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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
Country [2] 0 0
Austria
State/province [2] 0 0
Wien
Country [3] 0 0
Belgium
State/province [3] 0 0
Brugge
Country [4] 0 0
Belgium
State/province [4] 0 0
Brussels
Country [5] 0 0
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
Country [14] 0 0
Denmark
State/province [14] 0 0
Vejle
Country [15] 0 0
France
State/province [15] 0 0
Colmar
Country [16] 0 0
France
State/province [16] 0 0
Le Chesnay
Country [17] 0 0
France
State/province [17] 0 0
Lyon
Country [18] 0 0
France
State/province [18] 0 0
Marseille
Country [19] 0 0
France
State/province [19] 0 0
Rennes
Country [20] 0 0
France
State/province [20] 0 0
Saint Priest en Jarez
Country [21] 0 0
Germany
State/province [21] 0 0
Ahaus
Country [22] 0 0
Germany
State/province [22] 0 0
Ansbach
Country [23] 0 0
Germany
State/province [23] 0 0
Augsburg
Country [24] 0 0
Germany
State/province [24] 0 0
Bad Saarow
Country [25] 0 0
Germany
State/province [25] 0 0
Bayreuth
Country [26] 0 0
Germany
State/province [26] 0 0
Berlin
Country [27] 0 0
Germany
State/province [27] 0 0
Bielefeld
Country [28] 0 0
Germany
State/province [28] 0 0
Bietigheim
Country [29] 0 0
Germany
State/province [29] 0 0
Bochum
Country [30] 0 0
Germany
State/province [30] 0 0
Bottrop
Country [31] 0 0
Germany
State/province [31] 0 0
Bremen
Country [32] 0 0
Germany
State/province [32] 0 0
Burglengenfeld
Country [33] 0 0
Germany
State/province [33] 0 0
Coesfeld
Country [34] 0 0
Germany
State/province [34] 0 0
Cologne
Country [35] 0 0
Germany
State/province [35] 0 0
Cottbus
Country [36] 0 0
Germany
State/province [36] 0 0
Dresden
Country [37] 0 0
Germany
State/province [37] 0 0
Duesseldorf
Country [38] 0 0
Germany
State/province [38] 0 0
Dusseldorf
Country [39] 0 0
Germany
State/province [39] 0 0
Eisenach
Country [40] 0 0
Germany
State/province [40] 0 0
Erfurt
Country [41] 0 0
Germany
State/province [41] 0 0
Erlangen
Country [42] 0 0
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
Country [45] 0 0
Germany
State/province [45] 0 0
Forchheim
Country [46] 0 0
Germany
State/province [46] 0 0
Frankfurt (Oder)
Country [47] 0 0
Germany
State/province [47] 0 0
Frankfurt
Country [48] 0 0
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
Country [53] 0 0
Germany
State/province [53] 0 0
Greifswald
Country [54] 0 0
Germany
State/province [54] 0 0
Hagen
Country [55] 0 0
Germany
State/province [55] 0 0
Halle
Country [56] 0 0
Germany
State/province [56] 0 0
Hamburg
Country [57] 0 0
Germany
State/province [57] 0 0
Hamm
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Germany
State/province [58] 0 0
Hannover
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Germany
State/province [59] 0 0
Heidelberg
Country [60] 0 0
Germany
State/province [60] 0 0
Herne
Country [61] 0 0
Germany
State/province [61] 0 0
Herrsching
Country [62] 0 0
Germany
State/province [62] 0 0
Homburg
Country [63] 0 0
Germany
State/province [63] 0 0
Idar-Oberstein
Country [64] 0 0
Germany
State/province [64] 0 0
Jena
Country [65] 0 0
Germany
State/province [65] 0 0
Karlsruhe
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Germany
State/province [66] 0 0
Kassel
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Germany
State/province [67] 0 0
Kempten
Country [68] 0 0
Germany
State/province [68] 0 0
Kiel
Country [69] 0 0
Germany
State/province [69] 0 0
Koblenz
Country [70] 0 0
Germany
State/province [70] 0 0
Koblez
Country [71] 0 0
Germany
State/province [71] 0 0
Kronach
Country [72] 0 0
Germany
State/province [72] 0 0
Landshut
Country [73] 0 0
Germany
State/province [73] 0 0
Leer
Country [74] 0 0
Germany
State/province [74] 0 0
Leipzig
Country [75] 0 0
Germany
State/province [75] 0 0
Lemgo
Country [76] 0 0
Germany
State/province [76] 0 0
Loerrach
Country [77] 0 0
Germany
State/province [77] 0 0
Ludwigshafen
Country [78] 0 0
Germany
State/province [78] 0 0
Luebeck
Country [79] 0 0
Germany
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Magdeburg
Country [80] 0 0
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
Country [83] 0 0
Germany
State/province [83] 0 0
Muenchen
Country [84] 0 0
Germany
State/province [84] 0 0
Muenster
Country [85] 0 0
Germany
State/province [85] 0 0
Munich
Country [86] 0 0
Germany
State/province [86] 0 0
Neunkirchen
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Germany
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Norderstedt
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Germany
State/province [88] 0 0
Nuernberg
Country [89] 0 0
Germany
State/province [89] 0 0
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
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Rostock
Country [98] 0 0
Germany
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Saarbrucken
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Germany
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Sanderbusch
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Germany
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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
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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
Trial website
Trial related presentations / publications
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

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results are available at https://clinicaltrials.gov/study/NCT00281918