Trial 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)
NCT ID:
NCT05512390
Condition:
Diffuse Large B-Cell Lymphoma
Chronic Lymphocytic Leukemia
Follicular Lymphoma
Conditions: Official terms:
Lymphoma
Leukemia
Lymphoma, Follicular
Lymphoma, B-Cell
Leukemia, Lymphoid
Leukemia, Lymphocytic, Chronic, B-Cell
Lymphoma, Large B-Cell, Diffuse
Conditions: Keywords:
Diffuse Large B-Cell Lymphoma
Chronic Lymphocytic Leukemia
Follicular Lymphoma
Cancer
B-Cell Malignancies
ABBV-319
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Sequential Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
ABBV-319
Description:
Intravenous (IV); Infusion
Arm group label:
(ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants
Arm group label:
(ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants
Arm group label:
(ABBV-319) Follicular Lymphoma (FL) Participants
Arm group label:
Dose Escalation ABBV-319
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
recommended Phase 2 dose (RP2D) of ABBV-319 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 114 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 recommended 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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- For dose escalation (Part 1) only: Participants with documented diagnosis of B-cell
malignancies including those with histology based on criteria established by the
World Health Organization (WHO), and measurable disease requiring treatment, as per
the protocol.
- For the relapsed or refractory diffuse large b-cell lymphoma (DLBCL), follicular
lymphoma (FL), and Chronic lymphocytic leukemia (CLL) dose expansion cohorts (Part
2) only: Participants with documented diagnosis of one of the B-cell malignancies
noted in the protocol with histology based on criteria established by the WHO, and
measurable disease requiring treatment, as per the protocol.
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0
or 1.
- Laboratory values meeting the criteria noted in the protocol.
- For participants previously treated with a CD19-targeting therapy (eg, CD19
monoclonal antibody) a core or excision tumor biopsy subsequent to the most recent
CD19-targeting therapy must be collected.
- Participant must have measurable disease, as defined by the 2014 Lugano
Classification.
Exclusion Criteria:
- Known active central nervous system (CNS) disease, or primary CNS lymphoma.
- Know active infection or clinically significant uncontrolled conditions as per the
protocol.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Arizona Cancer Center - Tucson /ID# 247752
Address:
City:
Tucson
Zip:
85724
Country:
United States
Status:
Recruiting
Facility:
Name:
Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232
Address:
City:
Miami
Zip:
33136
Country:
United States
Status:
Recruiting
Facility:
Name:
Allina Health System /ID# 251782
Address:
City:
Minneapolis
Zip:
55407-1321
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Nebraska Medical Center /ID# 246715
Address:
City:
Omaha
Zip:
68198
Country:
United States
Status:
Recruiting
Facility:
Name:
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
Address:
City:
New York
Zip:
10065-6007
Country:
United States
Status:
Recruiting
Facility:
Name:
Novant Health Presbyterian Medical Center /ID# 246719
Address:
City:
Charlotte
Zip:
28204
Country:
United States
Status:
Recruiting
Facility:
Name:
Baylor Sammons Cancer Center /ID# 247715
Address:
City:
Dallas
Zip:
75246
Country:
United States
Status:
Recruiting
Facility:
Name:
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234
Address:
City:
San Antonio
Zip:
78229
Country:
United States
Status:
Recruiting
Facility:
Name:
Concord Repatriation General Hospital /ID# 249240
Address:
City:
Concord
Zip:
2139
Country:
Australia
Status:
Recruiting
Facility:
Name:
St Vincent's Hospital Melbourne /ID# 247624
Address:
City:
Fitzroy Melbourne
Zip:
3065
Country:
Australia
Status:
Recruiting
Facility:
Name:
One Clinical Research Pty Ltd /ID# 248392
Address:
City:
Nedlands
Zip:
6009
Country:
Australia
Status:
Recruiting
Facility:
Name:
Princess Margaret Cancer Centre /ID# 243936
Address:
City:
Toronto
Zip:
M5G 2M9
Country:
Canada
Status:
Recruiting
Facility:
Name:
The Chaim Sheba Medical Center /ID# 254884
Address:
City:
Ramat Gan
Zip:
5265601
Country:
Israel
Status:
Recruiting
Facility:
Name:
Hadassah Medical Center-Hebrew University /ID# 254885
Address:
City:
Jerusalem
Zip:
91120
Country:
Israel
Status:
Recruiting
Start date:
April 26, 2023
Completion date:
February 7, 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/NCT05512390
