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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06428019




Registration number
NCT06428019
Ethics application status
Date submitted
20/05/2024
Date registered
24/05/2024

Titles & IDs
Public title
A Study to Evaluate the Risk of Tumor Lysis Syndrome (TLS) in Adult Participants Receiving Oral Venetoclax in Combination With Intravenously Infused Obinutuzumab or Oral Acalabrutinib for Previously Untreated Chronic Lymphocytic Leukemia (CLL)
Scientific title
A Prospective, Open-Label, Phase IIb/III Study to Evaluate the Risk of TLS and Optimization of the Initiation of Venetoclax in Combination With Obinutuzumab or Acalabrutinib With Different Ramp- Up Periods in Previously Untreated Subjects With CLL
Secondary ID [1] 0 0
2024-512147-23-00
Secondary ID [2] 0 0
M24-287
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia 0 0
Condition category
Condition code
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 - Venetoclax
Treatment: Drugs - Acalabrutinib
Treatment: Drugs - Obinutuzumab

Experimental: Arm A: Venetoclax + Obinutuzumab - Participants will receive venetoclax in combination with obinutuzumab, with a 5 week venetoclax ramp up.

Experimental: Arm B: Venetoclax + Acalabrutinib - Participants will receive venetoclax in combination with acalabrutinib, with a 5 week venetoclax ramp up.

Experimental: Arm C: Venetoclax + Acalabrutinib - Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up A.

Experimental: Arm D: Venetoclax + Acalabrutinib - Participants will receive venetoclax in combination with acalabrutinib, with a modified venetoclax ramp up B.


Treatment: Drugs: Venetoclax
Oral: Tablet

Treatment: Drugs: Acalabrutinib
Oral: Tablet

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

Outcomes
Primary outcome [1] 0 0
Part 1: Percentage of Participants with Treatment-Emergent Laboratory Tumor Lysis Syndrome (TLS)-Venetoclax
Timepoint [1] 0 0
Up to 28 Months
Primary outcome [2] 0 0
Part 1: Percentage of Participants with Hyperkalemia-Venetoclax
Timepoint [2] 0 0
Up to 28 Months
Secondary outcome [1] 0 0
Part 1: Percentage of Participants with Treatment-Emergent Laboratory TLS
Timepoint [1] 0 0
Up to 28 Months
Secondary outcome [2] 0 0
Part 1: Percentage of Participants with Hyperkalemia
Timepoint [2] 0 0
Up to 28 Months
Secondary outcome [3] 0 0
Part 1: Percentage of Participants with Treatment-Emergent TLS-Related Events
Timepoint [3] 0 0
Up to 28 Months
Secondary outcome [4] 0 0
Part 1: Percentage of Participants with Adverse Events (AE) of TLS
Timepoint [4] 0 0
Up to 28 Months
Secondary outcome [5] 0 0
Part 1: Percentage of Participants with Reduction of Tumor Burden from Baseline
Timepoint [5] 0 0
Up to 28 Months

Eligibility
Key inclusion criteria
* Diagnosis of documented, previously untreated, chronic lymphocytic leukemia (CLL) requiring treatment according to the 2018 international workshop on chronic lymphocytic leukemia (iwCLL) criteria and have a life expectancy of > 6 months.
* Previously untreated small lymphocytic lymphoma (SLL) meeting the 2018 iwCLL criteria for treatment will also be equally considered as CLL for eligibility, screening, treatment and evaluation.
* Eastern Cooperative Oncology Group (ECOG) performance status <= 2.
* Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening, unless cytopenia is due to marrow involvement of CLL as listed in the protocol.
* Creatinine clearance (CrCl) >= 30 mL/min using the Cockcroft-Gault formula are eligible for inclusion.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Active/uncontrolled infection, no Richter's transformation, no active immune thrombocytopenia.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled 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
Parallel
Other design features
Phase
Phase 3
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
5/08/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/12/2026
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 0 0
Calvary Mater Newcastle /ID# 267408 - Waratah
Recruitment hospital [2] 0 0
Townsville University Hospital /ID# 266954 - Townsville
Recruitment postcode(s) [1] 0 0
2298 - Waratah
Recruitment postcode(s) [2] 0 0
4814 - Townsville
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Colorado
Country [4] 0 0
United States of America
State/province [4] 0 0
Connecticut
Country [5] 0 0
United States of America
State/province [5] 0 0
Florida
Country [6] 0 0
United States of America
State/province [6] 0 0
Illinois
Country [7] 0 0
United States of America
State/province [7] 0 0
Indiana
Country [8] 0 0
United States of America
State/province [8] 0 0
Iowa
Country [9] 0 0
United States of America
State/province [9] 0 0
Louisiana
Country [10] 0 0
United States of America
State/province [10] 0 0
Maryland
Country [11] 0 0
United States of America
State/province [11] 0 0
Missouri
Country [12] 0 0
United States of America
State/province [12] 0 0
Oklahoma
Country [13] 0 0
United States of America
State/province [13] 0 0
Oregon
Country [14] 0 0
United States of America
State/province [14] 0 0
Rhode Island
Country [15] 0 0
United States of America
State/province [15] 0 0
Texas
Country [16] 0 0
United States of America
State/province [16] 0 0
Virginia
Country [17] 0 0
United States of America
State/province [17] 0 0
Washington
Country [18] 0 0
France
State/province [18] 0 0
Loire
Country [19] 0 0
France
State/province [19] 0 0
Moselle
Country [20] 0 0
France
State/province [20] 0 0
Paris
Country [21] 0 0
France
State/province [21] 0 0
Provence-Alpes-Cote-d Azur
Country [22] 0 0
France
State/province [22] 0 0
Pyrenees-Atlantiques
Country [23] 0 0
France
State/province [23] 0 0
Savoie
Country [24] 0 0
France
State/province [24] 0 0
Somme
Country [25] 0 0
France
State/province [25] 0 0
Argenteuil
Country [26] 0 0
France
State/province [26] 0 0
Orléans
Country [27] 0 0
Greece
State/province [27] 0 0
Achaia
Country [28] 0 0
Greece
State/province [28] 0 0
Attiki
Country [29] 0 0
Greece
State/province [29] 0 0
Evros
Country [30] 0 0
Puerto Rico
State/province [30] 0 0
Rio Piedras
Country [31] 0 0
Serbia
State/province [31] 0 0
Beograd
Country [32] 0 0
Serbia
State/province [32] 0 0
Nisavski Okrug
Country [33] 0 0
Serbia
State/province [33] 0 0
Sumadijski Okrug
Country [34] 0 0
Serbia
State/province [34] 0 0
Vojvodina
Country [35] 0 0
Serbia
State/province [35] 0 0
Novi Sad
Country [36] 0 0
Spain
State/province [36] 0 0
A Coruna
Country [37] 0 0
Spain
State/province [37] 0 0
Madrid
Country [38] 0 0
Spain
State/province [38] 0 0
Navarra
Country [39] 0 0
Spain
State/province [39] 0 0
Sevilla
Country [40] 0 0
Taiwan
State/province [40] 0 0
Kaohsiung
Country [41] 0 0
Taiwan
State/province [41] 0 0
Taipei
Country [42] 0 0
Taiwan
State/province [42] 0 0
Taichung
Country [43] 0 0
Taiwan
State/province [43] 0 0
Taoyuan City
Country [44] 0 0
United Kingdom
State/province [44] 0 0
Nottinghamshire

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
ABBVIE INC.
Address 0 0
AbbVie
Country 0 0
Phone 0 0
Fax 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
Fax 0 0
Email 0 0
[email protected]
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.


Results not provided in https://clinicaltrials.gov/study/NCT06428019