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

Primary Purpose

Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rituximab
Cyclophosphamide
Fludarabine Phosphate
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Leukemia focused on measuring 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

Eligibility Criteria

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

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

Sites / Locations

  • Gosford Hospital
  • Westmead Institute for Cancer Research at Westmead Hospital
  • Royal Brisbane and Women's Hospital
  • Princess Alexandra Hospital
  • Peter MacCallum Cancer Centre
  • Frankston Hospital
  • Hanuschkrankenhaus
  • Rudolfinerhaus
  • Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
  • AZ Sint-Jan
  • Institut Jules Bordet
  • Cliniques Universitaires Saint-Luc
  • Universitair Ziekenhuis Antwerpen
  • U.Z. Gasthuisberg
  • Clinique Universitaire De Mont-Godinne
  • Masaryk University Hospital
  • Fakultni Nemocnice Hradec Kralove
  • University Hospital - Olomouc
  • University Hospital in Pilsen - Lochotin
  • First Medical Clinic of Charles University Hospital
  • Copenhagen County Herlev University Hospital
  • Vejle Sygehus
  • Hopital Louis Pasteur
  • Hopital Andre Mignot
  • Centre Leon Berard
  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
  • Centre Hospitalier Universitaire de Rennes
  • Institut de Cancerologie de la Loire
  • Praxis Fur Hamatologie und Onkologie Ahaus
  • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
  • Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
  • Klinikum Augsburg
  • Humaine - Clinic
  • Internistische Praxis - Bayreuth
  • Internistische Gemeinschaftspraxis - Berlin
  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • Onkologische Schwerpunktpraxis Bielefeld
  • Krankenhaus Bietigheim
  • Augusta-Kranken-Anstalt gGmbH
  • Marienhospital Bottrop gGmbH
  • DIAKO Ev. Diakonie Krankenhaus gGmbH
  • Krankenhaus Burglengenfeld
  • Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin
  • Praxis Fuer Haematologie Internistische Onkologie
  • Medizinische Universitaetsklinik I at the University of Cologne
  • Onkologische Schwerpunktpraxis
  • Onkologische Gemeinschaftspraxis - Dresden
  • Universitaetsklinikum Duesseldorf
  • Internistische Praxis - Dusseldorf
  • Florence-Nightingale-Krankenhause, Deaconess Kaiserswerth
  • Krankenhaus Benrath
  • St. Georg Klinikum Eisenach GmbH
  • Helios Klinikum Erfurt
  • Internistiche Praxis
  • Onkologische Schwerpunkt Praxis
  • St. Antonius Hospital
  • Universitaetsklinikum Essen
  • Evangelisches Krankenhaus Essen Werden
  • Staedtische Kliniken Esslingen
  • Internistische Gemeinschaftspraxis - Forchheim
  • Klinikum Frankfurt (Oder) GmbH
  • Staedtische Kliniken Frankfurt am Main - Hoechst
  • Gemeinschaftspraxis - Freiburg
  • Klinikum Garmisch - Partenkirchen GmbH
  • Internistische Praxis - Gerlingen
  • Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
  • Universitaetsklinikum Goettingen
  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
  • Internistische Praxis - Halle
  • Universitaetsklinikum Halle
  • Asklepios Klinik St. Georg
  • University Medical Center Hamburg - Eppendorf
  • St. Marien-Hospital Hamm - Klinik Knappenstrasse
  • Evangelische Krankenhaus Hamm
  • Krankenhaus Siloah - Medizinische Klinik II
  • Universitatsklinikum Heidelberg
  • Marienhospital at Ruhr University Bochum
  • Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
  • Universitaetsklinikum des Saarlandes
  • Clinic for Bone Marrow Transplantation and Hematology and Oncology
  • Gemeinschaftspraxis Innere Medizin
  • Staedtisches Klinikum Karlsruhe gGmbH
  • St. Vincentius-Kliniken
  • Internistische Gemeinschaftspraxis - Kassel
  • Klinikum Kempten Oberallgaeu
  • Internistische Praxis - Kiel
  • University Hospital Schleswig-Holstein - Kiel Campus
  • Praxis fuer Haematologie und Onkologie
  • Stiftungsklinikum Mittelrhein - Gesundheitszentrum Evangelisches Stift Sankt Martin Koblenz gGmbH
  • Internistische Onkologische Praxis - Kronach
  • Klinikum Landshut
  • Onkologische Schwerpunktpraxis - Leer
  • Klinikum "St. Georg" Leipzig
  • Klinikum Lippe - Lemgo
  • Internistische Praxis - Loerrach
  • Gemeinschaftspraxis - Ludwigshafen
  • Sana Kliniken Luebeck
  • Internistische Gemeinschaftspraxis - Magdeburg
  • Staedtisches Klinikum Magdeburg - Altstadt
  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
  • Universitatsklinik Mainz
  • III Medizinische Klinik Mannheim
  • Krankenhaus Maria Hilf GmbH
  • Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
  • University of Muenster
  • Haematologisch - Onkologische Gemeinschaftspraxis
  • Klinikum der Universitaet Muenchen - Grosshadern Campus
  • Staedtisches Krankenhaus Muenchen - Harlaching
  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen
  • Haematologische Schwerpunktpraxis
  • Onkologische Schwerpunktpraxis Dr. Schmidt
  • Praxis fuer Haematologie und Interne Onkologie
  • Klinikum Nuernberg - Klinikum Nord
  • Gemeinschaftspraxis - Oberhausen
  • Internistische Gemeinschaftspraxis - Offenbach
  • Internistische Gemeinschaftspraxis - Oldenburg
  • Klinikum Oldenburg
  • Asklepios Klinik Pasewalk
  • Municipal Hospital Complex
  • Klinikum Ernst Von Bergmann
  • Elisabeth Krankenhaus
  • Krankenhaus Barmherzige Brueder Regensburg
  • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
  • Caritasklinik St. Theresia
  • Nordwestkrankenhaus Sanderbusch
  • St. Marien - Krankenhaus Siegen GMBH
  • Internistische Gemeinschaftspraxis - Stuttgart
  • Haematologische Praxis
  • Klinik fuer Onkologie - Katharinenhospital Stuttgart
  • Diakonie Klinikum Stuttgart
  • Marienhospital Stuttgart
  • KKH Torgau
  • Onkologische Gemeinschaftspraxis - Trier
  • Krankenanstalt Mutterhaus der Borromaerinnen
  • Praxis Fuer Internistische Haematologie / Onkologie
  • Universitaetsklinikum Tuebingen
  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
  • Municipal Hospital Complex
  • Praxis fur Innere Medizin - Wanzleben
  • Haematologische Praxis
  • Schwerpunktpraxis Hamatologie/Onkologie - Wesel
  • Dr. Horst-Schmidt-Kliniken
  • Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
  • Kliniken St. Antonius
  • Hamatologisch - Onkologische Praxis Wurzburg
  • Soroka University Medical Center
  • BNAI Zion Medical Center
  • Rambam Medical Center
  • Hadassah University Hospital
  • Riverview Cancer Care Medical Associates, PC
  • Kaplan Hospital
  • Ospedale Oncologico A. Businco
  • Fondazione Centro San Raffaele Del Monte Tabor
  • Perugia Regional Cancer Center
  • Ospedale Sant' Eugenio
  • Policlinico A. Gemelli - Universita Cattolica del Sacro Cuore
  • Auckland City Hospital
  • Canterbury Health Laboratories
  • Palmerston North Hospital
  • Hospital General Universitario Morales Meseguer
  • Hospital Virgen Del La Salud

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Fludarabine+Cyclophosphamide+Rituximab (FCR)

Fludarabine+Cyclophosphamide (FC)

Arm Description

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
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.
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.
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.
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
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.
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.
Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)
The time from randomization to the start of a new treatment.

Full Information

First Posted
January 24, 2006
Last Updated
September 9, 2013
Sponsor
Hoffmann-La Roche
Collaborators
German CLL Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00281918
Brief Title
Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia
Acronym
CLL-8
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2013
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
October 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
German CLL Study Group

4. Oversight

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Fludarabine+Cyclophosphamide+Rituximab (FCR)
Arm Type
Experimental
Arm Title
Fludarabine+Cyclophosphamide (FC)
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Rituximab
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Intervention Description
Intravenous repeating dose
Intervention Type
Drug
Intervention Name(s)
Fludarabine Phosphate
Intervention Description
Intravenous repeating dose
Primary Outcome Measure Information:
Title
Progression-free Survival (PFS)
Description
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.
Time Frame
Median observation time at time of analysis was approximately 21 months
Title
Final Analysis: Time to Progression-free Survival Event
Description
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.
Time Frame
Median observation time was approximately 66.4 months
Secondary Outcome Measure Information:
Title
Event-free Survival (EFS)
Description
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.
Time Frame
Median observation time at time of analysis was approximately 21 months
Title
Overall Survival (OS)
Description
Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.
Time Frame
Median observation time at time of analysis was approximately 21 months
Title
Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).
Description
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.
Time Frame
Median observation time at time of analysis was approximately 21 months
Title
Final Analysis: Time to Overall Survival Event
Description
Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.
Time Frame
Median observation time was approximately 66.4 months
Title
Final Analysis: Time to Event-free Survival Event
Description
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.
Time Frame
Median observation time was approximately 66.4 months
Title
Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)
Description
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
Time Frame
Median observation time was approximately 66.4 months
Title
Final Analysis: Duration of Response
Description
Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.
Time Frame
Median observation time was approximately 66.4 months
Title
Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response
Description
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.
Time Frame
Median observation time was approximately 66.4 months
Title
Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)
Description
The time from randomization to the start of a new treatment.
Time Frame
Median observation time was approximately 66.4 months

10. Eligibility

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

12. IPD Sharing Statement

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Links:
URL
http://www.roche-trials.com/studyResultGet.action?studyResultNumber=ML17102
Description
Clinical Study Report Synopsis

Learn more about this trial

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

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