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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/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
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United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Illinois
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United States of America
State/province [4] 0 0
North Carolina
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United States of America
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Pennsylvania
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Belgium
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Antwerpen
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Belgium
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Bruxelles
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Belgium
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Leuven
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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
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Canada
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Nova Scotia
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Canada
State/province [13] 0 0
Ontario
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Canada
State/province [14] 0 0
Quebec
Country [15] 0 0
Denmark
State/province [15] 0 0
København Ø
Country [16] 0 0
Denmark
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Århus
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France
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Bobigny
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France
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Caen
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France
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Clermont Ferrand
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Creteil
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Le Mans
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France
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Lille
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Lyon
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France
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Marseille
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France
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Montpellier
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France
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Nantes
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France
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Paris
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France
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Pierre Benite
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France
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Poitiers
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France
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Rouen
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France
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Tours
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France
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Vandoeuvre Les Nancy
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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
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Campania
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Lombardia
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Italy
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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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Amsterdam
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Den Haag
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Netherlands
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Rotterdam
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New Zealand
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Auckland
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New Zealand
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Christchurch
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New Zealand
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Wellington
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Norway
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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
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Poland
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Warszawa
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Romania
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Bucharest
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Romania
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Bucuresti
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Romania
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Targu-mures
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Romania
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Timisoara
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Russian Federation
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Moscow
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Russian Federation
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Obninsk
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Russian Federation
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Samara
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Russian Federation
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St Petersburg
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Spain
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Madrid
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Spain
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Salamanca
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Spain
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Valencia
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Spain
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Zaragoza
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Sweden
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Huddinge
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Sweden
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Linkoeping
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United Kingdom
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Bournemouth
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United Kingdom
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Cambridge
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United Kingdom
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Glasgow
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Leeds
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United Kingdom
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Leicester
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United Kingdom
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Liverpool
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United Kingdom
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London
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United Kingdom
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Sutton
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United Kingdom
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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
The purpose of this study is to provide treatment for patients who have chronic lymphocytic
leukemia (CLL), and to compare the use of rituximab added to fludarabine+cyclophosphamide
(FC) with FC alone, to determine if rituximab lengthens the time a patient remains free of
leukemia symptoms.
Trial website
https://clinicaltrials.gov/ct2/show/NCT00090051
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