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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 15 months
Awards & highlights

ReVenG Trial 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.Check my eligibility
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.See study design
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.

ReVenG Trial 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.

ReVenG Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Overall response (OR) in Cohort 1 after end of combination treatment
Secondary outcome measures
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%
Anaemia
11%
Gastroenteritis
11%
Abdominal pain
11%
Electrocardiogram QT prolonged
11%
Febrile neutropenia
11%
Pneumonia pseudomonal
11%
Sepsis
11%
SARS-CoV-2 test positive
11%
Dermatitis
11%
Pneumonia
11%
Blood creatinine increased
11%
Rhinovirus infection
11%
White blood cell count decreased
11%
Neutrophil count decreased
11%
COVID-19
11%
Supraventricular tachycardia
11%
Hypokalaemia
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

ReVenG 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
~1990
Obinutuzumab
2015
Completed Phase 3
~3250

Find a Location

Who is running the clinical trial?

AbbVieLead Sponsor
950 Previous Clinical Trials
496,853 Total Patients Enrolled
F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer InstituteUNKNOWN
ABBVIE INC.Study DirectorAbbVie
390 Previous Clinical Trials
141,644 Total Patients Enrolled

Media Library

Obinutuzumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04895436 — Phase 2
Chronic Lymphocytic Leukemia Research Study Groups: Cohort 1 - venetoclax + obinutuzumab, Cohort 2 - venetoclax + obinutuzumab
Chronic Lymphocytic Leukemia 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Could you please list other research that has been done on Venetoclax?

"Venetoclax was first researched in 2012 at CHU de Dijon. To date, there have been 99 completed studies with 291 more currently underway. Many of these trials are based out of Duluth, Minnesota."

Answered by AI

Are new participants being signed up for this research project at this time?

"This study, which is currently recruiting participants, was originally posted on 3/28/2022 and most recently updated on 11/9/2022."

Answered by AI

Could you inform me as to how many people are enrolled in this clinical trial?

"Affirmative, the clinical trial is recruiting participants. According to information on clinicaltrials.gov, the posting date was March 28th, 2022 and the most recent update was November 9th, 2022. They are looking for 75 individuals across 14 sites."

Answered by AI

For what condition is Venetoclax most often given to patients?

"haematologic malignancies including small lymphocytic lymphoma, chronic lymphocytic leukemia (cll), and lymphoid leukemia can all be treated using Venetoclax."

Answered by AI

Is this trial only taking place in North America?

"There are currently 14 clinical trial sites recruiting for this study, including St. Luke's Hospital of Duluth /ID# 250021 in Duluth, Moores Cancer Center at UC San Diego /ID# 230157 in La Jolla, and Fox Chase Cancer Center /ID# 246851 in Philadelphia."

Answered by AI

Does Venetoclax put patients at risk?

"Venetoclax is still in Phase 2 of clinical trials, so there is only limited data supporting its safety."

Answered by AI

Who else is applying?

What state do they live in?
North Carolina
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~22 spots leftby Feb 2025