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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00090051




Registration number
NCT00090051
Ethics application status
Date submitted
23/08/2004
Date registered
25/08/2004
Date last updated
1/08/2017

Titles & IDs
Public title
FCR Versus FC Alone in the Treatment of Chronic Lymphocytic Leukemia (CLL) in Relapsed Patients
Scientific title
Open-label, Multicenter, Randomized, Comparative, Phase III Study to Evaluate the Efficacy and Safety of FCR vs. FC Alone in Previously Treated Patients With CD20 Positive B-cell CLL
Secondary ID [1] 0 0
BO17072
Secondary ID [2] 0 0
102-14
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic 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 - Fludarabine Phosphate
Treatment: Drugs - Cyclophosphamide

Active comparator: Fludarabine+Cyclophosphamide (FC) -

Experimental: Fludarabine+Cyclophosphamide+Rituximab (FCR) -


Treatment: Drugs: Rituximab
Intravenous repeating dose

Treatment: Drugs: Fludarabine Phosphate
Intravenous repeating dose

Treatment: Drugs: Cyclophosphamide
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) as Assessed by the Independent Review Committee (IRC)
Timepoint [1] 0 0
Mean observation time at time of analysis was approximately 26 months
Primary outcome [2] 0 0
Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)
Timepoint [2] 0 0
Mean observation time at time of analysis was approximately 26 months
Primary outcome [3] 0 0
Final Analysis: Time to Progression-Free Survival Event
Timepoint [3] 0 0
Median observation time was approximately 5 years
Secondary outcome [1] 0 0
Overall Survival (OS)
Timepoint [1] 0 0
Mean observation time at time of analysis was approximately 26 months
Secondary outcome [2] 0 0
Number of Participants With Overall Survival (OS) Events
Timepoint [2] 0 0
Mean observation time at time of analysis was approximately 26 months
Secondary outcome [3] 0 0
Event-free Survival (EFS)
Timepoint [3] 0 0
Mean observation time at time of analysis was approximately 26 months
Secondary outcome [4] 0 0
Number of Participants With Event-free Survival (EFS) Events
Timepoint [4] 0 0
Mean observation time at time of analysis was approximately 26 months
Secondary outcome [5] 0 0
Disease-free Survival (DFS)
Timepoint [5] 0 0
Mean observation time at time of analysis was approximately 26 months
Secondary outcome [6] 0 0
Number of Participants With Disease-free Survival (DFS) Events
Timepoint [6] 0 0
Mean observation time at time of analysis was approximately 26 months
Secondary outcome [7] 0 0
Final Analysis: Time to Overall Survival Event
Timepoint [7] 0 0
Median observation time was approximately 5 years
Secondary outcome [8] 0 0
Final Analysis: Time to Event-Free Survival Event
Timepoint [8] 0 0
Median observation time was approximately 5 years
Secondary outcome [9] 0 0
Final Analysis: Percentage of Participants With Complete Response
Timepoint [9] 0 0
Median observation time was approximately 5 years
Secondary outcome [10] 0 0
Final Analysis: Time to Disease-Free Survival Event
Timepoint [10] 0 0
Median observation time was approximately 5 years
Secondary outcome [11] 0 0
Final Analysis: Duration of Response
Timepoint [11] 0 0
Median observation time was approximately 5 years
Secondary outcome [12] 0 0
Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment
Timepoint [12] 0 0
Median observation time was approximately 5 years

Eligibility
Key inclusion criteria
* Age =18 years
* Established diagnosis of B-cell CLL by NCI Working Group criteria
* =1 previous line of chemotherapy
* Expected survival >6 months
* Acceptable hematologic status, liver function, renal function, and pulmonary function
* Negative serum pregnancy test for both pre-menopausal women and for women who are < 2 years after the onset of menopause
* Written informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Prior treatment with interferon, rituximab or other monoclonal antibody
* Prior allogeneic bone marrow transplant (BMT) or autologous BMT or peripheral stem cell transplant (PBSCT) or patients who are considered to be candidates for allogeneic or autologous BMT or PSCT as assessed by their treating physician
* Fertile men or women of childbearing potential not using adequate contraception
* Severe Grade 3 or 4 non-hematological toxicity or prolonged (> 2 weeks) Grade 3 or 4 cytopenia on prior fludarabine or nucleoside analogue regimen
* History of fludarabine-induced or clinically significant autoimmune cytopenia
* History of other malignancies within 2 years prior to study entry, except for adequately treated carcinoma in situ of the cervix; basal or squamous cell skin cancer; low-grade early stage localized prostate cancer treated surgically with curative intent; good prognosis ductal carcinoma in situ (DCIS) of the breast treated with lumpectomy alone with curative intent.
* Medical conditions requiring long term use (> 1 month) of systemic corticosteroids
* Active bacterial, viral, or fungal infection requiring systemic therapy
* Severe cardiac disease
* Seizure disorders requiring anticonvulsant therapy
* Severe chronic obstructive pulmonary disease with hypoxemia
* Uncontrolled diabetes mellitus or hypertension
* Transformation to aggressive B-cell malignancy.
* Known infection with HIV, HCV, or hepatitis B
* Treatment with any other investigational agent, or participation in another clinical trial within 30 days prior to entering this study
* Known hypersensitivity or anaphylactic reactions to murine antibodies or proteins
* Any co-existing medical or psychological condition that would preclude participation in the study or compromise ability to give informed consent

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
31/07/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
31/05/2012
Sample size
Target
Accrual to date
Final
552
Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
Recruitment hospital [1] 0 0
Concord Repatriation General Hospital; Haematology - Sydney
Recruitment hospital [2] 0 0
Mater Hospital; Division of Cancer Services - Brisbane
Recruitment hospital [3] 0 0
Frankston Hospital; Oncology/Haematology - Frankston
Recruitment hospital [4] 0 0
Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
Recruitment postcode(s) [1] 0 0
2139 - Sydney
Recruitment postcode(s) [2] 0 0
4101 - Brisbane
Recruitment postcode(s) [3] 0 0
3199 - Frankston
Recruitment postcode(s) [4] 0 0
3000 - Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Alabama
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Pennsylvania
Country [6] 0 0
Belgium
State/province [6] 0 0
Antwerpen
Country [7] 0 0
Belgium
State/province [7] 0 0
Bruxelles
Country [8] 0 0
Belgium
State/province [8] 0 0
Leuven
Country [9] 0 0
Canada
State/province [9] 0 0
Alberta
Country [10] 0 0
Canada
State/province [10] 0 0
British Columbia
Country [11] 0 0
Canada
State/province [11] 0 0
Newfoundland and Labrador
Country [12] 0 0
Canada
State/province [12] 0 0
Nova Scotia
Country [13] 0 0
Canada
State/province [13] 0 0
Ontario
Country [14] 0 0
Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Denmark
State/province [15] 0 0
København Ø
Country [16] 0 0
Denmark
State/province [16] 0 0
Århus
Country [17] 0 0
France
State/province [17] 0 0
Bobigny
Country [18] 0 0
France
State/province [18] 0 0
Caen
Country [19] 0 0
France
State/province [19] 0 0
Clermont Ferrand
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France
State/province [20] 0 0
Creteil
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France
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Le Mans
Country [22] 0 0
France
State/province [22] 0 0
Lille
Country [23] 0 0
France
State/province [23] 0 0
Lyon
Country [24] 0 0
France
State/province [24] 0 0
Marseille
Country [25] 0 0
France
State/province [25] 0 0
Montpellier
Country [26] 0 0
France
State/province [26] 0 0
Nantes
Country [27] 0 0
France
State/province [27] 0 0
Paris
Country [28] 0 0
France
State/province [28] 0 0
Pierre Benite
Country [29] 0 0
France
State/province [29] 0 0
Poitiers
Country [30] 0 0
France
State/province [30] 0 0
Rouen
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France
State/province [31] 0 0
Tours
Country [32] 0 0
France
State/province [32] 0 0
Vandoeuvre Les Nancy
Country [33] 0 0
Hungary
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Budapest
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Hungary
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Debrecen
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Hungary
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Pecs
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Hungary
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Szeged
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Italy
State/province [37] 0 0
Campania
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Italy
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Emilia-Romagna
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Italy
State/province [39] 0 0
Lazio
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Italy
State/province [40] 0 0
Lombardia
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Italy
State/province [41] 0 0
Puglia
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Italy
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Veneto
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Netherlands
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Amersfoort
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Netherlands
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Amsterdam
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Netherlands
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Den Haag
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Netherlands
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Rotterdam
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New Zealand
State/province [47] 0 0
Auckland
Country [48] 0 0
New Zealand
State/province [48] 0 0
Christchurch
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New Zealand
State/province [49] 0 0
Wellington
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Norway
State/province [50] 0 0
Bergen
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Norway
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Oslo
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Poland
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Lodz
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Poland
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Lublin
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Poland
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Poznan
Country [55] 0 0
Poland
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Warszawa
Country [56] 0 0
Romania
State/province [56] 0 0
Bucharest
Country [57] 0 0
Romania
State/province [57] 0 0
Bucuresti
Country [58] 0 0
Romania
State/province [58] 0 0
Targu-mures
Country [59] 0 0
Romania
State/province [59] 0 0
Timisoara
Country [60] 0 0
Russian Federation
State/province [60] 0 0
Moscow
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Russian Federation
State/province [61] 0 0
Obninsk
Country [62] 0 0
Russian Federation
State/province [62] 0 0
Samara
Country [63] 0 0
Russian Federation
State/province [63] 0 0
St Petersburg
Country [64] 0 0
Spain
State/province [64] 0 0
Madrid
Country [65] 0 0
Spain
State/province [65] 0 0
Salamanca
Country [66] 0 0
Spain
State/province [66] 0 0
Valencia
Country [67] 0 0
Spain
State/province [67] 0 0
Zaragoza
Country [68] 0 0
Sweden
State/province [68] 0 0
Huddinge
Country [69] 0 0
Sweden
State/province [69] 0 0
Linkoeping
Country [70] 0 0
United Kingdom
State/province [70] 0 0
Bournemouth
Country [71] 0 0
United Kingdom
State/province [71] 0 0
Cambridge
Country [72] 0 0
United Kingdom
State/province [72] 0 0
Glasgow
Country [73] 0 0
United Kingdom
State/province [73] 0 0
Leeds
Country [74] 0 0
United Kingdom
State/province [74] 0 0
Leicester
Country [75] 0 0
United Kingdom
State/province [75] 0 0
Liverpool
Country [76] 0 0
United Kingdom
State/province [76] 0 0
London
Country [77] 0 0
United Kingdom
State/province [77] 0 0
Sutton
Country [78] 0 0
United Kingdom
State/province [78] 0 0
Wakefield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Hoffmann-La Roche
Address
Country
Other collaborator category [1] 0 0
Commercial sector/industry
Name [1] 0 0
Biogen
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Commercial sector/industry
Name [2] 0 0
Genentech, Inc.
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
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/NCT00090051