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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
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)
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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
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Secondary ID [1]
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2023-504599-10-00
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Secondary ID [2]
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M20-356
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Universal Trial Number (UTN)
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Trial acronym
ReVenG
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia (CLL)
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Condition category
Condition code
Cancer
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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(has expanded access)
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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
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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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Overall response (OR) in Cohort 1 after end of combination treatment
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Assessment method [1]
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OR is defined as the percentage of participants achieving a best response of partial remission (PR), nodular partial remission (nPR), complete remission with incomplete marrow recovery (CRi), or complete remission (CR). Disease assessments will be based on the 2018 International Workshop for Chronic Lymphocytic Leukemia (iwCLL) criteria for tumor response.
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Timepoint [1]
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9 months
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Secondary outcome [1]
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OR in Cohort 1 after end of combination treatment
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Assessment method [1]
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OR rate is defined as the percentage of participants achieving a best response of CR or CRi
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Timepoint [1]
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9 months
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Secondary outcome [2]
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OR in Cohort 1 after end of treatment
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Assessment method [2]
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OR is defined as the percentage of participants achieving a best response of PR, nPR, CRi, or CR. Disease assessments will be based on the 2018 iwCLL criteria for tumor response.
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Timepoint [2]
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15 months
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Secondary outcome [3]
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Time to Response (TTR) in Cohort 1
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Assessment method [3]
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TTR is defined as the time from first dose until first response (PR or better).
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Timepoint [3]
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15 months
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Secondary outcome [4]
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Duration of Response (DOR) in Cohort 1
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Assessment method [4]
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DOR is defined as the time from first response (PR or better) until progressive disease (PD) or death.
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Timepoint [4]
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15 months
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Secondary outcome [5]
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Time to Next Treatment (TTNT) for CLL in Cohort 1
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Assessment method [5]
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TTNT is defined as the time from first dose until first dose of a non-protocol anti-CLL therapy.
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Timepoint [5]
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15 months
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Secondary outcome [6]
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Progression-free Survival (PFS) in Cohort 1
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Assessment method [6]
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PFS is defined as the time from first dose until PD or death.
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Timepoint [6]
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15 months
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Secondary outcome [7]
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Overall Survival (OS) in Cohort 1
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Assessment method [7]
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OS is defined as the time from first dose until death.
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Timepoint [7]
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15 months
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Secondary outcome [8]
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Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment
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Assessment method [8]
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Percentage of participants with uMRD rate, measured in peripheral blood.
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Timepoint [8]
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9 months
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Secondary outcome [9]
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Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment
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Assessment method [9]
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Percentage of participants with uMRD rate, measured in peripheral blood.
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Timepoint [9]
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15 months
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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.
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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
- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.
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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
Parallel
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Other design features
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Phase
Phase 2
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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
28/03/2022
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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
28/01/2029
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Actual
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Sample size
Target
75
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
SA,VIC
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Recruitment hospital [1]
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Royal Adelaide Hospital /ID# 229898 - Adelaide
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Recruitment hospital [2]
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Northern Hospital Epping /ID# 229847 - Epping
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Recruitment hospital [3]
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Peter MacCallum Cancer Ctr /ID# 254634 - Melbourne
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Recruitment postcode(s) [1]
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5000 - Adelaide
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Recruitment postcode(s) [2]
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3076 - Epping
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Recruitment postcode(s) [3]
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3000 - Melbourne
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Recruitment outside Australia
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United States of America
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State/province [1]
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California
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United States of America
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Iowa
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United States of America
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Massachusetts
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United States of America
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Michigan
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Minnesota
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United States of America
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New Jersey
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United States of America
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North Carolina
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United States of America
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Wisconsin
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Austria
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Niederoesterreich
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Austria
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Oberoesterreich
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Austria
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Wien
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Austria
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Salzburg
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Brazil
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Rio Grande Do Sul
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Brazil
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Sao Paulo
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Bulgaria
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Vratsa
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Germany
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Baden-Wuerttemberg
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Germany
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Bayern
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Germany
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Mecklenburg-Vorpommern
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Germany
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Nordrhein-Westfalen
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Germany
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Sachsen-Anhalt
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Germany
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Schleswig-Holstein
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Germany
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Berlin
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Germany
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Bremen
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Germany
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Essen
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Germany
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Halle (Saale)
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Germany
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Hamburg
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Germany
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Homburg
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Germany
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Landshut
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Germany
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Muenchen
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Germany
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Paderborn
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Israel
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Tel-Aviv
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Israel
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Yerushalayim
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Israel
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Haifa
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Italy
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Piemonte
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Italy
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Terni
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Romania
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Bucuresti
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Spain
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Madrid
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United Kingdom
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State/province [38]
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Norfolk
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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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Other collaborator category [1]
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Other
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Name [1]
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F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute
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Address [1]
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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 (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.
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Trial website
https://clinicaltrials.gov/study/NCT04895436
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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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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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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)?
Yes
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What data in particular will be shared?
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols, analyses plans, clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.
Supporting document/s available: Study protocol, Statistical analysis plan (SAP), Clinical study report (CSR)
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When will data be available (start and end dates)?
For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/
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Available to whom?
Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous independent scientific research, and will be provided following review and approval of a research proposal and statistical analysis plan and execution of a data sharing statement. Data requests can be submitted at any time after approval in the US and/or EU and a primary manuscript is accepted for publication. For more information on the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
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Available for what types of analyses?
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How or where can data be obtained?
IPD available at link: https://vivli.org/ourmember/abbvie/
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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/NCT04895436