RecruitingPhase 3NCT05197192

A Phase-3-trial of Acalabrutinib, Obinutuzumab & Venetoclax Compared to Obinutuzumab and Venetoclax in Previously Untreated Patients With High Risk CLL

A Prospective, Open-label, Multicentre, Randomized, Phase-3-trial of Acalabrutinib, Obinutuzumab and Venetoclax (GAVE) Compared to Obinutuzumab and Venetoclax (GVE) in Previously Untreated Patients With High Risk Chronic Lymphocytic Leukemia (CLL)

Sponsor

German CLL Study Group

Enrollment

202 participants

Start Date

Apr 19, 2022

Study Type

INTERVENTIONAL

Conditions

Chronic Lymphocytic Leukemia

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) 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).

Eligibility

Min Age: 18 YearsMax Age: 120 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing two combinations of drugs for previously untreated high-risk chronic lymphocytic leukemia (CLL): one group gets three drugs (acalabrutinib, obinutuzumab, and venetoclax) and the other gets two (obinutuzumab and venetoclax). Researchers want to find out which combination works better. **You may be eligible if...** - You are 18 or older - You have CLL or small lymphocytic lymphoma (SLL) that requires treatment - Your CLL is considered high-risk (specific chromosome or gene mutations present) - You have not yet received treatment for CLL - Your kidney, liver function, and blood counts meet minimum requirements - You test negative for active hepatitis B **You may NOT be eligible if...** - You have already received CLL treatment - You have active or uncontrolled infection - Your kidney or liver function is severely impaired Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGObinutuzumab

Obinutuzumab i.v. infusion: Cycle 1 Day 1: Obinutuzumab 100 mg i.v. Cycle 1 Day 1 (or 2): Obinutuzumab 900 mg i.v. Cycle 1 Day 8: Obinutuzumab 1000 mg i.v. Cycle 1 Day 15: Obinutuzumab 1000 mg i.v. Cycles 2-6: Day 1: Obinutuzumab 1000 mg i.v.

DRUGVenetoclax

Venetoclax p.o.: Cycle 1: Days 22-28: Venetoclax 20 mg (2 x 10 mg) Cycle 2: Days 1-7: Venetoclax 50 mg (1 x 50 mg) Cycle 2:Days 8-14: Venetoclax 100 mg (1 x 100 mg) Cycle 2:Days: 15-21: Venetoclax 200 mg (2 x 100 mg) Cycle 2:Days: 22-28: Venetoclax 400 mg (4 x 100 mg) Cycles 3-12: Days 1-28: Venetoclax 400 mg (4 x 100 mg)

DRUGAcalabrutinib

Cycles 15-24: Days 1-28: 100 mg acalabrutinib twice daily p.o. approx. every 12 hrs (corresponding to a total daily dose of 200 mg).

Locations(30)

Helios Klinikum Bad Saarow

Bad Saarow, Germany

DRK Kliniken Berlin Köpenick

Berlin, Germany

Ev. Diakoniekrankenhaus

Bremen, Germany

Universitätsklinik Köln

Cologne, Germany

St. Johannes Hospital

Dortmund, Germany

Marien Hospital Düsseldorf

Düsseldorf, Germany

St. Antonius-Hospital

Eschweiler, Germany

Universitaetsklinikum Essen

Essen, Germany

Katholisches Krankenhaus Hagen - St. Josefs Hospital

Hagen, Germany

Universitaetskliniken des Saarlandes

Homburg, Germany

Klinikum Idar-Oberstein SHG

Idar-Oberstein, Germany

Staedtisches Klinikum Karlsruhe

Karlsruhe, Germany

Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Germany

Klinikum Landshut

Landshut, Germany

Klinikum Lippe-Lemgo

Lemgo, Germany

St Vincenz Krankenhaus

Limburg, Germany

Universitaetsklinikum Magdeburg

Magdeburg, Germany

Klinikum Hochsauerland - St. Walburga Krankenhaus

Meschede, Germany

KH Kliniken Maria Hilf

Mönchengladbach, Germany

Krankenhaus Muenchen-Schwabing

Munich, Germany

Klinikum Rechts der Isar - Technische Universitaet Muenchen

Munich, Germany

Kliniken Ostalb, Stauferklinikum Schwäbisch Gmünd

Mutlangen, Germany

Klinikum Oldenburg

Oldenburg, Germany

Brüderkrankenhaus St. Josef Paderborn

Paderborn, Germany

Universitätsklinik Rostock

Rostock, Germany

Caritas-Klinik St. Theresia

Saarbrücken, Germany

Klinikum Sindelfingen-Böbingen

Sindelfingen, Germany

Marienhospital Stuttgart

Stuttgart, Germany

Universitaetsklinik Tuebingen

Tübingen, Germany

Universitätsklinik Ulm

Ulm, Germany

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NCT05197192

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