| Inclusion Criteria: | 1) >/= 18 years of age.
2) Histologically documented or cytologically confirmed diagnosis of one of the following hematological malignancies: Acute myelocytic leukemia (AML) refractory to standard induction treatment, or relapsed after standard therapy; Transformed myeloproliferative neoplasms (myelofibrosis, essential thrombocythemia [ET], polycythemia vera [PV] with at least 10% blasts in bone marrow and chronic myeloid leukemia in a blast phase) refractory or relapsing after standard therapy; or Acute lymphocytic leukemia (ALL) refractory to induction treatment, or relapsed after standard therapy.
3) Patients should not have received any prior chemotherapy for their leukemia or transformed myeloproliferative neoplasm (MPN) within 14 days and should have recovered from any toxicity related to prior chemotherapy to at least grade 1. In the presence of rapidly proliferating disease, patients can be included after a washout period of 7 days. Hydroxyurea can be administered as clinically indicated, and no washout is required.
4) Patients may not be candidates for, or must have declined, bone marrow transplantation from an HLA-identical donor in the immediate future (ie, within 4 weeks) or other chemotherapeutic regimens known to produce consistent remissions.
5) Patients with known meningeal infiltration may be enrolled only if radiation has been completed, and a clearing of peripheral blood blasts has been noted. Intrathecal therapy can be continued if judged to be in the best interest of the patient to prevent recurrence, provided there is no toxicity associated with it and there has been clearance of blasts in the cerebrospinal fluid.
6) ECOG Performance Status 0, 1 or 2.
7) Willing to adhere to the prohibitions and restrictions specified in this protocol.
8) Patient must have signed an informed consent document indicating that he/she understands the purpose of and procedures required for the study and is willing to participate in the study. |