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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05512390
Registration number
NCT05512390
Ethics application status
Date submitted
22/08/2022
Date registered
23/08/2022
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)
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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
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Secondary ID [1]
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M22-716
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Diffuse Large B-Cell Lymphoma
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Chronic Lymphocytic Leukemia
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Follicular Lymphoma
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Condition category
Condition code
Cancer
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Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
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Cancer
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Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
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Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Dose-Limiting Toxicities (DLT)
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Assessment method [1]
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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).
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Timepoint [1]
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Day 21
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Primary outcome [2]
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Number of Participants with Adverse Events (AE)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 30 Months
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Primary outcome [3]
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Maximum Observed Serum Concentration (Cmax) of ABBV-319
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Assessment method [3]
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Maximum observed serum concentration of ABBV-319.
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Timepoint [3]
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Up to 6 Months
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Primary outcome [4]
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Time to Cmax (Tmax) of ABBV-319
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Assessment method [4]
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Time to Cmax of ABBV-319.
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Timepoint [4]
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Up to 6 Months
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Primary outcome [5]
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Terminal Phase Elimination Half-Life (t1/2) of ABBV-319
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Assessment method [5]
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Terminal phase elimination half-life of ABBV-319.
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Timepoint [5]
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Up to 6 Months
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Primary outcome [6]
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Area Under the Serum Concentration Versus Time Curve (AUC) of ABBV-319
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Assessment method [6]
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Area under the serum concentration versus time curve (AUC) of ABBV-319.
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Timepoint [6]
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Up to 6 Months
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Primary outcome [7]
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Antidrug Antibody (ADA)
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Assessment method [7]
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Incidence and concentration of anti-drug antibodies.
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Timepoint [7]
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Up to 6 Months
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Secondary outcome [1]
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Number of Participants with Response of Partial Response (PR) or Better per Disease-Specific Criteria
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Assessment method [1]
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Number of participants with response of PR or better per disease-specific criteria.
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Timepoint [1]
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Up to 6 Months
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Secondary outcome [2]
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Duration of Response (DOR)
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Assessment method [2]
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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.
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Timepoint [2]
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Up to 6 Months
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Secondary outcome [3]
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Time to Response
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Assessment method [3]
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Time to response is defined for participants achieving a CR/PR as the time from starting therapy to first a CR/PR.
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Timepoint [3]
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Up to 6 Months
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Secondary outcome [4]
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Progression Free Survival (PFS) Time
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Assessment method [4]
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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.
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Timepoint [4]
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Up to 30 Months
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Secondary outcome [5]
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Overall survival (OS) Time
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Assessment method [5]
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OS is defined as time from first study treatment to death due to any cause.
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Timepoint [5]
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Up to 30 Months
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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.
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Other
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Other design features
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Phase
Phase 1
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
26/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
7/02/2027
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Actual
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Sample size
Target
114
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
NSW,VIC,WA
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Recruitment hospital [1]
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Concord Hospital /ID# 249240 - Concord
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Recruitment hospital [2]
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St Vincent's Hospital Melbourne /ID# 247624 - Fitzroy Melbourne
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Recruitment hospital [3]
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One Clinical Research Pty Ltd /ID# 248392 - Nedlands
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Recruitment postcode(s) [1]
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2139 - Concord
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Recruitment postcode(s) [2]
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3065 - Fitzroy Melbourne
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Recruitment postcode(s) [3]
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6009 - Nedlands
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arizona
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Country [2]
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United States of America
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State/province [2]
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Florida
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Country [3]
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United States of America
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State/province [3]
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Minnesota
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Country [4]
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United States of America
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State/province [4]
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New York
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Country [5]
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United States of America
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State/province [5]
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North Carolina
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Country [6]
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United States of America
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State/province [6]
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Texas
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Country [7]
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Canada
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State/province [7]
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Ontario
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Country [8]
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Israel
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State/province [8]
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Tel-Aviv
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Country [9]
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Israel
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State/province [9]
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Yerushalayim
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
AbbVie
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Address
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Country
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT05512390
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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ABBVIE INC.
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Address
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AbbVie
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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ABBVIE CALL CENTER
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Address
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Country
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Phone
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844-663-3742
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05512390