Research and Clinical Trials

Brief Description  
The primary objective of the study is to determine the maximum tolerated dose (MTD) and dose-limiting toxicities (DLT) of AC220 in patients with relapsed or refractory acute lymphoblastic leukemia (ALL), acute myelogenous leukemia (AML) or acute leukemia of ambiguous lineage. AC220 will be given in combination with Etoposide and Cytarabine for two couarses (each lasting four weeks) in the absence of disease progression.
Who may be Eligible  

  1. Patients must be >1 month and = 21 years of age at the time of enrollment.
  2. Patients must have one of the following:
    1. Patient must have relapsed/refractory acute myelogenous leukemia (AML) or leukemia of ambiguous lineage with = 5% blast in the bone marrow.
    2. Patient must have relapsed/refractory acute lymphoblastic leukemia (ALL) with =25% blasts in the bone marrow and and MLL gene rearrangement or hyperdiploid >50 chromossomes.
  3. Patient may have CNS 1or 2 disease.
  4. At least 90 days must have elapsed from Stem Cell Bone Marrow Transplant, and without evidence of Graft-versus-Host Disease (GVHD)
  5. Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study.
  6. Patients must have adequate renal, hepatic, and cardiac function.
  7. Patients will be excluded if they have CNS 3 disease.
  8. Patients will be excluded if they have a systemic fungal, bacterial, viral or other infection that is exhibiting ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment.
IRB Number  
Principal Investigator  
Oesterheld, Javier

For More Information, Contact  Beatriz  , Perez-Li
Phone:  (704) 355-1188  Fax:  (704) 446-5285  
Address:1025 Morehead Medical Drive Suite 600 Charlotte, NC 28204