Actively Recruiting
A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)
Led by AbbVie · Updated on 2026-01-16
154
Participants Needed
20
Research Sites
196 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
B-cell Lymphoma is an aggressive and rare cancer of a type of immune cells (a white blood cell responsible for fighting infections). Follicular Lymphoma is a slow-growing type of non-Hodgkin lymphoma. Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABBV-319 in adult participants in relapsed or refractory (R/R) diffuse large b-cell lymphoma (DLBCL), R/R follicular lymphoma (FL), or R/R CLL. Adverse events will be assessed. ABBV-319 is an investigational drug being developed for the treatment of R/R DLBCL, R/R FL, or R/R CLL. This study will include a dose escalation phase to determine the doses of ABBV-319 that will be used in the next phase and a dose expansion phase to determine the change in disease activity in participants with R/R DLBCL, R/R FL, and R/R CLL. Approximately 154 adult participants with R/R B cell lymphomas including R/R DLBCL, R/R FL, and R/R CLL will be enrolled in the study in sites world wide. In the Dose Escalation phase of the study participants will receive escalating intravenously infused doses of ABBV-319 in 21-day cycles, until the Phase 2 dose is determined. In the dose expansion phase of the study participants receive intravenously infused ABBV-319 in 21-day cycles. 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 an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.
CONDITIONS
Official Title
A Study to Assess the Adverse Events, Change in Disease Activity, and How Intravenously Infused ABBV-319 Moves Through the Bodies of Adult Participants With Relapsed or Refractory (R/R) Diffuse Large B-cell Lymphoma (DLBCL), Follicular Lymphoma (FL), or Chronic Lymphocytic Leukemia (CLL)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults diagnosed with B-cell malignancies including relapsed or refractory diffuse large B-cell lymphoma, follicular lymphoma, or chronic lymphocytic leukemia
- Measurable disease requiring treatment as defined by the 2014 Lugano Classification
- Laboratory values meeting study requirements
- For those previously treated with CD19-targeting therapy, a recent tumor biopsy must be collected
You will not qualify if you...
- Known active central nervous system disease or primary CNS lymphoma
- Known active infection or clinically significant uncontrolled medical conditions
- Eastern Cooperative Oncology Group (ECOG) performance status of 2 or higher
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 20 locations
1
University of Arizona Cancer Center - Tucson /ID# 247752
Tucson, Arizona, United States, 85724
Actively Recruiting
2
Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232
Miami, Florida, United States, 33136
Completed
3
Allina Health System /ID# 251782
Minneapolis, Minnesota, United States, 55407-1321
Actively Recruiting
4
University of Nebraska Medical Center /ID# 246715
Omaha, Nebraska, United States, 68198
Actively Recruiting
5
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
New York, New York, United States, 10065-6007
Actively Recruiting
6
Novant Health Presbyterian Medical Center /ID# 246719
Charlotte, North Carolina, United States, 28204
Actively Recruiting
7
Baylor Sammons Cancer Center /ID# 247715
Dallas, Texas, United States, 75246
Actively Recruiting
8
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234
San Antonio, Texas, United States, 78229
Actively Recruiting
9
Concord Repatriation General Hospital /ID# 249240
Concord, New South Wales, Australia, 2139
Actively Recruiting
10
St Vincent's Hospital Melbourne /ID# 247624
Fitzroy Melbourne, Victoria, Australia, 3065
Actively Recruiting
11
One Clinical Research Pty Ltd /ID# 248392
Nedlands, Western Australia, Australia, 6009
Actively Recruiting
12
Cross Cancer Institute /ID# 246717
Edmonton, Alberta, Canada, T6G 1Z2
Completed
13
University Health Network_Princess Margaret Cancer Centre /ID# 243936
Toronto, Ontario, Canada, M5G 2M9
Actively Recruiting
14
The Chaim Sheba Medical Center /ID# 254884
Ramat Gan, Tel Aviv, Israel, 5265601
Completed
15
Hadassah Medical Center-Hebrew University /ID# 254885
Jerusalem, Israel, 91120
Actively Recruiting
16
Seoul National University Hospital /ID# 263945
Seoul, Seoul Teugbyeolsi, South Korea, 03080
Actively Recruiting
17
Asan Medical Center /ID# 263220
Seoul, Seoul Teugbyeolsi, South Korea, 05505
Actively Recruiting
18
Samsung Medical Center /ID# 263294
Seoul, Seoul Teugbyeolsi, South Korea, 06351
Actively Recruiting
19
Hospital Universitario Marques de Valdecilla /ID# 262826
Santander, Cantabria, Spain, 39008
Actively Recruiting
20
Hospital Universitario Fundacion Jimenez Diaz /ID# 265198
Madrid, Spain, 28040
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
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