Back to resultsFludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Primary Purpose
Chronic Lymphocytic Leukemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Fludarabine
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Lymphocytic Leukemia focused on measuring B-cell chronic lymphocytic leukemia, stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia
Eligibility Criteria
DISEASE CHARACTERISTICS: Confirmed diagnosis of B-cell chronic lymphocytic leukemia Rai stage 0-II (Binet stage A) disease Meets 1 of the following criteria: High-risk disease, as defined by the following: Serum thymidine kinase level > 7.0 U/L Elevated β2-microglobulin level Presence of non-nodular bone marrow infiltration Short lymphocyte doubling time Low-risk disease Meets none of the criteria (as listed above) for high-risk disease PATIENT CHARACTERISTICS: Performance status Not specified Life expectancy More than 6 months Hematopoietic No autoimmune hemolytic anemia No thrombocytopenia Hepatic Not specified Renal Not specified Other No severe organ dysfunction No other prior or concurrent malignancy PRIOR CONCURRENT THERAPY: Chemotherapy No prior chemotherapy No other concurrent chemotherapy
Sites / Locations
- Hanuschkrankenhaus
- Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
- Klinikum St. Marien
- Internistische Praxis - Arnstadt
- Zentralklinikum Augsburg
- Kreiskrankenhaus Aurich
- Regional Hospital Am Plattenwald
- Regional Hospital Bad Hersfeld
- Arzt fuer Innere Medizin - Bad Reichenhall
- Humaine - Clinic
- Ermstalklinik Bad Urach
- Internistische Praxis - Berlin
- Internistische Gemeinschaftspraxis - Berlin
- Haematologisch-Onkologische Schwerpunktpraxis
- Internistische Praxis - Berlin
- Internistische Gemeinschaftspraxis - Berlin
- Charite - Campus Charite Mitte
- Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
- Charite - Campus Virchow Klinikum
- Gemeinschaftspraxis - Betzdorf
- Praxis Dres. F.& G. Doering
- Krankenhaus Burglengenfeld
- Onkologische Schwerpunktpraxis
- Staedtisches Klinikum Dessau
- Onkologische Gemeinschaftspraxis - Dresden
- Universitaetsklinik Duesseldorf
- Michael Schaefers und Partner
- Internistische Gemeinschaftpraxis - Ehingen
- Onkologische Schwerpunktpraxis - Erding
- Internistische/Onkologische Praxis - Erfurt
- Onkologische Schwerpunkt Praxis
- St. Antonius Hospital
- Universitaetsklinikum Essen
- Staedtische Kliniken Esslingen
- Internistische Gemeinschaftspraxis - Forchheim
- Klinikum Garmisch - Partenkirchen
- Gemeinschaftspraxis - Germering
- Internistische Praxisgemeinschaft
- Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
- Onkologische Gemeinschaftspraxis - Gross-Gerau
- St. Marien Hospital at Katholisches Krankenhaus hagen gem. GmbH
- Allgemeines Krankenhaus Hagen
- Internistische Praxis - Halle
- Internistische Gemeinschaftspraxis - Halle
- Martin Luther Universitaet
- Praxis fur Innere Medizin - Hamburg
- Allgemeines Krankenhaus St. Georg
- Universitaetsklinikum Hamburg-Eppendorf
- Schwerpunktpraxis Haematologie/Onkologie - Hannover
- Facharzt fuer Allgemeinmedizin - Hausham
- Facharzt fuer Innere Medizin - Hechingen
- Onkologische Schwerpunktpraxis Heidelberg
- Universitatsklinikum Heidelberg
- Medizinischen Klinik Dr. R. Schindlbeck
- Oncological Specialist Practice
- Universitaetsklinikum des Saarlandes
- Clinic for Bone Marrow Transplantation and Hematology and Oncology
- Praxis am Evangelischen Krankenhaus Bethanien
- Internistische Gemeinschaftspraxis - Jena
- Westpfalz-Klinikum GmbH
- Staedt Klinikum Karlsruhe GGMBH
- Facharzt Fuer Jnnere Medizin
- St. Vincentius-Kliniken
- Internistische Gemeinschaftspraxis - Kassel
- Staedtische Krankenhaus Kiel
- Praxis Fuer Haematologie Internistische Onkologie
- Medizinische Universitaetsklinik I at the University of Cologne
- Internistische Onkologische Praxis - Kronach
- Internistische Praxis - Landshut
- Onkologische Schwerpunktpraxis Leer
- Klinikum Lippe - Lemgo
- Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
- Gemeinschaftspraxis
- Philipps-Universitaet Marburg Klinikum
- Internistische Gemeinschaftspraxis - Memmingen
- Klinikum Minden
- Haematologische Praxis - Moenchengladbach
- Haematologisch-onkologische Gemeinschaftspraxis - Muenster
- Klinikum Innenstadt
- Krankenhaus Muenchen Schwabing
- Hamatologische Schwerpunktpraxis
- Munich Oncologic Practice at Elisenhof
- Klinikum der Universitaet Muenchen - Grosshadern Campus
- Staedtisches Krankenhaus Muenchen - Harlaching
- Klinikum Garmisch-Partenkirchen GmbH Abteilung fuer Innere Medizin Murnau
- Internistische Praxis - Neuenkirchen
- Onkologische Schwerpunktpraxis Dr. Schmidt
- Praxis fuer Haematologie und Interne Onkologie
- Sudharz-Krankenhaus Nordhausen gGmbH
- Klinikum Nuernberg - Klinikum Nord
- Internistische Gemeinschaftspraxis - Offenbach
- Hematologische Praxis
- Gemeinschaftliche Schwerpunktpraxis - Osnabrueck
- Municipal Hospital Complex
- Hematologische Onkologische Praxis
- Jakobi Krankenhaus
- Klinik und Poliklinik fuer Innere Medizin - Universitaet Rostock
- Caritasklinik St. Theresia
- Schwerpunktpraxis Fuer Haematologie Und Onkologie
- Onkologische Schwerpunktpraxis - Schrobenhausen
- Praxis - Schwenningen
- St. Marien - Krankenhaus Siegen GMBH
- Evang. Jung-Stilling Hospital
- Praxisgemeinschaft - Stade
- Onkologische Schwerpunktpraxis - Straubing
- Haematologische Praxis
- Diakonie Klinikum Stuttgart
- Onkologische Gemeinschaftspraxis - Trier
- Southwest German Cancer Center at Eberhard-Karls-University
- Universitaetsklinikum Ulm
- St. Marien Hospital
- Gemeinschaftspraxis - Weiden
- Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
- Internistische Praxis - Wendlingen
- Medizinische Klinik und Poliklinik II - Universitaetsklinikum Wuerzburg
- Kliniken St. Antonius
- Hamatologisch - Onkologische Praxis Wurzburg
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Fludarabine
watch & wait
Arm Description
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00262782
First Posted
December 6, 2005
Last Updated
February 18, 2020
Sponsor
German CLL Study Group
1. Study Identification
Unique Protocol Identification Number
NCT00262782
Brief Title
Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Official Title
Prognostic Factors and Risk-Adapted Therapy in Patients With Early Stage Chronic Lymphocytic Leukemia
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
April 1997 (undefined)
Primary Completion Date
December 2004 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
German CLL Study Group
4. Oversight
5. Study Description
Brief Summary
RATIONALE: Drugs used in chemotherapy, such as fludarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Sometimes, the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether fludarabine is more effective than observation in treating chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying fludarabine to see how well it works compared to observation only in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.
Detailed Description
OBJECTIVES:
Identify prognostic factors that predict a short survival in patients with stage 0-II B-cell chronic lymphocytic leukemia treated with fludarabine or observation only.
OUTLINE: This is a randomized study. Patients are stratified according to risk (high risk vs low risk). Patients in the low-risk group undergo observation only. Patients in the high-risk group are randomized to 1 of 2 treatment arms.
Arm I: Patients receive fludarabine.
Arm II: Patients undergo observation only.
PROJECTED ACCRUAL: A total of 880 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
B-cell chronic lymphocytic leukemia, stage 0 chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II 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
877 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Fludarabine
Arm Type
Experimental
Arm Title
watch & wait
Arm Type
No Intervention
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Other Intervention Name(s)
Fludura
Intervention Description
Fludarabine i.v. (25 mg/m2/d, d1-5) q28d; max 6 cycles
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS:
Confirmed diagnosis of B-cell chronic lymphocytic leukemia
Rai stage 0-II (Binet stage A) disease
Meets 1 of the following criteria:
High-risk disease, as defined by the following:
Serum thymidine kinase level > 7.0 U/L
Elevated β2-microglobulin level
Presence of non-nodular bone marrow infiltration
Short lymphocyte doubling time
Low-risk disease
Meets none of the criteria (as listed above) for high-risk disease
PATIENT CHARACTERISTICS:
Performance status
Not specified
Life expectancy
More than 6 months
Hematopoietic
No autoimmune hemolytic anemia
No thrombocytopenia
Hepatic
Not specified
Renal
Not specified
Other
No severe organ dysfunction
No other prior or concurrent malignancy
PRIOR CONCURRENT THERAPY:
Chemotherapy
No prior chemotherapy
No other 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
Hanuschkrankenhaus
City
Vienna
ZIP/Postal Code
A-1140
Country
Austria
Facility Name
Allg. Krankenhaus der Stadt Wien Universitaets-Kinderklinik
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Klinikum St. Marien
City
Amberg
ZIP/Postal Code
D-92224
Country
Germany
Facility Name
Internistische Praxis - Arnstadt
City
Arnstadt
ZIP/Postal Code
99310
Country
Germany
Facility Name
Zentralklinikum Augsburg
City
Augsburg
ZIP/Postal Code
DOH-86156
Country
Germany
Facility Name
Kreiskrankenhaus Aurich
City
Aurich
ZIP/Postal Code
D-26603
Country
Germany
Facility Name
Regional Hospital Am Plattenwald
City
Bad Friedrichshall
ZIP/Postal Code
74172
Country
Germany
Facility Name
Regional Hospital Bad Hersfeld
City
Bad Hersfeld
ZIP/Postal Code
36251
Country
Germany
Facility Name
Arzt fuer Innere Medizin - Bad Reichenhall
City
Bad Reichenhall
ZIP/Postal Code
83435
Country
Germany
Facility Name
Humaine - Clinic
City
Bad Saarow
ZIP/Postal Code
15526
Country
Germany
Facility Name
Ermstalklinik Bad Urach
City
Bad Urach
ZIP/Postal Code
D-72574
Country
Germany
Facility Name
Internistische Praxis - Berlin
City
Berlin
ZIP/Postal Code
10969
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Berlin
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
Haematologisch-Onkologische Schwerpunktpraxis
City
Berlin
ZIP/Postal Code
13357
Country
Germany
Facility Name
Internistische Praxis - Berlin
City
Berlin
ZIP/Postal Code
14052
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Berlin
City
Berlin
ZIP/Postal Code
14195
Country
Germany
Facility Name
Charite - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
D-10117
Country
Germany
Facility Name
Charite - Universitaetsmedizin Berlin - Campus Benjamin Franklin
City
Berlin
ZIP/Postal Code
D-12200
Country
Germany
Facility Name
Charite - Campus Virchow Klinikum
City
Berlin
ZIP/Postal Code
D-13353
Country
Germany
Facility Name
Gemeinschaftspraxis - Betzdorf
City
Betzdorf
ZIP/Postal Code
57518
Country
Germany
Facility Name
Praxis Dres. F.& G. Doering
City
Bremen
ZIP/Postal Code
28205
Country
Germany
Facility Name
Krankenhaus Burglengenfeld
City
Burglengenfeld
ZIP/Postal Code
93133
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis
City
Cottbus
ZIP/Postal Code
D-03046
Country
Germany
Facility Name
Staedtisches Klinikum Dessau
City
Dessau
ZIP/Postal Code
D-06847
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis - Dresden
City
Dresden
ZIP/Postal Code
01127
Country
Germany
Facility Name
Universitaetsklinik Duesseldorf
City
Duesseldorf
ZIP/Postal Code
D-40225
Country
Germany
Facility Name
Michael Schaefers und Partner
City
Duisburg
ZIP/Postal Code
D-47051
Country
Germany
Facility Name
Internistische Gemeinschaftpraxis - Ehingen
City
Ehingen
ZIP/Postal Code
89584
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis - Erding
City
Erding
ZIP/Postal Code
85435
Country
Germany
Facility Name
Internistische/Onkologische Praxis - Erfurt
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
Staedtische Kliniken Esslingen
City
Esslingen
ZIP/Postal Code
73730
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Forchheim
City
Forchheim
ZIP/Postal Code
91301
Country
Germany
Facility Name
Klinikum Garmisch - Partenkirchen
City
Garmisch-Partenkirchen
ZIP/Postal Code
N 82467
Country
Germany
Facility Name
Gemeinschaftspraxis - Germering
City
Germering
ZIP/Postal Code
82110
Country
Germany
Facility Name
Internistische Praxisgemeinschaft
City
Germering
ZIP/Postal Code
82110
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
Onkologische Gemeinschaftspraxis - Gross-Gerau
City
Gross-Gerau
ZIP/Postal Code
64521
Country
Germany
Facility Name
St. Marien Hospital at Katholisches Krankenhaus hagen gem. GmbH
City
Hagen
ZIP/Postal Code
58095
Country
Germany
Facility Name
Allgemeines Krankenhaus Hagen
City
Hagen
ZIP/Postal Code
D-58095
Country
Germany
Facility Name
Internistische Praxis - Halle
City
Halle
ZIP/Postal Code
06108
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Halle
City
Halle
ZIP/Postal Code
06110
Country
Germany
Facility Name
Martin Luther Universitaet
City
Halle
ZIP/Postal Code
D-06097
Country
Germany
Facility Name
Praxis fur Innere Medizin - Hamburg
City
Hamburg
ZIP/Postal Code
22457
Country
Germany
Facility Name
Allgemeines Krankenhaus 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
Schwerpunktpraxis Haematologie/Onkologie - Hannover
City
Hannover
ZIP/Postal Code
30169
Country
Germany
Facility Name
Facharzt fuer Allgemeinmedizin - Hausham
City
Hausham
ZIP/Postal Code
83734
Country
Germany
Facility Name
Facharzt fuer Innere Medizin - Hechingen
City
Hechingen
ZIP/Postal Code
72379
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis Heidelberg
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Universitatsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Medizinischen Klinik Dr. R. Schindlbeck
City
Herrsching
ZIP/Postal Code
82211
Country
Germany
Facility Name
Oncological Specialist Practice
City
Hildesheim
ZIP/Postal Code
31134
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
Praxis am Evangelischen Krankenhaus Bethanien
City
Iserlohn
ZIP/Postal Code
D-58644
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Jena
City
Jena
ZIP/Postal Code
07743
Country
Germany
Facility Name
Westpfalz-Klinikum GmbH
City
Kaiserslautern
ZIP/Postal Code
D-67653
Country
Germany
Facility Name
Staedt Klinikum Karlsruhe GGMBH
City
Karlsruhe
ZIP/Postal Code
76133
Country
Germany
Facility Name
Facharzt Fuer Jnnere Medizin
City
Karlsruhe
ZIP/Postal Code
76135
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
34117
Country
Germany
Facility Name
Staedtische Krankenhaus Kiel
City
Kiel
ZIP/Postal Code
23116
Country
Germany
Facility Name
Praxis Fuer Haematologie Internistische Onkologie
City
Koeln
ZIP/Postal Code
D-50677
Country
Germany
Facility Name
Medizinische Universitaetsklinik I at the University of Cologne
City
Koln
ZIP/Postal Code
D-50924
Country
Germany
Facility Name
Internistische Onkologische Praxis - Kronach
City
Kronach
ZIP/Postal Code
96317
Country
Germany
Facility Name
Internistische Praxis - Landshut
City
Landshut
ZIP/Postal Code
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
Universitaetsklinkum Magdeburg der Otto-von-Guericke-Universitaet Magdeburg
City
Magdeburg
ZIP/Postal Code
D-39120
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Mannheim
ZIP/Postal Code
D-68161
Country
Germany
Facility Name
Philipps-Universitaet Marburg Klinikum
City
Marburg
ZIP/Postal Code
D-35033
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Memmingen
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Facility Name
Klinikum Minden
City
Minden
ZIP/Postal Code
D-32427
Country
Germany
Facility Name
Haematologische Praxis - Moenchengladbach
City
Moenchengladbach
ZIP/Postal Code
41239
Country
Germany
Facility Name
Haematologisch-onkologische Gemeinschaftspraxis - Muenster
City
Muenster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Klinikum Innenstadt
City
Munich
ZIP/Postal Code
80331
Country
Germany
Facility Name
Krankenhaus Muenchen Schwabing
City
Munich
ZIP/Postal Code
80804
Country
Germany
Facility Name
Hamatologische Schwerpunktpraxis
City
Munich
ZIP/Postal Code
81679
Country
Germany
Facility Name
Munich Oncologic Practice at Elisenhof
City
Munich
ZIP/Postal Code
D-80335
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 Garmisch-Partenkirchen GmbH Abteilung fuer Innere Medizin Murnau
City
Murnau
ZIP/Postal Code
82418
Country
Germany
Facility Name
Internistische Praxis - Neuenkirchen
City
Neuenkirchen
ZIP/Postal Code
48485
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
Sudharz-Krankenhaus Nordhausen gGmbH
City
Nordhausen
ZIP/Postal Code
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
63065
Country
Germany
Facility Name
Hematologische Praxis
City
Oldenburg
ZIP/Postal Code
26121
Country
Germany
Facility Name
Gemeinschaftliche Schwerpunktpraxis - Osnabrueck
City
Osnabrueck
ZIP/Postal Code
49074
Country
Germany
Facility Name
Municipal Hospital Complex
City
Pforzheim
ZIP/Postal Code
D-75178
Country
Germany
Facility Name
Hematologische Onkologische Praxis
City
Regensburg
ZIP/Postal Code
93047
Country
Germany
Facility Name
Jakobi Krankenhaus
City
Rheine
ZIP/Postal Code
48431
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
N-66113
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis - Schrobenhausen
City
Schrobenhausen
ZIP/Postal Code
86529
Country
Germany
Facility Name
Praxis - Schwenningen
City
Schwenningen
ZIP/Postal Code
78054
Country
Germany
Facility Name
St. Marien - Krankenhaus Siegen GMBH
City
Siegen
ZIP/Postal Code
D-57072
Country
Germany
Facility Name
Evang. Jung-Stilling Hospital
City
Siegen
ZIP/Postal Code
D-57074
Country
Germany
Facility Name
Praxisgemeinschaft - Stade
City
Stade
ZIP/Postal Code
21680
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis - Straubing
City
Straubing
ZIP/Postal Code
94315
Country
Germany
Facility Name
Haematologische Praxis
City
Stuttgart
ZIP/Postal Code
D-70173
Country
Germany
Facility Name
Diakonie Klinikum Stuttgart
City
Stuttgart
ZIP/Postal Code
D-70176
Country
Germany
Facility Name
Onkologische Gemeinschaftspraxis - Trier
City
Trier
ZIP/Postal Code
54290
Country
Germany
Facility Name
Southwest German Cancer Center at Eberhard-Karls-University
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Universitaetsklinikum Ulm
City
Ulm
ZIP/Postal Code
D-89081
Country
Germany
Facility Name
St. Marien Hospital
City
Vechta
ZIP/Postal Code
D-49377
Country
Germany
Facility Name
Gemeinschaftspraxis - Weiden
City
Weiden
ZIP/Postal Code
92637
Country
Germany
Facility Name
Haematologisch-Onkologische Schwerpunktpraxis - Weilheim
City
Weilheim
ZIP/Postal Code
82362
Country
Germany
Facility Name
Internistische Praxis - Wendlingen
City
Wendlingen
ZIP/Postal Code
73240
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
97070
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
24009671
Citation
Gobel M, Eisele L, Mollmann M, Huttmann A, Johansson P, Scholtysik R, Bergmann M, Busch R, Dohner H, Hallek M, Seiler T, Stilgenbauer S, Klein-Hitpass L, Duhrsen U, Durig J. Progranulin is a novel independent predictor of disease progression and overall survival in chronic lymphocytic leukemia. PLoS One. 2013 Aug 23;8(8):e72107. doi: 10.1371/journal.pone.0072107. eCollection 2013.
Results Reference
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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
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Citation
Bergmann MA, Eichhorst BF, Busch R, et al.: Early and risk-adapted therapy with fludarabine in high-risk Binet stage A CLL patients prolongs progression free survival but not overall survival: results of the CLL1 protocol of the German CLL Study Group (GCLLSG). [Abstract] Blood 110 (11): A-2038, 2007.
Results Reference
result
Citation
Bergmann MA, Eichhorst BF, Busch R, et al.: Prospective evaluation of prognostic parameters in early stage chronic lymphocytic leukemia (CLL): results of the CLL1-protocol of the German CLL Study Group (GCLLSG). [Abstract] Blood 110 (11): A-625, 2007.
Results Reference
result
PubMed Identifier
28804126
Citation
Hoechstetter MA, Busch R, Eichhorst B, Buhler A, Winkler D, Eckart MJ, Vehling-Kaiser U, Schimke H, Jager U, Hurtz HJ, Hopfinger G, Hartmann F, Fuss H, Abenhardt W, Blau I, Freier W, Muller L, Goebeler M, Wendtner CM, Bahlo J, Fischer K, Bentz M, Emmerich B, Dohner H, Hallek M, Stilgenbauer S. Early, risk-adapted treatment with fludarabine in Binet stage A chronic lymphocytic leukemia patients: results of the CLL1 trial of the German CLL study group. Leukemia. 2017 Dec;31(12):2833-2837. doi: 10.1038/leu.2017.246. Epub 2017 Aug 14. No abstract available.
Results Reference
result
PubMed Identifier
32042081
Citation
Hoechstetter MA, Busch R, Eichhorst B, Buhler A, Winkler D, Bahlo J, Robrecht S, Eckart MJ, Vehling-Kaiser U, Jacobs G, Jager U, Hurtz HJ, Hopfinger G, Hartmann F, Fuss H, Abenhardt W, Blau I, Freier W, Muller L, Goebeler M, Wendtner C, Fischer K, Herling CD, Starck M, Bentz M, Emmerich B, Dohner H, Stilgenbauer S, Hallek M. Prognostic model for newly diagnosed CLL patients in Binet stage A: results of the multicenter, prospective CLL1 trial of the German CLL study group. Leukemia. 2020 Apr;34(4):1038-1051. doi: 10.1038/s41375-020-0727-y. Epub 2020 Feb 10.
Results Reference
result
PubMed Identifier
33131249
Citation
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.
Results Reference
derived
PubMed Identifier
32735048
Citation
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.
Results Reference
derived
PubMed Identifier
24797299
Citation
Pflug N, Bahlo J, Shanafelt TD, Eichhorst BF, Bergmann MA, Elter T, Bauer K, Malchau G, Rabe KG, Stilgenbauer S, Dohner H, Jager U, Eckart MJ, Hopfinger G, Busch R, Fink AM, Wendtner CM, Fischer K, Kay NE, Hallek M. Development of a comprehensive prognostic index for patients with chronic lymphocytic leukemia. Blood. 2014 Jul 3;124(1):49-62. doi: 10.1182/blood-2014-02-556399. Epub 2014 May 5.
Results Reference
derived
Links:
URL
http://www.dcllsg.de/en/trial/cll1/index.php
Description
Click here for more information about this study: CLL1 (German CLL Study Group)
Learn more about this trial
Fludarabine or Observation in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
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