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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
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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
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Secondary ID [1]
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BO17072
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Secondary ID [2]
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102-14
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Lymphocytic Leukemia
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Condition category
Condition code
Cancer
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Leukaemia - Acute leukaemia
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Cancer
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Leukaemia - Chronic leukaemia
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Cancer
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Children's - Leukaemia & Lymphoma
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Intervention/exposure
Study type
Interventional
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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
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Progression-free Survival (PFS) as Assessed by the Independent Review Committee (IRC)
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Assessment method [1]
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Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause, whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
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Timepoint [1]
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Mean observation time at time of analysis was approximately 26 months
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Primary outcome [2]
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Number of Participants With Progression-free Survival (PFS) Events Assessed by the Independent Review Committee (IRC)
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Assessment method [2]
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Progression-free survival as assessed by the IRC was defined as the time between randomization and the date of first documented disease progression, relapse after response, or death from any cause (PFS events), whichever came first. Patients without a PFS event were censored at their last tumor assessment date.
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Timepoint [2]
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Mean observation time at time of analysis was approximately 26 months
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Primary outcome [3]
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Final Analysis: Time to Progression-Free Survival Event
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Assessment method [3]
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Time to progression-free survival (PFS) event was defined as the time between randomization and the date of first documented PFS event: disease progression, relapse or death by any cause, whichever came first.
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Timepoint [3]
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Median observation time was approximately 5 years
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Secondary outcome [1]
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Overall Survival (OS)
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Assessment method [1]
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Overall survival was determined from the date of randomization to the date of death irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.
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Timepoint [1]
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Mean observation time at time of analysis was approximately 26 months
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Secondary outcome [2]
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Number of Participants With Overall Survival (OS) Events
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Assessment method [2]
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Overall survival was determined from the date of randomization to the date of death (OS event) irrespective of cause. Patients who had not died at the time of the final analysis (clinical data cut-off) were censored at the date of the last contact.
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Timepoint [2]
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Mean observation time at time of analysis was approximately 26 months
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Secondary outcome [3]
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Event-free Survival (EFS)
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Assessment method [3]
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Event free survival was measured from the day of randomization to the date of first documented PD, relapse after response, start of a new treatment or death from any cause. Patients without an EFS event were censored at their last tumor assessment date.
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Timepoint [3]
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Mean observation time at time of analysis was approximately 26 months
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Secondary outcome [4]
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Number of Participants With Event-free Survival (EFS) Events
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Assessment method [4]
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Event free survival was measured from the day of randomization to the date of first documented Progressive Disease (PD), relapse after response, start of a new treatment or death from any cause (EFS events). Patients without an EFS event were censored at their last tumor assessment date.
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Timepoint [4]
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Mean observation time at time of analysis was approximately 26 months
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Secondary outcome [5]
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Disease-free Survival (DFS)
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Assessment method [5]
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Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause. Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.
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Timepoint [5]
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Mean observation time at time of analysis was approximately 26 months
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Secondary outcome [6]
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Number of Participants With Disease-free Survival (DFS) Events
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Assessment method [6]
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Disease free survival was defined for all patients with a best overall response (BOR) of Complete Response (CR) and measured the time from first documented CR in a sequence of consecutive CRs until documented disease progression, relapse or death from any cause (DFS events). Patients without a DFS event at the time of the analysis (clinical data cut-off) were censored at their last tumor assessment date.
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Timepoint [6]
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Mean observation time at time of analysis was approximately 26 months
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Secondary outcome [7]
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Final Analysis: Time to Overall Survival Event
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Assessment method [7]
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Overall survival (OS) was determined from the date of randomization to the date of death (OS event) irrespective of cause.
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Timepoint [7]
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Median observation time was approximately 5 years
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Secondary outcome [8]
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Final Analysis: Time to Event-Free Survival Event
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Assessment method [8]
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Event free survival (EFS) was defined as the time from the day of randomization to the date of first EFS event: documented disease progression, relapse after response, start of a new treatment or death from any cause.
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Timepoint [8]
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Median observation time was approximately 5 years
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Secondary outcome [9]
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Final Analysis: Percentage of Participants With Complete Response
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Assessment method [9]
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Complete response was defined as the disappearance of all signs of cancer in response to treatment.
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Timepoint [9]
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Median observation time was approximately 5 years
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Secondary outcome [10]
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Final Analysis: Time to Disease-Free Survival Event
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Assessment method [10]
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Time to disease-free survival (DFS) event was defined as the time from first documented response until the first documented DFS event: disease progression, relapse or death from any cause.
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Timepoint [10]
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Median observation time was approximately 5 years
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Secondary outcome [11]
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Final Analysis: Duration of Response
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Assessment method [11]
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Duration of response was defined as the time between the date of the earliest qualifying response and the date of disease progression or death due to any cause.
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Timepoint [11]
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Median observation time was approximately 5 years
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Secondary outcome [12]
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Final Analysis: Time to New Chronic Lymphocytic Leukemia (CLL) Treatment
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Assessment method [12]
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Time to new CCL treatment was defined as the time from randomization to the first day of new treatment for CCL or death.
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Timepoint [12]
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Median observation time was approximately 5 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
31/07/2003
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
31/05/2012
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Sample size
Target
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Accrual to date
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Final
552
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Concord Repatriation General Hospital; Haematology - Sydney
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Recruitment hospital [2]
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Mater Hospital; Division of Cancer Services - Brisbane
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Recruitment hospital [3]
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Frankston Hospital; Oncology/Haematology - Frankston
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Recruitment hospital [4]
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Peter Maccallum Cancer Institute; Medical Oncology - Melbourne
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Recruitment postcode(s) [1]
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2139 - Sydney
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Recruitment postcode(s) [2]
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4101 - Brisbane
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Recruitment postcode(s) [3]
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3199 - Frankston
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Recruitment postcode(s) [4]
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3000 - Melbourne
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Recruitment outside Australia
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Alabama
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Leuven
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Ontario
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Bobigny
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Caen
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Creteil
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Nantes
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France
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France
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Pierre Benite
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Szeged
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Campania
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Italy
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Timisoara
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St Petersburg
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Madrid
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London
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Sutton
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Wakefield
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Funding & Sponsors
Primary sponsor type
Commercial sector/industry
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Name
Hoffmann-La Roche
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Other collaborator category [1]
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Commercial sector/industry
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Biogen
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Genentech, Inc.
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT00090051
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Trial related presentations / publications
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. Dufour A, Palermo G, Zellmeier E, Mellert G, Duchateau-Nguyen G, Schneider S, Benthaus T, Kakadia PM, Spiekermann K, Hiddemann W, Braess J, Truong S, Patten N, Wu L, Lohmann S, Dornan D, GuhaThakurta D, Yeh RF, Salogub G, Solal-Celigny P, Dmoszynska A, Robak T, Montillo M, Catalano J, Geisler CH, Weisser M, Bohlander SK. Inactivation of TP53 correlates with disease progression and low miR-34a expression in previously treated chronic lymphocytic leukemia patients. Blood. 2013 May 2;121(18):3650-7. doi: 10.1182/blood-2012-10-458695. Epub 2013 Mar 22.
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Public notes
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Contacts
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https://clinicaltrials.gov/study/NCT00090051
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