AML as defined by the WHO Classification persisting or recurring following one or more treatment courses except promyelocytic leukemia (APML) and except AML with myelodysplasia related changes.
COHORT : Have histologically or cytologically confirmed relapsed or refractory AML (i.e. >= % blasts by manual differential on bone marrow aspirate / biopsy / flow cytometry), excluding acute promyelocytic leukemia (APL; FAB M; t [; ])
COHORT : Have histologically and cytologically confirmed newly diagnosed AML (i.e. >= % blasts by manual differential on bone marrow aspirate/biopsy and/or in peripheral blood), excluding acute promyelocytic leukemia (APL; FAB M, t [;])
Diagnosed with APL-M or CBF-AML
Patient with AML according to WHO criteria (excluding acute promyelocytic leukemia [APL] [AML-M])
Patients diagnosed with APL, AML-M
Patients must have a confirmed diagnosis of one of the following:\r\n* Newly diagnosed AML (excluding acute promyelocytic leukemia [APL]) \r\n* Newly diagnosed intermediate- (INT-) or high-risk MDS\r\n* Relapsed or refractory AML, or INT- or high-risk MDS
AML ONLY: Acute promyelocytic leukemia (PML-RARA rearranged- AML-M)
For patients with newly diagnosed disease: diagnosis of high-grade MDS (>= % blasts by morphology) or AML other than acute promyelocytic leukemia (APL) with t(;)(q;q) or variants according to the World Health Organization (WHO) classification; for patients with relapsed/refractory disease: prior diagnosis of high-risk MDS or non-APL AML, with relapsed/refractory disease according to recommendations of the International Working Group, requiring first or subsequent salvage therapy; patients with mixed phenotype acute leukemia (MPAL) are eligible
Patients who have received any therapy other than hydroxyurea or ATRA with the purpose of treating their AML or patients with acute promyelocytic leukemia are not eligible
Patients must have histologically confirmed AML or ALL, excluding acute promyelocytic leukemia (APL); for histological confirmation, a bone marrow biopsy and aspirate must be reviewed at Oregon Health & Science University (OHSU)
DIAGNOSIS REQUIREMENT FOR PHASE II PATIENTS: Refractory AML without CR after induction therapy (primary induction failure) or relapsed AML after obtaining a CR; favorable-risk core binding factor (CBF) mutated AML and acute promyelocytic leukemia (APL) will be excluded
AML (acute promyelocytic leukemia [APL] excepted) or high-risk MDS (-% blasts in marrow by morphology or flow cytometry or blood)
Patient with AML-M (APL)
Patients may not have received prior chemotherapy for AML with the exception of hydroxyurea for increased blast count or leukapheresis for leukocytosis; patients who have received a limited and short-term exposure of ATRA (all trans retinoid acid) while AML-M (acute promyelocytic leukemia) was being ruled out, and which has been discontinued, will be eligible
Patients with newly diagnosed or relapsed/refractory AML, except acute promyelocytic leukemia (APL), requiring intensive induction chemotherapy
Molecular AML-risk group is less-than-favorable as defined by any of the following criteria: \r\n* The absence of good-risk karyotype t(;), inv(), t(;), or t(;)identified by metaphase karyotype\r\n* The absence of t(;), inv(), t(;), or t(;) identified by fluorescent in situ hybridization(FISH)\r\n* The absence of the corresponding fusion transcripts, AML-eight-twenty-one corepressor (ETO), core-binding factor, beta subunit (CBF?)-smooth muscle myosin heavy chain (SMMHC), or progressive multifocal leukoencephalopathy (PML)-retinoic acid receptor alpha (RARa), identified by reverse transcriptase-polymerase chain reaction (RT-PCR)\r\n* Patient does not have acute promyelocytic leukemia (APL, French-American-British [FAB] M)
Unequivocal diagnosis of AML based on the WHO classification, excluding acute promyelocytic leukemia
The patient has a diagnosis of AML or BPDCN according to WHO classification (AML; excluding acute promyelocytic leukemia [APL, FAB M]) or confirmed by hematopathology (BPDCN)
The patient has a diagnosis of AML or BPDCN according to WHO classification (AML; excluding acute promyelocytic leukemia [APL, FAB M]) or confirmed by hematopathology (BPDCN)
Patients must have morphologically confirmed newly diagnosed acute myelogenous leukemia (AML) with blood or bone marrow disease; patients with only extramedullary disease in the absence of bone marrow or blood involvement are eligible; note: this protocol uses World Health Organization (WHO) diagnostic criteria for AML; patients with acute promyelocytic leukemia (APL, French-American-British Classification [FAB], M) or blastic transformation of chronic myelogenous leukemia (CML) are not eligible
Pathological diagnosis of AML according to World Health Organization (WHO) criteria (with at least % blasts in the peripheral blood or bone marrow): newly diagnosed de novo AML; except for acute promyelocytic leukemia (APL); newly diagnosed secondary AML, defined as having a history of an antecedent hematologic disorder (myelodysplastic syndromes [MDS], myeloproliferative disease [MPD] or history of cytotoxic treatment for non-hematologic malignancy) or apparent de novo AML with MDS-associated karyotype
For patients with newly diagnosed disease: diagnosis of high-risk myelodysplastic syndrome (MDS) (>= % blasts) or AML other than acute promyelocytic leukemia (APL) with t(;)(q;q) or variants according to the World Health Organization (WHO) classification; for patients with relapsed/refractory disease: prior diagnosis of high-risk MDS or non-APL AML, with relapsed/refractory disease according to standard criteria requiring first or subsequent salvage therapy; patients with biphenotypic AML are eligible
Adults with acute myeloid leukemia (AML), excluding the M subtype (acute promyelocytic leukemia), that are not likely to respond to conventional therapy, including:\r\n* Relapsed or refractory AML after one to four prior induction regimens (not counting consolidation therapies while in complete response [CR], and not counting autologous transplant while in CR),\r\n* Newly diagnosed AML patients age not fit for standard therapy
Patients must have histologically or cytologically confirmed: \r\n* Pathologically confirmed intermediate or poor risk newly diagnosed AML (subtypes M, , , -), but excluding newly diagnosed core-binding factor (CBF) (t(;) or Meo subtype (inv() or t(;) AMLs and acute promyelocytic leukemia (acute promyelocytic leukemia [APL], M)\r\n* MDS with high risk features as defined by intermediate (INT)- or high International Prognostic Scoring System (IPSS) score with > % blasts in the bone marrow\r\n* Chronic myelomonocytic leukemia- (CMML-) defined as having > % blasts (including promonocytes) in the bone marrow or -% blasts (including promonocytes) in the peripheral blood
Subject was diagnosed as acute promyelocytic leukemia (APL) or AML with good risk cytogenetics; t(;), inv() or t(;). (Subjects with pending cytogenetics that require treatment may enroll. Any subject that is found to have good risk cytogenetics after initiation of treatment will discontinue ASP and be taken off trial).
Cytologically/histologically confirmed acute myeloid leukaemia (AML) according to WHO classification; (except for acute promyelocytic leukaemia (APL).
New diagnosis of AML, other than acute promyelocytic leukemia (APL) or poor-risk AML
Age ? years with relapsed/refractory AML of any type except for acute promyelocytic leukemia (APL; AML M), after at least prior AML therapy , who have never undergone, and who are not currently eligible for, stem cell transplantation, and are currently deemed unfit for intensive chemotherapy.
Patient must have one of the following histologically or cytologically documented measurable (may be measureable by tumor markers only, such as quantitative RT-PCR for WT transcript for AML, or CA- for ovarian carcinoma) advanced stage malignancies: non-small cell lung, ovarian, glioblastoma, and AML (not including acute promyelocytic leukemia), known to overexpress the WT protein.
Patient must have histologically or cytologically documented measurable (may be measurable by tumor markers only, such as quantitative RT-PCR for WT transcript for AML) advanced stage glioblastoma or AML (not including acute promyelocytic leukemia), known to overexpress the WT protein. Note: Determination of WT expression will not be assessed prior to patient enrollment.
Newly Diagnosed De novo AML according to WHO criteria except for Acute Promyelocytic Leukemia or patients with known favorable cytogenetics (see exclusion)
Patients must have morphologically confirmed newly diagnosed acute myelogenous leukemia (AML) with blood or bone marrow disease; patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible; note: this protocol uses World Health Organization (WHO) diagnostic criteria for AML; patients with acute promyelocytic leukemia (APL, French-American-British [FAB], M) or blastic transformation of chronic myelogenous leukemia (CML) are not eligible; patients with known core binding factor (CBF) or fms-like tyrosine kinase (FLT) related leukemias are eligible for this study, but should preferentially be placed on National Cancer Institute (NCI)-sponsored protocols specific for these subtypes, if available
Patients must have a diagnosis of acute myeloid leukemia (AML), acute promyelocytic leukemia (APL), acute lymphoblastic leukemia (ALL), infantile leukemia (either AML or ALL), AML with prior myelodysplastic syndrome (MDS), myelodysplastic/myeloproliferative neoplasms, or biphenotypic leukemia; patients with treatment-related AML (t-AML) will be eligible, provided they meet all other eligibility criteria; current disease status must be one for which there is no known curative therapy or therapy proven to prolong survival with an acceptable quality of life; patients must meet one of the following criteria:\r\n* First or greater relapse\r\n* Refractory to or more courses of induction or reinduction chemotherapy\r\n* First or greater relapse after allogeneic hematopoietic stem cell transplantation (HSCT)
Newly Diagnosed De novo AML according to WHO criteria except for Acute Promyelocytic Leukemia or patients with known favorable cytogenetics
All categories of AML will be included except for acute promyelocytic leukemia (APL) (AML-M as defined by French-American-British [FAB] classification, or APL with t(;)(q;q); PML-RARA as defined by the revised World Health Organization [WHO] classification of myeloid neoplasms and acute leukemias), acute megakaryocytic leukemia (AML-M type as per FAB or AML [megakaryoblastic] with t(;)(p;q); RBM-MKL as per WHO revised classification) and acute leukemias of ambiguous lineage (as per WHO revised classification), undergoing + remission IC with cytarabine and an anthracycline (daunorubicin or idarubicin); all cases have to be histopathologically confirmed by a diagnostic bone marrow biopsy; use of granulocyte colony-stimulating factor (G-CSF) for any indication must have been discontinued at least days prior to entry into the study
Patients must have a documented Unequivocal diagnosis of AML according to WHO classification (>% blasts in the bone marrow), excluding M (acute promyelocytic leukemia).
Subject has confirmed morphologically documented AML, excluding acute promyelocytic leukemia (APL), in CR (including CRp and CRi). For the purposes of enrollment, CR will be defined as < % blasts in the bone marrow with no morphologic characteristics of acute leukemia (e.g., Auer rods) in the bone marrow with no evidence of extramedullary disease such as central nervous system involvement or granulocytic sarcoma.