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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
Date last updated
4/06/2025

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)
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)
Secondary ID [1] 0 0
2023-507637-19
Secondary ID [2] 0 0
M24-291
Universal Trial Number (UTN)
Trial acronym
453 Ph1 CLL
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Small Lymphocytic Lymphoma 0 0
Condition category
Condition code
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma
Cancer 0 0 0 0
Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
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

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Part A and B: Percentage of Participants With Adverse Events (AEs)
Assessment method [1] 0 0
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.
Timepoint [1] 0 0
Up to 5 Years
Primary outcome [2] 0 0
Part A: Maximum Administered Dose (MAD) of ABBV-453
Assessment method [2] 0 0
MAD is defined as the highest administered dose if no maximum tolerated dose (MTD) is determined.
Timepoint [2] 0 0
Up to 18 Months
Primary outcome [3] 0 0
Part A: Maximum Tolerated Dose (MTD) of ABBV-453
Assessment method [3] 0 0
MTD is defined as the highest dose administered that does not result in a final determination of de-escalate at that dose level.
Timepoint [3] 0 0
Up to 18 Months
Secondary outcome [1] 0 0
Part A and B: Maximum Observed Plasma Concentration (Cmax) of ABBV-453
Assessment method [1] 0 0
Cmax is defined as the maximum observed plasma/serum concentration of ABBV-453.
Timepoint [1] 0 0
Up to 30 Months
Secondary outcome [2] 0 0
Part A and B: Time to Maximum Observed Concentration (Tmax) of ABBV-453
Assessment method [2] 0 0
Tmax is defined as the time to maximum observed concentration of ABBV-453.
Timepoint [2] 0 0
Up to 30 Months
Secondary outcome [3] 0 0
Part A and B: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-453
Assessment method [3] 0 0
Area under the plasma/serum concentration versus time curve (AUC) of ABBV-453.
Timepoint [3] 0 0
Up to 30 Months
Secondary outcome [4] 0 0
Part A and B: Overall Response Rate (ORR)
Assessment method [4] 0 0
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).
Timepoint [4] 0 0
Up to 5 Years
Secondary outcome [5] 0 0
Part A and B: Duration of Response (DOR) for Participants with PR/nPR or Better
Assessment method [5] 0 0
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.
Timepoint [5] 0 0
Up to 5 Years
Secondary outcome [6] 0 0
Part A and B: Complete response rate (CRR)
Assessment method [6] 0 0
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.
Timepoint [6] 0 0
Up to 5 Years
Secondary outcome [7] 0 0
Part A and B: Duration of Complete Response (DOCR)
Assessment method [7] 0 0
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.
Timepoint [7] 0 0
Up to 5 Years
Secondary outcome [8] 0 0
Part A and B: Percentage of Participants Achieving an Minimal Residual Disease (MRD) Negativity Among Participants Achieving a PR, nPR, CR, or CRi
Assessment method [8] 0 0
MRD response is defined as \< 1 cell in 10,000 leukocytes (\< 10\^-4).
Timepoint [8] 0 0
Up to 5 Years
Secondary outcome [9] 0 0
Part A and B: Progression-free survival (PFS)
Assessment method [9] 0 0
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.
Timepoint [9] 0 0
Up to 5 Years
Secondary outcome [10] 0 0
Part A and B: Overall survival (OS)
Assessment method [10] 0 0
OS is defined as the time from the first date of study treatment until date of death due to any cause.
Timepoint [10] 0 0
Up to 5 Years

Eligibility
Key inclusion criteria
* Relapsed/refractory (R/R) chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL) that has received at least 2 prior systemic therapies and have no available (or established) therapies known to provide clinical benefit and to which the participant would consent to receiving.
* Laboratory values meeting those listed in the protocol.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC,WA
Recruitment hospital [1] 0 0
Royal Prince Alfred Hospital /ID# 263129 - Sydney
Recruitment hospital [2] 0 0
Gold coast University Hospital /ID# 255785 - SouthPort
Recruitment hospital [3] 0 0
Austin Health /ID# 256776 - Heidelberg
Recruitment hospital [4] 0 0
Royal Perth Hospital /ID# 256464 - Perth
Recruitment postcode(s) [1] 0 0
2050 - Sydney
Recruitment postcode(s) [2] 0 0
4215 - SouthPort
Recruitment postcode(s) [3] 0 0
3084 - Heidelberg
Recruitment postcode(s) [4] 0 0
6000 - Perth
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Montana
Country [3] 0 0
United States of America
State/province [3] 0 0
North Carolina
Country [4] 0 0
United States of America
State/province [4] 0 0
Texas
Country [5] 0 0
Germany
State/province [5] 0 0
Baden-Wuerttemberg
Country [6] 0 0
Germany
State/province [6] 0 0
Schleswig-Holstein
Country [7] 0 0
Germany
State/province [7] 0 0
Berlin
Country [8] 0 0
Germany
State/province [8] 0 0
Halle (Saale)
Country [9] 0 0
Germany
State/province [9] 0 0
Hamburg
Country [10] 0 0
Israel
State/province [10] 0 0
HaMerkaz
Country [11] 0 0
Israel
State/province [11] 0 0
Tel-Aviv
Country [12] 0 0
Israel
State/province [12] 0 0
Yerushalayim
Country [13] 0 0
Italy
State/province [13] 0 0
Milano
Country [14] 0 0
Italy
State/province [14] 0 0
Bologna
Country [15] 0 0
Italy
State/province [15] 0 0
Perugia

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Email 0 0
Contact person for public queries
Name 0 0
ABBVIE CALL CENTER
Address 0 0
Country 0 0
Phone 0 0
844-663-3742
Email 0 0
abbvieclinicaltrials@abbvie.com
Contact person for scientific queries

Data sharing statement


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.