Actively Recruiting
A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL
Led by German CLL Study Group · Updated on 2025-08-17
202
Participants Needed
30
Research Sites
314 weeks
Total Duration
On this page
Sponsors
G
German CLL Study Group
Lead Sponsor
A
AstraZeneca
Collaborating Sponsor
AI-Summary
What this Trial Is About
This multicenter, prospective, open-label, randomized, superiority phase 3 study is designed to demonstrate that treatment with a triple combination of acalabrutinib, obinutuzumab and venetoclax (GAVe) prolong the progression-free survival (PFS) as compared to treatment with the combination of obinutuzumab and venetoclax (GVe) in pa-tients with high risk CLL (defined as having at least one of the follow-ing risk factors: 17p-deletion, TP53-mutation, complex karyotype or an unmutated IGHV-gene status).
CONDITIONS
Official Title
A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented diagnosis of CLL or SLL requiring treatment according to iwCLL criteria
- Age 18 years or older
- Presence of at least one high risk factor: 17p-deletion, TP53-mutation, complex karyotype (3 or more chromosomal aberrations), or unmutated IGHV gene
- Life expectancy of at least six months
- Adequate bone marrow function with platelet count above 30 x10^9/l
- Creatinine clearance of 30 ml/min or higher
- Adequate liver function with total bilirubin no more than twice the upper limit of normal and AST/ALT no more than 2.5 times the upper limit unless due to CLL or Gilbert's Syndrome
- Negative hepatitis B surface antigen and core antibody tests; patients with positive core antibody only allowed if HBV DNA PCR is negative and monitored monthly until 12 months after last treatment
- Negative hepatitis C RNA test within 6 weeks prior to registration
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
You will not qualify if you...
- Prior CLL-specific treatments, except corticosteroids up to 20 mg prednisolone equivalent within 10 days before study start
- Absence of high risk disease as defined by 17p-deletion, TP53-mutation, or complex karyotype
- Severe organ or system impairment rated 4 by CIRS, such as advanced cardiac disease (NYHA class 3 or 4) limiting treatment ability
- Any life-threatening illness or condition that could affect safety or drug absorption/metabolism
- Transformation of CLL to Richter syndrome
- Active cancers requiring systemic therapy other than CLL
- Uncontrolled or active infections including HIV or progressive multifocal leukoencephalopathy (PML)
- Use of anticoagulants warfarin or phenprocoumon
- Pregnancy or breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 30 locations
1
Helios Klinikum Bad Saarow
Bad Saarow, Germany, 15526
Actively Recruiting
2
DRK Kliniken Berlin Köpenick
Berlin, Germany, 12559
Actively Recruiting
3
Ev. Diakoniekrankenhaus
Bremen, Germany, 28239
Actively Recruiting
4
Universitätsklinik Köln
Cologne, Germany, 50937
Actively Recruiting
5
St. Johannes Hospital
Dortmund, Germany, 44137
Actively Recruiting
6
Marien Hospital Düsseldorf
Düsseldorf, Germany, 40479
Actively Recruiting
7
St. Antonius-Hospital
Eschweiler, Germany, 52249
Actively Recruiting
8
Universitaetsklinikum Essen
Essen, Germany, 45147
Actively Recruiting
9
Katholisches Krankenhaus Hagen - St. Josefs Hospital
Hagen, Germany, 58097
Actively Recruiting
10
Universitaetskliniken des Saarlandes
Homburg, Germany, 66424
Actively Recruiting
11
Klinikum Idar-Oberstein SHG
Idar-Oberstein, Germany, 55743
Actively Recruiting
12
Staedtisches Klinikum Karlsruhe
Karlsruhe, Germany, 76133
Actively Recruiting
13
Universitaetsklinikum Schleswig-Holstein Campus Kiel
Kiel, Germany, 24116
Actively Recruiting
14
Klinikum Landshut
Landshut, Germany, 84034
Actively Recruiting
15
Klinikum Lippe-Lemgo
Lemgo, Germany, 32657
Actively Recruiting
16
St Vincenz Krankenhaus
Limburg, Germany, 65549
Actively Recruiting
17
Universitaetsklinikum Magdeburg
Magdeburg, Germany, 39120
Actively Recruiting
18
Klinikum Hochsauerland - St. Walburga Krankenhaus
Meschede, Germany, 59872
Actively Recruiting
19
KH Kliniken Maria Hilf
Mönchengladbach, Germany, 41063
Actively Recruiting
20
Krankenhaus Muenchen-Schwabing
Munich, Germany, 80804
Actively Recruiting
21
Klinikum Rechts der Isar - Technische Universitaet Muenchen
Munich, Germany, 81675
Actively Recruiting
22
Kliniken Ostalb, Stauferklinikum Schwäbisch Gmünd
Mutlangen, Germany, 73557
Actively Recruiting
23
Klinikum Oldenburg
Oldenburg, Germany, 26133
Actively Recruiting
24
Brüderkrankenhaus St. Josef Paderborn
Paderborn, Germany, 33098
Actively Recruiting
25
Universitätsklinik Rostock
Rostock, Germany, 18057
Actively Recruiting
26
Caritas-Klinik St. Theresia
Saarbrücken, Germany, 66113
Actively Recruiting
27
Klinikum Sindelfingen-Böbingen
Sindelfingen, Germany, 71065
Actively Recruiting
28
Marienhospital Stuttgart
Stuttgart, Germany, 70199
Actively Recruiting
29
Universitaetsklinik Tuebingen
Tübingen, Germany, 72076
Actively Recruiting
30
Universitätsklinik Ulm
Ulm, Germany, 89081
Actively Recruiting
Research Team
B
Barbara Eichhorst, MD, Prof.
CONTACT
A
Anna Fink, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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