⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

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

Official Title: A Programme of Treatment Development for Older Patients With Acute Myeloid Leukemia and High Risk Myelodysplastic Syndrome

Study ID: NCT00454480

Study Description

Brief Summary: 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.

Detailed Description: OBJECTIVES: Primary (patients considered fit for intensive treatment) * Compare the efficacy and toxicity of daunorubicin hydrochloride and cytarabine (DA) vs daunorubicin hydrochloride and clofarabine (DClo) as induction therapy in older patients with acute myeloid leukemia or high-risk myelodysplastic syndromes. * Assess the value of gemtuzumab ozogamicin when given in combination with DA or DClo during course 1 of induction therapy. * Compare a total of two vs three courses of treatment in patients who achieve at least partial remission (\< 15% blasts) after course 1 of induction therapy. * Compare the use of demethylation maintenance therapy comprising azacitidine vs no maintenance therapy in these patients. * Assess the value of reduced-intensity allogeneic stem cell transplantation as consolidation in patients with matched donors. Primary (patients considered unfit for intensive treatment) * Compare the efficacy and toxicity of low-dose cytarabine with vs without gemtuzumab ozogamicin in these patients. * Compare the efficacy and toxicity of low-dose cytarabine with vs without arsenic trioxide in these patients. * Compare the efficacy and toxicity of low-dose cytarabine vs low-dose clofarabine in these patients. Secondary * Evaluate the relevance of the presence of a cytogenetic abnormality in the bone marrow of patients in morphological remission. * Correlate molecular detection of FLT3 and RAS mutation, genetic signature, and resistance protein status with response to treatment. * Evaluate methods of minimal residual disease monitoring. * Correlate gene methylation status with treatment with maintenance azacitidine. OUTLINE: This is a randomized, controlled, factorial design, prospective, multicenter study. Patients are stratified according to age (\< 60 years vs 60-64 years vs 65-69 years vs 70-74 years vs ≥ 75 years), performance status, WBC count (0-9.9,000/mm³ vs 10-49.9,000/mm³ vs 50-99.9,000/mm³ vs ≥ 100,000/mm³), and type of disease (de novo acute myeloid leukemia \[AML\] vs secondary AML vs high-risk myelodysplastic syndromes). Patients receive treatment according to disease status (fit for intensive treatment vs unfit for intensive treatment). * Intensive treatment (for patients considered fit for intensive treatment): * Induction therapy: Patients are randomized to 1 of 4 treatment arms. * Arm I: For course 1, patients receive daunorubicin hydrochloride (DH) IV over 1 hour on days 1, 3, and 5 and cytarabine IV twice daily on days 1-10. For course 2, patients receive DH as in course 1 and cytarabine IV twice daily on days 1-8. Courses are 4 weeks in duration. * Arm II: Patients receive DH IV over 1 hour on days 1, 3, and 5 and clofarabine IV over 1 hour on days 1-5. Treatment repeats every 4 weeks for 2 courses. * Arm III: For course 1, patients receive DH IV over 1 hour on days 1, 3, and 5, cytarabine IV twice daily on days 1-10, and gemtuzumab ozogamicin (GO) IV over 2 hours on day 1. For course 2, patients receive DH as in course 1 and cytarabine IV twice daily on days 1-8. Courses are 4 weeks in duration. * Arm IV: For course 1, patients receive DH and clofarabine as in arm II and GO as in arm III. For course 2, patients receive DH and clofarabine as in arm II. Courses are 4 weeks in duration. Patients who fail to achieve partial remission (PR) or complete remission (CR) after course 1 but achieve CR after course 2 receive a third course of chemotherapy comprising DH IV over 1 hour on days 1 and 3 and cytarabine IV twice daily on day 1-5. Patients then proceed to randomization for maintenance therapy. Patients who achieve PR or CR after course 1 and are in CR after course 2 are randomized to receive or not receive a third course of chemotherapy (as above). Patients then proceed to randomization for maintenance therapy. Patients who have an HLA-matched donor may proceed to nonintensive allogeneic stem cell transplantation (ASCT). * Nonintensive ASCT: Patients receive a nonintensive allograft comprising 1 of 2 mini-allograft protocols. * Protocol 1: Patients receive fludarabine on days -9 to -5, busulfan on days -3 and -2, and alemtuzumab on days -5 to -1. Patients undergo ASCT on day 0. * Protocol 2: Patients receive fludarabine on days -7 to -3, melphalan on day -2, and alemtuzumab on days -8 to -4. Patients undergo ASCT on day 0. * Maintenance Therapy: Patients are randomized to 1 of 2 treatment arms. * Arm I: Patients receive azacitidine subcutaneously (SC) once daily on days 1-5. Treatment repeats every 6 weeks for 9 courses in the absence of disease progression or unacceptable toxicity. * Arm II: Patients do not receive maintenance therapy. * Nonintensive treatment (for patients considered unfit for intensive treatment): Patients are randomized to 1 of 4 treatment arms. * Arm I: Patients receive low-dose cytarabine (LDC) SC twice daily on days 1-10. * Arm II: Patients receive LDC as in arm I and GO IV over 2 hours on day 1. * Arm III: Patients receive low-dose clofarabine IV over 1 hour once daily on days 1-5. * Arm IV: Patients receive LDC as in arm I and arsenic trioxide IV over 1-2 hours on days 1-5, 9, and 11. Treatment in all arms repeats every 4-6 weeks for 4 courses in the absence of disease progression or unacceptable toxicity. Bone marrow is collected at diagnosis and examined for characterization of FLT3 and RAS mutations by immunophenotyping, gene expression by DNA microarray, and cytogenetic analysis. Blood samples are collected at baseline and after 18, 36, and 54 weeks of treatment for assessment of gene methylation status. After completion of study therapy, patients are followed at 6 and 12 months and then annually thereafter. PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study.

Eligibility

Minimum Age:

Eligible Ages: CHILD, ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Basingstoke and North Hampshire NHS Foundation Trust, Basingstoke, England, United Kingdom

Royal United Hospital, Bath, England, United Kingdom

Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust, Birmingham, England, United Kingdom

Birmingham Heartlands Hospital, Birmingham, England, United Kingdom

Blackpool Victoria Hospital, Blackpool, England, United Kingdom

Royal Bournemouth Hospital, Bournemouth, England, United Kingdom

Bradford Royal Infirmary, Bradford, England, United Kingdom

Sussex Cancer Centre at Royal Sussex County Hospital, Brighton, England, United Kingdom

Queen's Hospital, Burton-upon-Trent, England, United Kingdom

West Suffolk Hospital, Bury St. Edmunds, England, United Kingdom

Addenbrooke's Hospital, Cambridge, England, United Kingdom

Kent and Canterbury Hospital, Canterbury, England, United Kingdom

St. Helier Hospital, Carshalton, England, United Kingdom

Gloucestershire Oncology Centre at Cheltenham General Hospital, Cheltenham, England, United Kingdom

Chesterfield Royal Hospital, Chesterfield, England, United Kingdom

Countess of Chester Hospital, Chester, England, United Kingdom

Saint Richards Hospital, Chichester, England, United Kingdom

Walsgrave Hospital, Coventry, England, United Kingdom

Mayday University Hospital, Croydon, England, United Kingdom

Derbyshire Royal Infirmary, Derby, England, United Kingdom

Doncaster Royal Infirmary, Doncaster, England, United Kingdom

Dorset County Hospital, Dorchester, England, United Kingdom

Russells Hall Hospital, Dudley, England, United Kingdom

Royal Devon and Exeter Hospital, Exeter, England, United Kingdom

Medway Maritime Hospital, Gillingham Kent, England, United Kingdom

Harrogate District Hospital, Harrogate, England, United Kingdom

Northwick Park Hospital, Harrow, England, United Kingdom

Hemel Hempstead General, Hemel Hempstead, England, United Kingdom

Wycombe General Hospital, High Wycombe, England, United Kingdom

Hull Royal Infirmary, Hull, England, United Kingdom

Ipswich Hospital, Ipswich, England, United Kingdom

West Middlesex University Hospital, Isleworth, England, United Kingdom

Kettering General Hosptial, Kettering, Northants, England, United Kingdom

Kidderminster Hospital, Kidderminster Worcestershire, England, United Kingdom

Crosshouse Hospital, Kilmarnock, England, United Kingdom

Leeds General Infirmary, Leeds, England, United Kingdom

Leicester Royal Infirmary, Leicester, England, United Kingdom

Royal Liverpool University Hospital, Liverpool, England, United Kingdom

Aintree University Hospital, Liverpool, England, United Kingdom

Saint Bartholomew's Hospital, London, England, United Kingdom

UCL Cancer Institute, London, England, United Kingdom

University Hospital Lewisham, London, England, United Kingdom

Queen Elizabeth Hospital - Woolwich, London, England, United Kingdom

King's College Hospital, London, England, United Kingdom

St. George's Hospital, London, England, United Kingdom

University College Hospital - London, London, England, United Kingdom

Maidstone Hospital, Maidstone, England, United Kingdom

Manchester Royal Infirmary, Manchester, England, United Kingdom

Christie Hospital, Manchester, England, United Kingdom

Trafford General Hospital, Manchester, England, United Kingdom

Borders General Hospital, Melrose, England, United Kingdom

James Paget Hospital, Norfolk, England, United Kingdom

Nottingham City Hospital, Nottingham, England, United Kingdom

Derriford Hospital, Plymouth, England, United Kingdom

Whiston Hospital, Prescot Merseyside, England, United Kingdom

Berkshire Cancer Centre at Royal Berkshire Hospital, Reading, England, United Kingdom

Conquest Hospital, Saint Leonards-on-Sea, England, United Kingdom

Hope Hospital, Salford, England, United Kingdom

Salisbury District Hospital, Salisbury, England, United Kingdom

Royal Hallamshire Hospital, Sheffield, England, United Kingdom

Southampton General Hospital, Southampton, England, United Kingdom

Southport and Formby District General Hospital, Southport, England, United Kingdom

Staffordshire General Hospital, Stafford, England, United Kingdom

Sunderland Royal Hospital, Sunderland, England, United Kingdom

Royal Marsden - Surrey, Sutton, England, United Kingdom

Great Western Hospital, Swindon, England, United Kingdom

Taunton and Somerset Hospital, Taunton Somerset, England, United Kingdom

Torbay Hospital, Torquay, England, United Kingdom

Royal Cornwall Hospital, Truro, Cornwall, England, United Kingdom

Hillingdon Hospital, Uxbridge, England, United Kingdom

Sandwell General Hospital, West Bromwich, England, United Kingdom

Arrowe Park Hospital, Wirral, England, United Kingdom

Worcester Royal Hospital, Worcester, England, United Kingdom

Worthing Hospital, Worthing, England, United Kingdom

Cancer Care Center, York, England, United Kingdom

Aberdeen Royal Infirmary, Aberdeen, Scotland, United Kingdom

Monklands General Hospital, Airdrie, Scotland, United Kingdom

Ninewells Hospital, Dundee, Scotland, United Kingdom

Edinburgh Cancer Centre at Western General Hospital, Edinburgh, Scotland, United Kingdom

Falkirk and District Royal Infirmary, Falkirk, Scotland, United Kingdom

Western Infirmary, Glasgow, Scotland, United Kingdom

Royal Infirmary - Castle, Glasgow, Scotland, United Kingdom

Victoria Infirmary, Glasgow, Scotland, United Kingdom

Southern General Hospital, Glasgow, Scotland, United Kingdom

Raigmore Hospital, Inverness, Scotland, United Kingdom

Victoria Hospital, Kirkcaldy, Scotland, United Kingdom

Royal Alexandra Hospital, Paisley, Scotland, United Kingdom

Dorset Cancer Centre, Wakefield, Scotland, United Kingdom

Pinderfields General Hospital, Wakefield, Scotland, United Kingdom

Ysbyty Gwynedd, Bangor, Wales, United Kingdom

University Hospital of Wales, Cardiff, Wales, United Kingdom

Glan Clwyd Hospital, Rhyl, Denbighshire, Wales, United Kingdom

South West Wales Cancer Institute, Swansea, Wales, United Kingdom

Hereford Hospitals, Hereford, , United Kingdom

Wexham Park Hospital, Slough, Berkshire, , United Kingdom

Kingston Hospital, Surrey, , United Kingdom

Contact Details

Name: Alan K. Burnett, MD, FRCP

Affiliation: University Hospital of Wales

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: