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Major CLL trial tests which drug combo works best for new patients

NCT ID NCT04608318

Disease control Sponsor: German CLL Study Group Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 trial compares three treatment approaches for people with previously untreated chronic lymphocytic leukemia (CLL): continuous ibrutinib alone, a fixed-duration combination of venetoclax plus obinutuzumab, or a fixed-duration combination of ibrutinib plus venetoclax. The study aims to see which strategy provides the longest time without cancer progression. About 897 participants are enrolled, and the trial is active but no longer recruiting.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Ibrutinib, venetoclax, obinutuzumab
What this could lead to
If successful, this trial could identify a more effective fixed-duration treatment for CLL that improves progression-free survival and reduces the need for continuous therapy.
What could go wrong
This is a large phase 3 trial, but results are not yet available. The treatments have known side effects including infection risk and bleeding. The best regimen may still require ongoing monitoring or retreatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 897 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2021

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Documented CLL requiring treatment according to iwCLL criteria. 2. Age at least 18 years. 3. Life expectancy ≥ 6 months. 4. Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements. 5. Adequate bone marrow function independent of growth factor or transfusion support within 2 weeks of screening initiation as follows, unless cytopenia is due to CLL: 1. Absolute neutrophil count ≥ 1.0 × 109/L 2. Platelet counts ≥ 30 × 109/L; in cases of thrombocytopenia clearly due to CLL (per the discretion of the investigator), platelet count should be ≥ 10 × 109/L 3. Total haemoglobin ≥ 8 g/dL (without transfusion support, unless anaemia is due to CLL) 6. GFR \>30ml/min directly measured with 24hr urine collection, calculated according to the modified formula of Cockcroft and Gault (for men: GFR ≈ ((140 - age) x bodyweight)/ (72 x creatinine), for women x 0, 85) or an equally accurate method. a. For patients with creatinine values within the normal range the calculation of the clearance is not necessary. Dehydrated patients with an estimated creatinine clearance less than 30 ml/min may be eligible if a repeat estimate after adequate hydration is \> 30 ml/min. 7. 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. 8. Negative serological 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/every three months if persistently negative until 12 months after last treatment cycle), and for hepatitis C (anti-HCV-ab negative; in case of positive HCV anti-body test, negative HCV-PCR is required). 9. Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0-2. Exclusion criteria: 1. 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). 2. Transformation of CLL (Richter transformation). When Richter transformation is suspected, PET-CT and/or biopsy should be performed to rule out transformation. 3. Patients with a history of PML. 4. An individual organ/ system impairment score of 4 as assessed by the CIRS definition 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). 5. Malignancies other than CLL currently requiring systemic therapies, not being treated with curative intent before (unless the malignant disease is in a stable remission due to the discretion of the treating physician or showing signs of progression after curative treatment. 6. Uncontrolled or active infection. 7. Patients with known infection with human immunodeficiency virus (HIV). 8. Requirement of therapy with strong CYP3A4 and CYP3A5 inhibitors/ inducers (incl. up to 7 days prior to study treatment start). 9. Anticoagulant therapy with warfarin, phenprocoumon or other vit-amin K antagonists (alternative anticoagulation is allowed (e.g. DOACs), but patients must be properly informed about the potential risk of bleeding under treatment with ibrutinib). 10. History of stroke or intracranial hemorrhage within 6 months prior to registration for study screening. 11. Known bleeding disorders 12. Child B / C liver cirrhosis 13. Use of investigational agents which might interfere with the study drug within 28 days prior to registration for study screening. 14. Vaccination with live vaccines 28 days prior to registration for study screening. 15. Major surgery less than 30 days before start of study treatment. 16. History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, known sensitivity or allergy to murine products. 17. Known hypersensitivity to any active substance or to any of the excipients of one of the drugs used in the trial. 18. Pregnant women and nursing mothers (a negative pregnancy test is required for all women of childbearing potential within 7 days before start of study treatment; further pregnancy testing will be performed monthly). 19. Fertile men or women of childbearing potential unless: 1. surgically sterile or ≥ 2 years after the onset of menopause 2. willing to use two methods of reliable contraception including one highly effective contraceptive method (Pearl Index \<1) and one additional effective (barrier) method during study treatment and for 18 months after the end of study treatment. 20. Legal incapacity. 21. Prisoners or subjects who are institutionalized by regulatory or court order. 22. Persons who are in dependence to the sponsor or an investigator.

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Conditions

The condition(s) this trial relates to.

B-cell chronic lymphocytic leukemia Leukemia, B-Cell

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic lymphoid leukemia

Contacts and locations

Locations

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162, Italy

  • Aalborg Universitetshospital

    Aalborg, 9000, Denmark

  • Aarhus Universitetshospital

    Aarhus, 8200, Denmark

  • Akershus University Hospital

    Lørenskog, 1478, Norway

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318AT, Netherlands

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800, Belgium

  • Algemeen Ziekenhuis St. Jan

    Bruges, 8000, Belgium

  • Alrijne Ziekenhuis

    Leiderdorp, 2353GA, Netherlands

  • Amphia Ziekenhuis

    Breda, 4818CK, Netherlands

  • Amsterdam Universitair Medische Centra

    Amsterdam, 1105AZ, Netherlands

  • Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

    Torino, 10126, Italy

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, 9513, Italy

  • Azienda Ospedaliero Universitaria di Ferrara

    Ferrara, 44124, Italy

  • Barmherzigen Brüder Krankenhaus

    Regensburg, 93049, Germany

  • Beaumont Hospital

    Dublin, Dublin 9, Ireland

  • Bnai-Zion Medical Center

    Haifa, 31048, Israel

  • Brüderkrankenhaus St. Josef Paderborn

    Paderborn, 33098, Germany

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532SZ, Netherlands

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt, 60389, Germany

  • Chaim Sheba Medical Center

    Ramat Gan, 52621, Israel

  • Charite Universitaetsmedizin - Campus Benjamin Franklin

    Berlin, 12203, Germany

  • Charite Universitätsmedizin - Campus Virchow Klinikum

    Berlin, 13353, Germany

  • Cork University Hospital

    Cork, T12DC4A, Ireland

  • Diakonessenhuis

    Utrecht, 3582 KE, Netherlands

  • Ev. Diakoniekrankenhaus

    Bremen, 28239, Germany

  • Evangelische Krankenhaus Hamm

    Hamm, 59063, Germany

  • Falu Lasarett

    Falun, 79182, Sweden

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

    Milan, 20122, Italy

  • Franciscus Vlietland

    Schiedam, 3118JH, Netherlands

  • Galilee Medical Center

    Nahariya, 22100, Israel

  • Gemeinschaftspraxis Haematologie und Onkologie

    Magdeburg, 39104, Germany

  • Gemeinschaftspraxis Hämatologie Onkologie

    Dresden, 1307, Germany

  • Gemeinschaftspraxis für Hämatologie & Onkologie

    Dortmund, 44263, Germany

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster, 48153, Germany

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Ravensburg, 88212, Germany

  • Gmelli University Hospital

    Roma, 168, Italy

  • H.O.T Onkologie Praxis Landshut

    Landshut, 84036, Germany

  • HFR Fribourg Hôpital cantonal

    Fribourg, 1708, Switzerland

  • Hadassah Medical Center Ein Kerem University Hospital

    Jerusalem, 91120, Israel

  • Hallands Sjukhus

    Varberg, 43281, Sweden

  • Hallands Sjukhus Halmstad

    Halmstad, 30185, Sweden

  • Hanusch Krankenhaus

    Vienna, 1140, Austria

  • Haukeland University Hospital

    Bergen, 5021, Norway

  • Helios Klinikum Berlin Buch

    Berlin, 13125, Germany

  • Helsinki University Hospital

    Helsinki, 29, Finland

  • Hospital Clinic de Barcelona

    Barcelona, 8036, Spain

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009, Spain

  • Hospital Clinico Universitario Valencia

    Valencia, 46010, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Costa del Sol

    Málaga, 29603, Spain

  • Hospital Duran i Reynals

    Barcelona, 8908, Spain

  • Hospital Germans Trias i Pujol

    Badalona, 8916, Spain

  • Hospital Marques de Valdecilla

    Santander, 39008, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, 33011, Spain

  • Hospital Universitario Infanta Leonor

    Madrid, 28031, Spain

  • Hospital Universitario La Princesa

    Madrid, 28006, Spain

  • Hospital Universitario Virgen de Valme

    Seville, 41014, Spain

  • Hämatologisch Onkologische Schwerpunktpraxis

    Würzburg, 97080, Germany

  • Hôpitaux Universitaires Genève

    Geneva, 1211, Switzerland

  • IRCCS Ospedale San Raffaele

    Milan, 202132, Italy

  • ISP Erlangen Onkologische Schwerpunktpraxis

    Erlangen, 91052, Germany

  • Inselspital Bern

    Bern, 3010, Switzerland

  • Isala Zwolle

    Zwolle, 8025AB, Netherlands

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223GZ, Netherlands

  • Kantonsspital Aarau

    Aarau, 5001, Switzerland

  • Kantonsspital Baden

    Baden, 5404, Switzerland

  • Kantonsspital Baselland

    Liestal, 4410, Switzerland

  • Kantonsspital Graubünden

    Chur, 7000, Switzerland

  • Kantonsspital Olten

    Olten, 4600, Switzerland

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007, Switzerland

  • Kantonsspital Winterthur

    Winterthur, 8401, Switzerland

  • Kaplan Medical Center

    Rehovot, 7610001, Israel

  • Karolinska University Hospital Solna

    Stockholm, 17176, Sweden

  • Kliniken Maria Hilf

    Mönchengladbach, 41063, Germany

  • Klinikum Lippe Lemgo

    Lemgo, 32657, Germany

  • Klinikum Oldenburg

    Oldenburg, 26133, Germany

  • Klinikum der Universitaet München - Grosshadern Campus

    München, 81377, Germany

  • Klinikum rechts der Isar - Technische Universitaet Muenchen

    München, 81675, Germany

  • LKH-Universtitätsklinikum Graz

    Graz, 8036, Austria

  • Landeskrankenhaus - Universitätskliniken Innsbruck

    Innsbruck, 6020, Austria

  • Lillebaelt Vejle Sygehus

    Vejle, 7100, Denmark

  • Luzerner Kantonsspital

    Lucerne, 6000, Switzerland

  • Lübecker Onkologische Schwerpunktpraxis

    Lübeck, 23562, Germany

  • MVZ Hämatologie Onkologie Koblenz

    Koblenz, 56727, Germany

  • MVZ Onkologische Kooperation Harz

    Goslar, 38642, Germany

  • MVZ Weiden GmbH

    Weiden, 92637, Germany

  • Maasstad Ziekenhuis

    Rotterdam, 3079DZ, Netherlands

  • Mannheimer Onkologie Praxis

    Mannheim, 68161, Germany

  • Marien Hospital Herne

    Herne, 44625, Germany

  • Marienhospital Stuttgart

    Stuttgart, 70199, Germany

  • Martini Ziekenhuis

    Groningen, 9728NT, Netherlands

  • Mater Misericordiae University Hospital

    Dublin, Dublin 7, Ireland

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934AD, Netherlands

  • Medizinische Universität Wien

    Vienna, 1090, Austria

  • Meir Medical Center

    Kfar Saba, 4428164, Israel

  • München Klinik Schwabing

    München, 80804, Germany

  • Nordwest Ziekenhuisgroep, Locatie Alkmaar

    Alkmaar, 1815JD, Netherlands

  • OLVG Amsterdam

    Amsterdam, 1091AC, Netherlands

  • Odense Universitetshospital

    Odense, 5000, Denmark

  • OncoResearch Lerchenfeld

    Hamburg, 22081, Germany

  • OnkoSaar Praxis für Hämatologie und Onkologie

    Saarbrücken, 66113, Germany

  • Onkologische Schwerpunktpraxis

    Esslingen am Neckar, 73728, Germany

  • Onkologische Schwerpunktpraxis Heidelberg

    Heidelberg, 69115, Germany

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707, Germany

  • Onkologisches Ambulanzzentrum - MediProjekt

    Hanover, 30171, Germany

  • Onkopraxis Probstheida

    Leipzig, 4289, Germany

  • Oslo University Hospital

    Oslo, 372, Norway

  • Ospedale Regionale Bellinzona e Valli

    Bellinzona, 6500, Switzerland

  • Ospedale S. Maria della Misericordia

    Perugia, 6123, Italy

  • Ospedale dell'Angelo

    Mestre, 30174, Italy

  • Praxis für Haematologie und Onkologie

    Koblenz, 56068, Germany

  • Praxis für Innere Medizin - Hämatologie und Onkologie

    Marburg, 35037, Germany

  • Rabin Medical Center Beilinson Hospital

    Petah Tikva, 4941492, Israel

  • Regionshospitalet Holstebro

    Holstebro, 7500, Denmark

  • Reinier de Graaf Ziekenhuis

    Delft, 2625AD, Netherlands

  • Residencia Sanitaria La Fe - Valencia

    Valencia, 46026, Spain

  • Rigshospitalet

    Copenhagen, 2100, Denmark

  • Rijnstate, Locatie Arnhem

    Arnhem, 6815AD, Netherlands

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376, Germany

  • Sahlgrenska University Hospital

    Gothenburg, 41346, Sweden

  • Sana Krankenhaus Benrath

    Düsseldorf, 40593, Germany

  • Schwerpunktpraxis für Hämatologie & Onkologie - OncoPro GbR

    Regensburg, 93053, Germany

  • Shamir Medical Center Assaf Harofeh

    Be’er Ya‘aqov, 70300, Israel

  • Skåne University Hospital

    Lund, 22185, Sweden

  • Slingeland ziekenhuis

    Doetinchem, 7009BL, Netherlands

  • Soedra Aelvsborgs Sjukhus

    Borås, 50182, Sweden

  • Soroka University Medical Center

    Beersheba, 84101, Israel

  • Spital Thun

    Thun, 3600, Switzerland

  • Spital Thurgau AG - Kantonsspital Münsterlingen

    Münsterlingen, 8596, Switzerland

  • Spitalzentrum Oberwallis

    Brig, 3900, Switzerland

  • St Vincents University Hospital

    Dublin, Dublin 4, Ireland

  • St Vincenz Krankenhaus

    Limburg, 65549, Germany

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435CM, Netherlands

  • St. Georg Klinikum Eisenach

    Eisenach, 99817, Germany

  • St. James's Hospital

    Dublin, Dublin 8, Ireland

  • St. Olavs Hospital Trondheim University Hospital

    Trondheim, 7030, Norway

  • Stadtspital Triemli

    Zurich, 8063, Switzerland

  • Stauferklinikum Schwäbisch Gmünd

    Mutlangen, 73557, Germany

  • Sunderby Hospital

    Luleå, 97180, Sweden

  • Sydvestjysk Sygehus Esbjerg

    Esbjerg, 6700, Denmark

  • Tampere University Hospital

    Tampere, 33520, Finland

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906, Israel

  • Turku University Hospital

    Turku, 20521, Finland

  • Umberto I - Policlinico di Roma - Sapienza Università

    Roma, 161, Italy

  • Umeå University Hospital

    Umeå, 90185, Sweden

  • Uniklinikum Gießen und Marburg

    Giessen, 35392, Germany

  • Universitaetsklinikum Essen

    Essen, 45147, Germany

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105, Germany

  • Universitair Ziekenhuis Leuven

    Leuven, 3000, Belgium

  • Universitetssjukhuset Linköping

    Linköping, 58185, Sweden

  • University Hospital Galway

    Galway, H91 YR71, Ireland

  • University Hospital Limerick

    Limerick, V94 F858, Ireland

  • University Hospital Waterford

    Waterford, X91 ER8E, Ireland

  • Universitätsklinik Carl Gustav Carus

    Dresden, 1307, Germany

  • Universitätsklinik Köln

    Cologne, 50924, Germany

  • Universitätsklinik Rostock

    Rostock, 18057, Germany

  • Universitätsklinik Tübingen

    Tübingen, 72076, Germany

  • Universitätskliniken des Saarlandes

    Homburg, 66424, Germany

  • Universitätsklinikum Augsburg

    Augsburg, 86156, Germany

  • Universitätsklinikum Erlangen

    Erlangen, 91054, Germany

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246, Germany

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120, Germany

  • Universitätsklinikum Jena

    Jena, 7747, Germany

  • Universitätsklinikum Leipzig

    Leipzig, 4103, Germany

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Universitätsspital Basel

    Basel, 4031, Switzerland

  • Universitätsspital Zuerich

    Zurich, 8091, Switzerland

  • Uppsala University Hospital

    Uppsala, 75185, Sweden

  • Vall d'Hebron University Hospital

    Barcelona, 8035, Spain

  • VieCuri Medish Centrum

    Venlo, 5912BL, Netherlands

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, 67655, Germany

  • Wiener Gesundheitsverbund Klinik Ottakring

    Vienna, 1160, Austria

  • Zealand University Hospital

    Roskilde, 4000, Denmark

  • Zentrum für abulante Hämatologie und Onkologie

    Siegburg, 53721, Germany

  • Ziekenhuis Gelderse Vallei

    Ede, 6716RP, Netherlands

  • Ziekenhuis Rivierenland Tiel

    Tiel, 4002WP, Netherlands

  • Ziekenhuis St Jansdal

    Harderwijk, 3844DG, Netherlands

  • Örebro University Hospital

    Örebro, 70185, Sweden

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