Phase 2 Study Of Clofarabine With High Dose Cytarabine And G-CSF Priming In Adult Patients Less Than Age 65 With Newly Diagnosed Acute Myeloid Leukemia Or Advanced Myelodysplastic Syndrome and/or Advanced Myeloproliferative Neoplasm
This phase II trial is studying how well giving clofarabine and cytarabine together with filgrastim works in treating patients with newly diagnosed acute myeloid leukemia (AML), advanced myelodysplastic syndrome (MDS), and/or advanced myeloproliferative neoplasm. Drugs used in chemotherapy, such as clofarabine and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving the drugs in different doses may kill more cancer cells. Colony stimulating factors, such as filgrastim, may increase the number of immune cells found in bone marrow or peripheral blood and may help the immune system recover from the side effects of chemotherapy.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- biological : filgrastim
- drug : Cytarabine
- drug : Clofarabine
Phase: Phase 2
Ages Eligible For Study:
- Diagnosis of acute myeloid leukemia by World Health Organization (WHO) criteria (except acute promyelocytic leukemia), or myelodysplastic syndrome, RAEB-2 by WHO classification or advanced myeloproliferative neoplasm with >= 10% blasts in the bone marrow or peripheral blood, including chronic myelomonocytic leukemia (CMML)-2 by WHO classification - Eastern Cooperative Oncology Group (ECOG) Performance Status 0 - 2 - Serum creatinine =< 1.0 mg/dL; if serum creatinine > 1.0 mg/dL, then the estimated glomerular filtration rate (GFR) must be > 60 mL/min/1.73 m^2 as calculated by the Modification of Diet in Renal Disease equation - Serum bilirubin =< 1.5 x upper limit of normal (ULN) unless elevation is thought to be due to Gilbert's syndrome, hemolysis, or hepatic infiltration by the hematologic malignancy - Aspartate transferase (AST)/alanine transferase (ALT) =< 2.5 x ULN unless elevation is thought to be due to hepatic infiltration by the hematologic malignancy - Alkaline phosphatase =< 2.5 x ULN - Capable of understanding the investigational nature, potential risks and benefits of the study, and able to provide valid informed consent - Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment - Male and female patients must use an effective contraceptive method during the study and for a minimum of 90 days after study treatment