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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/NCT00004218
Registration number
NCT00004218
Ethics application status
Date submitted
28/01/2000
Date registered
27/01/2003
Date last updated
18/12/2013
Titles & IDs
Public title
Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
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Scientific title
Chronic Lymphocytic Leukemia Trial 4: A Randomized Comparison of Chlorambucil, Fludarabine and Fludarabine Plus Cyclophosphamide
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Secondary ID [1]
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LRF-CLL4
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Secondary ID [2]
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CDR0000067454
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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:
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 - chlorambucil
Treatment: Drugs - cyclophosphamide
Treatment: Drugs - doxorubicin hydrochloride
Treatment: Drugs - fludarabine phosphate
Treatment: Drugs - prednisolone
Treatment: Drugs - vincristine sulfate
Treatment: Drugs: chlorambucil
Treatment: Drugs: cyclophosphamide
Treatment: Drugs: doxorubicin hydrochloride
Treatment: Drugs: fludarabine phosphate
Treatment: Drugs: prednisolone
Treatment: Drugs: vincristine sulfate
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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
Eligibility
Key inclusion criteria
DISEASE CHARACTERISTICS:
- Diagnosis of B-cell chronic lymphocytic leukemia (CLL) requiring therapy and meeting
the following criteria:
- Previously untreated disease
- Peripheral blood morphology, excluding other leukemia and low-grade lymphoma in
leukemic phase
- Cell markers: CD5+, CD23+, SmIg (weak), CD79b-, FMC7-
- Persistent lymphocytosis (greater than 10,000/mm^3)
- At least 40% bone marrow infiltration
- Stage 0 or I progressive disease indicated by at least one of the following:
- Persistent rise in lymphocyte count with doubling time less than 12 months
- Downward trend in hemoglobin and/or platelet count
- At least 50% increase in size of liver and/or spleen and/or lymph nodes
- Appearance of lymphadenopathy, hepatomegaly, or splenomegaly
- Constitutional symptoms caused by disease
- Pyrexia
- Night sweats
- Weight loss OR
- Stage II or III
PATIENT CHARACTERISTICS:
Age:
- Not specified
Performance status:
- Not specified
Life expectancy:
- Not specified
Hematopoietic:
- See Disease Characteristics
Hepatic:
- Bilirubin no greater than 2 times upper limit of normal (ULN)*
- SGOT/SGPT no greater than 2 times ULN* NOTE: * Unless due to CLL
Renal:
- Creatinine clearance at least 30 mL/min
Other:
- No other cancer or life-threatening disease
- Not pregnant
- Fertile patients must use effective contraception during and for 6 months after study
therapy
PRIOR CONCURRENT THERAPY:
Biologic therapy
- Not specified
Chemotherapy
- Not specified
Endocrine therapy
- No concurrent corticosteroids (e.g., dexamethasone) as antiemetics
Radiotherapy
- Not specified
Surgery
- Not specified
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Minimum age
No limit
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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
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
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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
1/10/1999
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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
1/07/2007
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Sample size
Target
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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Argentina
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Buenos Aires
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Croatia
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Zagreb
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Greece
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Ioannina
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Greece
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Rio Patras
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Ireland
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Dublin
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Ireland
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Galway
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Italy
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Bergamo
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New Zealand
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Christchurch
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Russian Federation
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Moscow
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United Kingdom
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England
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United Kingdom
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Northern Ireland
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United Kingdom
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Scotland
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Country [13]
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United Kingdom
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State/province [13]
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Wales
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Funding & Sponsors
Primary sponsor type
Other
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Name
Leukemia Research Fund
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Address
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Other collaborator category [1]
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Other
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Name [1]
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Medical Research Council
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Address [1]
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Ethics approval
Ethics application status
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Summary
Brief summary
RATIONALE: Drugs used in chemotherapy use different ways to stop cancer cells from dividing
so they stop growing or die. It is not yet known which regimen of chemotherapy is more
effective for chronic lymphocytic leukemia.
PURPOSE: This randomized phase III trial is studying chlorambucil to see how well it works
compared to fludarabine and cyclophosphamide or fludarabine alone in treating patients with
newly diagnosed chronic lymphocytic leukemia.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT00004218
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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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Daniel Catovsky, MD
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Address
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Royal Marsden NHS Foundation Trust
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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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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT00004218
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