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Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL) (CLL17)

Primary Purpose

Chronic Lymphoid Leukemia

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ibrutinib
Venetoclax
Obinutuzumab
Sponsored by
German CLL Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphoid Leukemia focused on measuring CLL

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 ≥ 9 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 until 12 months after last treatment cycle), negative testing for hepatitis C RNA within 6 weeks prior to registration for study screening (i.e. PCR only required when serology was positive).
  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 or phenprocoumon, (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.

Sites / Locations

  • LKH-Universtitätsklinikum Graz
  • Landeskrankenhaus - Universitätskliniken Innsbruck
  • Medizinische Universität Wien
  • Hanusch Krankenhaus
  • Wiener Gesundheitsverbund Klinik Ottakring
  • Algemeen Ziekenhuis St. Jan
  • Universitair Ziekenhuis Leuven
  • Algemeen Ziekenhuis Delta
  • Aalborg Universitetshospital
  • Aarhus Universitetshospital
  • Rigshospitalet
  • Sydvestjysk Sygehus Esbjerg
  • Regionshospitalet Holstebro
  • Odense Universitetshospital
  • Zealand University Hospital
  • Lillebaelt Vejle Sygehus
  • Helsinki University Hospital
  • Tampere University Hospital
  • Turku University Hospital
  • Universitätsklinikum Augsburg
  • Onkologische Schwerpunktpraxis Kurfürstendamm
  • Charite Universitaetsmedizin - Campus Benjamin Franklin
  • Helios Klinikum Berlin Buch
  • Charite Universitätsmedizin - Campus Virchow Klinikum
  • Ev. Diakoniekrankenhaus
  • Gemeinschaftspraxis für Hämatologie & Onkologie
  • Gemeinschaftspraxis Hämatologie Onkologie
  • Universitätsklinik Carl Gustav Carus
  • Sana Krankenhaus Benrath
  • St. Georg Klinikum Eisenach
  • ISP Erlangen Onkologische Schwerpunktpraxis
  • Universitätsklinikum Erlangen
  • Universitaetsklinikum Essen
  • Onkologische Schwerpunktpraxis
  • Centrum für Hämatologie und Onkologie Bethanien
  • Universitätsklinikum Freiburg
  • Uniklinikum Gießen und Marburg
  • MVZ Onkologische Kooperation Harz
  • Universitätsklinikum Hamburg-Eppendorf
  • OncoResearch Lerchenfeld
  • Evangelische Krankenhaus Hamm
  • Onkologisches Ambulanzzentrum - MediProjekt
  • Onkologische Schwerpunktpraxis Heidelberg
  • Universitätsklinikum Heidelberg
  • Marien Hospital Herne
  • Universitätskliniken des Saarlandes
  • Universitätsklinikum Jena
  • Westpfalz-Klinikum GmbH
  • Universitaetsklinikum Schleswig-Holstein Campus Kiel
  • Praxis für Haematologie und Onkologie
  • MVZ Hämatologie Onkologie Koblenz
  • Universitätsklinik Köln
  • H.O.T Onkologie Praxis Landshut
  • Universitätsklinikum Leipzig
  • Onkopraxis Probstheida
  • Klinikum Lippe Lemgo
  • St Vincenz Krankenhaus
  • Lübecker Onkologische Schwerpunktpraxis
  • Gemeinschaftspraxis Haematologie und Onkologie
  • Universitätsklinikum Magdeburg
  • Mannheimer Onkologie Praxis
  • Praxis für Innere Medizin - Hämatologie und Onkologie
  • Stauferklinikum Schwäbisch Gmünd
  • Kliniken Maria Hilf
  • München Klinik Schwabing
  • Klinikum der Universitaet München - Grosshadern Campus
  • Klinikum rechts der Isar - Technische Universitaet Muenchen
  • Gemeinschaftspraxis für Hämatologie und Onkologie
  • Klinikum Oldenburg
  • Brüderkrankenhaus St. Josef Paderborn
  • Gemeinschaftspraxis für Hämatologie und Onkologie
  • Barmherzigen Brüder Krankenhaus
  • Schwerpunktpraxis für Hämatologie & Onkologie - OncoPro GbR
  • Universitätsklinik Rostock
  • OnkoSaar Praxis für Hämatologie und Onkologie
  • Zentrum für abulante Hämatologie und Onkologie
  • Marienhospital Stuttgart
  • Robert-Bosch-Krankenhaus
  • Universitätsklinik Tübingen
  • Universitätsklinikum Ulm
  • MVZ Weiden GmbH
  • Hämatologisch Onkologische Schwerpunktpraxis
  • Cork University Hospital
  • St Vincents University Hospital
  • Mater Misericordiae University Hospital
  • St. James's Hospital
  • Beaumont Hospital
  • University Hospital Galway
  • University Hospital Limerick
  • University Hospital Waterford
  • Soroka University Medical Center
  • Shamir Medical Center Assaf Harofeh
  • Bnai-Zion Medical Center
  • Hadassah Medical Center Ein Kerem University Hospital
  • Meir Medical Center
  • Galilee Medical Center
  • Rabin Medical Center Beilinson Hospital
  • Chaim Sheba Medical Center
  • Kaplan Medical Center
  • Tel Aviv Sourasky Medical Center
  • Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
  • Azienda Ospedaliero Universitaria di Ferrara
  • Ospedale dell'Angelo
  • Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
  • ASST Grande Ospedale Metropolitano Niguarda
  • IRCCS Ospedale San Raffaele
  • Ospedale S. Maria della Misericordia
  • Umberto I - Policlinico di Roma - Sapienza Università
  • Gmelli University Hospital
  • Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
  • Nordwest Ziekenhuisgroep, Locatie Alkmaar
  • OLVG Amsterdam
  • Amsterdam Universitair Medische Centra
  • Rijnstate, Locatie Arnhem
  • Amphia Ziekenhuis
  • Reinier de Graaf Ziekenhuis
  • Slingeland ziekenhuis
  • Albert Schweitzer Ziekenhuis
  • Ziekenhuis Gelderse Vallei
  • Martini Ziekenhuis
  • Ziekenhuis St Jansdal
  • Medisch Centrum Leeuwarden
  • Alrijne Ziekenhuis
  • St. Antonius Ziekenhuis
  • Canisius-Wilhelmina Ziekenhuis
  • Maasstad Ziekenhuis
  • Jeroen Bosch Ziekenhuis
  • Franciscus Vlietland
  • Ziekenhuis Rivierenland Tiel
  • Diakonessenhuis
  • VieCuri Medish Centrum
  • Isala Zwolle
  • Haukeland University Hospital
  • Akershus University Hospital
  • Oslo University Hospital
  • St. Olavs Hospital Trondheim University Hospital
  • Hospital Germans Trias i Pujol
  • Vall d'Hebron University Hospital
  • Hospital Clinic de Barcelona
  • Hospital Duran i Reynals
  • Hospital Universitario La Princesa
  • Hospital Universitario Infanta Leonor
  • Hospital Universitario 12 de Octubre
  • Hospital Costa del Sol
  • Hospital Universitario Central de Asturias
  • Hospital Clinico Universitario de Salamanca
  • Hospital Marques de Valdecilla
  • Hospital Universitario Virgen de Valme
  • Hospital Clinico Universitario Valencia
  • Residencia Sanitaria La Fe - Valencia
  • Hospital Clinico Universitario Lozano Blesa
  • Soedra Aelvsborgs Sjukhus
  • Falu Lasarett
  • Sahlgrenska University Hospital
  • Hallands Sjukhus Halmstad
  • Universitetssjukhuset Linköping
  • Sunderby Hospital
  • Skåne University Hospital
  • Karolinska University Hospital Solna
  • Umeå University Hospital
  • Uppsala University Hospital
  • Hallands Sjukhus
  • Örebro University Hospital
  • Kantonsspital Aarau
  • Kantonsspital Baden
  • Universitätsspital Basel
  • Ospedale Regionale Bellinzona e Valli
  • Inselspital Bern
  • Spitalzentrum Oberwallis
  • Kantonsspital Graubünden
  • HFR Fribourg Hôpital cantonal
  • Hôpitaux Universitaires Genève
  • Kantonsspital Baselland
  • Luzerner Kantonsspital
  • Spital Thurgau AG - Kantonsspital Münsterlingen
  • Kantonsspital Olten
  • Kantonsspital St. Gallen
  • Spital Thun
  • Kantonsspital Winterthur
  • Stadtspital Triemli
  • Universitätsspital Zuerich

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

I (Ibrutinib)

VG (Obinutuzumab + Venetoclax)

VI (Venetoclax + Ibrutinib)

Arm Description

Ibrutinib p.o. will be administered until occurrence of unacceptable toxicity, progression of CLL or end of trial, whichever occurs first.

12 cycles (q 28d): Obinutuzumab i.v. + Venetoclax p.o. will be administered for 6 cycles, followed by 6 additional cycles of Venetoclax alone

15 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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
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)
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.
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)
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

Full Information

First Posted
October 23, 2020
Last Updated
February 22, 2023
Sponsor
German CLL Study Group
Collaborators
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Nordic CLL Study Group (NCLLSG), Swiss Group for Clinical Cancer Research (SAKK), Cancer Trials Ireland, Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA), Grupo Español de Leucemia Linfocítica Crónica (GELLC), The Israeli CLL Study Group (ICLLSG)
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1. Study Identification

Unique Protocol Identification Number
NCT04608318
Brief Title
Ibrutinib Monotherapy Versus Fixed-duration Venetoclax Plus Obinutuzumab Versus Fixed-duration Ibrutinib Plus Venetoclax in Patients With Previously Untreated Chronic Lymphocytic Leukaemia (CLL)
Acronym
CLL17
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2021 (Actual)
Primary Completion Date
March 2027 (Anticipated)
Study Completion Date
March 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German CLL Study Group
Collaborators
Stichting Hemato-Oncologie voor Volwassenen Nederland (HOVON), Nordic CLL Study Group (NCLLSG), Swiss Group for Clinical Cancer Research (SAKK), Cancer Trials Ireland, Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA), Grupo Español de Leucemia Linfocítica Crónica (GELLC), The Israeli CLL Study Group (ICLLSG)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphoid Leukemia
Keywords
CLL

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
897 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
I (Ibrutinib)
Arm Type
Experimental
Arm Description
Ibrutinib p.o. will be administered until occurrence of unacceptable toxicity, progression of CLL or end of trial, whichever occurs first.
Arm Title
VG (Obinutuzumab + Venetoclax)
Arm Type
Experimental
Arm Description
12 cycles (q 28d): Obinutuzumab i.v. + Venetoclax p.o. will be administered for 6 cycles, followed by 6 additional cycles of Venetoclax alone
Arm Title
VI (Venetoclax + Ibrutinib)
Arm Type
Experimental
Arm Description
15 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
Intervention Type
Biological
Intervention Name(s)
Ibrutinib
Other Intervention Name(s)
Imbruvica
Intervention Description
Cycles 1 - X: 420 mg daily, d1-28 p.o.
Intervention Type
Biological
Intervention Name(s)
Venetoclax
Other Intervention Name(s)
ABT-199, Venclyxto
Intervention Description
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.
Intervention Type
Biological
Intervention Name(s)
Obinutuzumab
Other Intervention Name(s)
GA101, Gazyvaro
Intervention Description
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.
Primary Outcome Measure Information:
Title
Investigator-assessed progression-free survival (PFS)
Description
Time from randomization to the first occurrence of progression or relapse (determined using standard iwCLL guidelines), or death from any cause, whichever occurs first
Time Frame
Up to 80 month
Secondary Outcome Measure Information:
Title
Rates of undetectable minimal residual disease (uMRD) in peripheral blood (PB) and bone marrow (BM)
Description
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.
Time Frame
At final restaging (RE): 18 months after start of treatment and additional BM assessment approx. 12 months after RE
Title
MRD levels in PB at different time points
Description
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)
Time Frame
Up to 80 month
Title
Overall response rate (ORR)
Description
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.
Time Frame
At final restaging (RE): 18 months after start of treatment
Title
CR/CRi rate
Description
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)
Time Frame
At final restaging (RE): 18 months after start of treatment
Title
Incidence of safety parameters such as adverse events (AE) and adverse events of particular/special interest (AEPI/AESI)
Description
Type, frequency, severity and relationship to study treatment.of AEs and AEPIs/AESIs
Time Frame
Up to 80 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 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 ≥ 9 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. 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. 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 until 12 months after last treatment cycle), negative testing for hepatitis C RNA within 6 weeks prior to registration for study screening (i.e. PCR only required when serology was positive). Eastern Cooperative Oncology Group Performance Status (ECOG) performance status 0-2. Exclusion criteria: 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. 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 or phenprocoumon, (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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Othman Al-Sawaf, Dr. med.
Organizational Affiliation
German CLL Study Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
LKH-Universtitätsklinikum Graz
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Landeskrankenhaus - Universitätskliniken Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Medizinische Universität Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Hanusch Krankenhaus
City
Wien
ZIP/Postal Code
1140
Country
Austria
Facility Name
Wiener Gesundheitsverbund Klinik Ottakring
City
Wien
ZIP/Postal Code
1160
Country
Austria
Facility Name
Algemeen Ziekenhuis St. Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Algemeen Ziekenhuis Delta
City
Roeselare
ZIP/Postal Code
8800
Country
Belgium
Facility Name
Aalborg Universitetshospital
City
Aalborg
ZIP/Postal Code
9000
Country
Denmark
Facility Name
Aarhus Universitetshospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet
City
Copenhagen
ZIP/Postal Code
2100
Country
Denmark
Facility Name
Sydvestjysk Sygehus Esbjerg
City
Esbjerg
ZIP/Postal Code
6700
Country
Denmark
Facility Name
Regionshospitalet Holstebro
City
Holstebro
ZIP/Postal Code
7500
Country
Denmark
Facility Name
Odense Universitetshospital
City
Odense
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Zealand University Hospital
City
Roskilde
ZIP/Postal Code
4000
Country
Denmark
Facility Name
Lillebaelt Vejle Sygehus
City
Vejle
ZIP/Postal Code
7100
Country
Denmark
Facility Name
Helsinki University Hospital
City
Helsinki
ZIP/Postal Code
29
Country
Finland
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33520
Country
Finland
Facility Name
Turku University Hospital
City
Turku
ZIP/Postal Code
20521
Country
Finland
Facility Name
Universitätsklinikum Augsburg
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Kurfürstendamm
City
Berlin
ZIP/Postal Code
10707
Country
Germany
Facility Name
Charite Universitaetsmedizin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
Helios Klinikum Berlin Buch
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Facility Name
Charite Universitätsmedizin - Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
Ev. Diakoniekrankenhaus
City
Bremen
ZIP/Postal Code
28239
Country
Germany
Facility Name
Gemeinschaftspraxis für Hämatologie & Onkologie
City
Dortmund
ZIP/Postal Code
44263
Country
Germany
Facility Name
Gemeinschaftspraxis Hämatologie Onkologie
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Universitätsklinik Carl Gustav Carus
City
Dresden
ZIP/Postal Code
1307
Country
Germany
Facility Name
Sana Krankenhaus Benrath
City
Düsseldorf
ZIP/Postal Code
40593
Country
Germany
Facility Name
St. Georg Klinikum Eisenach
City
Eisenach
ZIP/Postal Code
99817
Country
Germany
Facility Name
ISP Erlangen Onkologische Schwerpunktpraxis
City
Erlangen
ZIP/Postal Code
91052
Country
Germany
Facility Name
Universitätsklinikum Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Esslingen
ZIP/Postal Code
73728
Country
Germany
Facility Name
Centrum für Hämatologie und Onkologie Bethanien
City
Frankfurt
ZIP/Postal Code
60389
Country
Germany
Facility Name
Universitätsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Uniklinikum Gießen und Marburg
City
Gießen
ZIP/Postal Code
35392
Country
Germany
Facility Name
MVZ Onkologische Kooperation Harz
City
Goslar
ZIP/Postal Code
38642
Country
Germany
Facility Name
Universitätsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
OncoResearch Lerchenfeld
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Facility Name
Evangelische Krankenhaus Hamm
City
Hamm
ZIP/Postal Code
59063
Country
Germany
Facility Name
Onkologisches Ambulanzzentrum - MediProjekt
City
Hannover
ZIP/Postal Code
30171
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Marien Hospital Herne
City
Herne
ZIP/Postal Code
44625
Country
Germany
Facility Name
Universitätskliniken des Saarlandes
City
Homburg
ZIP/Postal Code
66424
Country
Germany
Facility Name
Universitätsklinikum Jena
City
Jena
ZIP/Postal Code
7747
Country
Germany
Facility Name
Westpfalz-Klinikum GmbH
City
Kaiserslautern
ZIP/Postal Code
67655
Country
Germany
Facility Name
Universitaetsklinikum Schleswig-Holstein Campus Kiel
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Praxis für Haematologie und Onkologie
City
Koblenz
ZIP/Postal Code
56068
Country
Germany
Facility Name
MVZ Hämatologie Onkologie Koblenz
City
Koblenz
ZIP/Postal Code
56727
Country
Germany
Facility Name
Universitätsklinik Köln
City
Köln
ZIP/Postal Code
50924
Country
Germany
Facility Name
H.O.T Onkologie Praxis Landshut
City
Landshut
ZIP/Postal Code
84036
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
ZIP/Postal Code
4103
Country
Germany
Facility Name
Onkopraxis Probstheida
City
Leipzig
ZIP/Postal Code
4289
Country
Germany
Facility Name
Klinikum Lippe Lemgo
City
Lemgo
ZIP/Postal Code
32657
Country
Germany
Facility Name
St Vincenz Krankenhaus
City
Limburg
ZIP/Postal Code
65549
Country
Germany
Facility Name
Lübecker Onkologische Schwerpunktpraxis
City
Lübeck
ZIP/Postal Code
23562
Country
Germany
Facility Name
Gemeinschaftspraxis Haematologie und Onkologie
City
Magdeburg
ZIP/Postal Code
39104
Country
Germany
Facility Name
Universitätsklinikum Magdeburg
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Mannheimer Onkologie Praxis
City
Mannheim
ZIP/Postal Code
68161
Country
Germany
Facility Name
Praxis für Innere Medizin - Hämatologie und Onkologie
City
Marburg
ZIP/Postal Code
35037
Country
Germany
Facility Name
Stauferklinikum Schwäbisch Gmünd
City
Mutlangen
ZIP/Postal Code
73557
Country
Germany
Facility Name
Kliniken Maria Hilf
City
Mönchengladbach
ZIP/Postal Code
41063
Country
Germany
Facility Name
München Klinik Schwabing
City
München
ZIP/Postal Code
80804
Country
Germany
Facility Name
Klinikum der Universitaet München - Grosshadern Campus
City
München
ZIP/Postal Code
81377
Country
Germany
Facility Name
Klinikum rechts der Isar - Technische Universitaet Muenchen
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Gemeinschaftspraxis für Hämatologie und Onkologie
City
Münster
ZIP/Postal Code
48153
Country
Germany
Facility Name
Klinikum Oldenburg
City
Oldenburg
ZIP/Postal Code
26133
Country
Germany
Facility Name
Brüderkrankenhaus St. Josef Paderborn
City
Paderborn
ZIP/Postal Code
33098
Country
Germany
Facility Name
Gemeinschaftspraxis für Hämatologie und Onkologie
City
Ravensburg
ZIP/Postal Code
88212
Country
Germany
Facility Name
Barmherzigen Brüder Krankenhaus
City
Regensburg
ZIP/Postal Code
93049
Country
Germany
Facility Name
Schwerpunktpraxis für Hämatologie & Onkologie - OncoPro GbR
City
Regensburg
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitätsklinik Rostock
City
Rostock
ZIP/Postal Code
18057
Country
Germany
Facility Name
OnkoSaar Praxis für Hämatologie und Onkologie
City
Saarbrücken
ZIP/Postal Code
66113
Country
Germany
Facility Name
Zentrum für abulante Hämatologie und Onkologie
City
Siegburg
ZIP/Postal Code
53721
Country
Germany
Facility Name
Marienhospital Stuttgart
City
Stuttgart
ZIP/Postal Code
70199
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
ZIP/Postal Code
70376
Country
Germany
Facility Name
Universitätsklinik Tübingen
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
MVZ Weiden GmbH
City
Weiden
ZIP/Postal Code
92637
Country
Germany
Facility Name
Hämatologisch Onkologische Schwerpunktpraxis
City
Würzburg
ZIP/Postal Code
97080
Country
Germany
Facility Name
Cork University Hospital
City
Cork
ZIP/Postal Code
T12DC4A
Country
Ireland
Facility Name
St Vincents University Hospital
City
Dublin
ZIP/Postal Code
Dublin 4
Country
Ireland
Facility Name
Mater Misericordiae University Hospital
City
Dublin
ZIP/Postal Code
Dublin 7
Country
Ireland
Facility Name
St. James's Hospital
City
Dublin
ZIP/Postal Code
Dublin 8
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
Dublin 9
Country
Ireland
Facility Name
University Hospital Galway
City
Galway
ZIP/Postal Code
H91 YR71
Country
Ireland
Facility Name
University Hospital Limerick
City
Limerick
ZIP/Postal Code
V94 F858
Country
Ireland
Facility Name
University Hospital Waterford
City
Waterford
ZIP/Postal Code
X91 ER8E
Country
Ireland
Facility Name
Soroka University Medical Center
City
Be'er Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Shamir Medical Center Assaf Harofeh
City
Be'er Ya'aqov
ZIP/Postal Code
70300
Country
Israel
Facility Name
Bnai-Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Hadassah Medical Center Ein Kerem University Hospital
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center
City
Kfar-Saba
ZIP/Postal Code
4428164
Country
Israel
Facility Name
Galilee Medical Center
City
Nahariya
ZIP/Postal Code
22100
Country
Israel
Facility Name
Rabin Medical Center Beilinson Hospital
City
Petach-Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rechovot
ZIP/Postal Code
7610001
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
City
Catania
ZIP/Postal Code
9513
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria di Ferrara
City
Ferrara
ZIP/Postal Code
44124
Country
Italy
Facility Name
Ospedale dell'Angelo
City
Mestre
ZIP/Postal Code
30174
Country
Italy
Facility Name
Fondazione IRCCS Ca'Granda Ospedale Maggiore Policlinico
City
Milano
ZIP/Postal Code
20122
Country
Italy
Facility Name
ASST Grande Ospedale Metropolitano Niguarda
City
Milano
ZIP/Postal Code
20162
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele
City
Milano
ZIP/Postal Code
202132
Country
Italy
Facility Name
Ospedale S. Maria della Misericordia
City
Perugia
ZIP/Postal Code
6123
Country
Italy
Facility Name
Umberto I - Policlinico di Roma - Sapienza Università
City
Roma
ZIP/Postal Code
161
Country
Italy
Facility Name
Gmelli University Hospital
City
Roma
ZIP/Postal Code
168
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
City
Torino
ZIP/Postal Code
10126
Country
Italy
Facility Name
Nordwest Ziekenhuisgroep, Locatie Alkmaar
City
Alkmaar
ZIP/Postal Code
1815JD
Country
Netherlands
Facility Name
OLVG Amsterdam
City
Amsterdam
ZIP/Postal Code
1091AC
Country
Netherlands
Facility Name
Amsterdam Universitair Medische Centra
City
Amsterdam
ZIP/Postal Code
1105AZ
Country
Netherlands
Facility Name
Rijnstate, Locatie Arnhem
City
Arnhem
ZIP/Postal Code
6815AD
Country
Netherlands
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4818CK
Country
Netherlands
Facility Name
Reinier de Graaf Ziekenhuis
City
Delft
ZIP/Postal Code
2625AD
Country
Netherlands
Facility Name
Slingeland ziekenhuis
City
Doetinchem
ZIP/Postal Code
7009BL
Country
Netherlands
Facility Name
Albert Schweitzer Ziekenhuis
City
Dordrecht
ZIP/Postal Code
3318AT
Country
Netherlands
Facility Name
Ziekenhuis Gelderse Vallei
City
Ede
ZIP/Postal Code
6716RP
Country
Netherlands
Facility Name
Martini Ziekenhuis
City
Groningen
ZIP/Postal Code
9728NT
Country
Netherlands
Facility Name
Ziekenhuis St Jansdal
City
Harderwijk
ZIP/Postal Code
3844DG
Country
Netherlands
Facility Name
Medisch Centrum Leeuwarden
City
Leeuwarden
ZIP/Postal Code
8934AD
Country
Netherlands
Facility Name
Alrijne Ziekenhuis
City
Leiderdorp
ZIP/Postal Code
2353GA
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis
City
Nieuwegein
ZIP/Postal Code
3435CM
Country
Netherlands
Facility Name
Canisius-Wilhelmina Ziekenhuis
City
Nijmegen
ZIP/Postal Code
6532SZ
Country
Netherlands
Facility Name
Maasstad Ziekenhuis
City
Rotterdam
ZIP/Postal Code
3079DZ
Country
Netherlands
Facility Name
Jeroen Bosch Ziekenhuis
City
s-Hertogenbosch
ZIP/Postal Code
5223GZ
Country
Netherlands
Facility Name
Franciscus Vlietland
City
Schiedam
ZIP/Postal Code
3118JH
Country
Netherlands
Facility Name
Ziekenhuis Rivierenland Tiel
City
Tiel
ZIP/Postal Code
4002WP
Country
Netherlands
Facility Name
Diakonessenhuis
City
Utrecht
ZIP/Postal Code
3582 KE
Country
Netherlands
Facility Name
VieCuri Medish Centrum
City
Venlo
ZIP/Postal Code
5912BL
Country
Netherlands
Facility Name
Isala Zwolle
City
Zwolle
ZIP/Postal Code
8025AB
Country
Netherlands
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Akershus University Hospital
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Oslo University Hospital
City
Oslo
ZIP/Postal Code
372
Country
Norway
Facility Name
St. Olavs Hospital Trondheim University Hospital
City
Trondheim
ZIP/Postal Code
7030
Country
Norway
Facility Name
Hospital Germans Trias i Pujol
City
Badalona
ZIP/Postal Code
8916
Country
Spain
Facility Name
Vall d'Hebron University Hospital
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
8036
Country
Spain
Facility Name
Hospital Duran i Reynals
City
Barcelona
ZIP/Postal Code
8908
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Costa del Sol
City
Málaga
ZIP/Postal Code
29603
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Clinico Universitario de Salamanca
City
Salamanca
ZIP/Postal Code
37007
Country
Spain
Facility Name
Hospital Marques de Valdecilla
City
Santander
ZIP/Postal Code
39008
Country
Spain
Facility Name
Hospital Universitario Virgen de Valme
City
Sevilla
ZIP/Postal Code
41014
Country
Spain
Facility Name
Hospital Clinico Universitario Valencia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Residencia Sanitaria La Fe - Valencia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Hospital Clinico Universitario Lozano Blesa
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Soedra Aelvsborgs Sjukhus
City
Borås
ZIP/Postal Code
50182
Country
Sweden
Facility Name
Falu Lasarett
City
Falun
ZIP/Postal Code
79182
Country
Sweden
Facility Name
Sahlgrenska University Hospital
City
Göteborg
ZIP/Postal Code
41346
Country
Sweden
Facility Name
Hallands Sjukhus Halmstad
City
Halmstad
ZIP/Postal Code
30185
Country
Sweden
Facility Name
Universitetssjukhuset Linköping
City
Linköping
ZIP/Postal Code
58185
Country
Sweden
Facility Name
Sunderby Hospital
City
Luleå
ZIP/Postal Code
97180
Country
Sweden
Facility Name
Skåne University Hospital
City
Lund
ZIP/Postal Code
22185
Country
Sweden
Facility Name
Karolinska University Hospital Solna
City
Stockholm
ZIP/Postal Code
17176
Country
Sweden
Facility Name
Umeå University Hospital
City
Umeå
ZIP/Postal Code
90185
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Hallands Sjukhus
City
Varberg
ZIP/Postal Code
43281
Country
Sweden
Facility Name
Örebro University Hospital
City
Örebro
ZIP/Postal Code
70185
Country
Sweden
Facility Name
Kantonsspital Aarau
City
Aarau
ZIP/Postal Code
5001
Country
Switzerland
Facility Name
Kantonsspital Baden
City
Baden
ZIP/Postal Code
5404
Country
Switzerland
Facility Name
Universitätsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Ospedale Regionale Bellinzona e Valli
City
Bellinzona
ZIP/Postal Code
6500
Country
Switzerland
Facility Name
Inselspital Bern
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Spitalzentrum Oberwallis
City
Brig
ZIP/Postal Code
3900
Country
Switzerland
Facility Name
Kantonsspital Graubünden
City
Chur
ZIP/Postal Code
7000
Country
Switzerland
Facility Name
HFR Fribourg Hôpital cantonal
City
Fribourg
ZIP/Postal Code
1708
Country
Switzerland
Facility Name
Hôpitaux Universitaires Genève
City
Geneve
ZIP/Postal Code
1211
Country
Switzerland
Facility Name
Kantonsspital Baselland
City
Liestal
ZIP/Postal Code
4410
Country
Switzerland
Facility Name
Luzerner Kantonsspital
City
Luzern
ZIP/Postal Code
6000
Country
Switzerland
Facility Name
Spital Thurgau AG - Kantonsspital Münsterlingen
City
Münsterlingen
ZIP/Postal Code
8596
Country
Switzerland
Facility Name
Kantonsspital Olten
City
Olten
ZIP/Postal Code
4600
Country
Switzerland
Facility Name
Kantonsspital St. Gallen
City
St Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Spital Thun
City
Thun
ZIP/Postal Code
3600
Country
Switzerland
Facility Name
Kantonsspital Winterthur
City
Winterthur
ZIP/Postal Code
8401
Country
Switzerland
Facility Name
Stadtspital Triemli
City
Zürich
ZIP/Postal Code
8063
Country
Switzerland
Facility Name
Universitätsspital Zuerich
City
Zürich
ZIP/Postal Code
8091
Country
Switzerland

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.dcllsg.de/en/trial/cll17/index.php
Description
Click here for more information about this study: CLL17 (German CLL Study Group)

Learn more about this trial

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

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