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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05512390
Other study ID # M22-716
Secondary ID
Status Recruiting
Phase Phase 1
First received
Last updated
Start date April 26, 2023
Est. completion date February 7, 2027

Study information

Verified date March 2024
Source AbbVie
Contact ABBVIE CALL CENTER
Phone 844-663-3742
Email abbvieclinicaltrials@abbvie.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 114
Est. completion date February 7, 2027
Est. primary completion date February 7, 2027
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
ABBV-319
Intravenous (IV); Infusion

Locations

Country Name City State
Australia Concord 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
Canada Princess Margaret Cancer Centre /ID# 243936 Toronto Ontario
Israel Hadassah Medical Center-Hebrew University /ID# 254885 Jerusalem Yerushalayim
Israel The Chaim Sheba Medical Center /ID# 254884 Ramat Gan Tel-Aviv
United States Novant Health Presbyterian Medical Center /ID# 246719 Charlotte North Carolina
United States Baylor Sammons Cancer Center /ID# 247715 Dallas Texas
United States Sylvester Comprehensive Cancer Center - University of Miami /ID# 247232 Miami Florida
United States Allina Health System /ID# 251782 Minneapolis Minnesota
United States Memorial Sloan Kettering Cancer Center-Koch Center /ID# 249246 New York New York
United States University of Texas Health San Antonio MD Anderson Cancer Center /ID# 256234 San Antonio Texas
United States University of Arizona Cancer Center - Tucson /ID# 247752 Tucson Arizona

Sponsors (1)

Lead Sponsor Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Australia,  Canada,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Dose-Limiting Toxicities (DLT) 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). Day 21
Primary Number of Participants with Adverse Events (AE) 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. Up to 30 Months
Primary Maximum Observed Serum Concentration (Cmax) of ABBV-319 Maximum observed serum concentration of ABBV-319. Up to 6 Months
Primary Time to Cmax (Tmax) of ABBV-319 Time to Cmax of ABBV-319. Up to 6 Months
Primary Terminal Phase Elimination Half-Life (t1/2) of ABBV-319 Terminal phase elimination half-life of ABBV-319. Up to 6 Months
Primary Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319 Area under the serum concentration versus time curve (AUC) of ABBV-319. Up to 6 Months
Primary Antidrug Antibody (ADA) Incidence and concentration of anti-drug antibodies. Up to 6 Months
Secondary Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria Number of participants with response of PR or better per disease-specific criteria. Up to 6 Months
Secondary Duration of Response (DOR) 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. Up to 6 Months
Secondary Time to Response Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR. Up to 6 Months
Secondary Progression Free Survival (PFS) Time 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. Up to 30 Months
Secondary Overall survival (OS) Time OS is defined as time from first study treatment to death due to any cause. Up to 30 Months
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