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)

Last updated: July 11, 2025
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

2

Condition

Chronic Lymphocytic Leukemia

Leukemia

Leukemia (Pediatric)

Treatment

Obinutuzumab

Venetoclax

Clinical Study ID

NCT04895436
M20-356
2021-001037-39
2023-504599-10-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Documented diagnosis of chronic lymphocytic leukemia (CLL) that requires treatmentfor CLL according to International Workshop for Chronic Lymphocytic Leukemia (iwCLL) 2018 criteria.

  • Previously completed venetoclax + anti-CD20 antibody +/- X regimen as a fixedduration first-line (1L) therapy and achieved documented response, defined ascomplete remission, complete remission with incomplete marrow recovery, partialremission, or nodular partial remission.

  • More than 24 months (Cohort 1) or 12-24 months (Cohort 2) have elapsed between lastdose of venetoclax and disease progression after completion of 1L treatment.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 75
Treatment Group(s): 2
Primary Treatment: Obinutuzumab
Phase: 2
Study Start date:
March 28, 2022
Estimated Completion Date:
January 31, 2029

Connect with a study center

  • Royal Adelaide Hospital /ID# 229898

    Adelaide, South Australia 5000
    Australia

    Active - Recruiting

  • Eastern Health /ID# 229842

    Box Hill, Victoria 3128
    Australia

    Site Not Available

  • Northern Hospital Epping /ID# 229847

    Epping, Victoria 3076
    Australia

    Active - Recruiting

  • Monash Medical Centre /ID# 229845

    Melbourne, Victoria 3168
    Australia

    Site Not Available

  • Peter MacCallum Cancer Ctr /ID# 254634

    Melbourne, Victoria 3000
    Australia

    Active - Recruiting

  • Universitaetsklinikum St. Poelten /ID# 243493

    Sankt Poelten, Niederoesterreich 3100
    Austria

    Active - Recruiting

  • Ordensklinikum Linz - Barmherzige Schwestern /ID# 249516

    Linz, Oberoesterreich 4010
    Austria

    Active - Recruiting

  • Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516

    Linz, Oberoesterreich 4010
    Austria

    Active - Recruiting

  • Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569

    Leoben, Steiermark 8700
    Austria

    Active - Recruiting

  • Medizinische Universitaet Innsbruck /ID# 230014

    Innsbruck, Tirol 6020
    Austria

    Site Not Available

  • Klinik Ottakring /ID# 230019

    Vienna, Wien 1160
    Austria

    Active - Recruiting

  • Medizinische Universitaet Wien /ID# 230013

    Vienna, Wien 1090
    Austria

    Active - Recruiting

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

    Salzburg, 5020
    Austria

    Completed

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

    Salzburg, 5020
    Austria

    Active - Recruiting

  • Hanusch Krankenhaus /ID# 230010

    Wien, 1140
    Austria

    Active - Recruiting

  • Hospital de Clinicas de Porto Alegre /ID# 243657

    Porto Alegre, Rio Grande Do Sul 90035-903
    Brazil

    Completed

  • Hospital Nove de Julho /ID# 243658

    São Paulo, Sao Paulo 01409-001
    Brazil

    Active - Recruiting

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

    Sao Paulo, 01236-030
    Brazil

    Active - Recruiting

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

    Sao Paulo, 01236-030
    Brazil

    Active - Recruiting

  • UMHAT Sveti Georgi EAD /ID# 272321

    Plovdiv, 4002
    Bulgaria

    Active - Recruiting

  • MHAT Hristo Botev /ID# 229687

    Vratsa, 3000
    Bulgaria

    Active - Recruiting

  • Stauferklinikum Schwaebisch Gmuend /ID# 230176

    Mutlangen, Baden-Wuerttemberg 73557
    Germany

    Active - Recruiting

  • Universitaetsklinikum Ulm /ID# 230164

    Ulm, Baden-Wuerttemberg 89081
    Germany

    Active - Recruiting

  • VK&K Studien GbR /ID# 230198

    Landshut, Bayern 84036
    Germany

    Active - Recruiting

  • Muenchen Klinik Schwabing /ID# 230197

    Muenchen, Bayern 80804
    Germany

    Completed

  • Universitaetsmedizin Rostock /ID# 230190

    Rostock, Mecklenburg-Vorpommern 18057
    Germany

    Active - Recruiting

  • Onkologische Kooperation Harz /ID# 230235

    Goslar, Niedersachsen 38642
    Germany

    Site Not Available

  • Universitaetsklinikum Koeln /ID# 230296

    Köln, Nordrhein-Westfalen 50937
    Germany

    Active - Recruiting

  • Universitaetsklinikum des Saarlandes /ID# 248747

    Homburg, Saarland 66424
    Germany

    Active - Recruiting

  • Gemeinschaftspraxis Haematologie - Onkologie BAG /ID# 230168

    Dresden, Sachsen-Anhalt 01307
    Germany

    Active - Recruiting

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186

    Kiel, Schleswig-Holstein 24105
    Germany

    Active - Recruiting

  • Charite Universitaetsklinikum Berlin - Campus Virchow /ID# 248748

    Berlin, 13353
    Germany

    Active - Recruiting

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

    Berlin, 13353
    Germany

    Active - Recruiting

  • Onkologische Schwerpunktpraxis /ID# 245465

    Berlin, 10707
    Germany

    Active - Recruiting

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

    Bremen, 28239
    Germany

    Completed

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

    Bremen, 28239
    Germany

    Completed

  • Universitaetsklinikum Essen /ID# 230181

    Essen, 45147
    Germany

    Active - Recruiting

  • Universitaetsklinikum Halle (Saale) /ID# 245350

    Halle (Saale), 06120
    Germany

    Active - Recruiting

  • OncoResearch Lerchenfeld GmbH /ID# 230191

    Hamburg, 22081
    Germany

    Active - Recruiting

  • Institut für Versorgungsforschung in der Onkologie GbR /ID# 230241

    Koblenz, 56068
    Germany

    Site Not Available

  • Klinikum Landshut AdöR der Stadt Landshut /ID# 242991

    Landshut, 84034
    Germany

    Active - Recruiting

  • Klinikum Landshut gGmbH /ID# 242991

    Landshut, 84034
    Germany

    Site Not Available

  • Bruederkrankenhaus St. Josef Paderborn /ID# 230177

    Paderborn, 33098
    Germany

    Active - Recruiting

  • The Chaim Sheba Medical Center /ID# 243219

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 243218

    Tel Aviv, Tel-Aviv 6423906
    Israel

    Active - Recruiting

  • Tel Aviv Sourasky Medical Center /ID# 243218

    Tel Aviv-Yafo, Tel-Aviv 6423906
    Israel

    Site Not Available

  • Hadassah /ID# 245059

    Jerusalem, Yerushalayim 91120
    Israel

    Active - Recruiting

  • Rabin Medical Center /ID# 243220

    Haifa, 4941492
    Israel

    Site Not Available

  • Rabin Medical Center /ID# 243220

    Petah Tikva, 4941492
    Israel

    Active - Recruiting

  • Rabin Medical Center /ID# 243220

    Petakh Tikva, 4941492
    Israel

    Site Not Available

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

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

  • AOU Citta della Salute e della Scienza di Torino /ID# 229504

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

  • Azienda Ospedaliera Universitaria Citta della Salute e della Scienza di Torino /ID# 229504

    Torino, Piemonte 10126
    Italy

    Active - Recruiting

  • A.O.U. Citta della Salute e della Scienza di Torino /ID# 229504

    Turin, Torino 10126
    Italy

    Site Not Available

  • Azienda Ospedaliera Santa Maria Terni /ID# 229442

    Terni, 05100
    Italy

    Active - Recruiting

  • Fundeni Clinical Institute /ID# 241614

    Bucharest, Bucuresti 022328
    Romania

    Active - Recruiting

  • Institutul Clinic Fundeni /ID# 241614

    Bucharest, Bucuresti 022328
    Romania

    Active - Recruiting

  • Institutul Clinic Fundeni /ID# 241614

    Sector 2, Bucuresti 022328
    Romania

    Site Not Available

  • Hospital Universitario de la Princesa /ID# 229665

    Madrid, 28006
    Spain

    Active - Recruiting

  • University Hospital Southampton NHS Foundation Trust /ID# 251003

    Southampton, Hampshire SO16 6YD
    United Kingdom

    Site Not Available

  • Blackpool Victoria Hospital /ID# 267280

    Blackpool, Lancashire FY3 8NR
    United Kingdom

    Active - Recruiting

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

    Norwich, Norfolk NR4 7UY
    United Kingdom

    Active - Recruiting

  • Nottingham University Hospitals NHS Trust /ID# 253340

    Nottingham, Nottinghamshire NG5 1PB
    United Kingdom

    Site Not Available

  • Leeds Teaching Hospitals NHS Trust /ID# 250732

    Leeds, West Yorkshire LS9 7TF
    United Kingdom

    Active - Recruiting

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

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Northwestern University Feinberg School of Medicine /ID# 230060

    Chicago, Illinois 60611-2927
    United States

    Site Not Available

  • Des Moines Oncology Research Association /ID# 232606

    Des Moines, Iowa 50309-1423
    United States

    Completed

  • Dana-Farber Cancer Institute /ID# 230061

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

  • Henry Ford Health System /ID# 230268

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Henry Ford Hospital /ID# 230268

    Detroit, Michigan 48202
    United States

    Completed

  • St. Luke's Hospital of Duluth /ID# 250021

    Duluth, Minnesota 55805
    United States

    Active - Recruiting

  • Hattiesburg Clinic /ID# 233443

    Hattiesburg, Mississippi 39401
    United States

    Active - Recruiting

  • Summit Medical Group-Florham Park /ID# 244782

    Florham Park, New Jersey 07932-1049
    United States

    Completed

  • Regional Cancer Care Associates /ID# 244620

    Hackensack, New Jersey 07601-7015
    United States

    Active - Recruiting

  • University of North Carolina /ID# 233313

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Novant Health Presbyterian Medical Center /ID# 230201

    Charlotte, North Carolina 28204
    United States

    Active - Recruiting

  • Novant Health Forsyth Medical Center /ID# 249533

    Winston-Salem, North Carolina 27103
    United States

    Active - Recruiting

  • Fox Chase Cancer Center /ID# 246851

    Philadelphia, Pennsylvania 19111
    United States

    Site Not Available

  • University of Wisconsin-Madiso /ID# 232612

    Madison, Wisconsin 53705
    United States

    Active - Recruiting

  • Medical College of Wisconsin /ID# 233426

    Milwaukee, Wisconsin 53226-3522
    United States

    Site Not Available

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