AzTrials
AzTrials

Chronic Lymphocytic Leukemia (CLL)Phase 2ReVenGNCT04895436

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 Phase 2 study testing Venetoclax and Obinutuzumab in people with Chronic Lymphocytic Leukemia (CLL), run by AbbVie at 58 sites in 11 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record

Search all trials

Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphocytic Leukemia (CLL)
What is being tested?
Venetoclax and Obinutuzumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
58 sitesin 11 countries
Study dates
28 Mar 2022to Jan 2029
Phase
Phase 2

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

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

Trial locations and contacts

58 sites in 11 countries. Contact the study team or a site near you to ask about taking part.

ABBVIE CALL CENTER contact

844-663-3742

abbvieclinicaltrials@abbvie.com

58 sites in 11 countries

Germany17 sites, 15 recruiting

  • Onkologische Schwerpunktpraxis /ID# 245465

    Berlin, 10707

    Recruiting

  • Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 248748

    Berlin, 13353

    Recruiting

  • Duplicate_DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238

    Bremen, 28239

    Completed

  • Universitaetsklinikum Koeln /ID# 230296

    Cologne, North Rhine-Westphalia, 50937

    Recruiting

  • BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 230168

    Dresden, Saxony, 01307

    Recruiting

  • Universitaetsklinikum Essen /ID# 230181

    Essen, 45147

    Recruiting

  • Universitaetsklinikum Halle (Saale) /ID# 245350

    Halle, 06120

    Recruiting

  • OncoResearch Lerchenfeld GmbH /ID# 230191

    Hamburg, 22081

    Recruiting

  • Universitaetsklinikum des Saarlandes /ID# 248747

    Homburg, Saarland, 66424

    Recruiting

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186

    Kiel, Schleswig-Holstein, 24105

    Recruiting

  • VK&K Studien GbR /ID# 230198

    Landshut, Bavaria, 84036

    Recruiting

  • Klinikum Landshut AdöR der Stadt Landshut /ID# 242991

    Landshut, 84034

    Recruiting

  • Muenchen Klinik Schwabing /ID# 230197

    Munich, Bavaria, 80804

    Completed

  • Stauferklinikum Schwaebisch Gmuend /ID# 230176

    Mutlangen, Baden-Wurttemberg, 73557

    Recruiting

  • Bruederkrankenhaus St. Josef Paderborn /ID# 230177

    Paderborn, 33098

    Recruiting

  • Universitaetsmedizin Rostock /ID# 230190

    Rostock, Mecklenburg-Vorpommern, 18057

    Recruiting

  • Universitaetsklinikum Ulm /ID# 230164

    Ulm, Baden-Wurttemberg, 89081

    Recruiting

Other trials in Germany

United States15 sites, 11 recruiting

  • Winship Cancer Institute of Emory University /ID# 230643

    Atlanta, Georgia, 30322

    Recruiting

  • Dana-Farber Cancer Institute /ID# 230061

    Boston, Massachusetts, 02215

    Recruiting

  • University of North Carolina /ID# 233313

    Chapel Hill, North Carolina, 27514

    Recruiting

  • Novant Health Presbyterian Medical Center /ID# 230201

    Charlotte, North Carolina, 28204

    Recruiting

  • The Ohio State University /ID# 230439

    Columbus, Ohio, 43210

    Recruiting

  • Des Moines Oncology Research Association /ID# 232606

    Des Moines, Iowa, 50309-1423

    Completed

  • Henry Ford Hospital /ID# 230268

    Detroit, Michigan, 48202

    Completed

  • St. Lukes Hospital of Duluth /ID# 250021

    Duluth, Minnesota, 55805

    Recruiting

  • Summit Medical Group-Florham Park /ID# 244782

    Florham Park, New Jersey, 07932-1049

    Completed

  • Regional Cancer Care Associates /ID# 244620

    Hackensack, New Jersey, 07601-7015

    Recruiting

  • Hattiesburg Clinic /ID# 233443

    Hattiesburg, Mississippi, 39401

    Recruiting

  • Moores Cancer Center at UC San Diego /ID# 230157

    La Jolla, California, 92093

    Recruiting

  • University of Wisconsin-Madiso /ID# 232612

    Madison, Wisconsin, 53705

    Completed

  • Pennsylvania Oncology Hematolo /ID# 249637

    Philadelphia, Pennsylvania, 19106

    Recruiting

  • Novant Health Forsyth Medical Center /ID# 249533

    Winston-Salem, North Carolina, 27103

    Recruiting

Other trials in United States

Austria7 sites, 6 recruiting

  • Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569

    Leoben, Styria, 8700

    Recruiting

  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516

    Linz, Upper Austria, 4010

    Recruiting

  • Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015

    Salzburg, 5020

    Completed

  • Universitaetsklinikum St. Poelten /ID# 243493

    Sankt Pölten, Lower Austria, 3100

    Recruiting

  • Medizinische Universitaet Wien /ID# 230013

    Vienna, State of Vienna, 1090

    Recruiting

  • Klinik Ottakring /ID# 230019

    Vienna, State of Vienna, 1160

    Recruiting

  • Hanusch Krankenhaus /ID# 230010

    Vienna, 1140

    Recruiting

Other trials in Austria

Israel4 sites, 4 recruiting

  • Hadassah /ID# 245059

    Jerusalem, Jerusalem, 91120

    Recruiting

  • Rabin Medical Center. /ID# 243220

    Petah Tikva, 4941492

    Recruiting

  • The Chaim Sheba Medical Center /ID# 243219

    Ramat Gan, Tel Aviv, 5265601

    Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 243218

    Tel Aviv, Tel Aviv, 6423906

    Recruiting

Other trials in Israel

Australia3 sites, 3 recruiting

  • Royal Adelaide Hospital /ID# 229898

    Adelaide, South Australia, 5000

    Recruiting

  • Northern Hospital Epping /ID# 229847

    Epping, Victoria, 3076

    Recruiting

  • Peter MacCallum Cancer Ctr /ID# 254634

    Melbourne, Victoria, 3000

    Recruiting

Other trials in Australia

Brazil3 sites, 2 recruiting

  • Hospital de Clinicas de Porto Alegre /ID# 243657

    Porto Alegre, Rio Grande do Sul, 90035-903

    Completed

  • Hospital Nove de Julho /ID# 243658

    São Paulo, São Paulo, 01409-001

    Recruiting

  • Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659

    São Paulo, 01236-030

    Recruiting

Other trials in Brazil

United Kingdom3 sites, 3 recruiting

  • Blackpool Victoria Hospital /ID# 267280

    Blackpool, Lancashire, FY3 8NR

    Recruiting

  • Leeds Teaching Hospitals NHS Trust /ID# 250732

    Leeds, West Yorkshire, LS9 7TF

    Recruiting

  • Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733

    Norwich, Norfolk, NR4 7UY

    Recruiting

Other trials in United Kingdom

Bulgaria2 sites, 2 recruiting

  • UMHAT Sveti Georgi EAD /ID# 272321

    Plovdiv, 4002

    Recruiting

  • MHAT Hristo Botev /ID# 229687

    Vratsa, 3000

    Recruiting

Other trials in Bulgaria

Italy2 sites, 2 recruiting

  • Azienda Ospedaliera Santa Maria Terni /ID# 229442

    Terni, 05100

    Recruiting

  • A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504

    Turin, Piedmont, 10126

    Recruiting

Other trials in Italy

Romania1 site, 1 recruiting

  • Fundeni Clinical Institute /ID# 241614

    Bucharest, Bucharest, 022328

    Recruiting

Other trials in Romania

Spain1 site, 1 recruiting

  • Hospital Universitario de la Princesa /ID# 229665

    Madrid, 28006

    Recruiting

Other trials in Spain

About this study

Official 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

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.

Read more

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.

Keywords
Chronic Lymphocytic Leukemia (CLL), Venetoclax, ABT-199, Venclexta, GDC-0199, Obinutuzumab, Gazyva, GA101, Cancer, ReVenG
Medical subject headings
Leukemia, Lymphocytic, Chronic, B-Cell, Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VenetoclaxDrug

    Also called Venclexta, ABT-199, GDC-0199

    Oral tablet

  • ObinutuzumabDrug

    Also called GA101, Gazyva

    Intravenous (IV) infusion

Study groups in NCT04895436
Study groupRoleWhat they receive
Cohort 1 - venetoclax + obinutuzumabExperimentalParticipants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for six 28-day cycles.
Receives: Drug: Venetoclax; Drug: Obinutuzumab
Cohort 2 - venetoclax + obinutuzumabExperimentalParticipants will receive venetoclax + obinutuzumab for six 28-day cycles followed by venetoclax for eighteen 28-day cycles.
Receives: Drug: Venetoclax; Drug: Obinutuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Overall response (OR) in Cohort 1 after end of combination treatment

    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.

    Measured: 9 months

Secondary outcomes (9)

  1. OR in Cohort 1 after end of combination treatment

    OR rate is defined as the percentage of participants achieving a best response of CR or CRi

    Measured: 9 months

  2. OR in Cohort 1 after end of treatment

    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.

    Measured: 15 months

  3. Time to Response (TTR) in Cohort 1

    TTR is defined as the time from first dose until first response (PR or better).

    Measured: 15 months

  4. Duration of Response (DOR) in Cohort 1

    DOR is defined as the time from first response (PR or better) until progressive disease (PD) or death.

    Measured: 15 months

  5. Time to Next Treatment (TTNT) for CLL in Cohort 1

    TTNT is defined as the time from first dose until first dose of a non-protocol anti-CLL therapy.

    Measured: 15 months

  6. Progression-free Survival (PFS) in Cohort 1

    PFS is defined as the time from first dose until PD or death.

    Measured: 15 months

  7. Overall Survival (OS) in Cohort 1

    OS is defined as the time from first dose until death.

    Measured: 15 months

  8. Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of combination treatment

    Percentage of participants with uMRD rate, measured in peripheral blood.

    Measured: 9 months

  9. Percentage of Participants with Undetectable Minimal Residual Disease (uMRD) rate (<10^-4) in Cohort 1 after end of treatment

    Percentage of participants with uMRD rate, measured in peripheral blood.

    Measured: 15 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 May 2021
  2. Study start28 Mar 2022
  3. Primary completionNov 2026 (estimated)
  4. Study completionJan 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04895436
Sponsor's protocol ID
M20-356
Other IDs
2023-504599-10-00, 2023
Acronym
ReVenG
Status last verified
Feb 2026
First submitted
19 May 2021
Last updated
9 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.
Expanded access
Available

Publications

  • Castonguay M, Anderson MA, Thompson P, Seymour JF. Venetoclax retreatment in chronic lymphocytic leukemia is biologically rational and clinically effective. Blood Adv. 2026 May 26;10(10):3357-3366. doi: 10.1182/bloodadvances.2026019871.

    PubMed 41843779

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in