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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT04895436




Registration number
NCT04895436
Ethics application status
Date submitted
19/05/2021
Date registered
20/05/2021
Date last updated
22/10/2024

Titles & IDs
Public title
Study to Assess Change in Disease Activity and Adverse Events of Oral Venetoclax With Intravenous (IV) Obinutuzumab in Adult Participants With Recurring Chronic Lymphocytic Leukemia (CLL)
Scientific title
A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia
Secondary ID [1] 0 0
2023-504599-10-00
Secondary ID [2] 0 0
M20-356
Universal Trial Number (UTN)
Trial acronym
ReVenG
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia (CLL) 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(has expanded access)
Description of intervention(s) / exposure
Treatment: Drugs - Venetoclax
Treatment: Drugs - Obinutuzumab

Experimental: Cohort 1 - venetoclax + obinutuzumab - Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.

Experimental: Cohort 2 - venetoclax + obinutuzumab - Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.


Treatment: Drugs: Venetoclax
Oral tablet

Treatment: Drugs: Obinutuzumab
Intravenous (IV) infusion
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Overall response (OR) in Cohort 1 after end of combination treatment
Timepoint [1] 0 0
9 months
Secondary outcome [1] 0 0
OR in Cohort 1 after end of combination treatment
Timepoint [1] 0 0
9 months
Secondary outcome [2] 0 0
OR in Cohort 1 after end of treatment
Timepoint [2] 0 0
15 months
Secondary outcome [3] 0 0
Time to Response (TTR) in Cohort 1
Timepoint [3] 0 0
15 months
Secondary outcome [4] 0 0
Duration of Response (DOR) in Cohort 1
Timepoint [4] 0 0
15 months
Secondary outcome [5] 0 0
Time to Next Treatment (TTNT) for CLL in Cohort 1
Timepoint [5] 0 0
15 months
Secondary outcome [6] 0 0
Progression-free Survival (PFS) in Cohort 1
Timepoint [6] 0 0
15 months
Secondary outcome [7] 0 0
Overall Survival (OS) in Cohort 1
Timepoint [7] 0 0
15 months
Secondary outcome [8] 0 0
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment
Timepoint [8] 0 0
9 months
Secondary outcome [9] 0 0
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment
Timepoint [9] 0 0
15 months

Eligibility
Key inclusion criteria
* Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatment for CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria.
* Previously completed venetoclax + anti-CD20 antibody +/- X regimen as a fixed duration first-line (1L) therapy and achieved documented response, defined as complete remission, complete remission with incomplete marrow recovery, partial remission, or nodular partial remission.
* More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between last dose of venetoclax and disease progression after completion of 1L treatment.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.

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
Parallel
Other design features
Phase
Phase 2
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
28/03/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
28/01/2029
Actual
Sample size
Target
75
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
SA,VIC
Recruitment hospital [1] 0 0
Royal Adelaide Hospital /ID# 229898 - Adelaide
Recruitment hospital [2] 0 0
Northern Hospital Epping /ID# 229847 - Epping
Recruitment hospital [3] 0 0
Peter MacCallum Cancer Ctr /ID# 254634 - Melbourne
Recruitment postcode(s) [1] 0 0
5000 - Adelaide
Recruitment postcode(s) [2] 0 0
3076 - Epping
Recruitment postcode(s) [3] 0 0
3000 - Melbourne
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
Iowa
Country [3] 0 0
United States of America
State/province [3] 0 0
Massachusetts
Country [4] 0 0
United States of America
State/province [4] 0 0
Michigan
Country [5] 0 0
United States of America
State/province [5] 0 0
Minnesota
Country [6] 0 0
United States of America
State/province [6] 0 0
New Jersey
Country [7] 0 0
United States of America
State/province [7] 0 0
North Carolina
Country [8] 0 0
United States of America
State/province [8] 0 0
Wisconsin
Country [9] 0 0
Austria
State/province [9] 0 0
Niederoesterreich
Country [10] 0 0
Austria
State/province [10] 0 0
Oberoesterreich
Country [11] 0 0
Austria
State/province [11] 0 0
Wien
Country [12] 0 0
Austria
State/province [12] 0 0
Salzburg
Country [13] 0 0
Brazil
State/province [13] 0 0
Rio Grande Do Sul
Country [14] 0 0
Brazil
State/province [14] 0 0
Sao Paulo
Country [15] 0 0
Bulgaria
State/province [15] 0 0
Vratsa
Country [16] 0 0
Germany
State/province [16] 0 0
Baden-Wuerttemberg
Country [17] 0 0
Germany
State/province [17] 0 0
Bayern
Country [18] 0 0
Germany
State/province [18] 0 0
Mecklenburg-Vorpommern
Country [19] 0 0
Germany
State/province [19] 0 0
Nordrhein-Westfalen
Country [20] 0 0
Germany
State/province [20] 0 0
Saarland
Country [21] 0 0
Germany
State/province [21] 0 0
Sachsen-Anhalt
Country [22] 0 0
Germany
State/province [22] 0 0
Schleswig-Holstein
Country [23] 0 0
Germany
State/province [23] 0 0
Berlin
Country [24] 0 0
Germany
State/province [24] 0 0
Bremen
Country [25] 0 0
Germany
State/province [25] 0 0
Essen
Country [26] 0 0
Germany
State/province [26] 0 0
Halle (Saale)
Country [27] 0 0
Germany
State/province [27] 0 0
Hamburg
Country [28] 0 0
Germany
State/province [28] 0 0
Landshut
Country [29] 0 0
Germany
State/province [29] 0 0
Paderborn
Country [30] 0 0
Israel
State/province [30] 0 0
Tel-Aviv
Country [31] 0 0
Israel
State/province [31] 0 0
Yerushalayim
Country [32] 0 0
Israel
State/province [32] 0 0
Haifa
Country [33] 0 0
Italy
State/province [33] 0 0
Piemonte
Country [34] 0 0
Italy
State/province [34] 0 0
Terni
Country [35] 0 0
Romania
State/province [35] 0 0
Bucuresti
Country [36] 0 0
Spain
State/province [36] 0 0
Madrid
Country [37] 0 0
United Kingdom
State/province [37] 0 0
Norfolk

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
AbbVie
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Chronic lymphocytic leukemia (CLL) is the most common leukemia (cancer of blood cells). The purpose of this study is to assess retreatment with venetoclax-obinutuzumab (VenG) in participants previously treated with fixed duration first-line (IL) therapy of venetoclax in combination with an anti-CD20 antibody +/- X (where X is any additional drug). Adverse events and change in disease activity will be assessed.

Venetoclax is an approved drug for the treatment of CLL. Study doctors put the participants in 1 of 2 groups, called cohorts, based on when symptoms of CLL came back after previous treatment in first-line. Approximately 75 adult participants with CLL who have been treated with venetoclax in combination with an anti-CD20 antibody +/- X will be enrolled in the study in approximately 60 sites worldwide.

Participants will receive intravenous (IV) obinutuzumab + oral venetoclax (VenG) in 28-day cycles for a total of 6 cycles per cohort, followed by 6 to 18 cycles of venetoclax alone, for a total treatment of 12 to 24 cycles, depending on the cohort.

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, checking for side effects and completing questionnaires.
Trial website
https://clinicaltrials.gov/study/NCT04895436
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



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT04895436