Venetoclax
DrugOral tablet
Other names: Venclexta, ABT-199, GDC-0199
NCT Number: NCT04895436
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Royal Adelaide Hospital /ID# 229898, Adelaide, South Australia, Australia
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Oral tablet
Other names: Venclexta, ABT-199, GDC-0199
Intravenous (IV) infusion
Other names: GA101, Gazyva
Time frame: 9 months
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.
Time frame: 9 months
OR rate is defined as the percentage of participants achieving a best response of CR or CRi
Time frame: 15 months
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.
Time frame: 15 months
TTR is defined as the time from first dose until first response (PR or better).
Time frame: 15 months
DOR is defined as the time from first response (PR or better) until progressive disease (PD) or death.
Time frame: 15 months
TTNT is defined as the time from first dose until first dose of a non-protocol anti-CLL therapy.
Time frame: 15 months
PFS is defined as the time from first dose until PD or death.
Time frame: 15 months
OS is defined as the time from first dose until death.
Time frame: 9 months
Percentage of participants with uMRD rate, measured in peripheral blood.
Time frame: 15 months
Percentage of participants with uMRD rate, measured in peripheral blood.
Contact information is provided by the study sponsor or research team.
AbbVie
Industry
A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia
Acronym: ReVenG
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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