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)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ABBV-319.
- Who it may be relevant to
- Registry conditions: Diffuse Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, Follicular Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Australia, Canada, Israel, South Korea +1
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official 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
Overview
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
- Drug ABBV-319
Intravenous (IV); Infusion
Primary outcome measures
- Number of Dose-Limiting Toxicities (DLT) [Time frame: Day 42]
- Number of Participants with Adverse Events (AE) [Time frame: Up to 30 Months]
- Maximum Observed Serum Concentration (Cmax) of ABBV-319 [Time frame: Up to 6 Months]
- Time to Cmax (Tmax) of ABBV-319 [Time frame: Up to 6 Months]
- Terminal Phase Elimination Half-Life (t1/2) of ABBV-319 [Time frame: Up to 6 Months]
- Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319 [Time frame: Up to 6 Months]
- Antidrug Antibody (ADA) [Time frame: Up to 6 Months]
Secondary outcome measures (5)
- Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria [Time frame: Up to 6 Months]
- Duration of Response (DOR) [Time frame: Up to 6 Months]
- Time to Response [Time frame: Up to 6 Months]
- Progression Free Survival (PFS) Time [Time frame: Up to 30 Months]
- Overall survival (OS) Time [Time frame: Up to 30 Months]
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.
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 8 centers
- University of Arizona Cancer Center - Tucson /ID# 247752 — Tucson
- Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232 — Miami
- Allina Health System /ID# 251782 — Minneapolis
- University of Nebraska Medical Center /ID# 246715 — Omaha
- Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246 — New York
- Novant Health Presbyterian Medical Center /ID# 246719 — Charlotte
- Baylor Sammons Cancer Center /ID# 247715 — Dallas
- University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234 — San Antonio
Australia · 3 centers
- Concord Repatriation General Hospital /ID# 249240 — Concord
- St Vincent's Hospital Melbourne /ID# 247624 — Fitzroy Melbourne
- One Clinical Research Pty Ltd /ID# 248392 — Nedlands
South Korea · 3 centers
- Seoul National University Hospital /ID# 263945 — Seoul
- Asan Medical Center /ID# 263220 — Seoul
- Samsung Medical Center /ID# 263294 — Seoul
Canada · 2 centers
- Cross Cancer Institute /ID# 246717 — Edmonton
- University Health Network_Princess Margaret Cancer Centre /ID# 243936 — Toronto
Israel · 2 centers
- The Chaim Sheba Medical Center /ID# 254884 — Ramat Gan
- Hadassah Medical Center-Hebrew University /ID# 254885 — Jerusalem
Spain · 2 centers
- Hospital Universitario Marques de Valdecilla /ID# 262826 — Santander
- Hospital Universitario Fundacion Jimenez Diaz /ID# 265198 — Madrid
Identifiers
NCT: NCT05512390 · M22-716