AML08: A Phase II Randomized Trial of Clofarabine Plus Cytarabine Versus Conventional Induction Therapy And A Phase II Study Of Natural Killer Cell Transplantation In Patients With Newly Diagnosed Acute Myeloid Leukemia
The purpose of this study is to see if we can improve the remission and survival rates for children with AML/MDS and the ways that fungal infections are diagnosed in patients with AML/MDS. We also will study the effects of clofarabine, sorafenib and valproic acid in high risk patients and how leukemia cells react to chemotherapy during treatment.
Stanford is now accepting new patients for this trial.
- drug : Cytarabine
- drug : Clofarabine
- drug : Etoposide
- drug : Daunorubicin
Phase: Phase 3
Ages Eligible For Study:
- Age less than or equal to 21 years at time of study entry. - No prior therapy for this malignancy except for one dose of intrathecal therapy and the use of hydroxyurea or low-dose cytarabine (100-200 mg/m2 per day for one week or less ) for hyperleukocytosis. - Written informed consent according to institutional guidelines - Female patients of childbearing potential must have a negative serum pregnancy test within 2 weeks prior to enrollment - Male and female participants must use an effective contraceptive method during the study and for a minimum of 6 months after study treatment.