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Rituximab, Fludarabine, and Cyclophosphamide or Observation Alone 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
Cyclophosphamide
Rituximab
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 0 chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia, stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia

Eligibility Criteria

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

DISEASE CHARACTERISTICS: Established diagnosis of B-cell chronic lymphocytic leukemia First diagnosis within 12 months before inclusion in study Previously untreated disease Binet stage A disease (Rai stage 0, I, or II) PATIENT CHARACTERISTICS: Life expectancy > 6 months ECOG performance status 0-2 Willingness to accept contraception (if randomized to arm I) for the duration of therapy and 12 months thereafter Negative serum pregnancy test All parameters for risk stratification (lymphocyte doubling time, cytogenetics, unmutated IgVH, and serum thymidine kinase level > 10) present PRIOR CONCURRENT THERAPY: No prior chemotherapy, radiotherapy, or antibody treatment No other concurrent chemotherapy

Sites / Locations

  • Universitaetsklinik fuer Innere Medizin I
  • Centre Hospitalier Universitaire d'Amiens
  • Centre Hospitalier Regional et Universitaire d'Angers
  • Centre Hospitalier Victor Dupouy
  • Hopital Avicenne
  • CHU de Caen
  • CHR Clermont Ferrand, Hotel Dieu
  • Centre Hospitalier Universitaire Henri Mondor
  • CHU de Grenoble - Hopital de la Tronche
  • Centre Jean Bernard
  • Centre Hospital Universitaire Hop Huriez
  • Hopital Edouard Herriot - Lyon
  • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
  • Centre Hospitalier de Meaux
  • CHR Hotel Dieu
  • Hopital Saint-Louis
  • CHU Pitie-Salpetriere
  • Hopital Necker
  • Hopital Haut Leveque
  • Centre Hospitalier Lyon Sud
  • CHU Poitiers
  • CHU - Robert Debre
  • Centre Henri Becquerel
  • Hopital Universitaire Hautepierre
  • CHU de Toulouse, Hotel Dieu
  • CHU de Nancy - Hopitaux de Brabois
  • Praxis fuer Innere Medizin Haematologie und Internistische Onkologie
  • Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
  • Kreiskrankenhaus Aurich
  • Klinikum am Bamberg
  • Internistische Gemeinschaftspraxis - Berlin
  • St. Hedwig Krankenhaus
  • Internistische Gemeinschaftspraxis Betzdorf
  • DIAKO Ev. Diakonie Krankenhaus gGmbH
  • Onkologische Schwerpunktpraxis at Facharzt fuer Innere Medizin
  • Praxis Fuer Haematologie Internistische Onkologie
  • Medizinische Universitaetsklinik I at the University of Cologne
  • Universitaetsklinikum Duesseldorf
  • Helios Klinikum Erfurt
  • Onkologische Schwerpunkt Praxis
  • St. Antonius Hospital
  • Universitaetsklinikum Essen
  • Internistische Gemeinschaftspraxis - Forchheim
  • Klinikum Frankfurt (Oder) GmbH
  • Internistische Gemeinschaftspraxis - Friedberg
  • Klinikum Garmisch - Partenkirchen GmbH
  • Internistische Praxisgemeinschaft
  • Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
  • Universitaetsklinikum Goettingen
  • Klinik Fuer Innere Medizin, Hematology/Oncology, Ernst Moritz Armdt Universitaet
  • Maria-Josef-Hospital Greven GmbH
  • St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
  • Internistische Gemeinschaftspraxis - Halle
  • Universitaetsklinikum Halle
  • Krankenhaus Siloah - Medizinische Klinik II
  • Praxis Dr. med Freddy Henne
  • Universitatsklinikum Heidelberg
  • Westpfalz-Klinikum GmbH
  • Internistische Gemeinschaftspraxis - Kassel
  • University Hospital Schleswig-Holstein - Kiel Campus
  • Internistische Onkologische Praxis - Kronach
  • Internistische Praxis - Landshut
  • Caritas - Krakenhaus Lebach
  • Onkologische Schwerpunktpraxis - Leer
  • Staedtisches Klinikum Magdeburg - Altstadt
  • Gemeinschaftspraxis
  • Klinikum Minden
  • Haematologische Praxis - Moenchengladbach
  • Munich Oncologic Practice at Elisenhof
  • Klinikum Rechts Der Isar - Technische Universitaet Muenchen
  • Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
  • Haematologische Schwerpunktpraxis
  • Klinikum Schwaebisch Gmuend Stauferklinik
  • Internistische Gemeinschaftspraxis - Offenbach
  • Internistische Gemeinschaftspraxis - Oldenburg
  • Internistische Schwerpunktpraxis
  • Schwerpunktpraxis fuer Haematologie und Onkologie
  • Diakonie - Krankenhaus
  • St. Marien - Krankenhaus Siegen GMBH
  • Robert-Bosch-Krankenhaus
  • Diakonie Klinikum Stuttgart
  • Onkologische Gemeinschaftspraxis - Trier
  • Universitaetsklinikum Tuebingen
  • Praxis fuer Haematologie und Onkologie
  • Comprehensive Cancer Center Ulm at Universitaetsklinikum Ulm
  • St. Marienhospital - Vechta
  • Burkhard and Reimann Gemeinschaftspraxis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

No Intervention

Arm Label

Cohort I (FCR)

Cohort II (W&W)

Cohort III (W&W)

Arm Description

Patients with 2 or more risk factors out of 4 (1. unfavorable molecular cytogenetics, 2. high serum thymidine kinase levels, 3. lymphocyte doubling time shorter than 12 months, 4. unmutated IgVH gene) who are randomized into cohort I receive Fludarabine, Cyclophosphamide and Rituximab (FCR) chemoimmunotherapy.

Patients with 2 or more risk factors out of 4 (1. unfavorable molecular cytogenetics, 2. high serum thymidine kinase levels, 3. lymphocyte doubling time shorter than 12 months, 4. unmutated IgVH gene) who are randomized into cohort II receive no treatment at all (watch & wait).

Patients with less than 2 risk factors out of 4 (1. unfavorable molecular cytogenetics, 2. high serum thymidine kinase levels, 3. lymphocyte doubling time shorter than 12 months, 4. unmutated IgVH gene) are assigned directly to cohort III and receive no treatment at all (watch & wait).

Outcomes

Primary Outcome Measures

Event-free survival
Development of a new prognostic staging system

Secondary Outcome Measures

Progression free survival
Overall survival
Time to progression to Binet stages B and C
Time to treatment
Quality of life
Pharmacoeconomic analysis
Overall response (complete and partial) rate in patients in the early treatment arm
Percentage of patients achieving complete molecular remission in the early treatment arm
Duration of response in patients in the early treatment arm
Adverse events in patients in the early treatment arm

Full Information

First Posted
January 10, 2006
Last Updated
May 21, 2019
Sponsor
German CLL Study Group
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1. Study Identification

Unique Protocol Identification Number
NCT00275054
Brief Title
Rituximab, Fludarabine, and Cyclophosphamide or Observation Alone in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia
Official Title
Randomized Phase III Trial Comparing Early Treatment With Fludarabine/Cyclophosphamide + Rituximab Versus Deferred Treatment in Untreated Binet Stage A Patients With CLL and High Risk of Progression
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
October 2005 (undefined)
Primary Completion Date
July 2007 (Actual)
Study Completion Date
June 2015 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
German CLL Study Group

4. Oversight

5. Study Description

Brief Summary
RATIONALE: Monoclonal antibodies, such as rituximab, can block cancer growth in different ways. Some find cancer cells and kill them or carry cancer-killing substances to them. Others interfere with the ability of cancer cells to grow and spread. 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. Sometimes the cancer may not need treatment until it progresses. In this case, observation may be sufficient. It is not yet known whether giving rituximab together with fludarabine and cyclophosphamide is more effective than observation alone in treating chronic lymphocytic leukemia. PURPOSE: This randomized phase III trial is studying rituximab, fludarabine, and cyclophosphamide to see how well they work compared to observation alone in treating patients with stage 0, stage I, or stage II B-cell chronic lymphocytic leukemia.
Detailed Description
OBJECTIVES: Primary Compare the effect, in terms of event-free survival, of deferred versus immediate treatment with rituximab, fludarabine, and cyclophosphamide in patients with previously untreated Binet stage A chronic lymphocytic leukemia at high risk for disease progression. Investigate and define a new prognostic staging system for patients with Binet stage A chronic lymphocytic leukemia. Secondary Compare the time to progression to Binet stages B and C in patients treated with these regimens. Compare the overall and progression-free survival of patients treated with these regimens. Compare the quality of life of patients treated with these regimens. Compare the time to treatment in patients treated with these regimens. Analyze the pharmacoeconomics of these regimens in these patients. Determine the overall response rate (partial and complete) in patients included in the early treatment arm. For patients included in the early treatment arm in complete remission, determine the percentage achieving complete molecular remission using the clone-specific CDR-III region as follow-up parameter. Determine the duration of response in patients included in the early treatment arm. Determine any adverse events related to treatment/safety of treatment. OUTLINE: This is a randomized, multicenter study. Patients are stratified according to risk factor profile (< 2 risk factors [low risk] vs ≥ 2 risk factors [high risk]). Low-risk patients are assigned to arm II. High-risk patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive rituximab IV on day 1, fludarabine IV on days 1-3, and cyclophosphamide IV on days 1-3. Treatment repeats every 28 days for up to 6 courses. Arm II: Patients undergo observation only until disease progression. PROJECTED ACCRUAL: A total of 600 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 0 chronic lymphocytic leukemia, B-cell 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
825 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort I (FCR)
Arm Type
Experimental
Arm Description
Patients with 2 or more risk factors out of 4 (1. unfavorable molecular cytogenetics, 2. high serum thymidine kinase levels, 3. lymphocyte doubling time shorter than 12 months, 4. unmutated IgVH gene) who are randomized into cohort I receive Fludarabine, Cyclophosphamide and Rituximab (FCR) chemoimmunotherapy.
Arm Title
Cohort II (W&W)
Arm Type
No Intervention
Arm Description
Patients with 2 or more risk factors out of 4 (1. unfavorable molecular cytogenetics, 2. high serum thymidine kinase levels, 3. lymphocyte doubling time shorter than 12 months, 4. unmutated IgVH gene) who are randomized into cohort II receive no treatment at all (watch & wait).
Arm Title
Cohort III (W&W)
Arm Type
No Intervention
Arm Description
Patients with less than 2 risk factors out of 4 (1. unfavorable molecular cytogenetics, 2. high serum thymidine kinase levels, 3. lymphocyte doubling time shorter than 12 months, 4. unmutated IgVH gene) are assigned directly to cohort III and receive no treatment at all (watch & wait).
Intervention Type
Drug
Intervention Name(s)
Fludarabine
Other Intervention Name(s)
Fludura
Intervention Description
cycles 1-6: 25 mg/m² i.v., d2-4, q28d
Intervention Type
Drug
Intervention Name(s)
Cyclophosphamide
Other Intervention Name(s)
Endoxan
Intervention Description
cycles 1-6: 250 mg/m² i.v., d2-4, q28d
Intervention Type
Biological
Intervention Name(s)
Rituximab
Other Intervention Name(s)
Mabthera, Rituxan
Intervention Description
cycle1: 375 mg/m² i.v., d1, q28d cycles 2-6: 500 mg/m² i.v., d1, q28d
Primary Outcome Measure Information:
Title
Event-free survival
Title
Development of a new prognostic staging system
Secondary Outcome Measure Information:
Title
Progression free survival
Title
Overall survival
Title
Time to progression to Binet stages B and C
Title
Time to treatment
Title
Quality of life
Title
Pharmacoeconomic analysis
Title
Overall response (complete and partial) rate in patients in the early treatment arm
Title
Percentage of patients achieving complete molecular remission in the early treatment arm
Title
Duration of response in patients in the early treatment arm
Title
Adverse events in patients in the early treatment arm

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
DISEASE CHARACTERISTICS: Established diagnosis of B-cell chronic lymphocytic leukemia First diagnosis within 12 months before inclusion in study Previously untreated disease Binet stage A disease (Rai stage 0, I, or II) PATIENT CHARACTERISTICS: Life expectancy > 6 months ECOG performance status 0-2 Willingness to accept contraception (if randomized to arm I) for the duration of therapy and 12 months thereafter Negative serum pregnancy test All parameters for risk stratification (lymphocyte doubling time, cytogenetics, unmutated IgVH, and serum thymidine kinase level > 10) present PRIOR CONCURRENT THERAPY: No prior chemotherapy, radiotherapy, or antibody treatment 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
Principal Investigator
Facility Information:
Facility Name
Universitaetsklinik fuer Innere Medizin I
City
Vienna
ZIP/Postal Code
A-1090
Country
Austria
Facility Name
Centre Hospitalier Universitaire d'Amiens
City
Amiens
ZIP/Postal Code
80054
Country
France
Facility Name
Centre Hospitalier Regional et Universitaire d'Angers
City
Angers
ZIP/Postal Code
49033
Country
France
Facility Name
Centre Hospitalier Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95107
Country
France
Facility Name
Hopital Avicenne
City
Bobigny
ZIP/Postal Code
93009
Country
France
Facility Name
CHU de Caen
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHR Clermont Ferrand, Hotel Dieu
City
Clermont-Ferrand
ZIP/Postal Code
63058
Country
France
Facility Name
Centre Hospitalier Universitaire Henri Mondor
City
Creteil
ZIP/Postal Code
94000
Country
France
Facility Name
CHU de Grenoble - Hopital de la Tronche
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
Centre Jean Bernard
City
Le Mans
ZIP/Postal Code
72000
Country
France
Facility Name
Centre Hospital Universitaire Hop Huriez
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
Hopital Edouard Herriot - Lyon
City
Lyon
ZIP/Postal Code
69437
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 de Meaux
City
Meaux
ZIP/Postal Code
77104
Country
France
Facility Name
CHR Hotel Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital Saint-Louis
City
Paris
ZIP/Postal Code
75475
Country
France
Facility Name
CHU Pitie-Salpetriere
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75743
Country
France
Facility Name
Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33604
Country
France
Facility Name
Centre Hospitalier Lyon Sud
City
Pierre Benite
ZIP/Postal Code
69495
Country
France
Facility Name
CHU Poitiers
City
Poitiers
ZIP/Postal Code
86021
Country
France
Facility Name
CHU - Robert Debre
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Centre Henri Becquerel
City
Rouen
ZIP/Postal Code
76038
Country
France
Facility Name
Hopital Universitaire Hautepierre
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
CHU de Toulouse, Hotel Dieu
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU de Nancy - Hopitaux de Brabois
City
Vandoeuvre-Les-Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Praxis fuer Innere Medizin Haematologie und Internistische Onkologie
City
Alsfeld
ZIP/Postal Code
36304
Country
Germany
Facility Name
Hamatologische/Onkologische Gemeinschaftspraxis - Augsburg
City
Augsburg
ZIP/Postal Code
86150
Country
Germany
Facility Name
Kreiskrankenhaus Aurich
City
Aurich
ZIP/Postal Code
26603
Country
Germany
Facility Name
Klinikum am Bamberg
City
Bamberg
ZIP/Postal Code
96049
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Berlin
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
St. Hedwig Krankenhaus
City
Berlin
ZIP/Postal Code
D-10115
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis Betzdorf
City
Betzdorf
ZIP/Postal Code
D-57518
Country
Germany
Facility Name
DIAKO Ev. Diakonie Krankenhaus gGmbH
City
Bremen
ZIP/Postal Code
D-28239
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
Universitaetsklinikum Duesseldorf
City
Duesseldorf
ZIP/Postal Code
D-40225
Country
Germany
Facility Name
Helios Klinikum Erfurt
City
Erfurt
ZIP/Postal Code
99012
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
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
Internistische Gemeinschaftspraxis - Friedberg
City
Friedberg
ZIP/Postal Code
86316
Country
Germany
City
Fürstenzell
ZIP/Postal Code
94981
Country
Germany
Facility Name
Klinikum Garmisch - Partenkirchen GmbH
City
Garmisch-Partenkirchen
ZIP/Postal Code
D-82467
Country
Germany
Facility Name
Internistische Praxisgemeinschaft
City
Germering
ZIP/Postal Code
82110
Country
Germany
Facility Name
Gemeinschaftspraxis Fuer Innere Medizin, Hematologie Und Onkologie
City
Giessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Universitaetsklinikum Goettingen
City
Gottingen
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
Maria-Josef-Hospital Greven GmbH
City
Greven
ZIP/Postal Code
48268
Country
Germany
Facility Name
St. Marien Hospital - Katholisches Krankenhaus Hagen gGmbH
City
Hagen
ZIP/Postal Code
D-58095
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Halle
City
Halle
ZIP/Postal Code
06110
Country
Germany
Facility Name
Universitaetsklinikum Halle
City
Halle
ZIP/Postal Code
D-06120
Country
Germany
Facility Name
Krankenhaus Siloah - Medizinische Klinik II
City
Hannover
ZIP/Postal Code
D-30449
Country
Germany
Facility Name
Praxis Dr. med Freddy Henne
City
Hechingen
ZIP/Postal Code
D-72379
Country
Germany
Facility Name
Universitatsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
D-69120
Country
Germany
Facility Name
Westpfalz-Klinikum GmbH
City
Kaiserslautern
ZIP/Postal Code
D-67653
Country
Germany
Facility Name
Internistische Gemeinschaftspraxis - Kassel
City
Kassel
ZIP/Postal Code
D-34117
Country
Germany
Facility Name
University Hospital Schleswig-Holstein - Kiel Campus
City
Kiel
ZIP/Postal Code
D-24116
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
Caritas - Krakenhaus Lebach
City
Lebach
ZIP/Postal Code
66822
Country
Germany
Facility Name
Onkologische Schwerpunktpraxis - Leer
City
Leer
ZIP/Postal Code
D-26789
Country
Germany
Facility Name
Staedtisches Klinikum Magdeburg - Altstadt
City
Magdeburg
ZIP/Postal Code
D-39104
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Mannheim
ZIP/Postal Code
D-68161
Country
Germany
Facility Name
Klinikum Minden
City
Minden
ZIP/Postal Code
D-32423
Country
Germany
Facility Name
Haematologische Praxis - Moenchengladbach
City
Moenchengladbach
ZIP/Postal Code
D-41239
Country
Germany
City
Monchenglasbach/Rheydt
ZIP/Postal Code
D-41239
Country
Germany
Facility Name
Munich Oncologic Practice at Elisenhof
City
Munich
ZIP/Postal Code
D-80335
Country
Germany
Facility Name
Klinikum Rechts Der Isar - Technische Universitaet Muenchen
City
Munich
ZIP/Postal Code
D-81241
Country
Germany
Facility Name
Hamatologie/Onkologie Praxisgemeinschaft - Muenchen
City
Munich
ZIP/Postal Code
D-81245
Country
Germany
Facility Name
Haematologische Schwerpunktpraxis
City
Munich
ZIP/Postal Code
D-81679
Country
Germany
Facility Name
Klinikum Schwaebisch Gmuend Stauferklinik
City
Mutlangen
ZIP/Postal Code
D-73557
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
City
Pforzheim
ZIP/Postal Code
75179
Country
Germany
Facility Name
Internistische Schwerpunktpraxis
City
Russelsheim
ZIP/Postal Code
65428
Country
Germany
Facility Name
Schwerpunktpraxis fuer Haematologie und Onkologie
City
Saarbruecken
ZIP/Postal Code
66113
Country
Germany
Facility Name
Diakonie - Krankenhaus
City
Schwäbisch Hall
ZIP/Postal Code
74523
Country
Germany
Facility Name
St. Marien - Krankenhaus Siegen GMBH
City
Siegen
ZIP/Postal Code
D-57072
Country
Germany
City
Singen
ZIP/Postal Code
D-78224
Country
Germany
Facility Name
Robert-Bosch-Krankenhaus
City
Stuttgart
ZIP/Postal Code
70376
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
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
D-72076
Country
Germany
Facility Name
Praxis fuer Haematologie und Onkologie
City
Twistringen
ZIP/Postal Code
D-27239
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
Burkhard and Reimann Gemeinschaftspraxis
City
Worms
ZIP/Postal Code
DOH-67547
Country
Germany

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
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
32071431
Citation
Herling CD, Cymbalista F, Gross-Ophoff-Muller C, Bahlo J, Robrecht S, Langerbeins P, Fink AM, Al-Sawaf O, Busch R, Porcher R, Cazin B, Dreyfus B, Ibach S, Lepretre S, Fischer K, Kaiser F, Eichhorst B, Wentner CM, Hoechstetter MA, Dohner H, Leblond V, Kneba M, Letestu R, Bottcher S, Stilgenbauer S, Hallek M, Levy V. Early treatment with FCR versus watch and wait in patients with stage Binet A high-risk chronic lymphocytic leukemia (CLL): a randomized phase 3 trial. Leukemia. 2020 Aug;34(8):2038-2050. doi: 10.1038/s41375-020-0747-7. Epub 2020 Feb 18.
Results Reference
derived
Links:
URL
http://www.dcllsg.de/en/trial/cll7/index.php
Description
Click here for more information about this study: CLL7 (German CLL Study Group)

Learn more about this trial

Rituximab, Fludarabine, and Cyclophosphamide or Observation Alone in Treating Patients With Stage 0, Stage I, or Stage II Chronic Lymphocytic Leukemia

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