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Monoclonal Antibodies

Venetoclax + Obinutuzumab for Chronic Lymphocytic Leukemia (ReVenG Trial)

Phase 2
Recruiting
Research Sponsored by AbbVie
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Received intervening treatment for CLL after completing previous treatment with a venetoclax + anti-CD20 antibody +/- X regimen
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights
No Placebo-Only Group

Summary

This trial will assess how well VenG works and how safe it is in adult participants with CLL who were previously treated with VenG.

Who is the study for?
Adults with recurring Chronic Lymphocytic Leukemia (CLL) who've previously responded to venetoclax-obinutuzumab treatment. Eligible participants are divided into two groups based on the time since their last dose and disease progression: more than 24 months for Cohort 1, or between 12-24 months for Cohort 2. Those who received other CLL treatments after VenG are excluded.
What is being tested?
The trial is testing retreatment with oral venetoclax and IV obinutuzumab in patients whose CLL returned after initial therapy. Participants will undergo a series of treatment cycles over several months to evaluate changes in disease activity and monitor any adverse events from the medications.
What are the potential side effects?
Potential side effects include typical reactions associated with cancer therapies such as nausea, fatigue, risk of infection due to low blood cell counts, liver function abnormalities, and infusion-related reactions from obinutuzumab.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have chronic lymphocytic leukemia needing treatment based on iwCLL 2018 criteria.
Select...
I completed a specific treatment for my cancer and it improved.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I've had treatment for CLL after my venetoclax and anti-CD20 therapy.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~15 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 15 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Overall response (OR) in Cohort 1 after end of combination treatment
Secondary study objectives
Duration of Response (DOR) in Cohort 1
OR in Cohort 1 after end of combination treatment
OR in Cohort 1 after end of treatment
+6 more

Side effects data

From 2022 Phase 3 trial • 389 Patients • NCT02005471
33%
Neutropenia
11%
SARS-CoV-2 test positive
11%
Sepsis
11%
Abdominal pain
11%
Pneumonia
11%
Rhinovirus infection
11%
COVID-19
11%
Gastroenteritis
11%
Pneumonia pseudomonal
11%
Electrocardiogram QT prolonged
11%
Anaemia
11%
Neutrophil count decreased
11%
Hypokalaemia
11%
Febrile neutropenia
11%
Supraventricular tachycardia
11%
Blood creatinine increased
11%
White blood cell count decreased
11%
Dermatitis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bendamustine + Rituximab Crossover Substudy
Venetoclax + Rituximab Re-Treatment Substudy
Venetoclax + Rituximab Main Study
Bendamustine + Rituximab Main Study

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Cohort 2 - venetoclax + obinutuzumabExperimental Treatment2 Interventions
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.
Group II: Cohort 1 - venetoclax + obinutuzumabExperimental Treatment2 Interventions
Participants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Venetoclax
2019
Completed Phase 3
~2240
Obinutuzumab
2014
Completed Phase 3
~3470

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
1,038 Previous Clinical Trials
523,214 Total Patients Enrolled
F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer InstituteUNKNOWN
ABBVIE INC.Study DirectorAbbVie
459 Previous Clinical Trials
163,999 Total Patients Enrolled

Media Library

Obinutuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04895436 — Phase 2
CLL Research Study Groups: Cohort 1 - venetoclax + obinutuzumab, Cohort 2 - venetoclax + obinutuzumab
CLL Clinical Trial 2023: Obinutuzumab Highlights & Side Effects. Trial Name: NCT04895436 — Phase 2
Obinutuzumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04895436 — Phase 2
~30 spots leftby Nov 2026
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