnosis of chronic
lymphocytic leukemia (CLL) who are 3L+, +/- cysteine-to-serine point mutation at
residue 481 of BTK-domain active site (C481S with histology based on WHO criteria,
with measurable disease requiring treatment as defined by the International Workshop
on Chronic Lymphocytic Leukemia (iwCLL).
- Dose Expansion (Part 3) Only: Participants with documented diagnosis of non-germinal
center B cell (GCB) Diffuse large B-cell lymphoma (DLBCL) who are 3L+ chimeric
antigen 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 before
study enrollment.
- Participants with prior central nervous system (CNS) disease that has been
effectively treated may be eligible.
- Participants with resolved coronavirus disease 2019 (COVID-19) infection are
eligible.
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 first
dose 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 associated
with COVID-19 infection or known exposure to a confirmed case of COVID-19 infection
during screening. If participant has signs/symptoms suggestive of COVID-19
infection, the participant must have a negative molecular (eg, polymerase chain
reaction) test or 3 negative antigen test results at least 24 hours apart.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of California Los Angeles /ID# 246357
Address:
City:
Los Angeles
Zip:
90095
Country:
United States
Status:
Recruiting
Facility:
Name:
Yale University School of Medicine /ID# 259081
Address:
City:
New Haven
Zip:
06510
Country:
United States
Status:
Recruiting
Facility:
Name:
Mount Sinai Medical Center-Miami Beach /ID# 248251
Address:
City:
Miami Beach
Zip:
33140-2948
Country:
United States
Status:
Recruiting
Facility:
Name:
Fort Wayne Medical Oncology and Hematology, Inc /ID# 250113
Address:
City:
Fort Wayne
Zip:
46804
Country:
United States
Status:
Recruiting
Facility:
Name:
Indiana University Melvin and Bren Simon Comprehensive Cancer Center /ID# 259872
Address:
City:
Indianapolis
Zip:
46202-5116
Country:
United States
Status:
Recruiting
Facility:
Name:
Tulane Cancer Center Clinic /ID# 249586
Address:
City:
New Orleans
Zip:
70112
Country:
United States
Status:
Completed
Facility:
Name:
START Midwest /ID# 252359
Address:
City:
Grand Rapids
Zip:
49546
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 245459
Address:
City:
New York
Zip:
10065-6007
Country:
United States
Status:
Recruiting
Facility:
Name:
Levine Cancer Institute /ID# 246363
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Cincinnati /ID# 262288
Address:
City:
Cincinnati
Zip:
45267-0585
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas MD Anderson Cancer Center /ID# 245463
Address:
City:
Houston
Zip:
77030
Country:
United States
Status:
Recruiting
Facility:
Name:
Northwest Medical Specialties - Tacoma /ID# 260376
Address:
City:
Tacoma
Zip:
98405
Country:
United States
Status:
Recruiting
Facility:
Name:
Monash University /ID# 246366
Address:
City:
Clayton
Zip:
3168
Country:
Australia
Status:
Recruiting
Facility:
Name:
The Alfred Hospital /ID# 248592
Address:
City:
Melbourne
Zip:
3004
Country:
Australia
Status:
Recruiting
Facility:
Name:
UZ Gent /ID# 246462
Address:
City:
Gent
Zip:
9000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
Universitair Ziekenhuis Leuven /ID# 246461
Address:
City:
Leuven
Zip:
3000
Country:
Belgium
Status:
Recruiting
Facility:
Name:
CHRU Lille - Hopital Claude Huriez /ID# 252054
Address:
City:
Lille
Zip:
59037
Country:
France
Status:
Recruiting
Facility:
Name:
IUCT Oncopole /ID# 259409
Address:
City:
Toulouse Cedex 9
Zip:
31059
Country:
France
Status:
Recruiting
Facility:
Name:
Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 252062
Address:
City:
Berlin
Zip:
13353
Country:
Germany
Status:
Recruiting
Facility:
Name:
Shamir Medical Center /ID# 257711
Address:
City:
Beer Ya'akov
Zip:
70300
Country:
Israel
Status:
Recruiting
Facility:
Name:
The Chaim Sheba Medical Center /ID# 251442
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center-Hebrew University /ID# 251441
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Facility:
Name:
Rabin Medical Center /ID# 257665
Address:
City:
Haifa
Zip:
4941492
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hospital Clinic de Barcelona /ID# 246543
Address:
City:
Barcelona
Zip:
08036
Country:
Spain
Status:
Recruiting
Facility:
Name:
Hospital Universitario Ramon y Cajal /ID# 246540
Address:
City:
Madrid
Zip:
28034
Country:
Spain
Status:
Recruiting
Facility:
Name:
Leeds Teaching Hospitals NHS Trust /ID# 245470
Address:
City:
Leeds
Zip:
LS9 7TF
Country:
United Kingdom
Status:
Recruiting
Facility:
Name:
The Christie Hospital /ID# 250325
Address:
City:
Manchester
Zip:
M20 4BX
Country:
United Kingdom
Status:
Recruiting
Start date:
April 4, 2023
Completion date:
June 27, 2027
Lead sponsor:
Agency:
AbbVie
Agency class:
Industry
Source:
AbbVie
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05618028
