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)

A Multicenter, Open-Label, Phase 2 Study to Evaluate the Efficacy and Safety of Venetoclax-Obinutuzumab Retreatment in Patients With Recurring Chronic Lymphocytic Leukemia

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04895436

Acronym

ReVenG

Enrollment

Registered

2021-05-20

Start date

2022-03-28

Completion date

2029-01-01

Last updated

2026-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Lymphocytic Leukemia (CLL)

Keywords

Chronic Lymphocytic Leukemia (CLL), Venetoclax, ABT-199, Venclexta, GDC-0199, Obinutuzumab, Gazyva, GA101, Cancer, ReVenG

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.

Interventions

DRUGVenetoclax

Oral tablet

DRUGObinutuzumab

Intravenous (IV) infusion

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Exclusion criteria

\- Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen.

Design outcomes

Primary

Measure	Time frame	Description
Overall response (OR) in Cohort 1 after end of combination treatment	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.

Secondary

Measure	Time frame	Description
OR in Cohort 1 after end of combination treatment	9 months	OR rate is defined as the percentage of participants achieving a best response of CR or CRi
OR in Cohort 1 after end of treatment	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 to Response (TTR) in Cohort 1	15 months	TTR is defined as the time from first dose until first response (PR or better).
Duration of Response (DOR) in Cohort 1	15 months	DOR is defined as the time from first response (PR or better) until progressive disease (PD) or death.
Time to Next Treatment (TTNT) for CLL in Cohort 1	15 months	TTNT is defined as the time from first dose until first dose of a non-protocol anti-CLL therapy.
Progression-free Survival (PFS) in Cohort 1	15 months	PFS is defined as the time from first dose until PD or death.
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment	9 months	Percentage of participants with uMRD rate, measured in peripheral blood.
Overall Survival (OS) in Cohort 1	15 months	OS is defined as the time from first dose until death.
Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment	15 months	Percentage of participants with uMRD rate, measured in peripheral blood.

Countries

Australia, Austria, Brazil, Bulgaria, Germany, Israel, Italy, Romania, Spain, United Kingdom, United States

Contacts

CONTACTABBVIE CALL CENTER

abbvieclinicaltrials@abbvie.com844-663-3742

STUDY_DIRECTORABBVIE INC.

AbbVie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026