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Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia

Primary Purpose

Chronic Lymphocytic Leukemia

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fludarabine plus Cyclophosphamide
Fludarabine
Sponsored by
German CLL Study Group
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring stage III chronic lymphocytic leukemia, stage IV chronic lymphocytic leukemia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS: Confirmed diagnosis of previously untreated chronic lymphocytic leukemia (CLL) Binet stage C and stage B are acceptable if there is rapid disease progression, symptoms of enlarged lymph nodes and organs, or severe B-symptoms Binet stage A is acceptable, if there are B-symptoms PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 6 months No severe organ dysfunction No other previous or concurrent neoplasms, autoimmune hemolytic anemia, or thrombocytopenia PRIOR CONCURRENT THERAPY: No prior or concurrent chemotherapy

Sites / Locations

  • Allgemeines Krankenhaus - Universitatskliniken
  • Hanuschkrankenhaus
  • Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
  • Internistische Praxis - Arnstadt
  • Specialist Practice for Oncology
  • Klinikum Augsburg
  • Kreiskrankenhaus Aurich
  • Kreiskrankenhaus
  • Caritas-Krankenhaus Bad Mergentheim
  • Humaine - Clinic
  • Internistische Praxis - Bad Salzuflen
  • Internistische Praxis - Bayreuth
  • Internistische Gemeinschaftspraxis - Bergisch Gladbach
  • Charite - Campus Charite Mitte
  • Onkolog - Haematolog Schwerpunktpraxis
  • Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
  • Onkologische Gemeinschaftspraxis - Berlin
  • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
  • Internistische Gemeinschaftspraxis - Berlin
  • Charite - Campus Virchow Klinikum
  • Evang. Waldkrankenhaus Spandau
  • Internistische Praxis - Berlin
  • Internistische Gemeinschaftspraxis - Berlin
  • Krankenhaus Bietigheim
  • DIAKO Ev. Diakonie Krankenhaus gGmbH
  • Internistische Praxis - Chemnitz
  • Medizinische Universitaetsklinik I at the University of Cologne
  • Onkologische Schwerpunktpraxis
  • Onkologische Gemeinschaftspraxis - Dresden
  • Krankenhaus Benrath
  • St. Georg Klinikum Eisenach GmbH
  • Hans - Susemihl - Krankenhaus
  • Internistische/Onkologische Praxis - Erfurt
  • Praxis DR. J. Weniger
  • Klinikum Erfurt
  • Praxis fuer Haematologie/Onkologie - Erfurt
  • Onkologische Schwerpunkt Praxis
  • St. Antonius Hospital
  • Universitaetsklinikum Essen
  • Onkologische Praxis - Essen
  • Evangelisches Krankenhaus Essen Werden
  • Staedtische Kliniken Esslingen
  • Internistische Gemeinschaftspraxis - Forchheim
  • Klinikum Frankfurt (Oder) GmbH
  • Gemeinschaftspraxis - Freiburg
  • Klinikum Garmisch - Partenkirchen GmbH
  • Internistische Praxis - Gerlingen
  • Internistische Praxisgemeinschaft
  • Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
  • Klinik fuer Radioonkologie und Strahlentherapie
  • Universitaetsklinikum Goettingen
  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
  • Praxis fuer Haematologie und Internistische Onkologie - Greifswald
  • Internistisch-Haematologische Gemeinschaftspraxis - Gustrow
  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
  • Internistische Praxis - Halle
  • Internistische Gemeinschaftspraxis - Halle
  • Asklepios Klinik St. Georg
  • Universitaetsklinikum Hamburg-Eppendorf
  • Evangelische Krankenhaus Hamm
  • St. Marien-Hospital Hamm - Klinik Knappenstrasse
  • Schwerpunktpraxis Haematologie/Onkologie - Hannover
  • Universitaets-Kinderklinik Heidelberg
  • SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen
  • Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
  • Onkologische Schwerpunktpraxis
  • Onkologische Gemeinschaftspraxis - Hoevelhof
  • Evang. Hospital
  • Universitaetsklinikum des Saarlandes
  • Clinic for Bone Marrow Transplantation and Hematology and Oncology
  • Internistische Praxis - Ingolstadt
  • Internistische Gemeinschaftspraxis - Jena
  • Westpfalz-Klinikum GmbH
  • Onkologische Gemeinschaftspraxis - Kaiserslautern
  • Staedtisches Klinikum Karlsruhe gGmbH
  • St. Vincentius-Kliniken
  • Internistische Gemeinschaftspraxis - Kassel
  • Klinikum Kempten Oberallgaeu
  • University Hospital Schleswig-Holstein - Kiel Campus
  • Praxis Fuer Haematologie Internistische Onkologie
  • Internistische Onkologische Praxis - Kronach
  • Internistische Praxis - Landshut
  • Onkologische Schwerpunktpraxis - Leer
  • Klinikum Lippe - Lemgo
  • Internistische Praxis - Ludwigsburg
  • Staedtisches Klinikum Magdeburg - Altstadt
  • Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
  • III Medizinische Klinik Mannheim
  • Haematologische Praxis - Moenchengladbach
  • Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
  • University of Muenster
  • Internistische Praxis - Muhr am See
  • Klinikum der Universitaet Muenchen - Innenstadt Campus
  • Munich Oncologic Practice at Elisenhof
  • Krankenhaus Muenchen Schwabing
  • Klinikum der Universitaet Muenchen - Grosshadern Campus
  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen
  • Onkologische Schwerpunktpraxis Dr. Schmidt
  • Praxis fuer Haematologie und Interne Onkologie
  • Sudharz-Krankenhaus Nordhausen gGmbH
  • Klinikum Nuernberg - Klinikum Nord
  • Internistische Gemeinschaftspraxis - Offenbach
  • Internistische Gemeinschaftspraxis - Oldenburg
  • Paracelsus Karankenhaus Ruit
  • Asklepios Klinik Pasewalk
  • Vogtland - Klinikum Plauen GMBH
  • Klinikum Ernst Von Bergmann
  • Internistische Gemeinschaftspraxis - Potsdam
  • Krankenhaus Barmherzige Brueder Regensburg
  • Staedtische Klinikum-Kinderklinik
  • Haematologische/Onkologische Schwerpunktpraxis - Rostock
  • Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
  • Caritasklinik St. Theresia
  • Schwerpunktpraxis fuer Haematologie und Onkologie
  • Klinikum Schwerin
  • St. Marien - Krankenhaus Siegen GMBH
  • Haematologische Praxis
  • Klinik fuer Onkologie - Katharinenhospital Stuttgart
  • Diakonie Klinikum Stuttgart
  • Internistische Gemeinschaftspraxis - Stuttgart
  • Marienhospital Stuttgart
  • Robert-Bosch-Krankenhaus
  • Krankenanstalt Mutterhaus der Borromaerinnen
  • Onkologische Gemeinschaftspraxis - Trier
  • Schwerpunktpraxis für Rheumatologie und Haematologie/Internistische Onkologie
  • Southwest German Cancer Center at Eberhard-Karls-University
  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
  • St. Marienhospital - Vechta
  • Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
  • Internistische Praxis - Wendlingen
  • Gemeinschaftspraxis
  • Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
  • Kliniken St. Antonius
  • Hamatologisch - Onkologische Praxis Wurzburg
  • Internistische Praxis - Zittau

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Fludarabine plus Cyclophosphamide

Fludarabine

Arm Description

Outcomes

Primary Outcome Measures

Progression-free survival
date of randomization until progression of disease or death of any cause
Overall survival
Date of randomization until date of death
Duration of remission
Clinical response was defined according to the guidelines of the NCI-sponsored workshop

Secondary Outcome Measures

Incidence of side effects
Toxic effects of treatment were evaluated according to the Common Toxicity Criteria (CTC 1.0)
Quality of life
EORTC QUOL Questionnaire

Full Information

First Posted
January 12, 2006
Last Updated
May 21, 2019
Sponsor
German CLL Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00276848
Brief Title
Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia
Official Title
Fludarabine Versus Fludarabine Plus Cyclophosphamide in First Line Therapy of Younger Patients (Up to 65 Years) With Advanced Chronic Lymphocytic Leukemia (CLL)
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
July 1999 (undefined)
Primary Completion Date
July 2003 (Actual)
Study Completion Date
July 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German CLL Study Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving fludarabine together with cyclophosphamide is more effective than fludarabine alone in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying giving fludarabine together with cyclophosphamide to see how well it works compared to fludarabine alone in treating patients with advanced chronic lymphocytic leukemia.
Detailed Description
OBJECTIVES: Primary Compare the progression-free survival, as well the overall survival and duration of remission in patients with previously untreated, advanced chronic lymphocytic leukemia treated with fludarabine with versus without cyclophosphamide. Secondary Compare the incidence of side effects and quality of life of patients treated with these drugs. OUTLINE: This is a multicenter, randomized study. Patients are randomized to 1 of 2 treatment arms Arm I: Patients receive fludarabine IV on days 1-5. Arm II: Patients receive fludarabine IV and cyclophosphamide IV on days 1-3. In both arms, treatment repeats every 28 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. PROJECTED ACCRUAL: A total of 375 patients will be accrued for this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Lymphocytic Leukemia
Keywords
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
375 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fludarabine plus Cyclophosphamide
Arm Type
Active Comparator
Arm Title
Fludarabine
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
Fludarabine plus Cyclophosphamide
Intervention Description
fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, plus cyclophosphamide dosed at 250 mg/m2, administered intravenously daily over 30 minutes for 3 days, repeated every 28 days for a maximum of 6 courses
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Intervention Description
fludarabine at a dose of 25 mg/m2, administered intravenously daily over 30 minutes for 5 days, or fludarabine dosed at 30 mg/m2, administered intravenously daily over 30 minutes for 3 days, , repeated every 28 days for a maximum of 6 courses
Primary Outcome Measure Information:
Title
Progression-free survival
Description
date of randomization until progression of disease or death of any cause
Time Frame
18 Month after end of treatment of the last patient
Title
Overall survival
Description
Date of randomization until date of death
Time Frame
18 Month after end of treatment of the last patient
Title
Duration of remission
Description
Clinical response was defined according to the guidelines of the NCI-sponsored workshop
Time Frame
18 Month after end of treatment of the last patient
Secondary Outcome Measure Information:
Title
Incidence of side effects
Description
Toxic effects of treatment were evaluated according to the Common Toxicity Criteria (CTC 1.0)
Time Frame
up to 28 days after the last dose of study medication
Title
Quality of life
Description
EORTC QUOL Questionnaire
Time Frame
18 Month after end of treatment of the last patient

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Confirmed diagnosis of previously untreated chronic lymphocytic leukemia (CLL) Binet stage C and stage B are acceptable if there is rapid disease progression, symptoms of enlarged lymph nodes and organs, or severe B-symptoms Binet stage A is acceptable, if there are B-symptoms PATIENT CHARACTERISTICS: ECOG performance status 0-2 Life expectancy > 6 months No severe organ dysfunction No other previous or concurrent neoplasms, autoimmune hemolytic anemia, or thrombocytopenia PRIOR CONCURRENT THERAPY: No prior or concurrent chemotherapy
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
Allgemeines Krankenhaus - Universitatskliniken
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Hanuschkrankenhaus
City
Vienna
ZIP/Postal Code
A-1140
Country
Austria
Facility Name
Gemeinschaftspraxis Fuer Innere Medizin, Haematologie Und Internistische Onkologie
City
Ansbach
ZIP/Postal Code
D-91522
Country
Germany
Facility Name
Internistische Praxis - Arnstadt
City
Arnstadt
ZIP/Postal Code
D-99310
Country
Germany
Facility Name
Specialist Practice for Oncology
City
Aschaffenburg
ZIP/Postal Code
D-63739
Country
Germany
Facility Name
Klinikum Augsburg
City
Augsburg
ZIP/Postal Code
D-86156
Country
Germany
Facility Name
Kreiskrankenhaus Aurich
City
Aurich
ZIP/Postal Code
D-26603
Country
Germany
Facility Name
Kreiskrankenhaus
City
Bad Hersfeld
ZIP/Postal Code
D-36251
Country
Germany
Facility Name
Caritas-Krankenhaus Bad Mergentheim
City
Bad Mergentheim
ZIP/Postal Code
D-97980
Country
Germany
Facility Name
Humaine - Clinic
City
Bad Saarow
ZIP/Postal Code
D-15526
Country
Germany
Facility Name
Internistische Praxis - Bad Salzuflen
City
Bad Salzuflen
ZIP/Postal Code
D-32105
Country
Germany
Facility Name
Internistische Praxis - Bayreuth
City
Bayreuth
ZIP/Postal Code
D-95448
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Bergisch Gladbach
City
Bergisch Gladbach
ZIP/Postal Code
D-51429
Country
Germany
Facility Name
Charite - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Onkolog - Haematolog Schwerpunktpraxis
City
Berlin
ZIP/Postal Code
D-10559
Country
Germany
Facility Name
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis - Berlin
City
Berlin
ZIP/Postal Code
D-13055
Country
Germany
Facility Name
Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch
City
Berlin
ZIP/Postal Code
D-13122
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Berlin
City
Berlin
ZIP/Postal Code
D-13347
Country
Germany
Facility Name
Charite - Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Evang. Waldkrankenhaus Spandau
City
Berlin
ZIP/Postal Code
D-13589
Country
Germany
Facility Name
Internistische Praxis - Berlin
City
Berlin
ZIP/Postal Code
D-14052
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Berlin
City
Berlin
ZIP/Postal Code
D-14195
Country
Germany
Facility Name
Krankenhaus Bietigheim
City
Bietigheim
ZIP/Postal Code
D-74321
Country
Germany
Facility Name
DIAKO Ev. Diakonie Krankenhaus gGmbH
City
Bremen
ZIP/Postal Code
D-28239
Country
Germany
Facility Name
Internistische Praxis - Chemnitz
City
Chemnitz
ZIP/Postal Code
D-09119
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
D-01127
Country
Germany
Facility Name
Krankenhaus Benrath
City
Dusseldorf
ZIP/Postal Code
D-40593
Country
Germany
Facility Name
St. Georg Klinikum Eisenach GmbH
City
Eisenach
ZIP/Postal Code
D-99817
Country
Germany
Facility Name
Hans - Susemihl - Krankenhaus
City
Emden
ZIP/Postal Code
D-26721
Country
Germany
Facility Name
Internistische/Onkologische Praxis - Erfurt
City
Erfurt
ZIP/Postal Code
D-99084
Country
Germany
Facility Name
Praxis DR. J. Weniger
City
Erfurt
ZIP/Postal Code
D-99085
Country
Germany
Facility Name
Klinikum Erfurt
City
Erfurt
ZIP/Postal Code
D-99089
Country
Germany
Facility Name
Praxis fuer Haematologie/Onkologie - Erfurt
City
Erfurt
ZIP/Postal Code
D-99094
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
D-52249
Country
Germany
Facility Name
Universitaetsklinikum Essen
City
Essen
ZIP/Postal Code
D-45122
Country
Germany
Facility Name
Onkologische Praxis - Essen
City
Essen
ZIP/Postal Code
D-45136
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
D-91301
Country
Germany
Facility Name
Klinikum Frankfurt (Oder) GmbH
City
Frankfurt
ZIP/Postal Code
D-15236
Country
Germany
Facility Name
Gemeinschaftspraxis - Freiburg
City
Freiburg
ZIP/Postal Code
D-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
D-70839
Country
Germany
Facility Name
Internistische Praxisgemeinschaft
City
Germering
ZIP/Postal Code
D-82110
Country
Germany
Facility Name
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
City
Giessen
ZIP/Postal Code
D-35392
Country
Germany
Facility Name
Klinik fuer Radioonkologie und Strahlentherapie
City
Goeppingen
ZIP/Postal Code
D-73035
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-17487
Country
Germany
Facility Name
Praxis fuer Haematologie und Internistische Onkologie - Greifswald
City
Greifswald
ZIP/Postal Code
D-17489
Country
Germany
Facility Name
Internistisch-Haematologische Gemeinschaftspraxis - Gustrow
City
Gustrow
ZIP/Postal Code
D-18273
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
D-06108
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Halle
City
Halle
ZIP/Postal Code
D-06110
Country
Germany
Facility Name
Asklepios Klinik St. Georg
City
Hamburg
ZIP/Postal Code
D-20099
Country
Germany
Facility Name
Universitaetsklinikum Hamburg-Eppendorf
City
Hamburg
ZIP/Postal Code
D-20246
Country
Germany
Facility Name
Evangelische Krankenhaus Hamm
City
Hamm
ZIP/Postal Code
D-59063
Country
Germany
Facility Name
St. Marien-Hospital Hamm - Klinik Knappenstrasse
City
Hamm
ZIP/Postal Code
D-59071
Country
Germany
Facility Name
Schwerpunktpraxis Haematologie/Onkologie - Hannover
City
Hannover
ZIP/Postal Code
D-30169
Country
Germany
Facility Name
Universitaets-Kinderklinik Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
SLK - Kliniken Heilbronn GmbH - Klinikum am Gesundbrunnen
City
Heilbronn
ZIP/Postal Code
D-74064
Country
Germany
Facility Name
Privatklinik Dr. R. Schindlbeck GmbH & Co. KG
City
Herrsching
ZIP/Postal Code
D-82211
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Hildesheim
ZIP/Postal Code
D-31134
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis - Hoevelhof
City
Hoevelhof
ZIP/Postal Code
D-33161
Country
Germany
Facility Name
Evang. Hospital
City
Holzminden
ZIP/Postal Code
D-37603
Country
Germany
Facility Name
Universitaetsklinikum des Saarlandes
City
Homburg
ZIP/Postal Code
D-66421
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
Internistische Praxis - Ingolstadt
City
Ingolstadt
ZIP/Postal Code
D-85049
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Jena
City
Jena
ZIP/Postal Code
D-07743
Country
Germany
Facility Name
Westpfalz-Klinikum GmbH
City
Kaiserslautern
ZIP/Postal Code
D-67653
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis - Kaiserslautern
City
Kaiserslautern
ZIP/Postal Code
D-67655
Country
Germany
Facility Name
Staedtisches Klinikum Karlsruhe gGmbH
City
Karlsruhe
ZIP/Postal Code
D-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
University Hospital Schleswig-Holstein - Kiel Campus
City
Kiel
ZIP/Postal Code
D-24105
Country
Germany
Facility Name
Praxis Fuer Haematologie Internistische Onkologie
City
Koeln
ZIP/Postal Code
D-50677
Country
Germany
Facility Name
Internistische Onkologische Praxis - Kronach
City
Kronach
ZIP/Postal Code
D-96317
Country
Germany
Facility Name
Internistische Praxis - Landshut
City
Landshut
ZIP/Postal Code
D-84028
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis - Leer
City
Leer
ZIP/Postal Code
D-26789
Country
Germany
Facility Name
Klinikum Lippe - Lemgo
City
Lemgo
ZIP/Postal Code
D-32657
Country
Germany
Facility Name
Internistische Praxis - Ludwigsburg
City
Ludwigsburg
ZIP/Postal Code
D-71638
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
III Medizinische Klinik Mannheim
City
Mannheim
ZIP/Postal Code
D-68305
Country
Germany
Facility Name
Haematologische Praxis - Moenchengladbach
City
Moenchengladbach
ZIP/Postal Code
D-41239
Country
Germany
Facility Name
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
City
Muenchen
ZIP/Postal Code
D-81245
Country
Germany
Facility Name
University of Muenster
City
Muenster
ZIP/Postal Code
D-48129
Country
Germany
Facility Name
Internistische Praxis - Muhr am See
City
Muhr am See
ZIP/Postal Code
D-91735
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen - Innenstadt Campus
City
Munich
ZIP/Postal Code
D-80331
Country
Germany
Facility Name
Munich Oncologic Practice at Elisenhof
City
Munich
ZIP/Postal Code
D-80335
Country
Germany
Facility Name
Krankenhaus Muenchen Schwabing
City
Munich
ZIP/Postal Code
D-80804
Country
Germany
Facility Name
Klinikum der Universitaet Muenchen - Grosshadern Campus
City
Munich
ZIP/Postal Code
D-81377
Country
Germany
Facility Name
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-81675
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
D-22844
Country
Germany
Facility Name
Sudharz-Krankenhaus Nordhausen gGmbH
City
Nordhausen
ZIP/Postal Code
D-99734
Country
Germany
Facility Name
Klinikum Nuernberg - Klinikum Nord
City
Nuernberg
ZIP/Postal Code
D-90419
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
Paracelsus Karankenhaus Ruit
City
Ostfildern
ZIP/Postal Code
D-73760
Country
Germany
Facility Name
Asklepios Klinik Pasewalk
City
Pasewalk
ZIP/Postal Code
D-17309
Country
Germany
Facility Name
Vogtland - Klinikum Plauen GMBH
City
Plauen
ZIP/Postal Code
D-08529
Country
Germany
Facility Name
Klinikum Ernst Von Bergmann
City
Postdam
ZIP/Postal Code
D-14467
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Potsdam
City
Potsdam
ZIP/Postal Code
D-14467
Country
Germany
Facility Name
Krankenhaus Barmherzige Brueder Regensburg
City
Regensburg
ZIP/Postal Code
D-93049
Country
Germany
Facility Name
Staedtische Klinikum-Kinderklinik
City
Rosenheim
ZIP/Postal Code
D-83022
Country
Germany
Facility Name
Haematologische/Onkologische Schwerpunktpraxis - Rostock
City
Rostock
ZIP/Postal Code
D-18057
Country
Germany
Facility Name
Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
City
Rostock
ZIP/Postal Code
D-18057
Country
Germany
Facility Name
Caritasklinik St. Theresia
City
Saarbrucken
ZIP/Postal Code
D-66113
Country
Germany
Facility Name
Schwerpunktpraxis fuer Haematologie und Onkologie
City
Saarbruecke
ZIP/Postal Code
D-66113
Country
Germany
Facility Name
Klinikum Schwerin
City
Schwerin
ZIP/Postal Code
D-19049
Country
Germany
Facility Name
St. Marien - Krankenhaus Siegen GMBH
City
Siegen
ZIP/Postal Code
D-57072
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
Internistische Gemeinschaftspraxis - 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
Robert-Bosch-Krankenhaus
City
Stuttgart
ZIP/Postal Code
D-70376
Country
Germany
Facility Name
Krankenanstalt Mutterhaus der Borromaerinnen
City
Trier
ZIP/Postal Code
D-54290
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis - Trier
City
Trier
ZIP/Postal Code
D-54290
Country
Germany
Facility Name
Schwerpunktpraxis für Rheumatologie und Haematologie/Internistische Onkologie
City
Tuebingen
ZIP/Postal Code
D-72070
Country
Germany
Facility Name
Southwest German Cancer Center at Eberhard-Karls-University
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
St. Marienhospital - Vechta
City
Vechta
ZIP/Postal Code
D-49377
Country
Germany
Facility Name
Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
City
Weilheim
ZIP/Postal Code
D-82362
Country
Germany
Facility Name
Internistische Praxis - Wendlingen
City
Wendlingen
ZIP/Postal Code
D-73240
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Worms
ZIP/Postal Code
D-67547
Country
Germany
Facility Name
Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
City
Wuerzburg
ZIP/Postal Code
D-97070
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
D-97070
Country
Germany
Facility Name
Internistische Praxis - Zittau
City
Zittau
ZIP/Postal Code
D-02763
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21139079
Citation
Eichhorst BF, Fischer K, Fink AM, Elter T, Wendtner CM, Goede V, Bergmann M, Stilgenbauer S, Hopfinger G, Ritgen M, Bahlo J, Busch R, Hallek M; German CLL Study Group (GCLLSG). Limited clinical relevance of imaging techniques in the follow-up of patients with advanced chronic lymphocytic leukemia: results of a meta-analysis. Blood. 2011 Feb 10;117(6):1817-21. doi: 10.1182/blood-2010-04-282228. Epub 2010 Dec 7.
Results Reference
background
PubMed Identifier
24412156
Citation
Cramer P, Bahlo J, Eichhorst B, Fischer K, Hallek M. Extramedullary manifestations of chronic lymphocytic leukaemia are not unusual. Leuk Res. 2014 Mar;38(3):284-5. doi: 10.1016/j.leukres.2013.11.015. Epub 2013 Dec 1. No abstract available.
Results Reference
background
PubMed Identifier
24584349
Citation
Goede V, Cramer P, Busch R, Bergmann M, Stauch M, Hopfinger G, Stilgenbauer S, Dohner H, Westermann A, Wendtner CM, Eichhorst B, Hallek M; German CLL Study Group. Interactions between comorbidity and treatment of chronic lymphocytic leukemia: results of German Chronic Lymphocytic Leukemia Study Group trials. Haematologica. 2014 Jun;99(6):1095-100. doi: 10.3324/haematol.2013.096792. Epub 2014 Feb 28.
Results Reference
background
PubMed Identifier
30911113
Citation
Jebaraj BMC, Tausch E, Landau DA, Bahlo J, Robrecht S, Taylor-Weiner AN, Bloehdorn J, Scheffold A, Mertens D, Bottcher S, Kneba M, Jager U, Zenz T, Wenger MK, Fingerle-Rowson G, Wendtner C, Fink AM, Wu CJ, Eichhorst B, Fischer K, Hallek M, Dohner H, Stilgenbauer S. Short telomeres are associated with inferior outcome, genomic complexity, and clonal evolution in chronic lymphocytic leukemia. Leukemia. 2019 Sep;33(9):2183-2194. doi: 10.1038/s41375-019-0446-4. Epub 2019 Mar 25.
Results Reference
background
PubMed Identifier
31092457
Citation
Sachanas S, Pangalis GA, Fink AM, Bahlo J, Fischer K, Levidou G, Kyrtsonis MC, Bartzi V, Vassilakopoulos TP, Kalpadakis C, Koulieris E, Moschogiannis M, Yiakoumis X, Tsirkinidis P, Angelopoulou MK, Eichhorst B, Hallek M. Small Lymphocytic Lymphoma: Analysis of Two Cohorts Including Patients in Clinical Trials of the German Chronic Lymphocytic Leukemia Study Group (GCLLSG) or in "Real-Life" Outside of Clinical Trials. Anticancer Res. 2019 May;39(5):2591-2598. doi: 10.21873/anticanres.13382.
Results Reference
background
PubMed Identifier
17389338
Citation
Eichhorst BF, Busch R, Obwandner T, Kuhn-Hallek I, Herschbach P, Hallek M; German CLL Study Group. Health-related quality of life in younger patients with chronic lymphocytic leukemia treated with fludarabine plus cyclophosphamide or fludarabine alone for first-line therapy: a study by the German CLL Study Group. J Clin Oncol. 2007 May 1;25(13):1722-31. doi: 10.1200/JCO.2006.05.6929. Epub 2007 Mar 26.
Results Reference
result
PubMed Identifier
16219797
Citation
Eichhorst BF, Busch R, Hopfinger G, Pasold R, Hensel M, Steinbrecher C, Siehl S, Jager U, Bergmann M, Stilgenbauer S, Schweighofer C, Wendtner CM, Dohner H, Brittinger G, Emmerich B, Hallek M; German CLL Study Group. Fludarabine plus cyclophosphamide versus fludarabine alone in first-line therapy of younger patients with chronic lymphocytic leukemia. Blood. 2006 Feb 1;107(3):885-91. doi: 10.1182/blood-2005-06-2395. Epub 2005 Oct 11.
Results Reference
result
Links:
URL
http://www.dcllsg.de/en/trial/cll4/index.php
Description
Click here for more information about this study: CLL4 (German CLL Study Group)

Learn more about this trial

Fludarabine With or Without Cyclophosphamide in Treating Patients With Advanced Chronic Lymphocytic Leukemia

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