Status:
COMPLETED
Combination Chemotherapy With or Without Gemtuzumab Ozogamicin or Tipifarnib in Treating Patients With Acute Myeloid Leukemia or High-Risk Myelodysplastic Syndromes
Lead Sponsor:
The University of New South Wales
Conditions:
Leukemia
Myelodysplastic Syndromes
Eligibility:
All Genders
Phase:
PHASE2
PHASE3
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 gemtuzuma...
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 clofarab...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
2000 Patients enrolled
Trial Details
Trial ID
NCT00454480
Start Date
August 1 2006
Last Update
August 26 2013
Active Locations (96)
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1
Basingstoke and North Hampshire NHS Foundation Trust
Basingstoke, England, United Kingdom, RG24 9NA
2
Royal United Hospital
Bath, England, United Kingdom, BA1 3NG
3
Queen Elizabeth Hospital at University Hospital of Birmingham NHS Trust
Birmingham, England, United Kingdom, B15 2TH
4
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom, B9 5SS