Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia (CLL-8)

Phase III Trial of Combined Immunochemotherapy With Fludarabine, Cyclophosphamide and Rituximab (FCR) Versus Chemotherapy With Fludarabine and Cyclophosphamide (FC) Alone in Patients With Previously Untreated Chronic Lymphocytic Leukaemia

This randomized phase III trial is studying fludarabine, cyclophosphamide, and rituximab to see how well they work compared to fludarabine and cyclophosphamide in treating patients with B-cell chronic lymphocytic leukemia.

Study Overview

• Status: Completed
• Conditions: Leukemia
• Intervention / Treatment: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Fludarabine Phosphate

• Study Type: Interventional
• Enrollment (Actual): 817
• Phase: Phase 3

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Gosford, New South Wales, Australia, 2250
      • Gosford Hospital
    • Westmead - Wentworthville, New South Wales, Australia, 2145
      • Westmead Institute for Cancer Research at Westmead Hospital
  • Queensland
    • Brisbane, Queensland, Australia, 4102
      • Princess Alexandra Hospital
    • Brisbane, Queensland, Australia, 4029
      • Royal Brisbane and Women's Hospital
  • Victoria
    • East Melbourne, Victoria, Australia, 3002
      • Peter MacCallum Cancer Centre
    • Frankston, Victoria, Australia, 3199
      • Frankston Hospital
• Austria
  • Vienna, Austria, A-1140
    • Hanuschkrankenhaus
  • Vienna, Austria, A-1190
    • Rudolfinerhaus
  • Wien, Austria, 1090
    • Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
• Belgium
  • Brugge, Belgium, 8000
    • AZ Sint-Jan
  • Brussels, Belgium, 1200
    • Cliniques universitaires Saint-Luc
  • Brussels, Belgium, 1000
    • Institut Jules Bordet
  • Edegem, Belgium, B-2650
    • Universitair Ziekenhuis Antwerpen
  • Leuven, Belgium, B-3000
    • U.Z. Gasthuisberg
  • Mont-Godinne Yvoir, Belgium, 5530
    • Clinique Universitaire De Mont-Godinne
• Czech Republic
  • Brno, Czech Republic, 62500
    • Masaryk University Hospital
  • Hradec Kralove, Czech Republic, 50005
    • Fakultni nemocnice Hradec Kralove
  • Olomouc, Czech Republic, 775 20
    • University Hospital - Olomouc
  • Pilsen-Lochotin, Czech Republic, 30460
    • University Hospital in Pilsen - Lochotin
  • Prague, Czech Republic, 128 08
    • First Medical Clinic of Charles University Hospital
• Denmark
  • Copenhagen, Denmark, DK-2730
    • Copenhagen County Herlev University Hospital
  • Vejle, Denmark, DK-7100
    • Vejle Sygehus
• France
  • Colmar, France, 68024
    • Hôpital Louis Pasteur
  • Le Chesnay, France, 78157
    • Hôpital André Mignot
  • Lyon, France, 69373
    • Centre Léon Bérard
  • Marseille, France, 13273
    • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
  • Rennes, France, 35033
    • Centre Hospitalier Universitaire de Rennes
  • Saint Priest en Jarez, France, 42270
    • Institut de Cancérologie de la Loire
• Germany
  • Ahaus, Germany, 48683
    • Praxis Fur Hamatologie und Onkologie Ahaus
  • Ansbach, Germany, 91522
    • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
  • Augsburg, Germany, DOH-86156
    • Klinikum Augsburg
  • Augsburg, Germany, 86150
    • Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
  • Bad Saarow, Germany, 15526
    • Humaine - Clinic
  • Bayreuth, Germany, 95448
    • Internistische Praxis - Bayreuth
  • Berlin, Germany, D-12200
    • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • Berlin, Germany, 13347
    • Internistische Gemeinschaftspraxis - Berlin
  • Bielefeld, Germany, D-33602
    • Onkologische Schwerpunktpraxis Bielefeld
  • Bietigheim, Germany, D-74321
    • Krankenhaus Bietigheim
  • Bochum, Germany, D-44791
    • Augusta-Kranken-Anstalt gGmbH
  • Bottrop, Germany, D-46236
    • Marienhospital Bottrop gGmbH
  • Bremen, Germany, D-28239
    • DIAKO Ev. Diakonie Krankenhaus gGmbH
  • Burglengenfeld, Germany, D-93133
    • Krankenhaus Burglengenfeld
  • Coesfeld, Germany, 48653
    • Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin
  • Cologne, Germany, D-50677
    • Praxis Fuer Haematologie Internistische Onkologie
  • Cologne, Germany, D-50924
    • Medizinische Universitaetsklinik I at the University of Cologne
  • Cottbus, Germany, D-03046
    • Onkologische Schwerpunktpraxis
  • Dresden, Germany, 01127
    • Onkologische Gemeinschaftspraxis - Dresden
  • Duesseldorf, Germany, D-40225
    • Universitaetsklinikum Duesseldorf
  • Dusseldorf, Germany, 40489
    • Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth
  • Dusseldorf, Germany, 40593
    • Krankenhaus Benrath
  • Dusseldorf, Germany, 40211
    • Internistische Praxis - Dusseldorf
  • Eisenach, Germany, 99817
    • St. Georg Klinikum Eisenach GmbH
  • Erfurt, Germany, 99084
    • Internistiche Praxis
  • Erfurt, Germany, 99012
    • Helios Klinikum Erfurt
  • Erlangen, Germany, D-91052
    • Onkologische Schwerpunkt Praxis
  • Eschweiler, Germany, DOH-52249
    • St. Antonius Hospital
  • Essen, Germany, D-45122
    • Universitaetsklinikum Essen
  • Essen, Germany, D-45239
    • Evangelisches Krankenhaus Essen Werden
  • Esslingen, Germany, D-73730
    • Staedtische Kliniken Esslingen
  • Forchheim, Germany, 91301
    • Internistische Gemeinschaftspraxis - Forchheim
  • Frankfurt, Germany, D-65929
    • Staedtische Kliniken Frankfurt am Main - Hoechst
  • Frankfurt (Oder), Germany, D-15236
    • Klinikum Frankfurt (Oder) GmbH
  • Freiburg, Germany, 79098
    • Gemeinschaftspraxis - Freiburg
  • Garmisch-Partenkirchen, Germany, D-82467
    • Klinikum Garmisch - Partenkirchen GmbH
  • Gerlingen, Germany, 70839
    • Internistische Praxis - Gerlingen
  • Giessen, Germany, 35392
    • Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
  • Goettingen, Germany, D-37075
    • Universitaetsklinikum Goettingen
  • Greifswald, Germany, D-17475
    • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
  • Hagen, Germany, D-58095
    • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
  • Halle, Germany, 06108
    • Internistische Praxis - Halle
  • Halle, Germany, D-06120
    • Universitaetsklinikum Halle
  • Hamburg, Germany, D-20246
    • University Medical Center Hamburg - Eppendorf
  • Hamburg, Germany, D-20099
    • Asklepios Klinik St. Georg
  • Hamm, Germany, D-59071
    • St. Marien-Hospital Hamm - Klinik Knappenstrasse
  • Hamm, Germany, DOH-59063
    • Evangelische Krankenhaus Hamm
  • Hannover, Germany, D-30449
    • Krankenhaus Siloah - Medizinische Klinik II
  • Heidelberg, Germany, D-69115
    • Universitatsklinikum Heidelberg
  • Herne, Germany, D-44625
    • Marienhospital at Ruhr University Bochum
  • Herrsching, Germany, D-82211
    • Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
  • Homburg, Germany, D-66424
    • Universitaetsklinikum des Saarlandes
  • Idar-Oberstein, Germany, D-55743
    • Clinic for Bone Marrow Transplantation and Hematology and Oncology
  • Jena, Germany, D-07743
    • Gemeinschaftspraxis Innere Medizin
  • Karlsruhe, Germany, 76133
    • Staedtisches Klinikum Karlsruhe gGmbH
  • Karlsruhe, Germany, D-76137
    • St. Vincentius-Kliniken
  • Kassel, Germany, D-34117
    • Internistische Gemeinschaftspraxis - Kassel
  • Kempten, Germany, D-87439
    • Klinikum Kempten Oberallgaeu
  • Kiel, Germany, D-24116
    • University Hospital Schleswig-Holstein - Kiel Campus
  • Kiel, Germany, 24105
    • Internistische Praxis - Kiel
  • Koblenz, Germany, D-56068
    • Praxis fuer Haematologie und Onkologie
  • Koblez, Germany, D-56068
    • Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH
  • Kronach, Germany, 96317
    • Internistische Onkologische Praxis - Kronach
  • Landshut, Germany, 84034
    • Klinikum Landshut
  • Leer, Germany, D-26789
    • Onkologische Schwerpunktpraxis - Leer
  • Leipzig, Germany, D-04126
    • Klinikum "St. Georg" Leipzig
  • Lemgo, Germany, D-32657
    • Klinikum Lippe - Lemgo
  • Loerrach, Germany, D-79539
    • Internistische Praxis - Loerrach
  • Ludwigshafen, Germany, 67061
    • Gemeinschaftspraxis - Ludwigshafen
  • Luebeck, Germany, 23560
    • Sana Kliniken Luebeck
  • Magdeburg, Germany, D-39120
    • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
  • Magdeburg, Germany, D-39104
    • Internistische Gemeinschaftspraxis - Magdeburg
  • Magdeburg, Germany, D-39104
    • Staedtisches Klinikum Magdeburg - Altstadt
  • Mainz, Germany, D-55101
    • Universitätsklinik Mainz
  • Mannheim, Germany, D-68305
    • III Medizinische Klinik Mannheim
  • Moenchengladbach, Germany, D-41063
    • Krankenhaus Maria Hilf GmbH
  • Muenchen, Germany, D-81241
    • Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
  • Muenster, Germany, D-48129
    • University of Muenster
  • Muenster, Germany, D-48149
    • Haematologisch - Onkologische Gemeinschaftspraxis
  • Munich, Germany, D-81377
    • Klinikum der Universitaet Muenchen - Grosshadern Campus
  • Munich, Germany, D-81675
    • Klinikum Rechts der Isar - Technische Universitaet Muenchen
  • Munich, Germany, D-81545
    • Staedtisches Krankenhaus Muenchen - Harlaching
  • Munich, Germany, D-81679
    • Haematologische Schwerpunktpraxis
  • Neunkirchen, Germany, D-66538
    • Onkologische Schwerpunktpraxis Dr. Schmidt
  • Norderstedt, Germany, 22844
    • Praxis fuer Haematologie und Interne Onkologie
  • Nuernberg, Germany, D-90419
    • Klinikum Nuernberg - Klinikum Nord
  • Oberhausen, Germany, D-46045
    • Gemeinschaftspraxis - Oberhausen
  • Offenbach, Germany, D-63065
    • Internistische Gemeinschaftspraxis - Offenbach
  • Oldenburg, Germany, D-26133
    • Klinikum Oldenburg
  • Oldenburg, Germany, D-26121
    • Internistische Gemeinschaftspraxis - Oldenburg
  • Pasewalk, Germany, 17309
    • Asklepios Klinik Pasewalk
  • Pforzheim, Germany, D-75178
    • Municipal Hospital Complex
  • Potsdam, Germany, D-14467
    • Klinikum Ernst von Bergmann
  • Recklinghausen, Germany, 45661
    • Elisabeth Krankenhaus
  • Regensburg, Germany, D-93049
    • Krankenhaus Barmherzige Brueder Regensburg
  • Rostock, Germany, D-18055
    • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
  • Saarbrucken, Germany, D-66113
    • Caritasklinik St. Theresia
  • Sanderbusch, Germany, 26452
    • Nordwestkrankenhaus Sanderbusch
  • Siegen, Germany, D-57072
    • St. Marien - Krankenhaus Siegen GMBH
  • Stuttgart, Germany, D-70174
    • Klinik fuer Onkologie - Katharinenhospital Stuttgart
  • Stuttgart, Germany, D-70176
    • Diakonie Klinikum Stuttgart
  • Stuttgart, Germany, D-70173
    • Haematologische Praxis
  • Stuttgart, Germany, D-70199
    • Marienhospital Stuttgart
  • Stuttgart, Germany, 70176
    • Internistische Gemeinschaftspraxis - Stuttgart
  • Torgau, Germany, 04860
    • KKH Torgau
  • Trier, Germany, D-54219
    • Krankenanstalt Mutterhaus der Borromaerinnen
  • Trier, Germany, 54290
    • Onkologische Gemeinschaftspraxis - Trier
  • Troisdorf, Germany, 53840
    • Praxis Fuer Internistische Haematologie / Onkologie
  • Tuebingen, Germany, D-72076
    • Universitaetsklinikum Tuebingen
  • Ulm, Germany, D-89081
    • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
  • Villingen-Schwenningen, Germany, D-78045
    • Municipal Hospital Complex
  • Wanzleben, Germany, 39164
    • Praxis fur Innere Medizin - Wanzleben
  • Weiden, Germany, D-92637
    • Haematologische Praxis
  • Wesel, Germany, 46483
    • Schwerpunktpraxis Hamatologie/Onkologie - Wesel
  • Wiesbaden, Germany, D-65199
    • Dr. Horst-Schmidt-Kliniken
  • Wuerzburg, Germany, D-97080
    • Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
  • Wuppertal 2, Germany, D-42283
    • Kliniken St. Antonius
  • Wurzburg, Germany, 97070
    • Hamatologisch - Onkologische Praxis Wurzburg
• Israel
  • Beer-Sheva, Israel, 84101
    • Soroka University Medical Center
  • Haifa, Israel, 31096
    • Rambam Medical Center
  • Haifa, Israel, 31048
    • Bnai Zion Medical Center
  • Jerusalem, Israel, 91120
    • Hadassah University Hospital
  • Kfar Saba, Israel, 44281
    • Riverview Cancer Care Medical Associates, PC
  • Rehovot, Israel, 76100
    • Kaplan Hospital
• Italy
  • Cagliari, Italy, 09121
    • Ospedale Oncologico A. Businco
  • Milano, Italy, 20132
    • Fondazione Centro San Raffaele del Monte Tabor
  • Perugia, Italy, 06122
    • Perugia Regional Cancer Center
  • Rome, Italy, 00144
    • Ospedale Sant' Eugenio
  • Rome, Italy, 00168
    • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
• New Zealand
  • Auckland, New Zealand, 1
    • Auckland City Hospital
  • Christchurch, New Zealand
    • Canterbury Health Laboratories
  • Palmerston North, New Zealand
    • Palmerston North Hospital
• Spain
  • Murcia, Spain, 30008
    • Hospital General Universitario Morales Meseguer
  • Toledo, Spain, 45004
    • Hospital Virgen Del La Salud

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

DISEASE CHARACTERISTICS:

• Diagnosed B-cell chronic lymphocytic leukemia (CLL) defined by the National Cancer Institute (NCI) Working Group criteria

• Meets 1 of the following criteria:

  • Binet stage C disease

  • Binet stage B disease AND ≥ 1 of the following signs or symptoms*:

    • B symptoms (night sweats, weight loss ≥ 10% within the previous 6 months, fevers > 38°C or 100.4°F for ≥ 2 weeks without evidence of infection), or constitutional symptoms (fatigue)
    • Continuous progression (doubling of peripheral lymphocyte count within the past 6 months and absolute lymphocyte count > 50 G/I)
    • Evidence of progressive marrow failure as manifested by the development/worsening of anemia and/or thrombocytopenia
    • Massive, progressive or painful splenomegaly or hypersplenism
    • Massive lymph nodes or lymph node clusters (> 10 cm in longest diameter), danger of organ complications through large lymphoma (e.g., vascular compression or tracheal narrowing), or progressive lymphadenopathy
    • Occurrence of symptomatic hyperviscosity problems at leukocyte counts > 200 G/I (symptomatic leukostasis) NOTE: * Marked hypogammaglobulinemia or the development of a monoclonal protein in the absence of any of the above criteria for active disease is not sufficient for eligibility
• No Binet stage A disease
• No transformation to an aggressive B-cell malignancy (e.g., diffuse large cell lymphoma, Richter's syndrome, or prolymphocytic leukemia)

PATIENT CHARACTERISTICS:

• Eastern Cooperative Oncology Group (ECOG) performance status 0-1
• Cumulative Illness Rating Scale (CIRS) score > 6
• Life expectancy > 6 months
• Bilirubin ≤ 2 times upper limit of normal (ULN)
• Alkaline phosphatase and transaminases ≤ 2 times ULN
• Creatinine clearance ≥ 70 mL/min
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception during and for 2 months after study treatment
• No known hypersensitivity with anaphylactic reaction to humanized monoclonal antibodies or any of the study drugs
• No cerebral dysfunction that precludes chemotherapy
• No active bacterial, viral, or fungal infection
• No clinically significant autoimmune cytopenia or Coombs-positive hemolytic anemia
• No other active malignancy requiring concurrent treatment except basal cell carcinoma or tumors treated curatively by surgery
• No medical or psychological condition that would preclude study therapy
• No concurrent disease that requires prolonged (> 1 month) therapy involving glucocorticoids

PRIOR CONCURRENT THERAPY:

• No previous treatment of CLL by chemotherapy, radiotherapy, or immunotherapy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fludarabine+Cyclophosphamide+Rituximab (FCR)	Drug: Rituximab; Intravenous repeating dose; Drug: Cyclophosphamide; Intravenous repeating dose; Drug: Fludarabine Phosphate; Intravenous repeating dose
Active Comparator: Fludarabine+Cyclophosphamide (FC)	Drug: Cyclophosphamide; Intravenous repeating dose; Drug: Fludarabine Phosphate; Intravenous repeating dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Progression-free Survival (PFS)	Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.	Median observation time at time of analysis was approximately 21 months
Final Analysis: Time to Progression-free Survival Event	Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.	Median observation time was approximately 66.4 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Event-free Survival (EFS)	Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.	Median observation time at time of analysis was approximately 21 months
Overall Survival (OS)	Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.	Median observation time at time of analysis was approximately 21 months
Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).	CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.	Median observation time at time of analysis was approximately 21 months
Final Analysis: Time to Overall Survival Event	Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.	Median observation time was approximately 66.4 months
Final Analysis: Time to Event-free Survival Event	Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause.	Median observation time was approximately 66.4 months
Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)	CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death	Median observation time was approximately 66.4 months
Final Analysis: Duration of Response	Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.	Median observation time was approximately 66.4 months
Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response	CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.	Median observation time was approximately 66.4 months
Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)	The time from randomization to the start of a new treatment.	Median observation time was approximately 66.4 months

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Collaborators: German CLL Study Group

Publications and helpful links

General Publications

• Jaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Dohner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027.
• Kreuzberger N, Damen JA, Trivella M, Estcourt LJ, Aldin A, Umlauff L, Vazquez-Montes MD, Wolff R, Moons KG, Monsef I, Foroutan F, Kreuzer KA, Skoetz N. Prognostic models for newly-diagnosed chronic lymphocytic leukaemia in adults: a systematic review and meta-analysis. Cochrane Database Syst Rev. 2020 Jul 31;7(7):CD012022. doi: 10.1002/14651858.CD012022.pub2.
• Pflug N, Bahlo J, Shanafelt TD, Eichhorst BF, Bergmann MA, Elter T, Bauer K, Malchau G, Rabe KG, Stilgenbauer S, Dohner H, Jager U, Eckart MJ, Hopfinger G, Busch R, Fink AM, Wendtner CM, Fischer K, Kay NE, Hallek M. Development of a comprehensive prognostic index for patients with chronic lymphocytic leukemia. Blood. 2014 Jul 3;124(1):49-62. doi: 10.1182/blood-2014-02-556399. Epub 2014 May 5.
• Dimier N, Delmar P, Ward C, Morariu-Zamfir R, Fingerle-Rowson G, Bahlo J, Fischer K, Eichhorst B, Goede V, van Dongen JJM, Ritgen M, Bottcher S, Langerak AW, Kneba M, Hallek M. A model for predicting effect of treatment on progression-free survival using MRD as a surrogate end point in CLL. Blood. 2018 Mar 1;131(9):955-962. doi: 10.1182/blood-2017-06-792333. Epub 2017 Dec 18.
• Bloehdorn J, Krzykalla J, Holzmann K, Gerhardinger A, Jebaraj BMC, Bahlo J, Humphrey K, Tausch E, Robrecht S, Mertens D, Schneider C, Fischer K, Hallek M, Dohner H, Benner A, Stilgenbauer S. Integrative prognostic models predict long-term survival after immunochemotherapy in chronic lymphocytic leukemia patients. Haematologica. 2022 Mar 1;107(3):615-624. doi: 10.3324/haematol.2020.251561.
• Fischer K, Bahlo J, Fink AM, Goede V, Herling CD, Cramer P, Langerbeins P, von Tresckow J, Engelke A, Maurer C, Kovacs G, Herling M, Tausch E, Kreuzer KA, Eichhorst B, Bottcher S, Seymour JF, Ghia P, Marlton P, Kneba M, Wendtner CM, Dohner H, Stilgenbauer S, Hallek M. Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial. Blood. 2016 Jan 14;127(2):208-15. doi: 10.1182/blood-2015-06-651125. Epub 2015 Oct 20.
• Weisser M, Yeh RF, Duchateau-Nguyen G, Palermo G, Nguyen TQ, Shi X, Stinson SY, Yu N, Dufour A, Robak T, Salogub GN, Dmoszynska A, Solal-Celigny P, Warzocha K, Loscertales J, Catalano J, Larratt L, Rossiev VA, Bence-Bruckler I, Geisler CH, Montillo M, Fischer K, Fink AM, Hallek M, Bloehdorn J, Busch R, Benner A, Dohner H, Valente N, Wenger MK, Stilgenbauer S, Dornan D. PTK2 expression and immunochemotherapy outcome in chronic lymphocytic leukemia. Blood. 2014 Jul 17;124(3):420-5. doi: 10.1182/blood-2013-12-538975. Epub 2014 Jun 10.
• Stilgenbauer S, Schnaiter A, Paschka P, Zenz T, Rossi M, Dohner K, Buhler A, Bottcher S, Ritgen M, Kneba M, Winkler D, Tausch E, Hoth P, Edelmann J, Mertens D, Bullinger L, Bergmann M, Kless S, Mack S, Jager U, Patten N, Wu L, Wenger MK, Fingerle-Rowson G, Lichter P, Cazzola M, Wendtner CM, Fink AM, Fischer K, Busch R, Hallek M, Dohner H. Gene mutations and treatment outcome in chronic lymphocytic leukemia: results from the CLL8 trial. Blood. 2014 May 22;123(21):3247-54. doi: 10.1182/blood-2014-01-546150. Epub 2014 Mar 20.
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Helpful Links

• Clinical Study Report Synopsis

Study record dates

Study Major Dates

• Study Start: July 1, 2003
• Primary Completion (Actual): July 1, 2007
• Study Completion (Actual): October 1, 2011

Study Registration Dates

• First Submitted: January 24, 2006
• First Submitted That Met QC Criteria: January 24, 2006
• First Posted (Estimate): January 25, 2006

Study Record Updates

• Last Update Posted (Estimate): September 19, 2013
• Last Update Submitted That Met QC Criteria: September 9, 2013
• Last Verified: September 1, 2013

More Information

Terms related to this study

• Keywords: B-cell chronic lymphocytic leukemia; stage I chronic lymphocytic leukemia; stage II chronic lymphocytic leukemia; stage III chronic lymphocytic leukemia; stage IV chronic lymphocytic leukemia
• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Leukemia, B-Cell; Leukemia; Leukemia, Lymphocytic, Chronic, B-Cell; Leukemia, Lymphoid; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antimetabolites, Antineoplastic; Antimetabolites; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Antineoplastic Agents, Alkylating; Alkylating Agents; Myeloablative Agonists; Antineoplastic Agents, Immunological; Cyclophosphamide; Rituximab; Fludarabine; Fludarabine phosphate
• Other Study ID Numbers: CDR0000454560; GCLLSG-CLL-8; EU-20560; ML17102