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)
Start Date
4/26/2023
Completion Date
2/1/2027
Summary
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.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
ABBV-319
Conditions
Locations
University of Arizona Cancer Center - Tucson /ID# 247752
Tucson, Arizona 85724
United States
Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232
Miami, Florida 33136
United States
Allina Health System /ID# 251782
Minneapolis, Minnesota 55407-1321
United States
University of Nebraska Medical Center /ID# 246715
Omaha, Nebraska 68198
United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
New York, New York 10065-6007
United States
Novant Health Presbyterian Medical Center /ID# 246719
Charlotte, North Carolina 28204
United States
Baylor Sammons Cancer Center /ID# 247715
Dallas, Texas 75246
United States
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234
San Antonio, Texas 78229
United States
Concord Repatriation General Hospital /ID# 249240
Concord, New South Wales 2139
Australia
St Vincent's Hospital Melbourne /ID# 247624
Fitzroy Melbourne, Victoria 3065
Australia
One Clinical Research Pty Ltd /ID# 248392
Nedlands, Western Australia 6009
Australia
Cross Cancer Institute /ID# 246717
Edmonton, Alberta T6G 1Z2
Canada
University Health Network_Princess Margaret Cancer Centre /ID# 243936
Toronto, Ontario M5G 2M9
Canada
The Chaim Sheba Medical Center /ID# 254884
Ramat Gan, Tel Aviv 5265601
Israel
Hadassah Medical Center-Hebrew University /ID# 254885
Jerusalem, 91120
Israel
Seoul National University Hospital /ID# 263945
Seoul, Seoul Teugbyeolsi 03080
South Korea
Asan Medical Center /ID# 263220
Seoul, Seoul Teugbyeolsi 05505
South Korea
Samsung Medical Center /ID# 263294
Seoul, Seoul Teugbyeolsi 06351
South Korea
Hospital Universitario Marques de Valdecilla /ID# 262826
Santander, Cantabria 39008
Spain
Hospital Universitario Fundacion Jimenez Diaz /ID# 265198
Madrid, 28040
Spain