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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT05618028
Registration number
NCT05618028
Ethics application status
Date submitted
14/11/2022
Date registered
16/11/2022
Date last updated
19/04/2024
Titles & IDs
Public title
Study to Evaluate Adverse Events and Change in Disease Activity in Adult Participants With B-Cell Malignancies Receiving Oral ABBV-525 Tablets
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Scientific title
A First-in-Human Study of ABBV-525 (MALT1 Inhibitor) in B-Cell Malignancies
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Secondary ID [1]
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M23-324
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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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B Cell Malignancies
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Non-Hodgkin's 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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Children's - Leukaemia & 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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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - ABBV-525
Experimental: ABBV-525 Dose Escalation - Participants will receive escalating doses of ABBV-525 until doses for optimization are determined, as part of an approximately 64 month study period.
Experimental: ABBV-525 Dose Optimization - Participants will receive one of two doses of ABBV-525 until the recommended phase 2 dose (RP2D) is determined, as part of an approximately 64 month study period.
Experimental: ABBV-525 Dose Expansion - Participants will receive the RP2D dose of ABBV-525, as part of an approximately 64 month study period.
Treatment: Drugs: ABBV-525
Oral; Tablet
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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 Participants With Adverse Events (AE)
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Assessment method [1]
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An AE is 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. A serious adverse event (SAE) is defined as any untoward medical occurrence, whether associated with study drug or not, that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or is an important medical event requiring medical or surgical intervention to prevent serious outcome.
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Timepoint [1]
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Up to Approximately 64 Months
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Primary outcome [2]
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Number of Participants With Dose-Limiting Toxicities (DLT)
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Assessment method [2]
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A DLT is defined as any 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 [2]
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Up to Approximately 28 Days
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Primary outcome [3]
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Number of Tumor Lysis Syndrome (TLS)
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Assessment method [3]
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TLS is confirmed by evaluation of electrolyte and fluid status and renal status including urine output.
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Timepoint [3]
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Up to Approximately 64 Months
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Primary outcome [4]
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Number of Participants With Clinically Significant Changes From Baseline in Clinical Laboratory Parameters
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Assessment method [4]
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Clinical laboratory parameters included tests of hematology, chemistry, urinalysis and prolactin. The investigator will assess the results for clinical significance.
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Timepoint [4]
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Up to Approximately 64 Months
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Primary outcome [5]
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Number of Participants With Clinically Significant Changes From Baseline in Vital Sign Parameters
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Assessment method [5]
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Vital sign parameters included body temperature, systolic and diastolic blood pressure, pulse rate, and respiratory rate. The investigator will assess the results for clinical significance.
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Timepoint [5]
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Up to Approximately 64 Months
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Primary outcome [6]
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Number of Participants With Clinically Significant Changes From Baseline in Electrocardiograms (ECG)
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Assessment method [6]
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A standard 12-lead ECG will be performed. The investigator will assess the results for clinical significance.
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Timepoint [6]
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Up to Approximately 64 Months
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Primary outcome [7]
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Maximum Observed Plasma Concentration (Cmax) of ABBV-525
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Assessment method [7]
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Maximum observed plasma concentration of ABBV-525.
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Timepoint [7]
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Up to 12 Months
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Primary outcome [8]
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Time to Cmax (Tmax) of ABBV-525
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Assessment method [8]
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Time to Cmax of ABBV-525.
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Timepoint [8]
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Up to 12 Months
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Primary outcome [9]
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Area Under the Plasma Concentration-Time Curve (AUC) of ABBV-525
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Assessment method [9]
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Area under the plasma concentration-time curve of ABBV-525.
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Timepoint [9]
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Up to 12 Months
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Secondary outcome [1]
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Overall Response Rate (ORR)
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Assessment method [1]
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ORR is defined as the percentage of participants with a best overall response (BOR) of complete response (CR)/very good partial response (VGPR)/partial response (PR) in participants receiving at least 1 dose of study drug.
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Timepoint [1]
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Up to Approximately 64 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 CR/VGPR/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 Approximately 64 Months
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Eligibility
Key inclusion criteria
- Dose Escalation (Part 1) Only: Participants with a documented diagnosis of one of the
following third line or later of treatment (3L)+ mature B-cell malignancies, from the
World Health Organization (WHO)-defined histologies as defined in the protocol.
- Dose Optimization (Part 2) Only: Participants with documented diagnosis of chronic
lymphocytic leukemia (CLL) who are 3L+, +/- cysteine-to-serine point mutation at
residue 481 of BTK-domain active site (C481S with histology based on WHO criteria,
with measurable disease requiring treatment as defined by the International Workshop
on Chronic Lymphocytic Leukemia (iwCLL).
- Dose Expansion (Part 3) Only: Participants with documented diagnosis of non-germinal
center B cell (GCB) Diffuse large B-cell lymphoma (DLBCL) who are 3L+ chimeric antigen
receptor T-cells (CAR-T)/Hematopoietic cell transplant (HCT) relapsed/refractory (R/R)
and/or ineligible with histology based on WHO criteria, with measurable disease
requiring treatment.
- Participant has an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)
of 0 or 1.
- Participant has a life expectancy >= 12 weeks.
- Adequate hematological and hepatic function as defined in the protocol.
- Must have archival or freshly collected tumor tissue for correlative studies before
study enrollment.
- Participants with prior central nervous system (CNS) disease that has been effectively
treated may be eligible.
- Participants with resolved coronavirus disease 2019 (COVID-19) infection are eligible.
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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 CNS disease, or primary CNS lymphoma.
- Known bleeding disorders.
- Known history of stroke or intracranial hemorrhage within 12 months prior to first
dose of study treatment.
- Uncontrolled active systemic infection, or active cytomegalovirus infection.
- Active hepatitis B or C infection.
- Known history of human immunodeficiency virus (HIV).
- Known active COVID-19 infection. Participant must not have signs/symptoms associated
with COVID-19 infection or known exposure to a confirmed case of COVID-19 infection
during screening. If participant has signs/symptoms suggestive of COVID-19 infection,
the participant must have a negative molecular (eg, polymerase chain reaction) test or
3 negative antigen test results at least 24 hours apart.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled 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
4/04/2023
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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
27/06/2027
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Actual
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Sample size
Target
100
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Monash University /ID# 246366 - Clayton
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Recruitment hospital [2]
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Alfred Health /ID# 248592 - Melbourne
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Recruitment postcode(s) [1]
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3168 - Clayton
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Recruitment postcode(s) [2]
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3004 - Melbourne
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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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California
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United States of America
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Florida
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United States of America
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State/province [3]
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Indiana
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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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Louisiana
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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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Michigan
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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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New York
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Country [7]
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United States of America
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State/province [7]
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North Carolina
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Country [8]
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United States of America
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State/province [8]
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Texas
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Country [9]
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United States of America
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State/province [9]
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Washington
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Country [10]
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Belgium
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State/province [10]
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Oost-Vlaanderen
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Country [11]
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Belgium
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State/province [11]
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Vlaams-Brabant
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Country [12]
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France
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State/province [12]
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Nord
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Country [13]
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France
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State/province [13]
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Toulouse Cedex 9
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Country [14]
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Israel
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State/province [14]
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H_efa
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Country [15]
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Israel
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State/province [15]
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HaMerkaz
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Country [16]
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Israel
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State/province [16]
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Tel-Aviv
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Country [17]
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Israel
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State/province [17]
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Yerushalayim
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Country [18]
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Spain
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State/province [18]
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Barcelona
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Spain
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State/province [19]
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Madrid
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Country [20]
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United Kingdom
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State/province [20]
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Manchester
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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 malignancies are a group of cancers of B lymphocytes, a type of white blood cell
responsible for fighting infections. The purpose of this study is to assess safety,
tolerability, pharmacokinetics and preliminary efficacy of ABBV-525 as a monotherapy.
ABBV-525 is an investigational drug being developed for the treatment of B-Cell Malignancies.
Study doctors put the participants in groups called treatment arms. Participants will receive
ABBV-525 at different doses. Approximately 100 adult participants will be enrolled in the
study across sites worldwide.
In part 1 (dose escalation), participants will receive escalating oral doses of ABBV-525. In
part 2 (dose optimization), participants will receive one of two oral doses of ABBV-525,
until the recommended phase 2 dose (RP2D) is determined. In part 3 (dose expansion),
participants will receive the RP2D oral dose of ABBV-525. The estimated duration of the study
is up to 64 months.
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 a hospital or
clinic and may require frequent medical assessments, blood tests, and scans.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05618028
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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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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
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05618028
Download to PDF