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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)

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]

2023-507637-19

Secondary ID [2]

M24-291

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Chronic Lymphocytic Leukemia

Small Lymphocytic Lymphoma

Condition category

Condition code

Cancer

Lymphoma (non Hodgkin's lymphoma) - High grade lymphoma

Cancer

Lymphoma (non Hodgkin's lymphoma) - Low grade lymphoma

Cancer

Leukaemia - Acute leukaemia

Cancer

Leukaemia - Chronic leukaemia

Cancer

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]

Treatment: Drugs

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Part A and B: Percentage of Participants With Adverse Events (AEs)

Timepoint [1]

Up to 5 Years

Primary outcome [2]

Part A: Maximum Administered Dose (MAD) of ABBV-453

Timepoint [2]

Up to 18 Months

Primary outcome [3]

Part A: Maximum Tolerated Dose (MTD) of ABBV-453

Timepoint [3]

Up to 18 Months

Secondary outcome [1]

Part A and B: Maximum Observed Plasma Concentration (Cmax) of ABBV-453

Timepoint [1]

Up to 30 Months

Secondary outcome [2]

Part A and B: Time to Maximum Observed Concentration (Tmax) of ABBV-453

Timepoint [2]

Up to 30 Months

Secondary outcome [3]

Part A and B: Area Under the Plasma/Serum Concentration Versus Time Curve (AUC) of ABBV-453

Timepoint [3]

Up to 30 Months

Secondary outcome [4]

Part A and B: Overall Response Rate (ORR)

Timepoint [4]

Up to 5 Years

Secondary outcome [5]

Part A and B: Duration of Response (DOR) for Participants with PR/nPR or Better

Timepoint [5]

Up to 5 Years

Secondary outcome [6]

Part A and B: Complete response rate (CRR)

Timepoint [6]

Up to 5 Years

Secondary outcome [7]

Part A and B: Duration of Complete Response (DOCR)

Timepoint [7]

Up to 5 Years

Secondary outcome [8]

Part A and B: Percentage of Participants Achieving an Minimal Residual Disease (MRD) Response among Participants Achieving a PR, nPR, CR, or CRi

Timepoint [8]

Up to 5 Years

Secondary outcome [9]

Part A and B: Progression-free survival (PFS)

Timepoint [9]

Up to 5 Years

Secondary outcome [10]

Part A and B: Overall survival (OS)

Timepoint [10]

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 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.

Minimum age

18 Years

Maximum age

No limit

Sex

Both males and females

Can healthy volunteers participate?

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

9/08/2024

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

21/07/2029

Actual

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW,QLD,VIC,WA

Recruitment hospital [1]

Royal Prince Alfred Hospital /ID# 263129 - Sydney

Recruitment hospital [2]

Gold coast University Hospital /ID# 255785 - SouthPort

Recruitment hospital [3]

Austin Health /ID# 256776 - Heidelberg

Recruitment hospital [4]

Royal Perth Hospital /ID# 256464 - Perth

Recruitment postcode(s) [1]

2050 - Sydney

Recruitment postcode(s) [2]

4215 - SouthPort

Recruitment postcode(s) [3]

3084 - Heidelberg

Recruitment postcode(s) [4]

6000 - Perth

Recruitment outside Australia

Country [1]

United States of America

State/province [1]

California

Country [2]

United States of America

State/province [2]

Montana

Country [3]

Germany

State/province [3]

Halle (Saale)

Country [4]

Germany

State/province [4]

Hamburg

Country [5]

Israel

State/province [5]

HaMerkaz

Country [6]

Israel

State/province [6]

Tel-Aviv

Country [7]

Israel

State/province [7]

Yerushalayim

Funding & Sponsors

Primary sponsor type

Commercial sector/industry

Name

AbbVie

Address

Country

Ethics approval

Ethics application status

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.

Trial website

https://clinicaltrials.gov/study/NCT06291220

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

ABBVIE INC.

Address

AbbVie

Country

Phone

Fax

Contact person for public queries

Name

ABBVIE CALL CENTER

Address

Country

Phone

844-663-3742

Fax

abbvieclinicaltrials@abbvie.com

Contact person for scientific queries

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

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

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For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06291220