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This study looks at combination chemotherapy given with or without Gemtuzumab Ozogamicin or Tipifarnib in patients with acute myeloid leukemia or high-risk myelodysplastic syndromes. Patients diagnosed with acute myeloid leukemia or high-risk myelodysplastic syndromes who had not previously had chemotherapy for leukemia were able to take part. Sponsored by The University of New South Wales, the study was conducted in Phase 2/Phase 3 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
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)