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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
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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]
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GCLLSG-CLL-8
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Secondary ID [2]
0
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
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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
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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]
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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]
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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]
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0
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]
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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]
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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]
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Median observation time was approximately 66.4 months
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Secondary outcome [6]
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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]
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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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Prague
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Copenhagen
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Colmar
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France
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Rennes
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Ahaus
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Oldenburg
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Pasewalk
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Recklinghausen
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Siegen
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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
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Germany
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Tuebingen
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Ulm
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Germany
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Villingen-Schwenningen
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Germany
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Wanzleben
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Germany
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Germany
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Germany
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Germany
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Wuppertal 2
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Beer-Sheva
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Israel
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Kfar Saba
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Israel
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Italy
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Italy
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Milano
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Italy
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Perugia
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Italy
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Rome
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Auckland
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Christchurch
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Palmerston North
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Spain
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Murcia
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Spain
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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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Other
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German CLL Study Group
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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/study/NCT00281918
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Trial related presentations / publications
Bloehdorn J, Krzykalla J, Holzmann K, Gerhardinger A, Jebaraj BMC, Bahlo J, Humphrey K, Tausch E, Robrecht S, Mertens D, Schneider C, Fischer K, Hallek M, Dohner H, Benner A, Stilgenbauer S. Integrative prognostic models predict long-term survival after immunochemotherapy in chronic lymphocytic leukemia patients. Haematologica. 2022 Mar 1;107(3):615-624. doi: 10.3324/haematol.2020.251561. Jaramillo S, Agathangelidis A, Schneider C, Bahlo J, Robrecht S, Tausch E, Bloehdorn J, Hoechstetter M, Fischer K, Eichhorst B, Goede V, Hallek M, Dohner H, Rosenquist R, Ghia P, Stamatopoulos K, Stilgenbauer S. Prognostic impact of prevalent chronic lymphocytic leukemia stereotyped subsets: analysis within prospective clinical trials of the German CLL Study Group (GCLLSG). Haematologica. 2020 Nov 1;105(11):2598-2607. doi: 10.3324/haematol.2019.231027. Kreuzberger N, Damen JA, Trivella M, Estcourt LJ, Aldin A, Umlauff L, Vazquez-Montes MD, Wolff R, Moons KG, Monsef I, Foroutan F, Kreuzer KA, Skoetz N. Prognostic models for newly-diagnosed chronic lymphocytic leukaemia in adults: a systematic review and meta-analysis. Cochrane Database Syst Rev. 2020 Jul 31;7(7):CD012022. doi: 10.1002/14651858.CD012022.pub2. Dimier N, Delmar P, Ward C, Morariu-Zamfir R, Fingerle-Rowson G, Bahlo J, Fischer K, Eichhorst B, Goede V, van Dongen JJM, Ritgen M, Bottcher S, Langerak AW, Kneba M, Hallek M. A model for predicting effect of treatment on progression-free survival using MRD as a surrogate end point in CLL. Blood. 2018 Mar 1;131(9):955-962. doi: 10.1182/blood-2017-06-792333. Epub 2017 Dec 18. Fischer K, Bahlo J, Fink AM, Goede V, Herling CD, Cramer P, Langerbeins P, von Tresckow J, Engelke A, Maurer C, Kovacs G, Herling M, Tausch E, Kreuzer KA, Eichhorst B, Bottcher S, Seymour JF, Ghia P, Marlton P, Kneba M, Wendtner CM, Dohner H, Stilgenbauer S, Hallek M. Long-term remissions after FCR chemoimmunotherapy in previously untreated patients with CLL: updated results of the CLL8 trial. Blood. 2016 Jan 14;127(2):208-15. doi: 10.1182/blood-2015-06-651125. Epub 2015 Oct 20. 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. Pflug N, Bahlo J, Shanafelt TD, Eichhorst BF, Bergmann MA, Elter T, Bauer K, Malchau G, Rabe KG, Stilgenbauer S, Dohner H, Jager U, Eckart MJ, Hopfinger G, Busch R, Fink AM, Wendtner CM, Fischer K, Kay NE, Hallek M. Development of a comprehensive prognostic index for patients with chronic lymphocytic leukemia. Blood. 2014 Jul 3;124(1):49-62. doi: 10.1182/blood-2014-02-556399. Epub 2014 May 5. Stilgenbauer S, Schnaiter A, Paschka P, Zenz T, Rossi M, Dohner K, Buhler A, Bottcher S, Ritgen M, Kneba M, Winkler D, Tausch E, Hoth P, Edelmann J, Mertens D, Bullinger L, Bergmann M, Kless S, Mack S, Jager U, Patten N, Wu L, Wenger MK, Fingerle-Rowson G, Lichter P, Cazzola M, Wendtner CM, Fink AM, Fischer K, Busch R, Hallek M, Dohner H. Gene mutations and treatment outcome in chronic lymphocytic leukemia: results from the CLL8 trial. Blood. 2014 May 22;123(21):3247-54. doi: 10.1182/blood-2014-01-546150. Epub 2014 Mar 20. Eichhorst BF, Fischer K, Fink AM, Elter T, Wendtner CM, Goede V, Bergmann M, Stilgenbauer S, Hopfinger G, Ritgen M, Bahlo J, Busch R, Hallek M; German CLL Study Group (GCLLSG). Limited clinical relevance of imaging techniques in the follow-up of patients with advanced chronic lymphocytic leukemia: results of a meta-analysis. Blood. 2011 Feb 10;117(6):1817-21. doi: 10.1182/blood-2010-04-282228. Epub 2010 Dec 7. Hallek M, Fischer K, Fingerle-Rowson G, Fink AM, Busch R, Mayer J, Hensel M, Hopfinger G, Hess G, von Grunhagen U, Bergmann M, Catalano J, Zinzani PL, Caligaris-Cappio F, Seymour JF, Berrebi A, Jager U, Cazin B, Trneny M, Westermann A, Wendtner CM, Eichhorst BF, Staib P, Buhler A, Winkler D, Zenz T, Bottcher S, Ritgen M, Mendila M, Kneba M, Dohner H, Stilgenbauer S; International Group of Investigators; German Chronic Lymphocytic Leukaemia Study Group. Addition of rituximab to fludarabine and cyclophosphamide in patients with chronic lymphocytic leukaemia: a randomised, open-label, phase 3 trial. Lancet. 2010 Oct 2;376(9747):1164-74. doi: 10.1016/S0140-6736(10)61381-5.
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Public notes
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Contacts
Principal investigator
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Michael Hallek, MD
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Medizinische Universitaetsklinik I at the University of Cologne
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No information has been provided regarding IPD availability
What supporting documents are/will be available?
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Results publications and other study-related documents
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Results are available at
https://clinicaltrials.gov/study/NCT00281918
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