Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
Recruitment status was Recruiting
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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 |
- 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 |
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
Hide Study 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 | |
| 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