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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT06291220
Registration number
NCT06291220
Ethics application status
Date submitted
27/02/2024
Date registered
4/03/2024
Titles & IDs
Public title
A Study Assessing Adverse Event and How Oral ABBV-453 Moves Through the Body in Adult Participants With Relapsed or Refractory (R/R) Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
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Scientific title
A Phase 1 Study Evaluating Safety, Pharmacokinetics, and Efficacy of ABBV-453 in Adult Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL)/Small Lymphocytic Lymphoma (SLL)
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Secondary ID [1]
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2023-507637-19
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Secondary ID [2]
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M24-291
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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:
Chronic Lymphocytic Leukemia
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Small Lymphocytic 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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0
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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 - Obinutuzumab
Treatment: Drugs - ABBV-453
Experimental: Part A: Cohort 1.1 ABBV-453 Dose A - Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose A is achieved, during the 5 year study duration.
Experimental: Part A: Cohort 1.2 ABBV-453 Dose B - Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose B is achieved, during the 5 year study duration.
Experimental: Part A: Cohort 1.3 ABBV-453 Dose C - Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose C is achieved, during the 5 year study duration.
Experimental: Part A: Cohort 1.4 ABBV-453 Dose D - Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose D is achieved, during the 5 year study duration.
Experimental: Part A: Cohort 1.5 ABBV-453 Dose E - Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose E is achieved, during the 5 year study duration.
Experimental: Part B: Cohort 2.1 ABBV-453 Dose E - Participants will receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the dose E is achieved, during the 5 year study duration.
Experimental: Part B: Cohort 2.2 ABBV-453 Dose E - Participants will no participate in the debulking period and receive escalating doses of ABBV-453, until the dose E is achieved, during the 5 year study duration.
Treatment: Drugs: Obinutuzumab
Intravenous Infusion
Treatment: Drugs: ABBV-453
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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Part A and B: Percentage of Participants With Adverse Events (AEs)
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Assessment method [1]
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An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above.
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Timepoint [1]
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Up to 5 Years
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Primary outcome [2]
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Part A: Maximum Administered Dose (MAD) of ABBV-453
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Assessment method [2]
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MAD is defined as the highest administered dose if no maximum tolerated dose (MTD) is determined.
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Timepoint [2]
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Up to 18 Months
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Primary outcome [3]
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Part A: Maximum Tolerated Dose (MTD) of ABBV-453
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Assessment method [3]
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MTD is defined as the highest dose administered that does not result in a final determination of de-escalate at that dose level.
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Timepoint [3]
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Up to 18 Months
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Secondary outcome [1]
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Part A and B: Maximum Observed Plasma Concentration (Cmax) of ABBV-453
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Assessment method [1]
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Cmax is defined as the maximum observed plasma/serum concentration of ABBV-453.
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Timepoint [1]
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Up to 30 Months
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Secondary outcome [2]
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Part A and B: Time to Maximum Observed Concentration (Tmax) of ABBV-453
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Assessment method [2]
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Tmax is defined as the time to maximum observed concentration of ABBV-453.
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Timepoint [2]
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Up to 30 Months
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Secondary outcome [3]
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Part A and B: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-453
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Assessment method [3]
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Area under the plasma/serum concentration versus time curve (AUC) of ABBV-453.
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Timepoint [3]
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Up to 30 Months
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Secondary outcome [4]
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Part A and B: Overall Response Rate (ORR)
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Assessment method [4]
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Percentage of participants achieving a complete response (CR), complete response with incomplete count recovery (CRi), partial response (PR), or nodular partial response (nPR) using disease-specific criteria per the International Workshop on Chronic Lymphocytic Leukemia (iwCLL, 2018).
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Timepoint [4]
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Up to 5 Years
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Secondary outcome [5]
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Part A and B: Duration of Response (DOR) for Participants with PR/nPR or Better
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Assessment method [5]
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DOR is defined as the time between the initial PR or better response assessment per Investigator according to iwCLL criteria to the time of progressive disease (PD) or death of any cause, whichever occurs earlier.
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Timepoint [5]
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Up to 5 Years
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Secondary outcome [6]
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Part A and B: Complete response rate (CRR)
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Assessment method [6]
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CRR is defined as the percentage of participants with a best overall response (BOR) of CR or CRi per Investigator review according to iwCLL for participants with relapsed or refractory CLL/SLL, regardless of reasons for study drug discontinuation, and prior to start of subsequent anti-cancer therapies in the participants receiving at least one dose of ABBV-453 monotherapy.
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Timepoint [6]
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Up to 5 Years
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Secondary outcome [7]
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Part A and B: Duration of Complete Response (DOCR)
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Assessment method [7]
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DOCR is defined as the time between the initial CR/CRi response assessment per Investigator according to iwCLL criteria to the time of PD or death of any cause, whichever occurs earlier.
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Timepoint [7]
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Up to 5 Years
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Secondary outcome [8]
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Part A and B: Percentage of Participants Achieving an Minimal Residual Disease (MRD) Response among Participants Achieving a PR, nPR, CR, or CRi
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Assessment method [8]
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MRD response is defined as \< 1 cell in 10,000 leukocytes (\< 10\^-4).
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Timepoint [8]
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Up to 5 Years
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Secondary outcome [9]
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Part A and B: Progression-free survival (PFS)
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Assessment method [9]
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PFS is defined as time from first study treatment to a documented PD (based on iwCLL criteria) as determined by the Investigator, or death due to any cause, whichever occurs earlier.
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Timepoint [9]
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Up to 5 Years
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Secondary outcome [10]
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Part A and B: Overall survival (OS)
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Assessment method [10]
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OS is defined as the time from the first date of study treatment until date of death due to any cause.
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Timepoint [10]
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Up to 5 Years
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Eligibility
Key inclusion criteria
* Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that has received at least 2 prior anti-cancer systemic therapies and does not have another therapy that is more appropriate at the judgement of the Investigator.
* Laboratory values meeting those listed in the protocol.
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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
* QT interval corrected for heart rate (QTc) using Fridericia's correction of > 470 msec (females) or > 450 msec (males), Grade 3 arrythmia, and/or other clinically significant cardiac abnormalities.
* Known to be B-cell leukemia/lymphoma 2 inhibitor (BCL-2i) refractory or has received a BCL-2i-containing regimen within (6 months) of starting study drug (e.g., venetoclax, lisaftoclax, BGV-11417).
* Has active human immunodeficiency virus (HIV) infection. HIV testing is not required unless required locally.
* Recent history (within 6 months) of:
* Congestive heart failure (defined as New York Heart Association, Class 2 or higher).
* Ischemic cardiovascular event.
* Cardiac arrhythmia requiring pharmacological or surgical intervention.
* Pericardial effusion.
* Pericarditis.
* Consumes known moderate or strong inhibitors of cytochrome P450 3A isoform subfamily (CYP3A) within 14 day or 5 half-lives of the drug (whichever is shorter) before the first dose of ABBV-453.
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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
9/08/2024
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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
21/07/2029
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Actual
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Sample size
Target
80
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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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Austin Health /ID# 256776 - Heidelberg
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Recruitment postcode(s) [1]
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3084 - Heidelberg
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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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Country [2]
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Israel
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State/province [2]
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HaMerkaz
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Country [3]
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Israel
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State/province [3]
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Tel-Aviv
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Country [4]
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Israel
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State/province [4]
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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
Chronic lymphocytic leukemia (CLL) is the most common leukemia in Western countries. The purpose of this study is to assess how well ABBV-453 works adult participants with relapsed/refractory (R/R) untreated CLL/small lymphocytic lymphoma (SLL). Adverse events, pharmacokinetics, and change in disease activity will be assessed. ABBV-453 is an investigational drug for the treatment of CLL and SLL. There are 2 parts to this study. In part A participants will be placed 1 of 5 cohorts with a specific target dose for each cohort and receive obinutuzumab during the debulking period followed escalating doses of ABBV-453, until the appropriate target dose is achieved. In part B participants will be placed in 2 cohorts and receive up to the maximum dose in part A, with cohort 2.1 including a debulking period (obinutuzumab) as in part A. Approximately 80 adult participants with previously R/R CLL/SLL will be enrolled in the study in approximately 28 sites across the world. Participants in part A will placed into 1 of 5 cohorts with a specific target dose for each cohort and will receive intravenous (IV) obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the appropriate target dose is achieved. Participants in part B will be place in one of 2 cohorts. Participants in cohort 2.1 will receive IV obinutuzumab as part of the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. Participants in cohort 2.2 will receive no treatment during the the debulking period, followed by escalating doses of oral ABBV-453 until the maximum target dose from part A is achieved. The estimated study duration is 5 years. 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. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.
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Trial website
https://clinicaltrials.gov/study/NCT06291220
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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/NCT06291220