Actively Recruiting
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)
Led by AbbVie · Updated on 2026-02-09
75
Participants Needed
58
Research Sites
353 weeks
Total Duration
On this page
Sponsors
A
AbbVie
Lead Sponsor
F
F. Hoffmann-La Roche Ltd; German CLL Study Group (GCLLSG); Dana-Farber Cancer Institute
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of chronic lymphocytic leukemia (CLL) requiring treatment according to iwCLL 2018 criteria
- Previously completed fixed duration first-line therapy with venetoclax + anti-CD20 antibody +/- other drugs and achieved a documented response
- More than 24 months (Cohort 1) or between 12 and 24 months (Cohort 2) have passed since last venetoclax dose and disease progression after first-line treatment
You will not qualify if you...
- Received any intervening treatment for CLL after completing previous treatment with venetoclax + anti-CD20 antibody +/- other drugs
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 58 locations
1
Moores Cancer Center at UC San Diego /ID# 230157
La Jolla, California, United States, 92093
Actively Recruiting
2
Winship Cancer Institute of Emory University /ID# 230643
Atlanta, Georgia, United States, 30322
Actively Recruiting
3
Des Moines Oncology Research Association /ID# 232606
Des Moines, Iowa, United States, 50309-1423
Completed
4
Dana-Farber Cancer Institute /ID# 230061
Boston, Massachusetts, United States, 02215
Actively Recruiting
5
Henry Ford Hospital /ID# 230268
Detroit, Michigan, United States, 48202
Completed
6
St. Lukes Hospital of Duluth /ID# 250021
Duluth, Minnesota, United States, 55805
Actively Recruiting
7
Hattiesburg Clinic /ID# 233443
Hattiesburg, Mississippi, United States, 39401
Actively Recruiting
8
Summit Medical Group-Florham Park /ID# 244782
Florham Park, New Jersey, United States, 07932-1049
Completed
9
Regional Cancer Care Associates /ID# 244620
Hackensack, New Jersey, United States, 07601-7015
Actively Recruiting
10
University of North Carolina /ID# 233313
Chapel Hill, North Carolina, United States, 27514
Actively Recruiting
11
Novant Health Presbyterian Medical Center /ID# 230201
Charlotte, North Carolina, United States, 28204
Actively Recruiting
12
Novant Health Forsyth Medical Center /ID# 249533
Winston-Salem, North Carolina, United States, 27103
Actively Recruiting
13
The Ohio State University /ID# 230439
Columbus, Ohio, United States, 43210
Actively Recruiting
14
Pennsylvania Oncology Hematolo /ID# 249637
Philadelphia, Pennsylvania, United States, 19106
Actively Recruiting
15
University of Wisconsin-Madiso /ID# 232612
Madison, Wisconsin, United States, 53705
Completed
16
Royal Adelaide Hospital /ID# 229898
Adelaide, South Australia, Australia, 5000
Actively Recruiting
17
Northern Hospital Epping /ID# 229847
Epping, Victoria, Australia, 3076
Actively Recruiting
18
Peter MacCallum Cancer Ctr /ID# 254634
Melbourne, Victoria, Australia, 3000
Actively Recruiting
19
Universitaetsklinikum St. Poelten /ID# 243493
Sankt Pölten, Lower Austria, Austria, 3100
Actively Recruiting
20
Medizinische Universitaet Wien /ID# 230013
Vienna, State of Vienna, Austria, 1090
Actively Recruiting
21
Klinik Ottakring /ID# 230019
Vienna, State of Vienna, Austria, 1160
Actively Recruiting
22
Landeskrankenhaus Hochsteiermark, Standort Leoben /ID# 267569
Leoben, Styria, Austria, 8700
Actively Recruiting
23
Ordensklinikum Linz GmbH Barmherzige Schwestern /ID# 249516
Linz, Upper Austria, Austria, 4010
Actively Recruiting
24
Landeskrankenhaus Salzburg-Universitaetsklinikum der PMU (LKH) /ID# 230015
Salzburg, Austria, 5020
Completed
25
Hanusch Krankenhaus /ID# 230010
Vienna, Austria, 1140
Actively Recruiting
26
Hospital de Clinicas de Porto Alegre /ID# 243657
Porto Alegre, Rio Grande do Sul, Brazil, 90035-903
Completed
27
Hospital Nove de Julho /ID# 243658
São Paulo, São Paulo, Brazil, 01409-001
Actively Recruiting
28
Instituto de Ensino e Pesquisas Sao Lucas /ID# 243659
São Paulo, Brazil, 01236-030
Actively Recruiting
29
UMHAT Sveti Georgi EAD /ID# 272321
Plovdiv, Bulgaria, 4002
Actively Recruiting
30
MHAT Hristo Botev /ID# 229687
Vratsa, Bulgaria, 3000
Actively Recruiting
31
Stauferklinikum Schwaebisch Gmuend /ID# 230176
Mutlangen, Baden-Wurttemberg, Germany, 73557
Actively Recruiting
32
Universitaetsklinikum Ulm /ID# 230164
Ulm, Baden-Wurttemberg, Germany, 89081
Actively Recruiting
33
VK&K Studien GbR /ID# 230198
Landshut, Bavaria, Germany, 84036
Actively Recruiting
34
Muenchen Klinik Schwabing /ID# 230197
Munich, Bavaria, Germany, 80804
Completed
35
Universitaetsmedizin Rostock /ID# 230190
Rostock, Mecklenburg-Vorpommern, Germany, 18057
Actively Recruiting
36
Universitaetsklinikum Koeln /ID# 230296
Cologne, North Rhine-Westphalia, Germany, 50937
Actively Recruiting
37
Universitaetsklinikum des Saarlandes /ID# 248747
Homburg, Saarland, Germany, 66424
Actively Recruiting
38
BAG Freiberg-Richter, Jacobasch, Illmer, Wolf /ID# 230168
Dresden, Saxony, Germany, 01307
Actively Recruiting
39
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 230186
Kiel, Schleswig-Holstein, Germany, 24105
Actively Recruiting
40
Onkologische Schwerpunktpraxis /ID# 245465
Berlin, Germany, 10707
Actively Recruiting
41
Charite Universitaetsmedizin Berlin Campus Virchow-Klinikum /ID# 248748
Berlin, Germany, 13353
Actively Recruiting
42
Duplicate_DIAKO Ev. Diakonie-Krankenhaus gemeinnuetzige GmbH /ID# 230238
Bremen, Germany, 28239
Completed
43
Universitaetsklinikum Essen /ID# 230181
Essen, Germany, 45147
Actively Recruiting
44
Universitaetsklinikum Halle (Saale) /ID# 245350
Halle, Germany, 06120
Actively Recruiting
45
OncoResearch Lerchenfeld GmbH /ID# 230191
Hamburg, Germany, 22081
Actively Recruiting
46
Klinikum Landshut AdöR der Stadt Landshut /ID# 242991
Landshut, Germany, 84034
Actively Recruiting
47
Bruederkrankenhaus St. Josef Paderborn /ID# 230177
Paderborn, Germany, 33098
Actively Recruiting
48
Hadassah /ID# 245059
Jerusalem, Jerusalem, Israel, 91120
Actively Recruiting
49
The Chaim Sheba Medical Center /ID# 243219
Ramat Gan, Tel Aviv, Israel, 5265601
Actively Recruiting
50
Tel Aviv Sourasky Medical Center /ID# 243218
Tel Aviv, Tel Aviv, Israel, 6423906
Actively Recruiting
51
Rabin Medical Center. /ID# 243220
Petah Tikva, Israel, 4941492
Actively Recruiting
52
A.O.U. CITTA' DELLA SALUTE E DELLA SCIENZA DI TORINO - Ospedale Molinette /ID# 229504
Turin, Piedmont, Italy, 10126
Actively Recruiting
53
Azienda Ospedaliera Santa Maria Terni /ID# 229442
Terni, Italy, 05100
Actively Recruiting
54
Fundeni Clinical Institute /ID# 241614
Bucharest, Bucharest, Romania, 022328
Actively Recruiting
55
Hospital Universitario de la Princesa /ID# 229665
Madrid, Spain, 28006
Actively Recruiting
56
Blackpool Victoria Hospital /ID# 267280
Blackpool, Lancashire, United Kingdom, FY3 8NR
Actively Recruiting
57
Norfolk and Norwich University Hospitals NHS Foundation Trust /ID# 250733
Norwich, Norfolk, United Kingdom, NR4 7UY
Actively Recruiting
58
Leeds Teaching Hospitals NHS Trust /ID# 250732
Leeds, West Yorkshire, United Kingdom, LS9 7TF
Actively Recruiting
Research Team
A
ABBVIE CALL CENTER
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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