Not Signed In -
Chlorambucil |
Leukeran |
Clinical Trial: Chemotherapy in Treating Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
This study is currently recruiting patients.
|
Purpose
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.
| Condition | Treatment or Intervention | Phase |
|---|---|---|
| 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 | Drug: chlorambucil Drug: cyclophosphamide Drug: doxorubicin Drug: fludarabine Drug: prednisolone Drug: vincristine Procedure: chemotherapy | Phase III |
MedlinePlus related topics: Leukemia, Adult Acute; Leukemia, Adult Chronic; Leukemia, Childhood
Study Type: Interventional
Study Design: Treatment
Official Title: Phase III Randomized Study of Chlorambucil Alone Versus Fludarabine With or Without Cyclophosphamide in Patients With Newly Diagnosed Chronic Lymphocytic Leukemia
Further Study Details:
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.
- 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.
- 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.
Eligibility
Genders Eligible for Study: Both
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
Location and Contact Information
Argentina
Hospital Alvarez, Buenos Aires, Argentina; Recruiting
Raimundo Fenando Bezares, MD 54-11-4612-3480 rfbezares@fibertel.com.ar
Hospital Italiano de Buenos Aires, Buenos Aires, CP1181ACH, Argentina; Recruiting
D. Fantl, MD 54-11-4958-2463 dorotea.fantl@hospitalitaliano.org.ar
Croatia
University Hospital Rebro, Zagreb, 10000, Croatia; Recruiting
I. Radman, MD 385-1-238-8277 iradman@inet.hr
Greece
University of Ioannina, Ioannina, GR-45110, Greece; Recruiting
K. L. Bouzantas, MD 32-2510-24974
University of Patras Medical School, Rio Patras, GR-26500, Greece; Recruiting
N Giannakoulas, MD 30-061-999-247 ngiannakoulas@hotmail.com
Ireland
Galway University Hospital, Galway, Ireland; Recruiting
M Murray, MD 353-91-524-222
St. James's Hospital, Dublin, 8, Ireland; Recruiting
Shaun R. McCann, MD 353-1-410-3756
Italy
Ospedali Riuniti di Bergamo, Bergamo, 24100, Italy; Recruiting
A Grassi, MD 39-035-269-859
New Zealand
Canterbury Health Laboratories, Christchurch, New Zealand; Recruiting
P. Ganly, PhD, FRCP, FRCPath, FRCPA 64-3-364-1450 peter.ganly@cdhb.govt.nz
Russian Federation
Russian Academy of Medical Sciences Cancer Research Center, Moscow, 115478, Russian Federation; Recruiting
M. A. Volkova, MD 095-324-28-24
United Kingdom, England
Addenbrooke's Hospital at Cambridge University Hospitals NHS Foundation Trust, Cambridge, England, CB2 2QQ, United Kingdom; Recruiting
Robert Marcus, MD 44-1223-217-071
Aintree University Hospital, Liverpool, England, L9 7AL, United Kingdom; Recruiting
W Sadik, MD 44-151-525-5980
Ashford Hospital, Ashford, England, TW15 3AA, United Kingdom; Recruiting
Andrew S. Laurie, MD 44-1932-723-432
Bassetlaw Hospital & Community Services NHS Trust, Nottinghamshire, England, S81 3SA, United Kingdom; Recruiting
B Paul, MD 44-1909-50-0990 beverley.paul@dbh.nhs.uk
Birmingham Heartlands and Solihull NHS Trust -Teaching, Birmingham, England, B9 5SS, United Kingdom; Recruiting
D.W. Milligan, MD 44-0121-424-2000 ext. 43703 an d.w.milligan@bham.ac.uk
Bishop Auckland Hospital, Durham, England, United Kingdom; Recruiting
G P Galvin, MD 44-1388-604-040
Blackpool Victoria Hospital, Blackpool, England, FY3 8NR, United Kingdom; Recruiting
P R Kelsey, MD 44-20-7210-4850
Bradford Hospitals NHS Trust, Bradford, England, BD9 6RJ, United Kingdom; Recruiting
J Newton, MD 44-1274-542-200
Cancer Care Centre at York Hospital, York, England, Y031 8HE, United Kingdom; Recruiting
L. R. Bond, MD 44-1904-725-854
Chesterfield Royal Hospital, Chesterfield, England, S44 5BL, United Kingdom; Recruiting
R Stewart, MD 44-1246-552-567
City Hospital - Birmingham, West Bromwich, England, B71 4HJ, United Kingdom; Recruiting
Penny J. Stableforth, MD 44-121-553-1831
Conquest Hospital, Saint Leonards-on-Sea, England, TN37 7RD, United Kingdom; Recruiting
J Beard, MD 44-1424-755-255
Countess of Chester Hospital, Chester, England, CH2 1UL, United Kingdom; Recruiting
Elisabeth Rhodes, MD 44-1244-365-000
Darlington Memorial, Darlington, England, DL3 6HX, United Kingdom; Recruiting
P J Williamson, MD 44-1325-74-3222
Dartford & Gravesham NHS Trust, Joyce Green Hospital, Dartford Kent, England, DA1 5PL, United Kingdom; Recruiting
Vivienne E. Andrews, MD 44-1322-227-242
Doncaster Royal Infirmary, Doncaster, England, DN2 5LT, United Kingdom; Recruiting
Gautam Majumdar, MD, FRCP, FRCPath 44-130-236-6666 gautam.majumdar@dbh.nhs.uk
Epsom General Hospital, Epsom Surrey, England, KT18 7E9, United Kingdom; Recruiting
Lydia Jones, MD, BSc, BS, FRCP, FRCPath 44-1372-735-735 lydia.jones@epsom-sthelier.nhs.uk
Farnborough Hospital, Orpington Kent, England, BR6 8ND, United Kingdom; Recruiting
C F M De Lord, MD 44-168-981-4100
Gloucester Royal NHS Trust - Glouchester Royal Hospital, Gloucester, England, GL1 3NN, United Kingdom; Recruiting
J Ropner, MD 44-1452-528-555
Good Hope Hospital Trust, West Midlands, England, B75 7RR, United Kingdom; Recruiting
Malcolm S. Hamilton, MD 0121-378-2211 ext. 2202 malcolm.hamilton@goodhope.nhs.uk
Guy's and St. Thomas' Hospitals NHS Foundation Trust, London, England, SE1 9RT, United Kingdom; Recruiting
Stephen Schey, MD 44-207-955-5000
Harrogate District Hospital, Harrogate, England, HG2 7SX, United Kingdom; Recruiting
A. G. Bynoe, MD 01423-885959
Hemel Hempstead General, Hemel Hempstead, England, United Kingdom; Recruiting
J F M Harrison, MD 44-1442-213-141
Horton Hospital, Banbury, England, OX16 9A, United Kingdom; Recruiting
Jill Durrant, MB, FRCPath 44-1865-404-863 jilldurrant@doctors.org.uk
Huddersfield Royal Infirmary, Huddersfield, West Yorks, England, HD3 3EA, United Kingdom; Recruiting
Contact Person 44-1484-342-000
Hull Royal Infirmary, Hull, England, HU3 2KZ, United Kingdom; Recruiting
R.L. Shields, MD 44-1482-674-542
Institute of Oncology and Radiology of Serbia, High Wycombe, England, United Kingdom; Recruiting
R. Aitchison, MD +44-1494 425224
Leeds General Infirmary at Leeds Teaching Hospital NHS Trust, Leeds, England, LS1 3EX, United Kingdom; Recruiting
J. A. Child, MD 44-113-392- 5153 tony.child@leedsth.nhs.uk
Leicester Royal Infirmary, Leicester, England, LE1 5WW, United Kingdom; Recruiting
M.J. Dyer, MD 44-116-252-3222 mjsd1@le.ac.uk
North Hampshire Hospital, Basingstoke, England, RG24 9NA, United Kingdom; Recruiting
A E Milne, MBBS, F,R,CP 44-1256-31-4793
North Staffs Royal Infirmary, Stoke on Trent, England, ST4 7LN, United Kingdom; Recruiting
P M Chipping, MD 44-1782-62-2463
Northampton General Hospital NHS Trust, Northampton, England, NN1 5BD, United Kingdom; Recruiting
J R Y Ross, MD 44-1604-63-4700
Northern Cancer Network, Newcastle upon Tyne, England, NE7 7DN, United Kingdom; Recruiting
J P Wallis, MD 44-191-291-9430
Nottingham City Hospital NHS Trust, Nottingham, England, NG5 1PB, United Kingdom; Recruiting
Andy Haynes, MD 0115-9691169 ext. 46704 andy.haynes@nottingham.ac.uk
Oldchurch Hospital, Romford, England, RM7 OBE, United Kingdom; Recruiting
Alison Brownell, MD 44-0170-345-533
Pontefract General Infirmary, Pontefract West Yorkshire, England, WF8 1PL, United Kingdom; Recruiting
D. Wright, MD 44-1977-600-600
Queen Elizabeth Hospital, Gateshead, England, NE9 6SX, United Kingdom; Recruiting
Alex M. Hendrick, MD 44-191-445-2909
Queen Elizabeth Hospital, Gateshead-Tyne and Wear, England, NE9 6SX, United Kingdom; Recruiting
G.P. Summerfield, DM, FRCP, FRCPPath 0191-403-2878
Rotherham District General Hospital - NHS Trust, Rotherham, England, S60 2UD, United Kingdom; Recruiting
Helen Barker, MD 44-1709-820-000
Royal Berkshire Hospital, Reading, England, RG1 5AN, United Kingdom; Recruiting
H Grech, MD 44-118-987-5111
Royal Bournemouth Hospital, Bournemouth, England, BH7 7DW, United Kingdom; Recruiting
David Graham Oscier, MD 1-20-270-4790 david.oscier@lineone.net
Royal Free and University College Medical School, London, England, NW3 2PF, United Kingdom; Recruiting
A B Mehta, MD 44-20-7679-2000
Royal Liverpool and Broadgreen Hospitals, Liverpool, England, L7 8XP, United Kingdom; Recruiting
P Chu, MD 44-151-706-2000
Royal Marsden NHS FoundationTrust - London, London, England, SW3 6JJ, United Kingdom; Recruiting
Daniel Catovsky, MD 44-20-7808-2880 ext.2875 daniel.catovsky@icr.ac.uk
Royal South Hants Hospital, Southampton, England, SO14 0YG, United Kingdom; Recruiting
A. Duncombe, MD 44-23-8063-4288
Royal Sussex County Hospital, Brighton, England, BN2 5BE, United Kingdom; Recruiting
J. R. Duncan, MD 44-1273-664-658 john.duncan@bsuh.nhs.uk
Russells Hall Hospital, Dudley, England, DY1 2HQ, United Kingdom; Recruiting
P Harrison, MB, FRCP, MRCPath 01384 456111
Saint Richards Hospital, Chichester, England, P019 4SE, United Kingdom; Recruiting
P. Stross, MD 44-1243-788-122
Scunthorpe General Hospital, Scunthorpe, England, DN15 7BH, United Kingdom; Recruiting
S. Jalihal, MD 44-1724-282-282 Sanjeev.Jalihal@nlg.nhs.uk
Selly Oak Hospital at University Hospital NHS Trust, Birmingham, England, B29 6JD, United Kingdom; Recruiting
J A Murray, MD 44-121-627-1627 ext. 53709 jim.murray@university-b.wmids.nhs.uk
Southampton General Hospital, Southampton, England, SO16 6YD, United Kingdom; Recruiting
Kim Orchard, MD 440-238-079-4118 kho@soton.ac.uk
St Helier Hospital, Carshalton, England, SM5 1AA, United Kingdom; Recruiting
J Mercieca, MD 44-20-8296-2972
St. George's Hospital, London, England, SW17 0QT, United Kingdom; Recruiting
C. E. Dearden, MD 020-8725-5446
St. Luke's Cancer Centre at Royal Surrey County Hospital, Guildford, England, GU2 5XX, United Kingdom; Recruiting
G. Robbins, MD 44-1483-571-122
Staffordshire General Hospital, Stafford, England, ST16 3SA, United Kingdom; Recruiting
Paul Revell, MD 44-1785-257-731 jayne.anslow@msgh-tr.wmids.nhs.uk
Stoke Mandeville Hospital, Aylesbury-Buckinghamshire, England, HP21 8AL, United Kingdom; Recruiting
A Watson, MD 44-1296-315-000
Torbay Hospital, Torquay Devon, England, TQ2 7AA, United Kingdom; Recruiting
S.R. Smith, MD 44-1803-65-5237
Walton General Hospital, Liverpool, England, L9 1AE, United Kingdom; Recruiting
P.A. Stevenson, MD, FACP, MB, ChB 44-151-525-3611
West Middlesex Hospital, Middlesex, England, N18 1QZ, United Kingdom; Recruiting
M. Sekhar, MD 44-208-321-5716 mallika.sekhar@wmuh-tr.nthames.nhs.uk
Wharfdale General Hospital, Otley, England, LS21 7AA, United Kingdom; Recruiting
G M Smith, MD 39-44-1943-465-522
Whipps Cross Hospital, London, England, E11 1NR, United Kingdom; Recruiting
C. Desilva, MD 44-20-8539-5522
Worthing Hospital, Worthing, England, BN11 2DH, United Kingdom; Recruiting
Colin L. Rist, MD 44-1903-205-111 colin.rist@wash.nhs.uk
United Kingdom, Northern Ireland
Belfast City Hospital Trust, Belfast, Northern Ireland, BT9 7AB, United Kingdom; Recruiting
R.J.G. Cuthbert, MD, FRCP, FRCPath 44-0-28-9032-9241 robert.cuthbert@bll.n.i.nhs.uk
Craigavon Area Hospital, Portadown, Craigavon, Northern Ireland, BT63 5QQ, United Kingdom; Recruiting
C. Humphrey, MD 028-38-612651
Ulster Hospital, Dundonald, Northern Ireland, BT16, United Kingdom; Recruiting
M El-Agnaf, MD 44-2-890-48-4511
United Kingdom, Scotland
Aberdeen Royal Infirmary, Aberdeen, Scotland, AB25 2ZN, United Kingdom; Recruiting
Dominic J. Culligan, MD 44-1224-553-394 dominic.culligan@arh.grampian.scot.nhs.uk
Dumfries Royal Infirmary, Dumfries, Scotland, DG1 4AP, United Kingdom; Recruiting
Raymond K. B. Dang, MD 44-1387-241-441 rdang@doctors.org.uk
Monklands General Hospital, Airdrie, Scotland, ML6 0JF, United Kingdom; Recruiting
J Murphy, MD 44-1236-748-748 john.murphy@lanahshire.scot.nhs.uk
Raigmore Hospital, Inverness, Scotland, 1V2 3UJ, United Kingdom; Recruiting
C. J. Lush, MD 463-704-258 chris.lush@haht.scot.nhs.uk
Royal Alexandra Hospital, Paisley, Scotland, United Kingdom; Recruiting
Pamela Mckay, MD 44-141-580-4225
Southern General Hospital, Glasgow, Scotland, G51 4TF, United Kingdom; Recruiting
A E Morrison, MD 44-141-201-1100
Victoria Hospital, Kirkcaldy, Scotland, KY2 5AH, United Kingdom; Recruiting
C J Mccallum, MD 44-1592-643-355
Western General Hospital, Edinburgh, Scotland, EH4 2XU, United Kingdom; Recruiting
P R E Johnson, MD 01-31-537-2595 peter.johnson@luht.scot.nhs.uk
United Kingdom, Wales
Nevill Hall Hospital, Gwent, Wales, United Kingdom; Recruiting
H W Habboush, MD 0873-732252 drhabboush@aol.com
Singleton Hospital, Swansea, Wales, SA 2 8QA, United Kingdom; Recruiting
Saad Al-Ismail, MD 44-1792-285-024 saad.al-ismail@swansea-tr.wales.nhs.uk
Ysbyty Gwynedd, Bangor, Wales, LL57 2PW, United Kingdom; Recruiting
J R C Searle, MD 44-01-4838-4384
Study chairs or principal investigators
Daniel Catovsky, MD, Study Chair, Royal Marsden NHS Trust
Daniel Catovsky, MD, Study Chair, Royal Marsden NHS Trust
More Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Study ID Numbers: CDR0000067454; LRF-CLL4; LRG-MRC-LEUK-CLL4; EU-99030; MRC-LEUK-CLL4; NCT00004218
Record last reviewed: May 2003
Last Updated: April 4, 2005
Record first received: January 28, 2000
ClinicalTrials.gov Identifier: NCT00004218
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Record last reviewed: May 2003
Last Updated: April 4, 2005
Record first received: January 28, 2000
ClinicalTrials.gov Identifier: NCT00004218
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08
Source: ClinicalTrials.gov
Cache Date: April 8, 2005
Resources
- Chlorambucil (Drug Digest)
- Leukeran (Drug Digest)
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