Chronic Lymphocytic Leukemia, Diffuse Large B-Cell Lymphoma, Follicular Lymphoma
Conditions
Keywords
Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma, Cancer, B-Cell Malignancies, ABBV-319
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 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.
Interventions
DRUGABBV-319
Intravenous (IV); Infusion
Sponsors
AbbVie
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. * 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. * Known active infection or clinically significant uncontrolled conditions as per the protocol. * Eastern Cooperative Oncology Group (ECOG) performance status \>= 2.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Dose-Limiting Toxicities (DLT) | Day 42 | A DLT is defined as any adverse event (AE) for which a clear alternative cause cannot be established (eg, attributed to the disease under study, another disease, or to a concomitant medication by the study investigators or medical monitor). |
| Number of Participants with Adverse Events (AE) | Up to 30 Months | AE is defined as any untoward medical occurrence in a participant or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. |
| Maximum Observed Serum Concentration (Cmax) of ABBV-319 | Up to 6 Months | Maximum observed serum concentration of ABBV-319. |
| Time to Cmax (Tmax) of ABBV-319 | Up to 6 Months | Time to Cmax of ABBV-319. |
| Terminal Phase Elimination Half-Life (t1/2) of ABBV-319 | Up to 6 Months | Terminal phase elimination half-life of ABBV-319. |
| Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319 | Up to 6 Months | Area under the serum concentration versus time curve (AUC) of ABBV-319. |
| Antidrug Antibody (ADA) | Up to 6 Months | Incidence and concentration of anti-drug antibodies. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria | Up to 6 Months | Number of participants with response of PR or better per disease-specific criteria. |
| Duration of Response (DOR) | Up to 6 Months | DOR is defined for participants achieving a complete response (CR)/PR as the time from the initial response per investigator review to disease progression or death of any cause, whichever occurs earlier. |
| Time to Response | Up to 6 Months | Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR. |
| Progression Free Survival (PFS) Time | Up to 30 Months | PFS is defined as time from first study treatment to a documented disease progression as determined by the investigator, or death due to any cause, whichever occurs earlier. |
| Overall survival (OS) Time | Up to 30 Months | OS is defined as time from first study treatment to death due to any cause. |
Countries
Australia, Canada, Israel, South Korea, Spain, United States
Contacts
STUDY_DIRECTORABBVIE INC.
AbbVie
Outcome results
None listed