Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00454480
First received: March 27, 2007
Last updated: August 5, 2011
Last verified: August 2008
  Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as gemtuzumab ozogamicin, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Tipifarnib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving combination chemotherapy together with gemtuzumab ozogamicin or tipifarnib may kill more cancer cells.

PURPOSE: This randomized phase II/III trial is studying different combination chemotherapy regimens to compare how well they work when given with or without gemtuzumab ozogamicin or tipifarnib in treating patients with acute myeloid leukemia or high-risk myelodysplastic syndromes.


Condition Intervention Phase
Leukemia
Myelodysplastic Syndromes
Biological: alemtuzumab
Drug: arsenic trioxide
Drug: azacitidine
Drug: busulfan
Drug: clofarabine
Drug: cytarabine
Drug: daunorubicin hydrochloride
Drug: fludarabine phosphate
Drug: gemtuzumab ozogamicin
Drug: melphalan
Drug: tipifarnib
Genetic: DNA methylation analysis
Genetic: cytogenetic analysis
Genetic: gene expression analysis
Genetic: mutation analysis
Other: diagnostic laboratory biomarker analysis
Other: immunologic technique
Procedure: allogeneic hematopoietic stem cell transplantation
Procedure: nonmyeloablative allogeneic hematopoietic stem cell transplantation
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Programme of Treatment Development for Older Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Overall survival [ Designated as safety issue: No ]
  • Achievement of complete remission and reasons for failure [ Designated as safety issue: No ]
  • Duration of remission, relapse rates, and deaths [ Designated as safety issue: No ]
  • Hematological and nonhematological toxicity [ Designated as safety issue: Yes ]
  • Supportive care requirements (and other aspects of health economics) [ Designated as safety issue: No ]

Estimated Enrollment: 2000
Study Start Date: August 2006
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of 1 of the following:

    • Acute myeloid leukemia (AML) meeting the following criteria:

      • De novo or secondary AML
      • No acute promyelocytic leukemia
    • High-risk myelodysplastic syndromes (> 10% marrow blasts; refractory anemia with excess blasts-2)
    • No blast transformation of chronic myeloid leukemia
  • Patients ≤ 60 years of age may be eligible provided they are considered unfit for clinical trial MRC-AMLI5

PATIENT CHARACTERISTICS:

  • Not pregnant or nursing
  • AST and ALT ≤ 2 times upper limit of normal (ULN) (for patients receiving gemtuzumab ozogamicin)
  • Bilirubin ≤ 2 times ULN (for patients receiving gemtuzumab ozogamicin)
  • Creatinine normal (for patients receiving clofarabine)
  • No other concurrent active malignancy except basal cell carcinoma

PRIOR CONCURRENT THERAPY:

  • No prior cytotoxic chemotherapy for AML

    • Hydroxyurea or similar low-dose therapy to control WBC count prior to initiation of intensive therapy allowed
  • No concurrent enzyme anticonvulsants, including phenytoin, phenobarbital, primidone, carbamazepine, or oxcarbazepine (for patients receiving tipifarnib)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00454480

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Locations
United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust Recruiting
Basingstoke, England, United Kingdom, RG24 9NA
Contact: A E Milne, MBBS, F,R,CP     44-238-079-4202        
Royal United Hospital Recruiting
Bath, England, United Kingdom, BA1 3NG
Contact: Christopher J. C. Knechtli, MB, ChB, PhD, FRCP, MRCPath     44-1225-824-704        
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust Recruiting
Birmingham, England, United Kingdom, B15 2TH
Contact: Contact Person     44-121-697-8482        
Birmingham Heartlands Hospital Recruiting
Birmingham, England, United Kingdom, B9 5SS
Contact: D. W. Milligan, MD     44-121-424-3699     d.w.milligan@bham.ac.uk    
Blackpool Victoria Hospital Recruiting
Blackpool, England, United Kingdom, FY3 8NR
Contact: P R Kelsey, MD     44-20-7210-4850        
Royal Bournemouth Hospital Recruiting
Bournemouth, England, United Kingdom, BH7 7DW
Contact: Sally Killick     44-1202-303-626     sally.killick@rbch.nhs.uk    
Bradford Royal Infirmary Recruiting
Bradford, England, United Kingdom, BD9 6RJ
Contact: J Newton, MD     44-1274-542-200        
Sussex Cancer Centre at Royal Sussex County Hospital Recruiting
Brighton, England, United Kingdom, BN2 5BE
Contact: Contact Person     44-1273-664-658        
Queen's Hospital Recruiting
Burton-upon-Trent, England, United Kingdom, DE13 0RB
Contact: Contact Person     44-1283-566-333        
West Suffolk Hospital Recruiting
Bury St. Edmunds, England, United Kingdom, IP33 2QZ
Contact: Contact Person     44-1284-712-701        
Addenbrooke's Hospital Recruiting
Cambridge, England, United Kingdom, CB2 2QQ
Contact: J. Craig, MD     44-1223-596-289        
Kent and Canterbury Hospital Recruiting
Canterbury, England, United Kingdom, CT1 3NG
Contact: Christopher Pocock     44-122-776-677     christopher.pocock@ekht.nhs.uk    
St. Helier Hospital Recruiting
Carshalton, England, United Kingdom, SM5 1AA
Contact: J Mercieca, MD     44-208-296-2972        
Gloucestershire Oncology Centre at Cheltenham General Hospital Recruiting
Cheltenham, England, United Kingdom, GL53 7AN
Contact: Evelyn Blundell, MD     44-189-682-6000        
Countess of Chester Hospital Recruiting
Chester, England, United Kingdom, CH2 1UL
Contact: Contact Person     44-1244-355-390        
Chesterfield Royal Hospital Recruiting
Chesterfield, England, United Kingdom, S44 5BL
Contact: Contact Person     44-1246-512-214        
Saint Richards Hospital Recruiting
Chichester, England, United Kingdom, P019 4SE
Contact: P.C. Bevan     44-1243-788-122        
Walsgrave Hospital Recruiting
Coventry, England, United Kingdom, CV2 2DX
Contact: B. Harrison     44-24-766-0202        
Mayday University Hospital Recruiting
Croydon, England, United Kingdom
Contact: Contact Person     44-208-401-3026        
Derbyshire Royal Infirmary Recruiting
Derby, England, United Kingdom, DE1 2QY
Contact: Contact Person     44-1332-347-141 x 4532        
Doncaster Royal Infirmary Recruiting
Doncaster, England, United Kingdom, DN2 5LT
Contact: Contact Person     44-1302-381-487        
Dorset County Hospital Recruiting
Dorchester, England, United Kingdom, DT1 2JY
Contact: Contact Person     44-1305-254-328        
Russells Hall Hospital Recruiting
Dudley, England, United Kingdom, DY1 2HQ
Contact: D. Bareford, MD     44-1384-244-158     d.bareford@bham.ac.uk    
Royal Devon and Exeter Hospital Recruiting
Exeter, England, United Kingdom, EX2 5DW
Contact: Contact Person     44-1392-402-928        
Medway Maritime Hospital Recruiting
Gillingham Kent, England, United Kingdom, ME7 5NY
Contact: Vivienne E. Andrews, MD     44-1634-825-219        
Harrogate District Hospital Recruiting
Harrogate, England, United Kingdom, HG2 7SX
Contact: A. Geraldine Bynoe, MD     44-1423-555-790     geraldine.bynoe@hhc-tr.northy.hs.uk    
Northwick Park Hospital Recruiting
Harrow, England, United Kingdom, HA1 3UJ
Contact: Contact Person     44-20-8869-2744        
Hemel Hempstead General Recruiting
Hemel Hempstead, England, United Kingdom, HP2 4AD
Contact: J F M Harrison, MD     44-144-221-3141        
Wycombe General Hospital Recruiting
High Wycombe, England, United Kingdom
Contact: J. Pattinson     44-1494-526-161        
Hull Royal Infirmary Recruiting
Hull, England, United Kingdom, HU3 2KZ
Contact: Contact Person     44-1482-607-738        
Ipswich Hospital Recruiting
Ipswich, England, United Kingdom, IP4 5PD
Contact: Contact Person     44-1473-703-718        
West Middlesex University Hospital Recruiting
Isleworth, England, United Kingdom, TW7 6AF
Contact: M. Sekhar, MD     44-208-321-5716     mallika.sekhar@wmuh-tr.nthames.nhs.uk    
Kettering General Hosptial Recruiting
Kettering, Northants, England, United Kingdom, NNI6 8UZ
Contact: Contact Person     44-1536-492-699        
Kidderminster Hospital Recruiting
Kidderminster Worcestershire, England, United Kingdom, DY11 6RJ
Contact: Robert Stockley     44-160-576-0635        
Crosshouse Hospital Recruiting
Kilmarnock, England, United Kingdom, KA2 OBE
Contact: Contact Person     44-1563-521-133        
Leeds General Infirmary Recruiting
Leeds, England, United Kingdom, LS1 3EX
Contact: Contact Person     44-113-392-2407        
Leicester Royal Infirmary Recruiting
Leicester, England, United Kingdom, LE1 5WW
Contact: A. Hunter, MD     0116-258-6602     ann.hunter@uhl-tr.nhs.uk    
Royal Liverpool University Hospital Recruiting
Liverpool, England, United Kingdom, L7 8XP
Contact: Richard E. Clark, MD     44-151-706-4344        
Aintree University Hospital Recruiting
Liverpool, England, United Kingdom, L9 7AL
Contact: Contact Person     44-151-529-4672        
King's College Hospital Recruiting
London, England, United Kingdom, SE5 8RX
Contact: Ghulam J. Mufti, MD     44-20-3299-3080     ghulam.mufti@kcl.ac.uk    
St. George's Hospital Recruiting
London, England, United Kingdom, SW17 0QT
Contact: Contact Person     44-208-725-5446        
Queen Elizabeth Hospital - Woolwich Recruiting
London, England, United Kingdom, SE18 4QH
Contact: Contact Person     44-208-836-6000        
Saint Bartholomew's Hospital Recruiting
London, England, United Kingdom, EC1A 7BE
Contact: Contact Person     44-207-601-8202        
University College Hospital - London Recruiting
London, England, United Kingdom, WC1E 6AU
Contact: Contact Person     44-20-7679-6224        
University Hospital Lewisham Recruiting
London, England, United Kingdom, SE13 6LH
Contact: Contact Person     44-208-333-3000 x 3281        
UCL Cancer Institute Recruiting
London, England, United Kingdom, NW1 2QG
Contact: Contact Person     44-20-7794-0500        
Maidstone Hospital Recruiting
Maidstone, England, United Kingdom, ME16 9QQ
Contact: Contact Person     44-1622-224-439        
Christie Hospital Recruiting
Manchester, England, United Kingdom, M20 4BX
Contact: Contact Person     44-161-446-3271        
Manchester Royal Infirmary Recruiting
Manchester, England, United Kingdom, M13 9WL
Contact: J.A.L. Yin, MD     44-161-274-4802        
Trafford General Hospital Recruiting
Manchester, England, United Kingdom, M31 3SL
Contact: Contact Person     44-161-746-2470        
Borders General Hospital Recruiting
Melrose, England, United Kingdom, TD6 9BS
Contact: John Tucker, MD     44-189-682-6000        
James Paget Hospital Recruiting
Norfolk, England, United Kingdom, NR31 6LA
Contact: Shalal Sadullah, MD     44-01-493-452-827     shalal.sadullah@jiaget.nhs.uk    
Nottingham City Hospital Recruiting
Nottingham, England, United Kingdom, NG5 1PB
Contact: Nigel H. Russell, MD     115-962-7708     nigelrussell@nottingham.ac.uk    
Derriford Hospital Recruiting
Plymouth, England, United Kingdom, PL6 8DH
Contact: Contact Person     44-1752-431        
Whiston Hospital Recruiting
Prescot Merseyside, England, United Kingdom, L35 5DR
Contact: Contact Person     44-151-430-1147        
Berkshire Cancer Centre at Royal Berkshire Hospital Recruiting
Reading, England, United Kingdom, RG1 5AN
Contact: Contact Person     44-118-322-7758        
Conquest Hospital Recruiting
Saint Leonards-on-Sea, England, United Kingdom, TN37 7RD
Contact: J Beard, MD     44-1424-755-255        
Hope Hospital Recruiting
Salford, England, United Kingdom, M6 8HD
Contact: John Houghton, MD     44-161-206-4982        
Salisbury District Hospital Recruiting
Salisbury, England, United Kingdom, SP2 8BJ
Contact: Contact Person     44-1722-429-043        
Royal Hallamshire Hospital Recruiting
Sheffield, England, United Kingdom, S1O 2JF
Contact: Contact Person     44-114-271-1732        
Southampton General Hospital Recruiting
Southampton, England, United Kingdom, SO16 6YD
Contact: Contact Person     44-23-8079-6164        
Southport and Formby District General Hospital Recruiting
Southport, England, United Kingdom, PR8 6PN
Contact: Contact Person     44-1704-547-471        
Staffordshire General Hospital Recruiting
Stafford, England, United Kingdom, ST16 3SA
Contact: Paul Revell, MD     44-178-525-7731     jayne.anslow@msgh-tr.wmids.nhs.uk    
Sunderland Royal Hospital Recruiting
Sunderland, England, United Kingdom, SR4 7TP
Contact: Mike J. Galloway, MD     44-191-565-6256     mike.galloway@chs.northy.nhs.uk    
Royal Marsden - Surrey Recruiting
Sutton, England, United Kingdom, SM2 5PT
Contact: Contact Person     44-208-661-3797        
Great Western Hospital Recruiting
Swindon, England, United Kingdom, SN3 6BB
Contact: Norbert E. Blesing, MD     44-1793-605-004     neblesing@hotmail.com    
Taunton and Somerset Hospital Recruiting
Taunton Somerset, England, United Kingdom, TA1 5DA
Contact: Contact Person     44-1823-342-270        
Torbay Hospital Recruiting
Torquay, England, United Kingdom, TQ2 7AA
Contact: Deborah Turner     44-180-365-5244     deborah.turner2@nhs.net    
Royal Cornwall Hospital Recruiting
Truro, Cornwall, England, United Kingdom, TR1 3LJ
Contact: Anton Kruger     44-187-225-2506     anton.kruger@rcht.cornwall.nhs.uk    
Hillingdon Hospital Recruiting
Uxbridge, England, United Kingdom, UB8 3NN
Contact: R. Kaczmarski, MD     44-1-895-238-282        
Sandwell General Hospital Recruiting
West Bromwich, England, United Kingdom, B71 4HJ
Contact: Contact Person     44-121-507-3427        
Arrowe Park Hospital Recruiting
Wirral, England, United Kingdom, CH49 5PE
Contact: Galvani, MD     44-151-604-7122        
Worcester Royal Hospital Recruiting
Worcester, England, United Kingdom, WR5 1DD
Contact: Contact Person     44-1905-763-333        
Worthing Hospital Recruiting
Worthing, England, United Kingdom, BN11 2DH
Contact: A. O'Driscolla     44-1903-20-5111        
Cancer Care Center Recruiting
York, England, United Kingdom, Y031 8HE
Contact: L. R. Bond, MD     44-1904-725-854        
Aberdeen Royal Infirmary Recruiting
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Contact: Dominic J. Culligan, MD     44-122-455-3394     dominic.culligan@arh.grampian.scot.nhs.uk    
Monklands General Hospital Recruiting
Airdrie, Scotland, United Kingdom, ML6 0JF
Contact: Contact Person     44-1236-712-104        
Ninewells Hospital Recruiting
Dundee, Scotland, United Kingdom, DD1 9SY
Contact: Keith Gelly, MD     44-138-266-0111        
Edinburgh Cancer Centre at Western General Hospital Recruiting
Edinburgh, Scotland, United Kingdom, EH4 2XU
Contact: P R E Johnson, MD     44-131-537-2595     peter.johnson@luht.scot.nhs.uk    
Falkirk and District Royal Infirmary Recruiting
Falkirk, Scotland, United Kingdom, FK1 5QE
Contact: Contact Person     44-1324-624-000 x 5480        
Southern General Hospital Recruiting
Glasgow, Scotland, United Kingdom, G51 4TF
Contact: A E Morrison, MD     44-141-201-1100        
Western Infirmary Recruiting
Glasgow, Scotland, United Kingdom, G11 6NT
Contact: Pamela Mckay, MD     44-141-211-1817        
Victoria Infirmary Recruiting
Glasgow, Scotland, United Kingdom, G42 9TY
Contact: Contact Person     44-141-201-5648        
Royal Infirmary - Castle Recruiting
Glasgow, Scotland, United Kingdom, G4 0SF
Contact: Contact Person     44-141-211-4492        
Raigmore Hospital Recruiting
Inverness, Scotland, United Kingdom, 1V2 3UJ
Contact: C. J. Lush, MD     463-704-258     chris.lush@haht.scot.nhs.uk    
Victoria Hospital Recruiting
Kirkcaldy, Scotland, United Kingdom, KY2 5AH
Contact: Contact Person     44-1592-643-355 x 8527        
Royal Alexandra Hospital Recruiting
Paisley, Scotland, United Kingdom
Contact: Contact Person     44-141-314-6163        
Pinderfields General Hospital Recruiting
Wakefield, Scotland, United Kingdom, WF1 4DG
Contact: Contact Person     44-1924-212-132        
Dorset Cancer Centre Recruiting
Wakefield, Scotland, United Kingdom, WF1 4DG
Contact: Contact Person     44-1202-442-498        
Ysbyty Gwynedd Recruiting
Bangor, Wales, United Kingdom, LL57 2PW
Contact: Contact Person     44-1248-384-370        
University Hospital of Wales Recruiting
Cardiff, Wales, United Kingdom, CF14 4XW
Contact: Alan K. Burnett, MD, FRCP     44-29-2074-2375     burnettak@cardiff.ac.uk    
Glan Clwyd Hospital Recruiting
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
Contact: Christine Hoyle     44-174-5534-391     christine.hoyle@cd-tr.wales.nhs.uk    
South West Wales Cancer Institute Recruiting
Swansea, Wales, United Kingdom, SA2 8QA
Contact: Saad Al-Ismail, MD     44-1792-285-024     saad.al-ismail@swansea-tr.wales.nhs.uk    
Hereford Hospitals Recruiting
Hereford, United Kingdom, HR1 2ER
Contact: Contact Person     44-1432-364-435        
Wexham Park Hospital Recruiting
Slough, Berkshire, United Kingdom, SL2 4HL
Contact: Contact Person     44-1753-633-418        
Kingston Hospital Recruiting
Surrey, United Kingdom, KT2 7QB
Contact: Contact Person     44-208-546-7711 x 2043        
Sponsors and Collaborators
The University of New South Wales
Investigators
Study Chair: Alan K. Burnett, MD, FRCP The University of New South Wales
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00454480     History of Changes
Other Study ID Numbers: CDR0000526121, UHW-AML16, EU-20677, ISRCTN11036523, EUDRACT-2005-002846-14, MREC-CU106
Study First Received: March 27, 2007
Last Updated: August 5, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
untreated adult acute myeloid leukemia
de novo myelodysplastic syndromes
secondary acute myeloid leukemia
secondary myelodysplastic syndromes
previously treated myelodysplastic syndromes
refractory anemia with excess blasts
adult acute basophilic leukemia
adult acute eosinophilic leukemia
adult acute megakaryoblastic leukemia (M7)
adult acute minimally differentiated myeloid leukemia (M0)
adult acute monoblastic leukemia (M5a)
adult acute monocytic leukemia (M5b)
adult acute myeloblastic leukemia with maturation (M2)
adult acute myeloblastic leukemia without maturation (M1)
adult erythroleukemia (M6a)
adult pure erythroid leukemia (M6b)
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
adult acute myelomonocytic leukemia (M4)
childhood myelodysplastic syndromes

Additional relevant MeSH terms:
Leukemia
Leukemia, Myeloid, Acute
Leukemia, Myeloid
Myelodysplastic Syndromes
Preleukemia
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Azacitidine
Cytarabine
Fludarabine monophosphate
Vidarabine
Arsenic trioxide
Fludarabine
Clofarabine
Alemtuzumab
Tipifarnib
Gemtuzumab
Busulfan
Daunorubicin
Melphalan
Campath 1G
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 23, 2013