Back to resultsChemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
Primary Purpose
Leukemia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
chlorambucil
cyclophosphamide
doxorubicin hydrochloride
fludarabine phosphate
prednisolone
vincristine sulfate
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia focused on measuring stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia, stage 0 chronic lymphocytic leukemia
Eligibility 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
Sites / Locations
- Hospital Italiano de Buenos Aires
- Hospital Alvarez
- University Hospital Rebro
- University of Ioannina
- University of Patras Medical School
- St. James' Hospital
- Galway University Hospital
- Ospedali Riuniti di Bergamo
- Canterbury Health Laboratories
- Russian Academy of Medical Sciences Cancer Research Center
- Stoke Mandeville Hospital
- Horton Hospital
- North Hampshire Hospital
- Selly Oak Hospital at University Hospital NHS Trust
- Birmingham Heartlands Hospital
- Blackpool Victoria Hospital
- Royal Bournemouth Hospital
- Bradford Hospitals NHS Trust
- Royal Sussex County Hospital
- Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
- St Helier Hospital
- Chesterfield Royal Hospital
- Countess of Chester Hospital
- Saint Richards Hospital
- Darlington Memorial
- Dartford & Gravesham NHS Trust, Joyce Green Hospital
- Doncaster Royal Infirmary
- Russells Hall Hospital
- Bishop Auckland Hospital
- Epsom General Hospital
- Queen Elizabeth Hospital
- Queen Elizabeth Hospital
- Gloucester Royal NHS Trust - Glouchester Royal Hospital
- St. Luke's Cancer Centre at Royal Surrey County Hospital
- Harrogate District Hospital
- Hemel Hempstead General
- Institute of Oncology and Radiology of Serbia
- Huddersfield Royal Infirmary
- Hull Royal Infirmary
- Clinical Trials and Research Unit of the University of Leeds
- Leicester Royal Infirmary
- Royal Liverpool and Broadgreen Hospitals
- Walton General Hospital
- Aintree University Hospital
- Whipps Cross Hospital
- Royal Free and University College Medical School
- Guy's and St. Thomas' Hospitals NHS Foundation Trust
- St. George's Hospital
- Royal Marsden NHS Foundation Trust - London
- West Middlesex Hospital
- Northern Cancer Network
- Northampton General Hospital NHS Trust
- Bassetlaw Hospital & Community Services NHS Trust
- Nottingham City Hospital NHS Trust
- Farnborough Hospital
- Wharfdale General Hospital
- Pontefract General Infirmary
- Berkshire Cancer Centre at Royal Berkshire Hospital
- Oldchurch Hospital
- Rotherham District General Hospital - NHS Trust
- Conquest Hospital
- Scunthorpe General Hospital
- Royal South Hants Hospital
- Southampton General Hospital
- Staffordshire General Hospital
- North Staffs Royal Infirmary
- St. Peter's Hospital NHS Trust
- Torbay Hospital
- City Hospital - Birmingham
- Good Hope Hospital Trust
- Worthing Hospital
- Cancer Care Centre at York Hospital
- Belfast City Hospital Trust
- Ulster Hospital
- Craigavon Area Hospital
- Aberdeen Royal Infirmary
- Monklands General Hospital
- Dumfries Royal Infirmary
- Western General Hospital
- Southern General Hospital
- Raigmore Hospital
- Victoria Hospital
- Royal Alexandra Hospital
- Ysbyty Gwynedd
- Nevill Hall Hospital
- Singleton Hospital
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00004218
First Posted
January 28, 2000
Last Updated
December 17, 2013
Sponsor
Leukemia Research Fund
Collaborators
Medical Research Council
1. Study Identification
Unique Protocol Identification Number
NCT00004218
Brief Title
Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
Official Title
Chronic Lymphocytic Leukemia Trial 4: A Randomized Comparison of Chlorambucil, Fludarabine and Fludarabine Plus Cyclophosphamide
Study Type
Interventional
2. Study Status
Record Verification Date
January 2006
Overall Recruitment Status
Completed
Study Start Date
October 1999 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Leukemia Research Fund
Collaborators
Medical Research Council
4. Oversight
5. Study Description
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.
Detailed Description
OBJECTIVES:
Compare the survival rate of patients with newly diagnosed chronic lymphocytic leukemia treated with chlorambucil alone vs fludarabine with or without cyclophosphamide.
Compare the response rate and duration of remission in patients treated with these regimens.
Compare the toxic effects of these regimens in these patients.
Compare the quality of life of patients treated with these regimens.
Determine the impact of the drug response information provided by the DiSC assay on response rate and survival in relapsed or nonresponding patients.
Assess the prognostic value of five genetic markers: trisomy 12 and deletions at 11q23, 13q14, p53, and 6q21 in patients treated with these regimens.
OUTLINE: This is a randomized study. Patients enter one of three treatment arms in the first randomization. Depending on response, some patients may also participate in a second randomization to one of two treatment arms.
First randomization:
Arm I: Patients receive oral chlorambucil daily for 7 days. Treatment repeats every 4 weeks until maximum response or up to 1 year.
Arm II: Patients receive fludarabine IV or orally daily for 5 days. Treatment repeats every 4 weeks for 3-8 courses.
Arm III: Patients receive cyclophosphamide IV and fludarabine IV for 3 days or orally daily for 5 days. Treatment repeats every 4 weeks for 3-8 courses.
Patients who relapse after being in remission for at least 1 year may repeat the initial therapy or may participate in a second randomization. Patients who experience progressive disease or relapse within 1 year after treatment proceed to a second randomization.
Second randomization:
Arm I: Treatment is guided by the results of the DiSC assay. Treatment may be one of the first-line treatments with fludarabine or standard CHOP chemotherapy repeated every 4 weeks (cyclophosphamide IV, doxorubicin IV, vincristine IV, and oral prednisolone on days 1-5) or any other therapy guided by the results of the DiSC assay.
Arm II: Treatment is physician's choice, which may include any of the options in arm I.
Quality of life is assessed prior to initial therapy; at 3, 6, and 12 months; and then annually thereafter.
Patients are followed annually for survival.
PROJECTED ACCRUAL: A total of 750 patients will be accrued for this study within 6-7 years.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia
Keywords
stage I chronic lymphocytic leukemia, stage II chronic lymphocytic leukemia, stage III chronic lymphocytic leukemia, B-cell chronic lymphocytic leukemia, stage 0 chronic lymphocytic leukemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
chlorambucil
Intervention Type
Drug
Intervention Name(s)
cyclophosphamide
Intervention Type
Drug
Intervention Name(s)
doxorubicin hydrochloride
Intervention Type
Drug
Intervention Name(s)
fludarabine phosphate
Intervention Type
Drug
Intervention Name(s)
prednisolone
Intervention Type
Drug
Intervention Name(s)
vincristine sulfate
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel Catovsky, MD
Organizational Affiliation
Royal Marsden NHS Foundation Trust
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Italiano de Buenos Aires
City
Buenos Aires
ZIP/Postal Code
CP1181ACH
Country
Argentina
Facility Name
Hospital Alvarez
City
Buenos Aires
Country
Argentina
Facility Name
University Hospital Rebro
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University of Ioannina
City
Ioannina
ZIP/Postal Code
GR-45110
Country
Greece
Facility Name
University of Patras Medical School
City
Rio Patras
ZIP/Postal Code
GR-26500
Country
Greece
Facility Name
St. James' Hospital
City
Dublin
ZIP/Postal Code
8
Country
Ireland
Facility Name
Galway University Hospital
City
Galway
Country
Ireland
Facility Name
Ospedali Riuniti di Bergamo
City
Bergamo
ZIP/Postal Code
24100
Country
Italy
Facility Name
Canterbury Health Laboratories
City
Christchurch
Country
New Zealand
Facility Name
Russian Academy of Medical Sciences Cancer Research Center
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Stoke Mandeville Hospital
City
Aylesbury-Buckinghamshire
State/Province
England
ZIP/Postal Code
HP21 8AL
Country
United Kingdom
Facility Name
Horton Hospital
City
Banbury
State/Province
England
ZIP/Postal Code
OX16 9A
Country
United Kingdom
Facility Name
North Hampshire Hospital
City
Basingstoke
State/Province
England
ZIP/Postal Code
RG24 9NA
Country
United Kingdom
Facility Name
Selly Oak Hospital at University Hospital NHS Trust
City
Birmingham
State/Province
England
ZIP/Postal Code
B29 6JD
Country
United Kingdom
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Blackpool Victoria Hospital
City
Blackpool
State/Province
England
ZIP/Postal Code
FY3 8NR
Country
United Kingdom
Facility Name
Royal Bournemouth Hospital
City
Bournemouth
State/Province
England
ZIP/Postal Code
BH7 7DW
Country
United Kingdom
Facility Name
Bradford Hospitals NHS Trust
City
Bradford
State/Province
England
ZIP/Postal Code
BD9 6RJ
Country
United Kingdom
Facility Name
Royal Sussex County Hospital
City
Brighton
State/Province
England
ZIP/Postal Code
BN2 5BE
Country
United Kingdom
Facility Name
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
State/Province
England
ZIP/Postal Code
CB2 2QQ
Country
United Kingdom
Facility Name
St Helier Hospital
City
Carshalton
State/Province
England
ZIP/Postal Code
SM5 1AA
Country
United Kingdom
Facility Name
Chesterfield Royal Hospital
City
Chesterfield
State/Province
England
ZIP/Postal Code
S44 5BL
Country
United Kingdom
Facility Name
Countess of Chester Hospital
City
Chester
State/Province
England
ZIP/Postal Code
CH2 1UL
Country
United Kingdom
Facility Name
Saint Richards Hospital
City
Chichester
State/Province
England
ZIP/Postal Code
P019 4SE
Country
United Kingdom
Facility Name
Darlington Memorial
City
Darlington
State/Province
England
ZIP/Postal Code
DL3 6HX
Country
United Kingdom
Facility Name
Dartford & Gravesham NHS Trust, Joyce Green Hospital
City
Dartford Kent
State/Province
England
ZIP/Postal Code
DA1 5PL
Country
United Kingdom
Facility Name
Doncaster Royal Infirmary
City
Doncaster
State/Province
England
ZIP/Postal Code
DN2 5LT
Country
United Kingdom
Facility Name
Russells Hall Hospital
City
Dudley
State/Province
England
ZIP/Postal Code
DY1 2HQ
Country
United Kingdom
Facility Name
Bishop Auckland Hospital
City
Durham
State/Province
England
Country
United Kingdom
Facility Name
Epsom General Hospital
City
Epsom Surrey
State/Province
England
ZIP/Postal Code
KT18 7E9
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Gateshead-Tyne and Wear
State/Province
England
ZIP/Postal Code
NE9 6SX
Country
United Kingdom
Facility Name
Queen Elizabeth Hospital
City
Gateshead
State/Province
England
ZIP/Postal Code
NE9 6SX
Country
United Kingdom
Facility Name
Gloucester Royal NHS Trust - Glouchester Royal Hospital
City
Gloucester
State/Province
England
ZIP/Postal Code
GL1 3NN
Country
United Kingdom
Facility Name
St. Luke's Cancer Centre at Royal Surrey County Hospital
City
Guildford
State/Province
England
ZIP/Postal Code
GU2 5XX
Country
United Kingdom
Facility Name
Harrogate District Hospital
City
Harrogate
State/Province
England
ZIP/Postal Code
HG2 7SX
Country
United Kingdom
Facility Name
Hemel Hempstead General
City
Hemel Hempstead
State/Province
England
Country
United Kingdom
Facility Name
Institute of Oncology and Radiology of Serbia
City
High Wycombe
State/Province
England
Country
United Kingdom
Facility Name
Huddersfield Royal Infirmary
City
Huddersfield, West Yorks
State/Province
England
ZIP/Postal Code
HD3 3EA
Country
United Kingdom
Facility Name
Hull Royal Infirmary
City
Hull
State/Province
England
ZIP/Postal Code
HU3 2KZ
Country
United Kingdom
Facility Name
Clinical Trials and Research Unit of the University of Leeds
City
Leeds
State/Province
England
ZIP/Postal Code
LS2 9N9
Country
United Kingdom
Facility Name
Leicester Royal Infirmary
City
Leicester
State/Province
England
ZIP/Postal Code
LE1 5WW
Country
United Kingdom
Facility Name
Royal Liverpool and Broadgreen Hospitals
City
Liverpool
State/Province
England
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
Walton General Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 1AE
Country
United Kingdom
Facility Name
Aintree University Hospital
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Whipps Cross Hospital
City
London
State/Province
England
ZIP/Postal Code
E11 1NR
Country
United Kingdom
Facility Name
Royal Free and University College Medical School
City
London
State/Province
England
ZIP/Postal Code
NW1 2QG
Country
United Kingdom
Facility Name
Guy's and St. Thomas' Hospitals NHS Foundation Trust
City
London
State/Province
England
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
St. George's Hospital
City
London
State/Province
England
ZIP/Postal Code
SW17 0QT
Country
United Kingdom
Facility Name
Royal Marsden NHS Foundation Trust - London
City
London
State/Province
England
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
West Middlesex Hospital
City
Middlesex
State/Province
England
ZIP/Postal Code
N18 1QZ
Country
United Kingdom
Facility Name
Northern Cancer Network
City
Newcastle-Upon-Tyne
State/Province
England
ZIP/Postal Code
NE27 OQJ
Country
United Kingdom
Facility Name
Northampton General Hospital NHS Trust
City
Northampton
State/Province
England
ZIP/Postal Code
NN1 5BD
Country
United Kingdom
Facility Name
Bassetlaw Hospital & Community Services NHS Trust
City
Nottinghamshire
State/Province
England
ZIP/Postal Code
S81 3SA
Country
United Kingdom
Facility Name
Nottingham City Hospital NHS Trust
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
Farnborough Hospital
City
Orpington Kent
State/Province
England
ZIP/Postal Code
BR6 8ND
Country
United Kingdom
Facility Name
Wharfdale General Hospital
City
Otley
State/Province
England
ZIP/Postal Code
LS21 7AA
Country
United Kingdom
Facility Name
Pontefract General Infirmary
City
Pontefract West Yorkshire
State/Province
England
ZIP/Postal Code
WF8 1PL
Country
United Kingdom
Facility Name
Berkshire Cancer Centre at Royal Berkshire Hospital
City
Reading
State/Province
England
ZIP/Postal Code
RG1 5AN
Country
United Kingdom
Facility Name
Oldchurch Hospital
City
Romford
State/Province
England
ZIP/Postal Code
RM7 OBE
Country
United Kingdom
Facility Name
Rotherham District General Hospital - NHS Trust
City
Rotherham
State/Province
England
ZIP/Postal Code
S60 2UD
Country
United Kingdom
Facility Name
Conquest Hospital
City
Saint Leonards-on-Sea
State/Province
England
ZIP/Postal Code
TN37 7RD
Country
United Kingdom
Facility Name
Scunthorpe General Hospital
City
Scunthorpe
State/Province
England
ZIP/Postal Code
DN15 7BH
Country
United Kingdom
Facility Name
Royal South Hants Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO14 0YG
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Staffordshire General Hospital
City
Stafford
State/Province
England
ZIP/Postal Code
ST16 3SA
Country
United Kingdom
Facility Name
North Staffs Royal Infirmary
City
Stoke-On-Trent
State/Province
England
ZIP/Postal Code
ST4 7LN
Country
United Kingdom
Facility Name
St. Peter's Hospital NHS Trust
City
Surrey
State/Province
England
ZIP/Postal Code
KT 16 OPZ
Country
United Kingdom
Facility Name
Torbay Hospital
City
Torquay Devon
State/Province
England
ZIP/Postal Code
TQ2 7AA
Country
United Kingdom
Facility Name
City Hospital - Birmingham
City
West Bromwich
State/Province
England
ZIP/Postal Code
B71 4HJ
Country
United Kingdom
Facility Name
Good Hope Hospital Trust
City
West Midlands
State/Province
England
ZIP/Postal Code
B75 7RR
Country
United Kingdom
Facility Name
Worthing Hospital
City
Worthing
State/Province
England
ZIP/Postal Code
BN11 2DH
Country
United Kingdom
Facility Name
Cancer Care Centre at York Hospital
City
York
State/Province
England
ZIP/Postal Code
Y031 8HE
Country
United Kingdom
Facility Name
Belfast City Hospital Trust
City
Belfast
State/Province
Northern Ireland
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
Ulster Hospital
City
Dundonald
State/Province
Northern Ireland
ZIP/Postal Code
BT16
Country
United Kingdom
Facility Name
Craigavon Area Hospital
City
Portadown, Craigavon
State/Province
Northern Ireland
ZIP/Postal Code
BT63 5QQ
Country
United Kingdom
Facility Name
Aberdeen Royal Infirmary
City
Aberdeen
State/Province
Scotland
ZIP/Postal Code
AB25 2ZN
Country
United Kingdom
Facility Name
Monklands General Hospital
City
Airdrie
State/Province
Scotland
ZIP/Postal Code
ML6 0JF
Country
United Kingdom
Facility Name
Dumfries Royal Infirmary
City
Dumfries
State/Province
Scotland
ZIP/Postal Code
DG1 4AP
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Southern General Hospital
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
State/Province
Scotland
ZIP/Postal Code
1V2 3UJ
Country
United Kingdom
Facility Name
Victoria Hospital
City
Kirkcaldy
State/Province
Scotland
ZIP/Postal Code
KY2 5AH
Country
United Kingdom
Facility Name
Royal Alexandra Hospital
City
Paisley
State/Province
Scotland
Country
United Kingdom
Facility Name
Ysbyty Gwynedd
City
Bangor
State/Province
Wales
ZIP/Postal Code
LL57 2PW
Country
United Kingdom
Facility Name
Nevill Hall Hospital
City
Gwent
State/Province
Wales
Country
United Kingdom
Facility Name
Singleton Hospital
City
Swansea
State/Province
Wales
ZIP/Postal Code
SA 2 8QA
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
22168274
Citation
Else M, Cocks K, Crofts S, Wade R, Richards SM, Catovsky D, Smith AG; UK National Cancer Research Institute (NCRI) Chronic Lymphocytic Leukaemia Trials Group. Quality of life in chronic lymphocytic leukemia: 5-year results from the multicenter randomized LRF CLL4 trial. Leuk Lymphoma. 2012 Jul;53(7):1289-98. doi: 10.3109/10428194.2011.649479. Epub 2012 Mar 1.
Results Reference
result
PubMed Identifier
21483000
Citation
Gonzalez D, Martinez P, Wade R, Hockley S, Oscier D, Matutes E, Dearden CE, Richards SM, Catovsky D, Morgan GJ. Mutational status of the TP53 gene as a predictor of response and survival in patients with chronic lymphocytic leukemia: results from the LRF CLL4 trial. J Clin Oncol. 2011 Jun 1;29(16):2223-9. doi: 10.1200/JCO.2010.32.0838. Epub 2011 Apr 11.
Results Reference
result
PubMed Identifier
21659360
Citation
Wade R, Di Bernardo MC, Richards S, Rossi D, Crowther-Swanepoel D, Gaidano G, Oscier DG, Catovsky D, Houlston RS. Association between single nucleotide polymorphism-genotype and outcome of patients with chronic lymphocytic leukemia in a randomized chemotherapy trial. Haematologica. 2011 Oct;96(10):1496-503. doi: 10.3324/haematol.2011.043471. Epub 2011 Jun 9.
Results Reference
result
PubMed Identifier
20511662
Citation
Oscier D, Wade R, Davis Z, Morilla A, Best G, Richards S, Else M, Matutes E, Catovsky D; Chronic Lymphocytic Leukaemia Working Group, UK National Cancer Research Institute. Prognostic factors identified three risk groups in the LRF CLL4 trial, independent of treatment allocation. Haematologica. 2010 Oct;95(10):1705-12. doi: 10.3324/haematol.2010.025338. Epub 2010 May 29.
Results Reference
result
PubMed Identifier
19016733
Citation
Else M, Smith AG, Cocks K, Richards SM, Crofts S, Wade R, Catovsky D. Patients' experience of chronic lymphocytic leukaemia: baseline health-related quality of life results from the LRF CLL4 trial. Br J Haematol. 2008 Dec;143(5):690-7. doi: 10.1111/j.1365-2141.2008.07407.x. Epub 2008 Oct 18.
Results Reference
result
PubMed Identifier
17658394
Citation
Catovsky D, Richards S, Matutes E, Oscier D, Dyer M, Bezares RF, Pettitt AR, Hamblin T, Milligan DW, Child JA, Hamilton MS, Dearden CE, Smith AG, Bosanquet AG, Davis Z, Brito-Babapulle V, Else M, Wade R, Hillmen P; UK National Cancer Research Institute (NCRI) Haematological Oncology Clinical Studies Group; NCRI Chronic Lymphocytic Leukaemia Working Group. Assessment of fludarabine plus cyclophosphamide for patients with chronic lymphocytic leukaemia (the LRF CLL4 Trial): a randomised controlled trial. Lancet. 2007 Jul 21;370(9583):230-239. doi: 10.1016/S0140-6736(07)61125-8.
Results Reference
result
Citation
Dearden CE, Wade RL, Else M, et al.: The combination of fludarabine and cyclophosphamide has a beneficial effect on the incidence of hemolytic anemia in chronic lymphocytic leukemia: results from the UK LRF CLL4 trial. [Abstract] Blood 110 (11): A-2044, 2007.
Results Reference
result
PubMed Identifier
23091097
Citation
Skowronska A, Parker A, Ahmed G, Oldreive C, Davis Z, Richards S, Dyer M, Matutes E, Gonzalez D, Taylor AM, Moss P, Thomas P, Oscier D, Stankovic T. Biallelic ATM inactivation significantly reduces survival in patients treated on the United Kingdom Leukemia Research Fund Chronic Lymphocytic Leukemia 4 trial. J Clin Oncol. 2012 Dec 20;30(36):4524-32. doi: 10.1200/JCO.2011.41.0852. Epub 2012 Oct 22.
Results Reference
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Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
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