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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05512390




Registration number
NCT05512390
Ethics application status
Date submitted
22/08/2022
Date registered
23/08/2022
Date last updated
5/03/2024

Titles & IDs
Public 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)
Scientific title
A First In Human Multicenter, Open-Label Study to Determine the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of ABBV-319 in B-cell Malignancies
Secondary ID [1] 0 0
M22-716
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma 0 0
Chronic Lymphocytic Leukemia 0 0
Follicular Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ABBV-319

Experimental: Dose Escalation ABBV-319 - Participants with relapsed or refractory (R/R) B cell lymphomas including diffuse large b-cell lymphoma (DLBCL) or follicular lymphoma (FL), and Chronic lymphocytic leukemia (CLL) will receive escalating doses of ABBV-319 in 21-day cycles, until the recommended Phase 2 dose (RP2D) is determined.

Experimental: (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants - Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles.

Experimental: (ABBV-319) Follicular Lymphoma (FL) Participants - Participants with R/R FL will receive ABBV-319 in 21-day cycles.

Experimental: (ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants - Participants with R/R CLL will receive ABBV-319 in 21-day cycles.


Treatment: Drugs: ABBV-319
Intravenous (IV); Infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Dose-Limiting Toxicities (DLT)
Timepoint [1] 0 0
Day 21
Primary outcome [2] 0 0
Number of Participants with Adverse Events (AE)
Timepoint [2] 0 0
Up to 30 Months
Primary outcome [3] 0 0
Maximum Observed Serum Concentration (Cmax) of ABBV-319
Timepoint [3] 0 0
Up to 6 Months
Primary outcome [4] 0 0
Time to Cmax (Tmax) of ABBV-319
Timepoint [4] 0 0
Up to 6 Months
Primary outcome [5] 0 0
Terminal Phase Elimination Half-Life (t1/2) of ABBV-319
Timepoint [5] 0 0
Up to 6 Months
Primary outcome [6] 0 0
Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319
Timepoint [6] 0 0
Up to 6 Months
Primary outcome [7] 0 0
Antidrug Antibody (ADA)
Timepoint [7] 0 0
Up to 6 Months
Secondary outcome [1] 0 0
Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria
Timepoint [1] 0 0
Up to 6 Months
Secondary outcome [2] 0 0
Duration of Response (DOR)
Timepoint [2] 0 0
Up to 6 Months
Secondary outcome [3] 0 0
Time to Response
Timepoint [3] 0 0
Up to 6 Months
Secondary outcome [4] 0 0
Progression Free Survival (PFS) Time
Timepoint [4] 0 0
Up to 30 Months
Secondary outcome [5] 0 0
Overall survival (OS) Time
Timepoint [5] 0 0
Up to 30 Months

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
26/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
7/02/2027
Actual
Sample size
Target
114
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
Recruitment hospital [1] 0 0
Concord Hospital /ID# 249240 - Concord
Recruitment hospital [2] 0 0
St Vincent's Hospital Melbourne /ID# 247624 - Fitzroy Melbourne
Recruitment hospital [3] 0 0
One Clinical Research Pty Ltd /ID# 248392 - Nedlands
Recruitment postcode(s) [1] 0 0
2139 - Concord
Recruitment postcode(s) [2] 0 0
3065 - Fitzroy Melbourne
Recruitment postcode(s) [3] 0 0
6009 - Nedlands
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Minnesota
Country [4] 0 0
United States of America
State/province [4] 0 0
New York
Country [5] 0 0
United States of America
State/province [5] 0 0
North Carolina
Country [6] 0 0
United States of America
State/province [6] 0 0
Texas
Country [7] 0 0
Canada
State/province [7] 0 0
Ontario
Country [8] 0 0
Israel
State/province [8] 0 0
Tel-Aviv
Country [9] 0 0
Israel
State/province [9] 0 0
Yerushalayim

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
AbbVie
Address
Country

Ethics approval
Ethics application status

Summary
Brief 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.
Trial website
https://clinicaltrials.gov/ct2/show/NCT05512390
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Fax 0 0
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05512390