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)
- Conditions
- Diffuse Large B-Cell LymphomaChronic Lymphocytic LeukemiaFollicular Lymphoma
- Interventions
- Registration Number
- NCT05512390
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 154
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Dose Escalation ABBV-319 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 doses of ABBV-319 that will be used in the next phase are determined. (ABBV-319) Diffuse Large B-cell Lymphoma (DLBCL) Participants ABBV-319 Participants with R/R DLBCL will receive ABBV-319 in 21-day cycles. (ABBV-319) Follicular Lymphoma (FL) Participants ABBV-319 Participants with R/R FL will receive ABBV-319 in 21-day cycles. (ABBV-319) Chronic Lymphocytic Leukemia (CLL) Participants ABBV-319 Participants with R/R CLL will receive ABBV-319 in 21-day cycles.
- Primary Outcome Measures
Name Time Method Antidrug Antibody (ADA) Up to 6 Months Incidence and concentration of anti-drug antibodies.
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.
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.
- Secondary Outcome Measures
Name Time Method Overall survival (OS) Time Up to 30 Months OS is defined as time from first study treatment to death due to any cause.
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.
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.
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.
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.
Trial Locations
- Locations (15)
University of Arizona Cancer Center - Tucson /ID# 247752
🇺🇸Tucson, Arizona, United States
Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232
🇺🇸Miami, Florida, United States
Allina Health System /ID# 251782
🇺🇸Minneapolis, Minnesota, United States
University of Nebraska Medical Center /ID# 246715
🇺🇸Omaha, Nebraska, United States
Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246
🇺🇸New York, New York, United States
Novant Health Presbyterian Medical Center /ID# 246719
🇺🇸Charlotte, North Carolina, United States
Baylor Sammons Cancer Center /ID# 247715
🇺🇸Dallas, Texas, United States
University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234
🇺🇸San Antonio, Texas, United States
Concord Repatriation General Hospital /ID# 249240
🇦🇺Concord, New South Wales, Australia
St Vincent's Hospital Melbourne /ID# 247624
🇦🇺Fitzroy Melbourne, Victoria, Australia
One Clinical Research Pty Ltd /ID# 248392
🇦🇺Nedlands, Western Australia, Australia
Cross Cancer Institute /ID# 246717
🇨🇦Edmonton, Alberta, Canada
University Health Network_Princess Margaret Cancer Centre /ID# 243936
🇨🇦Toronto, Ontario, Canada
The Chaim Sheba Medical Center /ID# 254884
🇮🇱Ramat Gan, Tel-Aviv, Israel
Hadassah Medical Center-Hebrew University /ID# 254885
🇮🇱Jerusalem, Israel