Status:
RECRUITING
A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL
Lead Sponsor:
German CLL Study Group
Collaborating Sponsors:
AstraZeneca
Conditions:
Chronic Lymphocytic Leukemia
Eligibility:
All Genders
18-120 years
Phase:
PHASE3
Brief Summary
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...
Detailed Description
CLL is the most frequent leukemia in industrialized countries. International guidelines agree on diagnosis and management of this disease. The clinical course of CLL is highly variable and can be pred...
Eligibility Criteria
Inclusion
- Documented CLL/SLL requiring treatment according to iwCLL criteria
- Age at least 18 years
- At least one of the following risk factors: 17p-deletion, TP53-mutation, complex karyotype (defined as defined as the presence of 3 or more chromosomal aberrations in 2 or more metaphases) or an unmutated IGHV gene status.
- Life expectancy ≥ six months
- Adequate bone marrow function indicated by a platelet count \>30 x10\^9/l
- Creatinine clearance ≥ 30ml/min
- Adequate liver function as indicated by a total bilirubin ≤ 2 x, AST/ ALT ≤ 2.5 x the institutional ULN value, unless directly attributable to the patient's CLL or to Gilbert's Syndrome
- Negative testing for hepatitis B (HbsAg negative and anti-HBc negative; patients positive for anti-HBc may be included if PCR for HBV DNA is negative and HBV-DNA PCR is performed every month until 12 months after last treatment cycle),or hepatitis C (negative testing for hepatitis C RNA within 6 wee
- ks prior to registration for study screening (i.e. PCR only required when serology was positive))
- ECOG (Eastern Cooperative Oncology Group Performance Status) status 0-2
Exclusion
- Any prior CLL-specific therapies (except corticosteroid treatment administered due to necessary immediate intervention; within the last 10 days before start of study treatment, only dose equivalents up to 20 mg prednisolone are permitted)
- Absence of high risk disease (17p-deletion, TP53-mutation complex karyotype
- An individual organ/system impairment score of 4 as assessed by the CIRS definition (e.g. advanced cardiac disease (NYHA class 3 or 4) limiting the ability to receive the study treatment or any other life-threatening illness, medical condition or organ system dysfunction that, in the investigator´s opinion, could compromise the patients safety or interfere with the absorption or metabolism of the study drugs (e.g. inability to swallow tablets or impaired resorption in the gastrointestinal tract)
- Transformation of CLL (Richter transformation)
- Malignancies other than CLL currently requiring systemic therapies
- Uncontrolled or active infection of HIV/PML or any other active infection
- Anticoagulant therapy with warfarin or phenoprocoumon
- Pregnant women and nursing mothers
Key Trial Info
Start Date :
April 19 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2028
Estimated Enrollment :
202 Patients enrolled
Trial Details
Trial ID
NCT05197192
Start Date
April 19 2022
End Date
May 1 2028
Last Update
August 17 2025
Active Locations (30)
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1
Helios Klinikum Bad Saarow
Bad Saarow, Germany, 15526
2
DRK Kliniken Berlin Köpenick
Berlin, Germany, 12559
3
Ev. Diakoniekrankenhaus
Bremen, Germany, 28239
4
Universitätsklinik Köln
Cologne, Germany, 50937