Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
Leukemia, Myelodysplastic Syndromes
About this trial
This is an interventional treatment trial for Leukemia focused on measuring 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
Eligibility 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)
Sites / Locations
- Basingstoke and North Hampshire NHS Foundation Trust
- Royal United Hospital
- Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
- Birmingham Heartlands Hospital
- Blackpool Victoria Hospital
- Royal Bournemouth Hospital
- Bradford Royal Infirmary
- Sussex Cancer Centre at Royal Sussex County Hospital
- Queen's Hospital
- West Suffolk Hospital
- Addenbrooke's Hospital
- Kent and Canterbury Hospital
- St. Helier Hospital
- Gloucestershire Oncology Centre at Cheltenham General Hospital
- Chesterfield Royal Hospital
- Countess of Chester Hospital
- Saint Richards Hospital
- Walsgrave Hospital
- Mayday University Hospital
- Derbyshire Royal Infirmary
- Doncaster Royal Infirmary
- Dorset County Hospital
- Russells Hall Hospital
- Royal Devon and Exeter Hospital
- Medway Maritime Hospital
- Harrogate District Hospital
- Northwick Park Hospital
- Hemel Hempstead General
- Wycombe General Hospital
- Hull Royal Infirmary
- Ipswich Hospital
- West Middlesex University Hospital
- Kettering General Hosptial
- Kidderminster Hospital
- Crosshouse Hospital
- Leeds General Infirmary
- Leicester Royal Infirmary
- Royal Liverpool University Hospital
- Aintree University Hospital
- Saint Bartholomew's Hospital
- UCL Cancer Institute
- University Hospital Lewisham
- Queen Elizabeth Hospital - Woolwich
- King's College Hospital
- St. George's Hospital
- University College Hospital - London
- Maidstone Hospital
- Manchester Royal Infirmary
- Christie Hospital
- Trafford General Hospital
- Borders General Hospital
- James Paget Hospital
- Nottingham City Hospital
- Derriford Hospital
- Whiston Hospital
- Berkshire Cancer Centre at Royal Berkshire Hospital
- Conquest Hospital
- Hope Hospital
- Salisbury District Hospital
- Royal Hallamshire Hospital
- Southampton General Hospital
- Southport and Formby District General Hospital
- Staffordshire General Hospital
- Sunderland Royal Hospital
- Royal Marsden - Surrey
- Great Western Hospital
- Taunton and Somerset Hospital
- Torbay Hospital
- Royal Cornwall Hospital
- Hillingdon Hospital
- Sandwell General Hospital
- Arrowe Park Hospital
- Worcester Royal Hospital
- Worthing Hospital
- Cancer Care Center
- Aberdeen Royal Infirmary
- Monklands General Hospital
- Ninewells Hospital
- Edinburgh Cancer Centre at Western General Hospital
- Falkirk and District Royal Infirmary
- Western Infirmary
- Royal Infirmary - Castle
- Victoria Infirmary
- Southern General Hospital
- Raigmore Hospital
- Victoria Hospital
- Royal Alexandra Hospital
- Dorset Cancer Centre
- Pinderfields General Hospital
- Ysbyty Gwynedd
- University Hospital of Wales
- Glan Clwyd Hospital
- South West Wales Cancer Institute
- Hereford Hospitals
- Wexham Park Hospital
- Kingston Hospital