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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/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
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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
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Secondary ID [1]
0
0
GCLLSG-CLL-8
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Secondary ID [2]
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0
CDR0000454560
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Universal Trial Number (UTN)
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Trial acronym
CLL-8
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Leukemia
0
0
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Condition category
Condition code
Cancer
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0
0
0
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Leukaemia - Acute leukaemia
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Cancer
0
0
0
0
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Leukaemia - Chronic leukaemia
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Cancer
0
0
0
0
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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 - 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
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Intervention code [1]
0
0
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)
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Assessment method [1]
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Progression-free survival (PFS) was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.
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Timepoint [1]
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Median observation time at time of analysis was approximately 21 months
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Primary outcome [2]
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Final Analysis: Time to Progression-free Survival Event
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Assessment method [2]
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Progression-free survival was defined as the time between randomization and the date of first documented disease progression, relapse or death by any cause, whichever came first.
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Timepoint [2]
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Median observation time was approximately 66.4 months
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Secondary outcome [1]
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Event-free Survival (EFS)
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Assessment method [1]
0
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Event-free survival (EFS) was defined as the time between randomization and the date of disease progression, relapse, start of new CLL treatment or death by any cause.
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Timepoint [1]
0
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Median observation time at time of analysis was approximately 21 months
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Secondary outcome [2]
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Overall Survival (OS)
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Assessment method [2]
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Overall survival (OS) was defined as the time between randomization and the date of death due to any cause. Median OS was not reached.
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Timepoint [2]
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Median observation time at time of analysis was approximately 21 months
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Secondary outcome [3]
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Disease-free Survival (DFS) of Patients With Confirmed Complete Response (CR).
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Assessment method [3]
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CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death. Median DFS was not reached.
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Timepoint [3]
0
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Median observation time at time of analysis was approximately 21 months
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Secondary outcome [4]
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Final Analysis: Time to Overall Survival Event
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Assessment method [4]
0
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Overall survival (OS) was defined as the time between randomization and the date of death due to any cause.
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Timepoint [4]
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Median observation time was approximately 66.4 months
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Secondary outcome [5]
0
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Final Analysis: Time to Event-free Survival Event
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Assessment method [5]
0
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Event-free survival was defined as the time between randomization and the date of disease progression, relapse, start of new Chronic Lymphocytic Leukemia treatment or death by any cause.
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Timepoint [5]
0
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Median observation time was approximately 66.4 months
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Secondary outcome [6]
0
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Final Analysis: Time to Disease-free Survival (DFS) Event in Participants With Complete Response (CR)
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Assessment method [6]
0
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CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. DFS was calculated from time of CR to relapse or death
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Timepoint [6]
0
0
Median observation time was approximately 66.4 months
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Secondary outcome [7]
0
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Final Analysis: Duration of Response
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Assessment method [7]
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Duration of response was defined as the time from the first documented Complete Response, Partial Response to disease progression or death by any cause.
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Timepoint [7]
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Median observation time was approximately 66.4 months
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Secondary outcome [8]
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Final Analysis: Percentage of Participants With Complete Response (CR) and Partial Response
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Assessment method [8]
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CR is defined by at least 8 weeks of: 1)Absence of lymphadenopathy 2)No hepatomegaly or splenomegaly 3)Absence of B-symptoms 4)Normal blood count 5)Bone marrow aspirate and biopsy 8 weeks after the clinical and laboratory results demonstrated that a CR was achieved. A marrow sample had to be normocellular for age with less than 30% lymphocytes. Lymphoid nodules had to be absent. If marrow was hypocellular,a repeat biopsy was taken 4 weeks later and samples were re-reviewed in conjunction with the prior pathology. Partial response is defined as a decrease in the size of a tumor, or in the extent of cancer in the body, in response to treatment.
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Timepoint [8]
0
0
Median observation time was approximately 66.4 months
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Secondary outcome [9]
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Final Analysis: Time to New Treatment for Chronic Lymphocytic Leukemia(CLL)
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Assessment method [9]
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The time from randomization to the start of a new treatment.
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Timepoint [9]
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Median observation time was approximately 66.4 months
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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
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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
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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
1/07/2003
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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
1/10/2011
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Sample size
Target
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Accrual to date
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Final
817
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Recruitment in Australia
Recruitment state(s)
NSW,QLD,VIC
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Recruitment hospital [1]
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Gosford Hospital - Gosford
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Recruitment hospital [2]
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Westmead Institute for Cancer Research at Westmead Hospital - Westmead - Wentworthville
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Recruitment hospital [3]
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Royal Brisbane and Women's Hospital - Brisbane
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Recruitment hospital [4]
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Princess Alexandra Hospital - Brisbane
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Recruitment hospital [5]
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Peter MacCallum Cancer Centre - East Melbourne
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Recruitment hospital [6]
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Frankston Hospital - Frankston
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Recruitment postcode(s) [1]
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2250 - Gosford
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Recruitment postcode(s) [2]
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2145 - Westmead - Wentworthville
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Recruitment postcode(s) [3]
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4029 - Brisbane
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Recruitment postcode(s) [4]
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4102 - Brisbane
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Recruitment postcode(s) [5]
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3002 - East Melbourne
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Recruitment postcode(s) [6]
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3199 - Frankston
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Recruitment outside Australia
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Austria
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Vienna
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Austria
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Wien
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Belgium
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Brugge
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Belgium
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Brussels
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Belgium
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Edegem
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Belgium
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Leuven
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Belgium
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Mont-Godinne Yvoir
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Brno
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Hradec Kralove
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Olomouc
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Pilsen-Lochotin
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Prague
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Copenhagen
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Vejle
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Colmar
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France
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Rennes
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Oldenburg
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Pasewalk
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Recklinghausen
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Regensburg
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Stuttgart
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Country [102]
0
0
Germany
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State/province [102]
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0
Torgau
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Country [103]
0
0
Germany
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State/province [103]
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0
Trier
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Country [104]
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0
Germany
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State/province [104]
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0
Troisdorf
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Country [105]
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0
Germany
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State/province [105]
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0
Tuebingen
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Country [106]
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0
Germany
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State/province [106]
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0
Ulm
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Country [107]
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0
Germany
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State/province [107]
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0
Villingen-Schwenningen
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Country [108]
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Germany
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State/province [108]
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Wanzleben
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Country [109]
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0
Germany
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State/province [109]
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0
Weiden
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Country [110]
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0
Germany
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State/province [110]
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0
Wesel
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Country [111]
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0
Germany
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State/province [111]
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0
Wiesbaden
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Country [112]
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0
Germany
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State/province [112]
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0
Wuerzburg
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Country [113]
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0
Germany
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State/province [113]
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0
Wuppertal 2
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Country [114]
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0
Germany
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State/province [114]
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0
Wurzburg
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Country [115]
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0
Israel
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State/province [115]
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0
Beer-Sheva
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Country [116]
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Israel
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State/province [116]
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Haifa
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Country [117]
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Israel
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State/province [117]
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Jerusalem
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Country [118]
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0
Israel
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State/province [118]
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0
Kfar Saba
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Country [119]
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0
Israel
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State/province [119]
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0
Rehovot
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Country [120]
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0
Italy
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State/province [120]
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0
Cagliari
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Country [121]
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0
Italy
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State/province [121]
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0
Milano
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Country [122]
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0
Italy
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State/province [122]
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0
Perugia
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Country [123]
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0
Italy
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State/province [123]
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0
Rome
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Country [124]
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0
New Zealand
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State/province [124]
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0
Auckland
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Country [125]
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0
New Zealand
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State/province [125]
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0
Christchurch
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Country [126]
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0
New Zealand
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State/province [126]
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0
Palmerston North
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Country [127]
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0
Spain
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State/province [127]
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0
Murcia
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Country [128]
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0
Spain
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State/province [128]
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0
Toledo
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Hoffmann-La Roche
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Address
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Country
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Other collaborator category [1]
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0
Other
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Name [1]
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German CLL Study Group
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Address [1]
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0
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Country [1]
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0
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00281918
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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0
Michael Hallek, MD
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Address
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Medizinische Universitaetsklinik I at the University of Cologne
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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0
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00281918
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