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

This study has been completed.
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00454480
First received: March 27, 2007
Last updated: August 23, 2013
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
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00454480

  Hide Study Locations
Locations
United Kingdom
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
Royal United Hospital
Bath, England, United Kingdom, BA1 3NG
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom, B9 5SS
Blackpool Victoria Hospital
Blackpool, England, United Kingdom, FY3 8NR
Royal Bournemouth Hospital
Bournemouth, England, United Kingdom, BH7 7DW
Bradford Royal Infirmary
Bradford, England, United Kingdom, BD9 6RJ
Sussex Cancer Centre at Royal Sussex County Hospital
Brighton, England, United Kingdom, BN2 5BE
Queen's Hospital
Burton-upon-Trent, England, United Kingdom, DE13 0RB
West Suffolk Hospital
Bury St. Edmunds, England, United Kingdom, IP33 2QZ
Addenbrooke's Hospital
Cambridge, England, United Kingdom, CB2 2QQ
Kent and Canterbury Hospital
Canterbury, England, United Kingdom, CT1 3NG
St. Helier Hospital
Carshalton, England, United Kingdom, SM5 1AA
Gloucestershire Oncology Centre at Cheltenham General Hospital
Cheltenham, England, United Kingdom, GL53 7AN
Countess of Chester Hospital
Chester, England, United Kingdom, CH2 1UL
Chesterfield Royal Hospital
Chesterfield, England, United Kingdom, S44 5BL
Saint Richards Hospital
Chichester, England, United Kingdom, P019 4SE
Walsgrave Hospital
Coventry, England, United Kingdom, CV2 2DX
Mayday University Hospital
Croydon, England, United Kingdom
Derbyshire Royal Infirmary
Derby, England, United Kingdom, DE1 2QY
Doncaster Royal Infirmary
Doncaster, England, United Kingdom, DN2 5LT
Dorset County Hospital
Dorchester, England, United Kingdom, DT1 2JY
Russells Hall Hospital
Dudley, England, United Kingdom, DY1 2HQ
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom, EX2 5DW
Medway Maritime Hospital
Gillingham Kent, England, United Kingdom, ME7 5NY
Harrogate District Hospital
Harrogate, England, United Kingdom, HG2 7SX
Northwick Park Hospital
Harrow, England, United Kingdom, HA1 3UJ
Hemel Hempstead General
Hemel Hempstead, England, United Kingdom, HP2 4AD
Wycombe General Hospital
High Wycombe, England, United Kingdom
Hull Royal Infirmary
Hull, England, United Kingdom, HU3 2KZ
Ipswich Hospital
Ipswich, England, United Kingdom, IP4 5PD
West Middlesex University Hospital
Isleworth, England, United Kingdom, TW7 6AF
Kettering General Hosptial
Kettering, Northants, England, United Kingdom, NNI6 8UZ
Kidderminster Hospital
Kidderminster Worcestershire, England, United Kingdom, DY11 6RJ
Crosshouse Hospital
Kilmarnock, England, United Kingdom, KA2 OBE
Leeds General Infirmary
Leeds, England, United Kingdom, LS1 3EX
Leicester Royal Infirmary
Leicester, England, United Kingdom, LE1 5WW
Royal Liverpool University Hospital
Liverpool, England, United Kingdom, L7 8XP
Aintree University Hospital
Liverpool, England, United Kingdom, L9 7AL
King's College Hospital
London, England, United Kingdom, SE5 8RX
St. George's Hospital
London, England, United Kingdom, SW17 0QT
Queen Elizabeth Hospital - Woolwich
London, England, United Kingdom, SE18 4QH
Saint Bartholomew's Hospital
London, England, United Kingdom, EC1A 7BE
University College Hospital - London
London, England, United Kingdom, WC1E 6AU
University Hospital Lewisham
London, England, United Kingdom, SE13 6LH
UCL Cancer Institute
London, England, United Kingdom, NW1 2QG
Maidstone Hospital
Maidstone, England, United Kingdom, ME16 9QQ
Christie Hospital
Manchester, England, United Kingdom, M20 4BX
Manchester Royal Infirmary
Manchester, England, United Kingdom, M13 9WL
Trafford General Hospital
Manchester, England, United Kingdom, M31 3SL
Borders General Hospital
Melrose, England, United Kingdom, TD6 9BS
James Paget Hospital
Norfolk, England, United Kingdom, NR31 6LA
Nottingham City Hospital
Nottingham, England, United Kingdom, NG5 1PB
Derriford Hospital
Plymouth, England, United Kingdom, PL6 8DH
Whiston Hospital
Prescot Merseyside, England, United Kingdom, L35 5DR
Berkshire Cancer Centre at Royal Berkshire Hospital
Reading, England, United Kingdom, RG1 5AN
Conquest Hospital
Saint Leonards-on-Sea, England, United Kingdom, TN37 7RD
Hope Hospital
Salford, England, United Kingdom, M6 8HD
Salisbury District Hospital
Salisbury, England, United Kingdom, SP2 8BJ
Royal Hallamshire Hospital
Sheffield, England, United Kingdom, S1O 2JF
Southampton General Hospital
Southampton, England, United Kingdom, SO16 6YD
Southport and Formby District General Hospital
Southport, England, United Kingdom, PR8 6PN
Staffordshire General Hospital
Stafford, England, United Kingdom, ST16 3SA
Sunderland Royal Hospital
Sunderland, England, United Kingdom, SR4 7TP
Royal Marsden - Surrey
Sutton, England, United Kingdom, SM2 5PT
Great Western Hospital
Swindon, England, United Kingdom, SN3 6BB
Taunton and Somerset Hospital
Taunton Somerset, England, United Kingdom, TA1 5DA
Torbay Hospital
Torquay, England, United Kingdom, TQ2 7AA
Royal Cornwall Hospital
Truro, Cornwall, England, United Kingdom, TR1 3LJ
Hillingdon Hospital
Uxbridge, England, United Kingdom, UB8 3NN
Sandwell General Hospital
West Bromwich, England, United Kingdom, B71 4HJ
Arrowe Park Hospital
Wirral, England, United Kingdom, CH49 5PE
Worcester Royal Hospital
Worcester, England, United Kingdom, WR5 1DD
Worthing Hospital
Worthing, England, United Kingdom, BN11 2DH
Cancer Care Center
York, England, United Kingdom, Y031 8HE
Aberdeen Royal Infirmary
Aberdeen, Scotland, United Kingdom, AB25 2ZN
Monklands General Hospital
Airdrie, Scotland, United Kingdom, ML6 0JF
Ninewells Hospital
Dundee, Scotland, United Kingdom, DD1 9SY
Edinburgh Cancer Centre at Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Falkirk and District Royal Infirmary
Falkirk, Scotland, United Kingdom, FK1 5QE
Southern General Hospital
Glasgow, Scotland, United Kingdom, G51 4TF
Western Infirmary
Glasgow, Scotland, United Kingdom, G11 6NT
Victoria Infirmary
Glasgow, Scotland, United Kingdom, G42 9TY
Royal Infirmary - Castle
Glasgow, Scotland, United Kingdom, G4 0SF
Raigmore Hospital
Inverness, Scotland, United Kingdom, 1V2 3UJ
Victoria Hospital
Kirkcaldy, Scotland, United Kingdom, KY2 5AH
Royal Alexandra Hospital
Paisley, Scotland, United Kingdom
Pinderfields General Hospital
Wakefield, Scotland, United Kingdom, WF1 4DG
Dorset Cancer Centre
Wakefield, Scotland, United Kingdom, WF1 4DG
Ysbyty Gwynedd
Bangor, Wales, United Kingdom, LL57 2PW
University Hospital of Wales
Cardiff, Wales, United Kingdom, CF14 4XW
Glan Clwyd Hospital
Rhyl, Denbighshire, Wales, United Kingdom, LL 18 5UJ
South West Wales Cancer Institute
Swansea, Wales, United Kingdom, SA2 8QA
Hereford Hospitals
Hereford, United Kingdom, HR1 2ER
Wexham Park Hospital
Slough, Berkshire, United Kingdom, SL2 4HL
Kingston Hospital
Surrey, United Kingdom, KT2 7QB
Sponsors and Collaborators
The University of New South Wales
Investigators
Study Chair: Alan K. Burnett, MD, FRCP University Hospital of 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 23, 2013
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, Myeloid
Leukemia, Myeloid, Acute
Myelodysplastic Syndromes
Preleukemia
Leukemia
Syndrome
Neoplasms by Histologic Type
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Precancerous Conditions
Disease
Pathologic Processes
Fludarabine
Arsenic trioxide
Fludarabine phosphate
Gemtuzumab
Tipifarnib
Daunorubicin
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors

ClinicalTrials.gov processed this record on September 22, 2014