AzTrials
AzTrials

LeukemiaPhase 3CLL-8NCT00281918

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

A Phase 3 study testing Rituximab, Cyclophosphamide and Fludarabine Phosphate in people with Leukemia, run by Hoffmann-La Roche at 162 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Leukemia
What is being tested?
Rituximab, Cyclophosphamide and Fludarabine Phosphate
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
817 participants
Where
162 sitesin 11 countries
Study dates
Jul 2003to Oct 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

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

Trial locations and contacts

162 sites in 11 countries.

162 sites in 11 countries

Germany118 sites

  • Praxis Fur Hamatologie und Onkologie Ahaus

    Ahaus, 48683

  • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie

    Ansbach, 91522

  • Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg

    Augsburg, 86150

  • Klinikum Augsburg

    Augsburg, DOH-86156

  • Humaine - Clinic

    Bad Saarow, 15526

  • Internistische Praxis - Bayreuth

    Bayreuth, 95448

  • Internistische Gemeinschaftspraxis - Berlin

    Berlin, 13347

  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin

    Berlin, D-12200

  • Onkologische Schwerpunktpraxis Bielefeld

    Bielefeld, D-33602

  • Krankenhaus Bietigheim

    Bietigheim, D-74321

  • Augusta-Kranken-Anstalt gGmbH

    Bochum, D-44791

  • Marienhospital Bottrop gGmbH

    Bottrop, D-46236

  • DIAKO Ev. Diakonie Krankenhaus gGmbH

    Bremen, D-28239

  • Krankenhaus Burglengenfeld

    Burglengenfeld, D-93133

  • Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin

    Coesfeld, 48653

  • Praxis Fuer Haematologie Internistische Onkologie

    Cologne, D-50677

  • Medizinische Universitaetsklinik I at the University of Cologne

    Cologne, D-50924

  • Onkologische Schwerpunktpraxis

    Cottbus, D-03046

  • Onkologische Gemeinschaftspraxis - Dresden

    Dresden, 01127

  • Internistische Praxis - Dusseldorf

    Düsseldorf, 40211

  • Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth

    Düsseldorf, 40489

  • Krankenhaus Benrath

    Düsseldorf, 40593

  • Universitaetsklinikum Duesseldorf

    Düsseldorf, D-40225

  • St. Georg Klinikum Eisenach GmbH

    Eisenach, 99817

  • Helios Klinikum Erfurt

    Erfurt, 99012

  • Internistiche Praxis

    Erfurt, 99084

  • Onkologische Schwerpunkt Praxis

    Erlangen, D-91052

  • St. Antonius Hospital

    Eschweiler, DOH-52249

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Evangelisches Krankenhaus Essen Werden

    Essen, D-45239

  • Staedtische Kliniken Esslingen

    Esslingen am Neckar, D-73730

  • Internistische Gemeinschaftspraxis - Forchheim

    Forchheim, 91301

  • Staedtische Kliniken Frankfurt am Main - Hoechst

    Frankfurt, D-65929

  • Klinikum Frankfurt (Oder) GmbH

    Frankfurt (Oder), D-15236

  • Gemeinschaftspraxis - Freiburg

    Freiburg im Breisgau, 79098

  • Klinikum Garmisch - Partenkirchen GmbH

    Garmisch-Partenkirchen, D-82467

  • Internistische Praxis - Gerlingen

    Gerlingen, 70839

  • Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie

    Giessen, 35392

  • Universitaetsklinikum Goettingen

    Göttingen, D-37075

  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet

    Greifswald, D-17475

  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH

    Hagen, D-58095

  • Internistische Praxis - Halle

    Halle, 06108

  • Universitaetsklinikum Halle

    Halle, D-06120

  • Asklepios Klinik St. Georg

    Hamburg, D-20099

  • University Medical Center Hamburg - Eppendorf

    Hamburg, D-20246

  • St. Marien-Hospital Hamm - Klinik Knappenstrasse

    Hamm, D-59071

  • Evangelische Krankenhaus Hamm

    Hamm, DOH-59063

  • Krankenhaus Siloah - Medizinische Klinik II

    Hanover, D-30449

  • Universitatsklinikum Heidelberg

    Heidelberg, D-69115

  • Marienhospital at Ruhr University Bochum

    Herne, D-44625

  • Privatklinik Dr. R. Schindlbeck GmbH & Co. KG

    Herrsching am Ammersee, D-82211

  • Universitaetsklinikum des Saarlandes

    Homburg, D-66424

  • Clinic for Bone Marrow Transplantation and Hematology and Oncology

    Idar-Oberstein, D-55743

  • Gemeinschaftspraxis Innere Medizin

    Jena, D-07743

  • Staedtisches Klinikum Karlsruhe gGmbH

    Karlsruhe, 76133

  • St. Vincentius-Kliniken

    Karlsruhe, D-76137

  • Internistische Gemeinschaftspraxis - Kassel

    Kassel, D-34117

  • Klinikum Kempten Oberallgaeu

    Kempten, D-87439

  • Internistische Praxis - Kiel

    Kiel, 24105

  • University Hospital Schleswig-Holstein - Kiel Campus

    Kiel, D-24116

  • Praxis fuer Haematologie und Onkologie

    Koblenz, D-56068

  • Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH

    Koblez, D-56068

  • Internistische Onkologische Praxis - Kronach

    Kronach, 96317

  • Klinikum Landshut

    Landshut, 84034

  • Onkologische Schwerpunktpraxis - Leer

    Leer, D-26789

  • Klinikum "St. Georg" Leipzig

    Leipzig, D-04126

  • Klinikum Lippe - Lemgo

    Lemgo, D-32657

  • Internistische Praxis - Loerrach

    Loerrach, D-79539

  • Sana Kliniken Luebeck

    Lübeck, 23560

  • Gemeinschaftspraxis - Ludwigshafen

    Ludwigshafen, 67061

  • Internistische Gemeinschaftspraxis - Magdeburg

    Magdeburg, D-39104

  • Staedtisches Klinikum Magdeburg - Altstadt

    Magdeburg, D-39104

  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg

    Magdeburg, D-39120

  • Universitatsklinik Mainz

    Mainz, D-55101

  • III Medizinische Klinik Mannheim

    Mannheim, D-68305

  • Krankenhaus Maria Hilf GmbH

    Mönchengladbach, D-41063

  • Hamatologie/Onkologie Praxisgemeinschaft - Muenchen

    München, D-81241

  • Klinikum der Universitaet Muenchen - Grosshadern Campus

    Munich, D-81377

  • Staedtisches Krankenhaus Muenchen - Harlaching

    Munich, D-81545

  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen

    Munich, D-81675

  • Haematologische Schwerpunktpraxis

    Munich, D-81679

  • University of Muenster

    Münster, D-48129

  • Haematologisch - Onkologische Gemeinschaftspraxis

    Münster, D-48149

  • Onkologische Schwerpunktpraxis Dr. Schmidt

    Neunkirchen, D-66538

  • Praxis fuer Haematologie und Interne Onkologie

    Norderstedt, 22844

  • Klinikum Nuernberg - Klinikum Nord

    Nuremberg, D-90419

  • Gemeinschaftspraxis - Oberhausen

    Oberhausen, D-46045

  • Internistische Gemeinschaftspraxis - Offenbach

    Offenbach, D-63065

  • Internistische Gemeinschaftspraxis - Oldenburg

    Oldenburg, D-26121

  • Klinikum Oldenburg

    Oldenburg, D-26133

  • Asklepios Klinik Pasewalk

    Pasewalk, 17309

  • Municipal Hospital Complex

    Pforzheim, D-75178

  • Klinikum Ernst Von Bergmann

    Potsdam, D-14467

  • Elisabeth Krankenhaus

    Recklinghausen, 45661

  • Krankenhaus Barmherzige Brueder Regensburg

    Regensburg, D-93049

  • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock

    Rostock, D-18055

  • Caritasklinik St. Theresia

    Saarbrücken, D-66113

  • Nordwestkrankenhaus Sanderbusch

    Sanderbusch, 26452

  • St. Marien - Krankenhaus Siegen GMBH

    Siegen, D-57072

  • Internistische Gemeinschaftspraxis - Stuttgart

    Stuttgart, 70176

  • Haematologische Praxis

    Stuttgart, D-70173

  • Klinik fuer Onkologie - Katharinenhospital Stuttgart

    Stuttgart, D-70174

  • Diakonie Klinikum Stuttgart

    Stuttgart, D-70176

  • Marienhospital Stuttgart

    Stuttgart, D-70199

  • KKH Torgau

    Torgau, 04860

  • Onkologische Gemeinschaftspraxis - Trier

    Trier, 54290

  • Krankenanstalt Mutterhaus der Borromaerinnen

    Trier, D-54219

  • Praxis Fuer Internistische Haematologie / Onkologie

    Troisdorf, 53840

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm

    Ulm, D-89081

  • Municipal Hospital Complex

    Villingen-Schwenningen, D-78045

  • Praxis fur Innere Medizin - Wanzleben

    Wanzleben, 39164

  • Haematologische Praxis

    Weiden, D-92637

  • Schwerpunktpraxis Hamatologie/Onkologie - Wesel

    Wesel, 46483

  • Dr. Horst-Schmidt-Kliniken

    Wiesbaden, D-65199

  • Kliniken St. Antonius

    Wuppertal, D-42283

  • Hamatologisch - Onkologische Praxis Wurzburg

    Würzburg, 97070

  • Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg

    Würzburg, D-97080

Other trials in Germany

Australia6 sites

  • Royal Brisbane and Women's Hospital

    Brisbane, Queensland, 4029

  • Princess Alexandra Hospital

    Brisbane, Queensland, 4102

  • Peter MacCallum Cancer Centre

    East Melbourne, Victoria, 3002

  • Frankston Hospital

    Frankston, Victoria, 3199

  • Gosford Hospital

    Gosford, New South Wales, 2250

  • Westmead Institute for Cancer Research at Westmead Hospital

    Westmead - Wentworthville, New South Wales, 2145

Other trials in Australia

Belgium6 sites

  • AZ Sint-Jan

    Bruges, 8000

  • Institut Jules Bordet

    Brussels, 1000

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Universitair Ziekenhuis Antwerpen

    Edegem, B-2650

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • Clinique Universitaire De Mont-Godinne

    Mont-Godinne Yvoir, 5530

Other trials in Belgium

France6 sites

  • Hopital Louis Pasteur

    Colmar, 68024

  • Hopital Andre Mignot

    Le Chesnay, 78157

  • Centre Leon Berard

    Lyon, 69373

  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes

    Marseille, 13273

  • Centre Hospitalier Universitaire de Rennes

    Rennes, 35033

  • Institut de Cancerologie de la Loire

    Saint-Priest-en-Jarez, 42270

Other trials in France

Israel6 sites

  • Soroka University Medical Center

    Beersheba, 84101

  • BNAI Zion Medical Center

    Haifa, 31048

  • Rambam Medical Center

    Haifa, 31096

  • Hadassah University Hospital

    Jerusalem, 91120

  • Riverview Cancer Care Medical Associates, PC

    Kfar Saba, 44281

  • Kaplan Hospital

    Rehovot, 76100

Other trials in Israel

Czechia5 sites

  • Masaryk University Hospital

    Brno, 62500

  • Fakultni Nemocnice Hradec Kralove

    Hradec Králové, 50005

  • University Hospital - Olomouc

    Olomouc, 775 20

  • University Hospital in Pilsen - Lochotin

    Pilsen-Lochotin, 30460

  • First Medical Clinic of Charles University Hospital

    Prague, 128 08

Other trials in Czechia

Italy5 sites

  • Ospedale Oncologico A. Businco

    Cagliari, 09121

  • Fondazione Centro San Raffaele Del Monte Tabor

    Milan, 20132

  • Perugia Regional Cancer Center

    Perugia, 06122

  • Ospedale Sant' Eugenio

    Rome, 00144

  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore

    Rome, 00168

Other trials in Italy

Austria3 sites

  • Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik

    Vienna, 1090

  • Hanuschkrankenhaus

    Vienna, A-1140

  • Rudolfinerhaus

    Vienna, A-1190

Other trials in Austria

New Zealand3 sites

  • Auckland City Hospital

    Auckland, 1

  • Canterbury Health Laboratories

    Christchurch

  • Palmerston North Hospital

    Palmerston North

Other trials in New Zealand

Denmark2 sites

  • Copenhagen County Herlev University Hospital

    Copenhagen, DK-2730

  • Vejle Sygehus

    Vejle, DK-7100

Other trials in Denmark

Spain2 sites

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Hospital Virgen Del La Salud

    Toledo, 45004

Other trials in Spain

About this study

Official title: 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.

Conditions
Leukemia
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
Medical subject headings
Leukemia, Leukemia, Lymphocytic, Chronic, B-Cell

What participants receive

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

Study groups in NCT00281918
Study groupRoleWhat they receive
Fludarabine+Cyclophosphamide+Rituximab (FCR)ExperimentalNot described
Receives: Drug: Rituximab; Drug: Cyclophosphamide; Drug: Fludarabine Phosphate
Fludarabine+Cyclophosphamide (FC)Active comparatorNot described
Receives: Drug: Cyclophosphamide; Drug: Fludarabine Phosphate

What is being measured

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

  1. 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.

    Measured: Median observation time at time of analysis was approximately 21 months

  2. 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.

    Measured: Median observation time was approximately 66.4 months

Secondary outcomes (9)

  1. 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.

    Measured: Median observation time at time of analysis was approximately 21 months

  2. 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.

    Measured: Median observation time at time of analysis was approximately 21 months

  3. 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.

    Measured: Median observation time at time of analysis was approximately 21 months

  4. 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.

    Measured: Median observation time was approximately 66.4 months

  5. 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.

    Measured: Median observation time was approximately 66.4 months

  6. 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

    Measured: Median observation time was approximately 66.4 months

  7. 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.

    Measured: Median observation time was approximately 66.4 months

  8. 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.

    Measured: Median observation time was approximately 66.4 months

  9. Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)

    The time from randomization to the start of a new treatment.

    Measured: Median observation time was approximately 66.4 months

Timeline

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

  1. First posted25 Jan 2006 (estimated)
  2. Study startJul 2003
  3. Primary completionJul 2007
  4. Study completionOct 2011

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
817 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00281918
Sponsor's protocol ID
CDR0000454560
Other IDs
GCLLSG-CLL-8, EU-20560, ML17102
Acronym
CLL-8
Status last verified
Sep 2013
First submitted
24 Jan 2006
Last updated
19 Sep 2013

Publications

  • Langerbeins P, Giza A, Robrecht S, Cramer P, von Tresckow J, Al-Sawaf O, Fink AM, Furstenau M, Kutsch N, Simon F, Goede V, Hoechstetter M, Niemann CU, da Cunha-Bang C, Kater A, Dubois J, Gregor M, Staber PB, Tausch E, Schneider C, Stilgenbauer S, Eichhorst B, Fischer K, Hallek M. Reassessing the chronic lymphocytic leukemia International Prognostic Index in the era of targeted therapies. Blood. 2024 Jun 20;143(25):2588-2598. doi: 10.1182/blood.2023022564.

    PubMed 38620092

  • 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.

    PubMed 33730841

  • 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.

    PubMed 33131249

  • 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.

    PubMed 32735048

  • 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.

    PubMed 29255066

  • 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.

    PubMed 26486789

  • 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.

    PubMed 24916506

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Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Rituximab, Cyclophosphamide and Fludarabine Phosphate in people with Leukemia, run by Hoffmann-La Roche at 162 sites in 11 countries.

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

Who may be eligible to take part?

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: finished, as of the sponsor's last update on 19 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 162 sites in Germany, Australia, Belgium, France, Israel and 6 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?

Yes. Results are posted in the registry (first posted 29 Mar 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Progression-free Survival (PFS) (time frame: Median observation time at time of analysis was approximately 21 months). The study lists 2 primary outcomes in all. 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 NCT00281918, which also lists 11 linked publications.

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 19 Sep 2013.

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