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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00281918




Registration number
NCT00281918
Ethics application status
Date submitted
24/01/2006
Date registered
25/01/2006
Date last updated
19/09/2013

Titles & IDs
Public title
Fludarabine and Cyclophosphamide With or Without Rituximab in Patients With Previously Untreated Chronic B-Cell Lymphocytic Leukemia
Scientific 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
Secondary ID [1] 0 0
GCLLSG-CLL-8
Secondary ID [2] 0 0
CDR0000454560
Universal Trial Number (UTN)
Trial acronym
CLL-8
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Leukemia 0 0
Condition category
Condition code
Cancer 0 0 0 0
Leukaemia - Acute leukaemia
Cancer 0 0 0 0
Leukaemia - Chronic leukaemia
Cancer 0 0 0 0
Children's - Leukaemia & Lymphoma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Rituximab
Treatment: Drugs - Cyclophosphamide
Treatment: Drugs - Fludarabine Phosphate

Experimental: Fludarabine+Cyclophosphamide+Rituximab (FCR) -

Active comparator: Fludarabine+Cyclophosphamide (FC) -


Treatment: Drugs: Rituximab
Intravenous repeating dose

Treatment: Drugs: Cyclophosphamide
Intravenous repeating dose

Treatment: Drugs: Fludarabine Phosphate
Intravenous repeating dose
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Progression-free Survival (PFS)
Timepoint [1] 0 0
Median observation time at time of analysis was approximately 21 months
Primary outcome [2] 0 0
Final Analysis: Time to Progression-free Survival Event
Timepoint [2] 0 0
Median observation time was approximately 66.4 months
Secondary outcome [1] 0 0
Event-free Survival (EFS)
Timepoint [1] 0 0
Median observation time at time of analysis was approximately 21 months
Secondary outcome [2] 0 0
Overall Survival (OS)
Timepoint [2] 0 0
Median observation time at time of analysis was approximately 21 months
Secondary outcome [3] 0 0
Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).
Timepoint [3] 0 0
Median observation time at time of analysis was approximately 21 months
Secondary outcome [4] 0 0
Final Analysis: Time to Overall Survival Event
Timepoint [4] 0 0
Median observation time was approximately 66.4 months
Secondary outcome [5] 0 0
Final Analysis: Time to Event-free Survival Event
Timepoint [5] 0 0
Median observation time was approximately 66.4 months
Secondary outcome [6] 0 0
Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)
Timepoint [6] 0 0
Median observation time was approximately 66.4 months
Secondary outcome [7] 0 0
Final Analysis: Duration of Response
Timepoint [7] 0 0
Median observation time was approximately 66.4 months
Secondary outcome [8] 0 0
Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response
Timepoint [8] 0 0
Median observation time was approximately 66.4 months
Secondary outcome [9] 0 0
Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)
Timepoint [9] 0 0
Median observation time was approximately 66.4 months

Eligibility
Key inclusion 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/07/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/10/2011
Sample size
Target
Accrual to date
Final
817
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Gosford Hospital - Gosford
Recruitment hospital [2] 0 0
Westmead Institute for Cancer Research at Westmead Hospital - Westmead - Wentworthville
Recruitment hospital [3] 0 0
Royal Brisbane and Women's Hospital - Brisbane
Recruitment hospital [4] 0 0
Princess Alexandra Hospital - Brisbane
Recruitment hospital [5] 0 0
Peter MacCallum Cancer Centre - East Melbourne
Recruitment hospital [6] 0 0
Frankston Hospital - Frankston
Recruitment postcode(s) [1] 0 0
2250 - Gosford
Recruitment postcode(s) [2] 0 0
2145 - Westmead - Wentworthville
Recruitment postcode(s) [3] 0 0
4029 - Brisbane
Recruitment postcode(s) [4] 0 0
4102 - Brisbane
Recruitment postcode(s) [5] 0 0
3002 - East Melbourne
Recruitment postcode(s) [6] 0 0
3199 - Frankston
Recruitment outside Australia
Country [1] 0 0
Austria
State/province [1] 0 0
Vienna
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Austria
State/province [2] 0 0
Wien
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Belgium
State/province [3] 0 0
Brugge
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Belgium
State/province [4] 0 0
Brussels
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Belgium
State/province [5] 0 0
Edegem
Country [6] 0 0
Belgium
State/province [6] 0 0
Leuven
Country [7] 0 0
Belgium
State/province [7] 0 0
Mont-Godinne Yvoir
Country [8] 0 0
Czech Republic
State/province [8] 0 0
Brno
Country [9] 0 0
Czech Republic
State/province [9] 0 0
Hradec Kralove
Country [10] 0 0
Czech Republic
State/province [10] 0 0
Olomouc
Country [11] 0 0
Czech Republic
State/province [11] 0 0
Pilsen-Lochotin
Country [12] 0 0
Czech Republic
State/province [12] 0 0
Prague
Country [13] 0 0
Denmark
State/province [13] 0 0
Copenhagen
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Denmark
State/province [14] 0 0
Vejle
Country [15] 0 0
France
State/province [15] 0 0
Colmar
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France
State/province [16] 0 0
Le Chesnay
Country [17] 0 0
France
State/province [17] 0 0
Lyon
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France
State/province [18] 0 0
Marseille
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France
State/province [19] 0 0
Rennes
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France
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Saint Priest en Jarez
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Germany
State/province [21] 0 0
Ahaus
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Germany
State/province [22] 0 0
Ansbach
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Germany
State/province [23] 0 0
Augsburg
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Germany
State/province [24] 0 0
Bad Saarow
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Germany
State/province [25] 0 0
Bayreuth
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Germany
State/province [26] 0 0
Berlin
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Germany
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Bielefeld
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Germany
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Bietigheim
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Germany
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Bochum
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Germany
State/province [30] 0 0
Bottrop
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Germany
State/province [31] 0 0
Bremen
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Germany
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Burglengenfeld
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Germany
State/province [33] 0 0
Coesfeld
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Germany
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Cologne
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Cottbus
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Germany
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Dresden
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Germany
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Duesseldorf
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Germany
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Dusseldorf
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Germany
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Eisenach
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Germany
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Erfurt
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Germany
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Erlangen
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Germany
State/province [42] 0 0
Eschweiler
Country [43] 0 0
Germany
State/province [43] 0 0
Essen
Country [44] 0 0
Germany
State/province [44] 0 0
Esslingen
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Germany
State/province [45] 0 0
Forchheim
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Germany
State/province [46] 0 0
Frankfurt (Oder)
Country [47] 0 0
Germany
State/province [47] 0 0
Frankfurt
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Germany
State/province [48] 0 0
Freiburg
Country [49] 0 0
Germany
State/province [49] 0 0
Garmisch-Partenkirchen
Country [50] 0 0
Germany
State/province [50] 0 0
Gerlingen
Country [51] 0 0
Germany
State/province [51] 0 0
Giessen
Country [52] 0 0
Germany
State/province [52] 0 0
Goettingen
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Germany
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Greifswald
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Germany
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Hagen
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Germany
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Halle
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Germany
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Hamburg
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Germany
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Hamm
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Germany
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Hannover
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Germany
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Heidelberg
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Germany
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Herne
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Germany
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Herrsching
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Germany
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Homburg
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Germany
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Idar-Oberstein
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Germany
State/province [64] 0 0
Jena
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Germany
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Karlsruhe
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Germany
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Kassel
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Germany
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Kempten
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Germany
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Kiel
Country [69] 0 0
Germany
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Koblenz
Country [70] 0 0
Germany
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Koblez
Country [71] 0 0
Germany
State/province [71] 0 0
Kronach
Country [72] 0 0
Germany
State/province [72] 0 0
Landshut
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Germany
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Leer
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Leipzig
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Germany
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Lemgo
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Germany
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Loerrach
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Germany
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Ludwigshafen
Country [78] 0 0
Germany
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Luebeck
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Germany
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Magdeburg
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Germany
State/province [80] 0 0
Mainz
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Germany
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Mannheim
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Germany
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Moenchengladbach
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Germany
State/province [83] 0 0
Muenchen
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Germany
State/province [84] 0 0
Muenster
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Germany
State/province [85] 0 0
Munich
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Germany
State/province [86] 0 0
Neunkirchen
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Germany
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Norderstedt
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Germany
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Nuernberg
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Germany
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Oberhausen
Country [90] 0 0
Germany
State/province [90] 0 0
Offenbach
Country [91] 0 0
Germany
State/province [91] 0 0
Oldenburg
Country [92] 0 0
Germany
State/province [92] 0 0
Pasewalk
Country [93] 0 0
Germany
State/province [93] 0 0
Pforzheim
Country [94] 0 0
Germany
State/province [94] 0 0
Potsdam
Country [95] 0 0
Germany
State/province [95] 0 0
Recklinghausen
Country [96] 0 0
Germany
State/province [96] 0 0
Regensburg
Country [97] 0 0
Germany
State/province [97] 0 0
Rostock
Country [98] 0 0
Germany
State/province [98] 0 0
Saarbrucken
Country [99] 0 0
Germany
State/province [99] 0 0
Sanderbusch
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Germany
State/province [100] 0 0
Siegen
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Germany
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Stuttgart
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Germany
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Torgau
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Germany
State/province [103] 0 0
Trier
Country [104] 0 0
Germany
State/province [104] 0 0
Troisdorf
Country [105] 0 0
Germany
State/province [105] 0 0
Tuebingen
Country [106] 0 0
Germany
State/province [106] 0 0
Ulm
Country [107] 0 0
Germany
State/province [107] 0 0
Villingen-Schwenningen
Country [108] 0 0
Germany
State/province [108] 0 0
Wanzleben
Country [109] 0 0
Germany
State/province [109] 0 0
Weiden
Country [110] 0 0
Germany
State/province [110] 0 0
Wesel
Country [111] 0 0
Germany
State/province [111] 0 0
Wiesbaden
Country [112] 0 0
Germany
State/province [112] 0 0
Wuerzburg
Country [113] 0 0
Germany
State/province [113] 0 0
Wuppertal 2
Country [114] 0 0
Germany
State/province [114] 0 0
Wurzburg
Country [115] 0 0
Israel
State/province [115] 0 0
Beer-Sheva
Country [116] 0 0
Israel
State/province [116] 0 0
Haifa
Country [117] 0 0
Israel
State/province [117] 0 0
Jerusalem
Country [118] 0 0
Israel
State/province [118] 0 0
Kfar Saba
Country [119] 0 0
Israel
State/province [119] 0 0
Rehovot
Country [120] 0 0
Italy
State/province [120] 0 0
Cagliari
Country [121] 0 0
Italy
State/province [121] 0 0
Milano
Country [122] 0 0
Italy
State/province [122] 0 0
Perugia
Country [123] 0 0
Italy
State/province [123] 0 0
Rome
Country [124] 0 0
New Zealand
State/province [124] 0 0
Auckland
Country [125] 0 0
New Zealand
State/province [125] 0 0
Christchurch
Country [126] 0 0
New Zealand
State/province [126] 0 0
Palmerston North
Country [127] 0 0
Spain
State/province [127] 0 0
Murcia
Country [128] 0 0
Spain
State/province [128] 0 0
Toledo

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
German CLL Study Group
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
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.
Trial website
https://clinicaltrials.gov/study/NCT00281918
Trial related presentations / publications
Bloehdorn J, Krzykalla J, Holzmann K, Gerhardinger A, Jebaraj BMC, Bahlo J, Humphrey K, Tausch E, Robrecht S, Mertens D, Schneider C, Fischer K, Hallek M, Dohner H, Benner A, Stilgenbauer S. Integrative prognostic models predict long-term survival after immunochemotherapy in chronic lymphocytic leukemia patients. Haematologica. 2022 Mar 1;107(3):615-624. doi: 10.3324/haematol.2020.251561.
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.
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.
Dimier N, Delmar P, Ward C, Morariu-Zamfir R, Fingerle-Rowson G, Bahlo J, Fischer K, Eichhorst B, Goede V, van Dongen JJM, Ritgen M, Bottcher S, Langerak AW, Kneba M, Hallek M. A model for predicting effect of treatment on progression-free survival using MRD as a surrogate end point in CLL. Blood. 2018 Mar 1;131(9):955-962. doi: 10.1182/blood-2017-06-792333. Epub 2017 Dec 18.
Fischer K, Bahlo J, Fink AM, Goede V, Herling CD, Cramer P, Langerbeins P, von Tresckow J, Engelke A, Maurer C, Kovacs G, Herling M, Tausch E, Kreuzer KA, Eichhorst B, Bottcher S, Seymour JF, Ghia P, Marlton P, Kneba M, Wendtner CM, Dohner H, Stilgenbauer S, Hallek M. Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial. Blood. 2016 Jan 14;127(2):208-15. doi: 10.1182/blood-2015-06-651125. Epub 2015 Oct 20.
Weisser M, Yeh RF, Duchateau-Nguyen G, Palermo G, Nguyen TQ, Shi X, Stinson SY, Yu N, Dufour A, Robak T, Salogub GN, Dmoszynska A, Solal-Celigny P, Warzocha K, Loscertales J, Catalano J, Larratt L, Rossiev VA, Bence-Bruckler I, Geisler CH, Montillo M, Fischer K, Fink AM, Hallek M, Bloehdorn J, Busch R, Benner A, Dohner H, Valente N, Wenger MK, Stilgenbauer S, Dornan D. PTK2 expression and immunochemotherapy outcome in chronic lymphocytic leukemia. Blood. 2014 Jul 17;124(3):420-5. doi: 10.1182/blood-2013-12-538975. Epub 2014 Jun 10.
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.
Stilgenbauer S, Schnaiter A, Paschka P, Zenz T, Rossi M, Dohner K, Buhler A, Bottcher S, Ritgen M, Kneba M, Winkler D, Tausch E, Hoth P, Edelmann J, Mertens D, Bullinger L, Bergmann M, Kless S, Mack S, Jager U, Patten N, Wu L, Wenger MK, Fingerle-Rowson G, Lichter P, Cazzola M, Wendtner CM, Fink AM, Fischer K, Busch R, Hallek M, Dohner H. Gene mutations and treatment outcome in chronic lymphocytic leukemia: results from the CLL8 trial. Blood. 2014 May 22;123(21):3247-54. doi: 10.1182/blood-2014-01-546150. Epub 2014 Mar 20.
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.
Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, Hensel M, Hopfinger G, Hess G, von Grunhagen U, Bergmann M, Catalano J, Zinzani PL, Caligaris-Cappio F, Seymour JF, Berrebi A, Jager U, Cazin B, Trneny M, Westermann A, Wendtner CM, Eichhorst BF, Staib P, Buhler A, Winkler D, Zenz T, Bottcher S, Ritgen M, Mendila M, Kneba M, Dohner H, Stilgenbauer S; International Group of Investigators; German Chronic Lymphocytic Leukaemia Study Group. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010 Oct 2;376(9747):1164-74. doi: 10.1016/S0140-6736(10)61381-5.
Public notes

Contacts
Principal investigator
Name 0 0
Michael Hallek, MD
Address 0 0
Medizinische Universitaetsklinik I at the University of Cologne
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00281918