AzTrials
AzTrials

Chronic Lymphoid LeukemiaPhase 3CLL17NCT04608318

Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

A Phase 3 study testing Ibrutinib, Venetoclax and Obinutuzumab in people with Chronic Lymphoid Leukemia, run by German CLL Study Group at 181 sites in 13 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The aim of this study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients with previously untreated CLL. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Chronic Lymphoid Leukemia
What is being tested?
Ibrutinib, Venetoclax and Obinutuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
897 participants
Where
181 sitesin 13 countries
Study dates
1 Mar 2021to Sep 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Documented CLL requiring treatment according to iwCLL criteria.
  • Age at least 18 years.
  • Life expectancy ≥ 6 months.
  • Ability and willingness to provide written informed consent and to adhere to the study visit schedule and other protocol requirements.
  • 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:
  • Absolute neutrophil count ≥ 1.0 × 109/L
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  • 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
  • Total haemoglobin ≥ 8 g/dL (without transfusion support, unless anaemia is due to CLL)
  • 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.
  • 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.
  • 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 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).
  • Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0-2.

Who cannot join

  • 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).
  • Transformation of CLL (Richter transformation). When Richter transformation is suspected, PET-CT and/or biopsy should be performed to rule out transformation.
  • Patients with a history of PML.
  • 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).
  • 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.
  • Uncontrolled or active infection.
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  • Patients with known infection with human immunodeficiency virus (HIV).
  • Requirement of therapy with strong CYP3A4 and CYP3A5 inhibitors/ inducers (incl. up to 7 days prior to study treatment start).
  • 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).
  • History of stroke or intracranial hemorrhage within 6 months prior to registration for study screening.
  • Known bleeding disorders
  • Child B / C liver cirrhosis
  • Use of investigational agents which might interfere with the study drug within 28 days prior to registration for study screening.
  • Vaccination with live vaccines 28 days prior to registration for study screening.
  • Major surgery less than 30 days before start of study treatment.
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies, known sensitivity or allergy to murine products.
  • Known hypersensitivity to any active substance or to any of the excipients of one of the drugs used in the trial.
  • 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).
  • Fertile men or women of childbearing potential unless:
  • surgically sterile or ≥ 2 years after the onset of menopause
  • 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.
  • Legal incapacity.
  • Prisoners or subjects who are institutionalized by regulatory or court order.
  • Persons who are in dependence to the sponsor or an investigator.

Trial locations and contacts

181 sites in 13 countries.

181 sites in 13 countries

Germany63 sites

  • Universitätsklinikum Augsburg

    Augsburg, 86156

  • Onkologische Schwerpunktpraxis Kurfürstendamm

    Berlin, 10707

  • Charite Universitaetsmedizin - Campus Benjamin Franklin

    Berlin, 12203

  • Helios Klinikum Berlin Buch

    Berlin, 13125

  • Charite Universitätsmedizin - Campus Virchow Klinikum

    Berlin, 13353

  • Ev. Diakoniekrankenhaus

    Bremen, 28239

  • Universitätsklinik Köln

    Cologne, 50924

  • Gemeinschaftspraxis für Hämatologie & Onkologie

    Dortmund, 44263

  • Gemeinschaftspraxis Hämatologie Onkologie

    Dresden, 1307

  • Universitätsklinik Carl Gustav Carus

    Dresden, 1307

  • Sana Krankenhaus Benrath

    Düsseldorf, 40593

  • St. Georg Klinikum Eisenach

    Eisenach, 99817

  • ISP Erlangen Onkologische Schwerpunktpraxis

    Erlangen, 91052

  • Universitätsklinikum Erlangen

    Erlangen, 91054

  • Universitaetsklinikum Essen

    Essen, 45147

  • Onkologische Schwerpunktpraxis

    Esslingen am Neckar, 73728

  • Centrum für Hämatologie und Onkologie Bethanien

    Frankfurt, 60389

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Uniklinikum Gießen und Marburg

    Giessen, 35392

  • MVZ Onkologische Kooperation Harz

    Goslar, 38642

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • OncoResearch Lerchenfeld

    Hamburg, 22081

  • Evangelische Krankenhaus Hamm

    Hamm, 59063

  • Onkologisches Ambulanzzentrum - MediProjekt

    Hanover, 30171

  • Onkologische Schwerpunktpraxis Heidelberg

    Heidelberg, 69115

  • Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Marien Hospital Herne

    Herne, 44625

  • Universitätskliniken des Saarlandes

    Homburg, 66424

  • Universitätsklinikum Jena

    Jena, 7747

  • Westpfalz-Klinikum GmbH

    Kaiserslautern, 67655

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105

  • Praxis für Haematologie und Onkologie

    Koblenz, 56068

  • MVZ Hämatologie Onkologie Koblenz

    Koblenz, 56727

  • H.O.T Onkologie Praxis Landshut

    Landshut, 84036

  • Universitätsklinikum Leipzig

    Leipzig, 4103

  • Onkopraxis Probstheida

    Leipzig, 4289

  • Klinikum Lippe Lemgo

    Lemgo, 32657

  • St Vincenz Krankenhaus

    Limburg, 65549

  • Lübecker Onkologische Schwerpunktpraxis

    Lübeck, 23562

  • Gemeinschaftspraxis Haematologie und Onkologie

    Magdeburg, 39104

  • Universitätsklinikum Magdeburg

    Magdeburg, 39120

  • Mannheimer Onkologie Praxis

    Mannheim, 68161

  • Praxis für Innere Medizin - Hämatologie und Onkologie

    Marburg, 35037

  • Kliniken Maria Hilf

    Mönchengladbach, 41063

  • München Klinik Schwabing

    München, 80804

  • Klinikum der Universitaet München - Grosshadern Campus

    München, 81377

  • Klinikum rechts der Isar - Technische Universitaet Muenchen

    München, 81675

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Münster, 48153

  • Stauferklinikum Schwäbisch Gmünd

    Mutlangen, 73557

  • Klinikum Oldenburg

    Oldenburg, 26133

  • Brüderkrankenhaus St. Josef Paderborn

    Paderborn, 33098

  • Gemeinschaftspraxis für Hämatologie und Onkologie

    Ravensburg, 88212

  • Barmherzigen Brüder Krankenhaus

    Regensburg, 93049

  • Schwerpunktpraxis für Hämatologie & Onkologie - OncoPro GbR

    Regensburg, 93053

  • Universitätsklinik Rostock

    Rostock, 18057

  • OnkoSaar Praxis für Hämatologie und Onkologie

    Saarbrücken, 66113

  • Zentrum für abulante Hämatologie und Onkologie

    Siegburg, 53721

  • Marienhospital Stuttgart

    Stuttgart, 70199

  • Robert-Bosch-Krankenhaus

    Stuttgart, 70376

  • Universitätsklinik Tübingen

    Tübingen, 72076

  • Universitätsklinikum Ulm

    Ulm, 89081

  • MVZ Weiden GmbH

    Weiden, 92637

  • Hämatologisch Onkologische Schwerpunktpraxis

    Würzburg, 97080

Other trials in Germany

Netherlands22 sites

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223GZ

  • Nordwest Ziekenhuisgroep, Locatie Alkmaar

    Alkmaar, 1815JD

  • OLVG Amsterdam

    Amsterdam, 1091AC

  • Amsterdam Universitair Medische Centra

    Amsterdam, 1105AZ

  • Rijnstate, Locatie Arnhem

    Arnhem, 6815AD

  • Amphia Ziekenhuis

    Breda, 4818CK

  • Reinier de Graaf Ziekenhuis

    Delft, 2625AD

  • Slingeland ziekenhuis

    Doetinchem, 7009BL

  • Albert Schweitzer Ziekenhuis

    Dordrecht, 3318AT

  • Ziekenhuis Gelderse Vallei

    Ede, 6716RP

  • Martini Ziekenhuis

    Groningen, 9728NT

  • Ziekenhuis St Jansdal

    Harderwijk, 3844DG

  • Medisch Centrum Leeuwarden

    Leeuwarden, 8934AD

  • Alrijne Ziekenhuis

    Leiderdorp, 2353GA

  • St. Antonius Ziekenhuis

    Nieuwegein, 3435CM

  • Canisius-Wilhelmina Ziekenhuis

    Nijmegen, 6532SZ

  • Maasstad Ziekenhuis

    Rotterdam, 3079DZ

  • Franciscus Vlietland

    Schiedam, 3118JH

  • Ziekenhuis Rivierenland Tiel

    Tiel, 4002WP

  • Diakonessenhuis

    Utrecht, 3582 KE

  • VieCuri Medish Centrum

    Venlo, 5912BL

  • Isala Zwolle

    Zwolle, 8025AB

Other trials in Netherlands

Switzerland18 sites

  • Kantonsspital Aarau

    Aarau, 5001

  • Kantonsspital Baden

    Baden, 5404

  • Universitätsspital Basel

    Basel, 4031

  • Ospedale Regionale Bellinzona e Valli

    Bellinzona, 6500

  • Inselspital Bern

    Bern, 3010

  • Spitalzentrum Oberwallis

    Brig, 3900

  • Kantonsspital Graubünden

    Chur, 7000

  • HFR Fribourg Hôpital cantonal

    Fribourg, 1708

  • Hôpitaux Universitaires Genève

    Geneva, 1211

  • Kantonsspital Baselland

    Liestal, 4410

  • Luzerner Kantonsspital

    Lucerne, 6000

  • Spital Thurgau AG - Kantonsspital Münsterlingen

    Münsterlingen, 8596

  • Kantonsspital Olten

    Olten, 4600

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • Spital Thun

    Thun, 3600

  • Kantonsspital Winterthur

    Winterthur, 8401

  • Stadtspital Triemli

    Zurich, 8063

  • Universitätsspital Zuerich

    Zurich, 8091

Other trials in Switzerland

Spain15 sites

  • Hospital Germans Trias i Pujol

    Badalona, 8916

  • Vall d'Hebron University Hospital

    Barcelona, 8035

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Duran i Reynals

    Barcelona, 8908

  • Hospital Universitario La Princesa

    Madrid, 28006

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Costa del Sol

    Málaga, 29603

  • Hospital Universitario Central de Asturias

    Oviedo, 33011

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Hospital Marques de Valdecilla

    Santander, 39008

  • Hospital Universitario Virgen de Valme

    Seville, 41014

  • Hospital Clinico Universitario Valencia

    Valencia, 46010

  • Residencia Sanitaria La Fe - Valencia

    Valencia, 46026

  • Hospital Clinico Universitario Lozano Blesa

    Zaragoza, 50009

Other trials in Spain

Sweden12 sites

  • Soedra Aelvsborgs Sjukhus

    Borås, 50182

  • Falu Lasarett

    Falun, 79182

  • Sahlgrenska University Hospital

    Gothenburg, 41346

  • Hallands Sjukhus Halmstad

    Halmstad, 30185

  • Universitetssjukhuset Linköping

    Linköping, 58185

  • Sunderby Hospital

    Luleå, 97180

  • Skåne University Hospital

    Lund, 22185

  • Örebro University Hospital

    Örebro, 70185

  • Karolinska University Hospital Solna

    Stockholm, 17176

  • Umeå University Hospital

    Umeå, 90185

  • Uppsala University Hospital

    Uppsala, 75185

  • Hallands Sjukhus

    Varberg, 43281

Other trials in Sweden

Israel10 sites

  • Shamir Medical Center Assaf Harofeh

    Be’er Ya‘aqov, 70300

  • Soroka University Medical Center

    Beersheba, 84101

  • Bnai-Zion Medical Center

    Haifa, 31048

  • Hadassah Medical Center Ein Kerem University Hospital

    Jerusalem, 91120

  • Meir Medical Center

    Kfar Saba, 4428164

  • Galilee Medical Center

    Nahariya, 22100

  • Rabin Medical Center Beilinson Hospital

    Petah Tikva, 4941492

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

  • Kaplan Medical Center

    Rehovot, 7610001

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

Italy10 sites

  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele

    Catania, 9513

  • Azienda Ospedaliero Universitaria di Ferrara

    Ferrara, 44124

  • Ospedale dell'Angelo

    Mestre, 30174

  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico

    Milan, 20122

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, 20162

  • IRCCS Ospedale San Raffaele

    Milan, 202132

  • Ospedale S. Maria della Misericordia

    Perugia, 6123

  • Umberto I - Policlinico di Roma - Sapienza Università

    Roma, 161

  • Gmelli University Hospital

    Roma, 168

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

    Torino, 10126

Other trials in Italy

Denmark8 sites

  • Aalborg Universitetshospital

    Aalborg, 9000

  • Aarhus Universitetshospital

    Aarhus, 8200

  • Rigshospitalet

    Copenhagen, 2100

  • Sydvestjysk Sygehus Esbjerg

    Esbjerg, 6700

  • Regionshospitalet Holstebro

    Holstebro, 7500

  • Odense Universitetshospital

    Odense, 5000

  • Zealand University Hospital

    Roskilde, 4000

  • Lillebaelt Vejle Sygehus

    Vejle, 7100

Other trials in Denmark

Ireland8 sites

  • Cork University Hospital

    Cork, T12DC4A

  • St Vincents University Hospital

    Dublin, Dublin 4

  • Mater Misericordiae University Hospital

    Dublin, Dublin 7

  • St. James's Hospital

    Dublin, Dublin 8

  • Beaumont Hospital

    Dublin, Dublin 9

  • University Hospital Galway

    Galway, H91 YR71

  • University Hospital Limerick

    Limerick, V94 F858

  • University Hospital Waterford

    Waterford, X91 ER8E

Other trials in Ireland

Austria5 sites

  • LKH-Universtitätsklinikum Graz

    Graz, 8036

  • Landeskrankenhaus - Universitätskliniken Innsbruck

    Innsbruck, 6020

  • Medizinische Universität Wien

    Vienna, 1090

  • Hanusch Krankenhaus

    Vienna, 1140

  • Wiener Gesundheitsverbund Klinik Ottakring

    Vienna, 1160

Other trials in Austria

Norway4 sites

  • Haukeland University Hospital

    Bergen, 5021

  • Akershus University Hospital

    Lørenskog, 1478

  • Oslo University Hospital

    Oslo, 372

  • St. Olavs Hospital Trondheim University Hospital

    Trondheim, 7030

Other trials in Norway

Belgium3 sites

  • Algemeen Ziekenhuis St. Jan

    Bruges, 8000

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

  • Algemeen Ziekenhuis Delta

    Roeselare, 8800

Other trials in Belgium

Finland3 sites

  • Helsinki University Hospital

    Helsinki, 29

  • Tampere University Hospital

    Tampere, 33520

  • Turku University Hospital

    Turku, 20521

Other trials in Finland

About this study

Official title: A Phase 3 Multicentre, Randomized, Prospective, Open-label Trial of Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL)

The aim of this study is to compare the efficacy of continuous ibrutinib monotherapy with fixed-duration venetoclax plus obinutuzumab and fixed-duration ibrutinib plus venetoclax by measuring progression-free survival (PFS) in patients with previously untreated CLL.

Keywords
CLL
Medical subject headings
Leukemia, B-Cell

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IbrutinibBiological

    Also called Imbruvica

    Cycles 1 - X: 420 mg daily, d1-28 p.o.

  • VenetoclaxBiological

    Also called ABT-199, Venclyxto

    Arm VG

    Cycle 1: 20 mg (2 tabl. at 10 mg), d22-28 p.o.

    Cycle 2: 50 mg (1 tabl. at 50 mg), d1-7; 100 mg (1 tabl. at 100 mg), d8-14; 200 mg (2 tabl. at 100 mg), d15-21; 400 mg (4 tabl. at 100 mg), d22-28 p.o.

    Cycles 3-12: 400 mg (4 tabl. at 100 mg), d1-28 p.o.

    Arm VI

    Cycle 4: 20 mg (2 tabl. at 10 mg), d1-7; 50 mg (1 tabl. at 50 mg), d8-14; 100 mg (1 tabl. at 100 mg), d15-21; 200 mg (2 tabl. at 100 mg), d22-28 p.o.

    Cycles 5-15: 400 mg (4 tabl. at 100 mg), d1-28 p.o.

  • ObinutuzumabBiological

    Also called GA101, Gazyvaro

    Cycle 1: (100 mg, d1 + 900 mg, d2) or 1000 mg, d1; 1000 mg, d8 + d15 i.v. Cycle 2 - 6: 1000 mg, d1 i.v.

Study groups in NCT04608318
Study groupRoleWhat they receive
I (Ibrutinib)ExperimentalIbrutinib p.o. will be administered until occurrence of unacceptable toxicity, progression of CLL or end of trial, whichever occurs first.
Receives: Biological: Ibrutinib
VG (Obinutuzumab + Venetoclax)Experimental12 cycles (q 28d): Obinutuzumab i.v. + Venetoclax p.o. will be administered for 6 cycles, followed by 6 additional cycles of Venetoclax alone
Receives: Biological: Venetoclax; Biological: Obinutuzumab
VI (Venetoclax + Ibrutinib)Experimental15 cycles (q 28d): Ibrutinib p.o. + Venetoclax p.o. will be administered for a total of 12 cycles with a prior Ibrutinib monotherapy lead-in of 3 cycles
Receives: Biological: Ibrutinib; Biological: Venetoclax

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Investigator-assessed progression-free survival (PFS)

    Time from randomization to the first occurrence of progression or relapse (determined using standard iwCLL guidelines), or death from any cause, whichever occurs first

    Measured: Up to 80 month

Secondary outcomes (9)

  1. Rates of undetectable minimal residual disease (uMRD) in peripheral blood (PB) and bone marrow (BM)

    Undetectable MRD (uMRD) is defined as <10-4 (=1 CLL-cell per 10,000 leukocytes analyzed).The uMRD rate is defined as the proportion of patients having achieved uMRD.

    Measured: At final restaging (RE): 18 months after start of treatment and additional BM assessment approx. 12 months after RE

  2. MRD levels in PB at different time points

    MRD is defined as the number of CLL-cells that can be detected in peripheral blood (PB) or bone marrow (BM). MRD values will be categorized into negative (<10-4) and positive (≥10-4)

    Measured: Up to 80 month

  3. Overall response rate (ORR)

    Proportion of patients having achieved a complete response (CR), a CR with incomplete recovery of the bone marrow (CRi), or a partial response (PR) as best response.

    Measured: At final restaging (RE): 18 months after start of treatment

  4. CR/CRi rate

    Proportion of patients having achieved a CR or CRi as best response (= number of patients with best response CR or CRi divided by the number of the intention-to-treat population (ITT) population)

    Measured: At final restaging (RE): 18 months after start of treatment

  5. Event-free survival

    Event-free survival (EFS) (I vs VG and I vs VI)

    Measured: Up to 80 month

  6. Time to next treatment

    Time to next treatment (TTNT)

    Measured: Up to 80 month

  7. PFS2

    Progression free survival 2 (i.e. PFS after second-line treatment)

    Measured: Up to 80 month

  8. Incidence of safety parameters such as adverse events (AE) and adverse events of particular/special interest (AEPI/AESI)

    Type, frequency, severity and relationship to study treatment.of AEs and AEPIs/AESIs

    Measured: Up to 80 month

  9. Safety parameter TLS

    Tumour lysis syndrome (TLS) risk category after G or I lead-in (before venetoclax ramp up)

    Measured: Up to 80 month

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2020
  2. Study start1 Mar 2021
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
897 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04608318
Sponsor's protocol ID
CLL17
Other IDs
2022-500439-35-00, 2019-003854-99, 2019
Acronym
CLL17
Status last verified
Apr 2026
First submitted
23 Oct 2020
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Al-Sawaf O, Stumpf J, Zhang C, Simon F, Bosch F, Feyzi E, Ghia P, Gregor M, Kater AP, Lindstrom V, Mattsson M, Niemann CU, Staber PB, Tadmor T, Thornton P, Wendtner CM, Janssens A, Noesslinger T, Bohn JP, da Cunha-Bang C, Poulsen CB, Ranti J, Illmer T, Schoettker B, Bottcher S, Gaska T, Vandenberghe E, Clifford R, Benjamini O, Frustaci AM, Scarfo L, Sportoletti P, Schreurs J, Levin MD, van der Straaten H, van der Klift M, Tran H, de la Serna J, Loscertales J, Lindblad O, Bergendahl Sandstedt A, Goede J, Baumann M, Fink AM, Fischer K, Ritgen M, Kreuzer KA, Schneider C, Tausch E, Stilgenbauer S, Robrecht S, Eichhorst B, Hallek M; CLL17 Trial Investigators. Fixed-Duration versus Continuous Treatment for Chronic Lymphocytic Leukemia. N Engl J Med. 2026 Mar 12;394(11):1084-1096. doi: 10.1056/NEJMoa2515458. Epub 2025 Dec 6.

    PubMed 41358601

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ibrutinib, Venetoclax and Obinutuzumab in people with Chronic Lymphoid Leukemia, run by German CLL Study Group at 181 sites in 13 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 181 sites in Germany, Netherlands, Switzerland, Spain, Sweden and 8 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Investigator-assessed progression-free survival (PFS) (time frame: Up to 80 month). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04608318, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.

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