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+Current or prior diagnosis of AML
+Patients may not have features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated
+Patients must not have treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic syndrome (MDS) or features suggestive of AML/MDS
+Patients must be suspected to have previously untreated acute myelogenous leukemia (AML) or myelodysplastic syndrome with excess blasts-2 (MDS-EB-2)
+Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML
+Patients with promyelocytic leukemia (French-American-British [FAB] M3)
+No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear
+Must not have received systemic antineoplastic therapy including radiation therapy within 14 days of the study enrollment, except hydroxyurea or 6-mercaptopurine for the purposes of cytoreduction; patients may also have received all-trans retinoic acid (ATRA) if there is an early suspicion of acute promyelocytic leukemia (acute promyelocytic leukemia [APL], M3-AML), although if confirmed to have APL these patients will be excluded from the study
+Patient has acute promyelocytic leukemia (APML)
+Participants with a previously documented diagnosis of myelodysplastic syndrome (MDS) (or any dysplastic leukocyte morphology suggestive of MDS) or acute myeloid leukemia
+Patients must have previously untreated MDS or AML according to the WHO 2016 classification.
+Confirmed diagnosis of primary or secondary AML [any subtype except acute promyelocytic leukemia (APL)] according to World Health Organization (WHO) classification or MDS with an International Prognostic Scoring System (IPSS) risk category of Intermediate 2 or High Risk
+Dose Escalation - Relapsed or refractory AML (excluding acute promyelocytic leukemia) or PDCN, based on World Health Organization Classification. All patients enrolled on this study will have CD123+ disease.
+Patients with myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML
+Diagnosis of AML per World Health Organization (WHO) criteria (except acute promyelocytic leukemia)
+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.
+Relapsed or refractory acute myelocytic leukemia (AML) with nucleophosmin-1 (NPM1) mutations and no available therapies.
+Relapsed or refractory acute promyelocytic leukemia (APL), with no available therapies. Note: Prior exposure to arsenic trioxide is allowed; however, subjects who have failed arsenic trioxide within the last 12 months are not allowed.
+Subject has a diagnosis of acute promyelocytic leukemia (APL)
+COHORT 1: Have histologically or cytologically confirmed relapsed or refractory AML (i.e. >= 5 % blasts by manual differential on bone marrow aspirate / biopsy / flow cytometry), excluding acute promyelocytic leukemia (APL; FAB M3; t [15; 17])
+COHORT 2: Have histologically and cytologically confirmed newly diagnosed AML (i.e. >= 20% blasts by manual differential on bone marrow aspirate/biopsy and/or in peripheral blood), excluding acute promyelocytic leukemia (APL; FAB M3, t [15;17])
+No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear
+Prior history of acute leukemia or AML
+Documented AML by peripheral blood or bone marrow analyses meeting World Health Organization (WHO) criteria, excluding patients with acute promyelocytic leukemia (APL)
+A diagnosis of acute promyelocytic leukemia as defined by the 2008 World Health Organization classification system
+Acute myelogenous leukemia (AML):
+Known history of MDS or AML
+Patients with Down syndrome, acute promyelocytic leukemia, juvenile myelomonocytic leukemia, or bone marrow failure syndromes are not eligible
+Newly diagnosed with acute myelogenous leukemia (except acute promyelocytic leukemia) and has failed one or two prior standard induction attempts. Failure is defined as:
+Subjects with any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
+Subject is diagnosed as acute promyelocytic leukemia (APL).
+diagnosis of AML
+Patients with mature B-cell ALL or acute myelogenous leukemia (AML)
+Acute Myelogeneous Leukemia (AML) in CR1 that is NOT considered as favorable-risk. Favorable risk is defined as having one of the following: t(8.21) without CKIT mutation, inv(16) without CKIT mutation or t(16;16), normal karyotype with mutated NPM1 and not FLT-ITD, normal karyotype with double mutated CEBPA, Acute promyelocytic leukemia (APL) in first molecular remission at end of consolidation
+Pathologically-confirmed diagnoses of relapsed AML: patients with AML that have relapsed at least once or are primary induction failure will be eligible
+Acute progranulocytic leukemia (APL, M3)
+Diagnosed with acute promyelocytic leukemia (APL, M3)
+Acute promyelocytic leukemia (APL, French-American-British (FAB) subtype M3), according to WHO classification.
+Acute promyelocytic leukemia
+AML as defined by the WHO Classification persisting or recurring following one or more treatment courses except promyelocytic leukemia (APML) and except AML secondary to prior myelodysplastic syndrome. For Germany only: AML as defined by the WHO Classification either persisting/refractory after at least 2 primary induction courses (ie, no response after at least 2 prior chemotherapy cycles) or recurring after having achieved an initial response to chemotherapy except promyelocytic leukemia (APML) and except AML secondary to prior myelodysplastic syndrome.
+AML (with the exception of AML M3), patients with relapsed or refractory AML following treatment with cytotoxic chemotherapy or a targeted or biologic agent
+AML (with the exception of AML M3):
+A diagnosis of recurrent, persistent, or progressive acute myelogenous leukemia (AML), defined as >= 5% blasts in a patient with known prior history of AML, or recurrent, persistent, or progressive myelodysplastic syndrome (MDS) according to World Health Organization (WHO) criteria
+World Health Organization (WHO)-confirmed acute myeloid leukemia (AML)
+Patients with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear
+Diagnosis of acute promyelocytic leukemia (M3 classification)
+Patients with acute myelogenous leukemia (AML) who are in first or second complete remission
+Subject must have confirmation of non-acute promyelocytic leukemia (APL) AML by World Health Organization (WHO) criteria and be ineligible or unwilling to undergo treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidities or other factors
+Subject has acute promyelocytic leukemia
+Subjects with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of \r\nmyelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
+Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML)
+an established, confirmed diagnosis of AML by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3; and
+Patients with AML or biphenotypic or bilineage leukemia (including a myeloid component) who have failed prior therapy; patients with AML should have failed prior therapy or have relapsed after prior therapy; patients with isolated extramedullary AML are eligible
+AML patients with prior history of MDS or CMML who received therapy for the MDS or CMML and progressed to AML, are eligible at the time of diagnosis of AML regardless of any prior therapy for MDS; the World Health Organization (WHO) classification will be used for AML
+Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British [FAB] class M3-AML)
+Patient with AML according to 2016 WHO criteria (excluding acute promyelocytic leukemia [APL] [AML-M3])
+ARMS A-G: RR AML: Patients with AML who are refractory or relapsed (any salvage) with no available therapies or not candidates for available therapies. For patients with prior MDS or chronic myelomonocytic leukemia (CMML) or myeloproliferative neoplasm (MPN) who transformed to AML, therapy received for MDS, CMML, or MPN is NOT considered as prior therapy for AML.
+Acute promyelocytic leukemia (APL).
+Patients with myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML), or features suggestive of MDS/AML
+Previously untreated AML (de novo or secondary) defined according to World Health Organization (WHO) criteria, excluding APL [AML with t(15;17)], with locally documented IDH1 and/or IDH2 gene mutation scheduled for induction therapy followed by consolidation therapy. Secondary AML is defined as AML arising after myelodysplastic syndromes (MDSs) or other antecedent hematologic disorders (AHDs) or AML arising after exposure to genotoxic injury including radiation and/or chemotherapy. Subjects may have had previous treatment for MDS or other AHD, including hypomethylating agents (HMAs), provided that the last dose of administration is ? 14 days prior to study drug initiation
+Participant must have confirmation of Acute Myeloid Leukemia (AML) by World Health Organization (WHO) criteria, previously untreated and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due age or comorbidities.
+Experimental therapies for MDS or Acute Myeloid Leukemia (AML).
+Participant has acute promyelocytic leukemia
+Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
+Patients with previously untreated AML (except acute promyelocytic leukemia [APL]) who have at least one of the following:\r\n* Adverse genetic features as per the European Leukemia Net guidelines\r\n* Treatment related AML or AML with antecedent myelodysplastic syndrome (MDS); (patient who have received treatment with hypomethylating agents for MDS and have now transformed to AML are eligible)\r\n* Are over the age of 55 years and considered fit for chemotherapy\r\n* Patients with AML with MDS-related changes
+World Health Organization (WHO)-confirmed AML, other than acute promyelocytic leukemia (APL), with no standard treatment options available
+Subjects diagnosed with Acute Promyelocytic Leukemia.
+Has a diagnosis of acute promyelocytic leukemia (APL) as defined by the World Health Organization
+Acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or myelodysplastic syndrome (MDS) in confirmed relapse based on bone marrow examination after allogeneic HCT; biopsy confirmed myeloid sarcoma or extramedullary AML may also be considered
+Within 7 days prior to administration of study treatment: No features suggestive of myelodysplastic syndrome/acute myeloid leukemia on peripheral blood smear.
+Acute promyelocytic leukemia (APL); patients with brief exposure to all-trans retinoic acid (ATRA), arsenic trioxide (ATO) or similar product for suspected APL, who later turn out not to have APL, are eligible for the study
+Patients with t(15;17) karyotypic abnormality or acute promyelocytic leukemia (French-American-British [FAB] class M3-AML)
+Patient must not have any known history of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
+Acute Promyelocytic Leukemia
+Known myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
+Patients with a diagnosis of acute promyelocytic leukemia
+Diagnosis of acute promyelocytic leukemia (APL M3): t(15;17)(q22;q12); (promyelocytic leukemia [PML]/retinoic acid receptor [RAR] alpha [a]) and variants excluded.
+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-2 (INT-2) or high-risk MDS\r\n* Relapsed or refractory AML, or INT-2 or high-risk MDS
+Participant must have histological confirmation of Acute Myeloid Leukemia (AML) by World Health Organization criteria, be ineligible for intensive induction chemotherapy and either be:
+Participants that have acute promyelocytic leukemia (APL).
+Diagnosis of acute myeloid leukemia (AML) (other than acute promyelocytic leukemia [APL]) with refractory/relapsed disease; patients with relapsed/refractory high-risk ([intermediate-2 or higher by International Prognostic Scoring System [IPSS] and/or >= 10% blasts]). Myelodysplastic syndrome (MDS) will also be eligible. (Treatment approach for relapsed/refractory AML is very similar to that of high risk MDS)
+Acute promyelocytic leukemia with PML-RARA or t(15;17)
+Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome/acute myeloid leukemia (MDS/AML)
+Patients with myelodysplastic syndrome/acute myeloid leukaemia or with features suggestive of MDS/AML
+Acute promyelocytic leukemia (APL, M3 subtype of AML) or patients with a t(9:22) cytogenetic translocation.
+Patients may not have features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated
+AML ONLY: Acute promyelocytic leukemia (PML-RARA rearranged- AML-M3)
+Diagnosis of untreated “high-grade” myeloid neoplasm (>= 10% myeloid blasts by morphology in bone marrow and/or peripheral blood) or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2016 World Health Organization (WHO) classification; patients with acute leukemias of ambiguous lineage are eligible; outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution and cytogenetic/molecular information is available
+Patients with cytologically confirmed and documented de novo, secondary or therapy-related AML, excluding acute promyelocytic leukaemia (APL, French-American British M3 classification):
+Patients with AML who are refractory (up to salvage 2) or relapsed (up to 2nd relapse); for patients with prior myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) or myeloproliferative neoplasm (MPN) who transformed to AML, therapy received for MDS, CMML, or MPN is NOT considered as prior therapy for AML
+Acute promyelocytic leukemia (APL)
+Known history or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
+For patients with newly diagnosed disease: diagnosis of “high-grade” MDS (>= 10% blasts by morphology) or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2016 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 2003 recommendations of the International Working Group, requiring first or subsequent salvage therapy; patients with mixed phenotype acute leukemia (MPAL) are eligible
+Acute promyelocytic leukemia
+Patients with acute promyelocytic leukemia
+Patients must have histologically or cytologically documented newly diagnosed de novo acute myeloid leukemia (non-acute promyelocytic leukemia [APL]) that has not yet been treated; hydrea and all-trans retinoic acid (ATRA) previous treatments are acceptable
+Patients must not have a secondary acute myeloid leukemia (AML) (defined as a history of prior radiation therapy or systemic chemotherapy, antecedent myelodysplastic syndrome [MDS], myeloproliferative neoplasm [MPN] or chronic myelomonocytic leukemia [CMML])
+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
+Untreated secondary AML, including AML that has progressed from myelodysplastic syndrome (MDS)
+Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA
+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)
+Acute promyelocytic leukemia (M3 leukemia, per French-American-British classification)
+Diagnosis acute promyelocytic leukemia (APL) with t(15;17)(q22;q12); promyelocytic leukemia-retinoic acid receptor alpha (PML-RARA)
+Secondary AML (defined as development of AML in patients with an antecedent hematological malignancy)
+Newly diagnosed disease with either a diagnosis of “high-risk” MDS (>= 10% blasts in marrow or blood), high-risk myeloproliferative neoplasm (MPN; >= 10% blasts in blood or bone marrow), or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2008 World Health Organization (WHO) classification; patients with biphenotypic AML are eligible; such “high-risk” MDS or MPN have natural history much closer to AML than to lower risk MDS or MPN and have responded similarly to “AML-type” therapy
+Has a diagnosis of acute promyelocytic leukemia (APL) as defined by the World Health Organization
+Acute promyelocytic leukemia (APL, M3) unless failed regimens that included tretinoin, arsenic trioxide, anthracyclines and cytarabine and currently NOT candidates for stem cell transplantation
+Diagnosis of AML according to World Health Organization (WHO) 2008 criteria; therapy related AML may be included if in complete response and off treatment for their prior malignancy for more than 2 years; AML arising after documented myeloproliferative disease (MPD) are excluded
+Patient with documented acute promyelocytic leukemia (PML) and/or PML- retinoic acid receptor (RAR) transcript
+All patients with histologically or cytologically confirmed relapsed or refractory AML (except acute promyelocytic leukemia); relapsed disease or refractory (refractory to a non-high-dose cytarabine-containing regimen only); receiving 1st, 2nd or 3rd salvage; any cytogenetic or molecular abnormality; patients with secondary AML (after prior myelodysplasia or therapy for other cancers) will be included
+All patients with histologically or cytologically confirmed relapsed or refractory acute myeloid leukemia (AML) (except acute promyelocytic leukemia) or relapsed or refractory high-risk myelodysplastic syndrome (HRMDS) (intermediate 2 [Int-2] or higher risk by International Prognostic Scoring System [IPSS]); patients with chronic myelomonocytic leukemia (CMML) can be enrolled if they can be classified as HRMDS using MDS criteria; patients should not have received more than one salvage therapy; second induction regimen or stem cell transplant in remission will be considered salvage therapy; refractory subjects, up to second consecutive salvage
+Patients must have histologic evidence of high risk acute myeloid leukemia defined as one of the following:\r\n* Primary refractory non-M3 AML\r\n** Residual leukemia after a minimum of 2 prior courses of chemotherapy (same or different)\r\n** Evidence of leukemia recurrence after a nadir bone marrow biopsy demonstrates no evidence of residual leukemia\r\n** Evidence of leukemia after induction therapy which, in the opinion of the investigator, would be appropriate for reinduction with sirolimus/MEC therapy\r\n* Relapsed non-M3 AML\r\n* Previously untreated non-M3 AML age > 60 with no evidence of favorable karyotype defined by presence of t(8;21)(q22;q22) [AML1-ETO], inversion (inv)16(p13;q22), or t(16;16)(p13;q22) [core-binding factor (CBF)beta; myosin, heavy chain (MYH)11] by cytogenetics, fluorescence in situ hybridization (FISH), or real time-polymerase chain reaction (RT-PCR)\r\n* Previously untreated secondary AML (from antecedent hematologic malignancy or following therapy with radiation or chemotherapy for another disease) with no evidence of favorable karyotype defined by presence of t(8;21)(q22;q22) [AML1-ETO], inv16(p13;q22), or t(16;16)(p13;q22) [CBFbeta;MYH11] by cytogenetics, FISH, or RT-PCR
+Subjects with French American British (FAB) M3 (t (15; 17) (q22; q21) [promyelocytic leukemia (PML)-retinoic acid receptor (RAR) alpha]) are not eligible
+Patients must have a diagnosis of acute myeloid leukemia (AML) according to World Health Organization (WHO) criteria; therapy-related and secondary AML (arising after a period of myelodysplastic syndrome [MDS]) allowed; prior treatment for MDS with hypomethylator-based therapy and lenalidomide allowed, but not allowed if used after the diagnosis of AML is made, since enrollment to this study is not for relapsed AML
+Prior chemotherapy treatment for AML (prior treatment with hydroxyurea and/or leukapheresis to control white blood cell count, or all-trans retinoic acid [ATRA] for suspected acute promyelocytic leukemia [APML] is acceptable); prior chemotherapy for MDS or myeloproliferative neoplasms (MPN) such as azacitidine, decitabine, and thalidomide, is permitted, but such treatments once MDS or MPN has transformed to AML is not permitted
+APL (acute promyelocytic leukemia) by WHO criteria [AML with t(15;17)]
+Documented/confirmed first/second refractory/relapsed AML using World Health Organization classification, except acute promyelocytic leukemia
+AML secondary to any prior chemotherapy unrelated to leukemia
+Acute promyelocytic leukemia
+Diagnosis of acute promyelocytic leukemia
+No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear (measured within 28 days prior to administration of study treatment)
+Subjects with acute promyelocytic leukemia (APL)
+No features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated
+Patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) who received therapy for the MDS or CMML and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML; the World Health Organization (WHO) classification will be used for AML; prior therapy for MDS or CMML will not be considered as a prior therapy for AML
+Acute promyelocytic leukemia (APL)
+Must have a histopathologically documented diagnosis of primary or secondary AML (excluding acute promyelocytic leukemia), as defined by World Health Organization (WHO) criteria (Jaffe et al, 2001), for whom no standard therapies are anticipated to result in a durable remission according to the clinical judgment of the principal investigator, or who refuses standard therapies (phase 1b and 2).
+Has a diagnosis of acute promyelocytic leukemia.
+Diagnosis of acute promyelocytic leukemia (APL), AML - M3 by French American British (FAB) classification based on morphology, immunophenotype, molecular, or cytogenetics studies
+Acute promyelocytic leukemia (French-American-British [FAB] M3 AML)
+Patients with acute myeloid leukemia (AML) in first remission after one course of induction and with favorable cytogenetics (t[8;21], inv 16, or t[15;17]) and/or molecular profile (nucleophosmin [NPM]1)
+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
+For Phase II only: Patients (any age) with MDS or CMML who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML. The WHO classification will be used for AML
+Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB] classification M3 or WHO classification of APL with t (15;17)(q22;q12), promyelocytic leukemia protein [PML]/retinoic acid receptor alpha [RARa] and variants)
+Relapsed or refractory AML
+Acute myeloid leukemia (AML) in 1st remission – for patients whose AML does not have ‘good risk’ cytogenetic features (i.e. t8;21, t15;17, inv 16)
+High risk acute myelogenous leukemia or high risk myelodysplastic syndrome (Revised International Prognosis Scoring System [r-IPSS] score 3 or above) status post allogeneic bone marrow transplant from matched related or unrelated donors; high risk acute myeloid leukemia (AML) patients in this study are defined as AML patients with residual leukemia at the time of transplant, very poor cytogenetics (i.e. deletion 3 or monosomy 3, deletion 7 or monosomy 7 and complex cytogenetics) or secondary AML; patients with acute promyelocytic leukemia are not eligible for this study
+History of cytologically or histologically confirmed diagnosis of AML (except acute promyelocytic leukemia) according to the 2008 World Health Organization (WHO) classification (bone marrow [BM] or peripheral blood [PB] blast counts ?20%).
+Subjects with relapsed/refractory AML must have received either induction chemotherapy for AML or hypomethylating agents for hematologic disease before AML.
+Have an established, pathologically confirmed diagnoses of AML by World Health Organization (WHO) criteria excluding acute promyelocytic leukemia (APL-M3) with a bone marrow of >5% blasts based on histology or flow cytometry
+Diagnosed with acute promyelocytic leukemia (APL, M3)
+Subjects with acute promyelocytic leukemia (M3)
+AML (acute promyelocytic leukemia [APL] excepted) or high-risk MDS (10-19% blasts in marrow by morphology or flow cytometry or blood)
+AML is of the sub-type of acute promyelocytic leukemia
+Acute myeloid leukemia (AML) after first relapse or with primary refractory disease
+History or current diagnosis of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
+Acute Leukemia (AML or ALL) patient or allo-HCT recipient with a diagnosis of IA
+AML either de novo or secondary who either :
+Patient with AML-M3 (APL)
+Has acute promyelocytic leukemia (APL, FAB M3).
+Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic Syndromes (MDS)/acute myeloid leukemia (AML).
+Diagnosis of acute promyelocytic leukemia (APL, or AML M3 subtype).
+Has acute promyelocytic leukemia (AML subtype M3)
+Diagnosis of untreated “high-grade” myeloid neoplasm (? 10% blasts in blood or bone marrow) or acute myeloid leukemia (AML) other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2016 World Health Organization (WHO) classification; outside diagnostic material is acceptable to establish diagnosis; submission of peripheral blood specimen for  flow cytometry performed at the study institution should be considered; diagnostic material must have been submitted for cytogenetic and/or molecular testing as clinically appropriate
+Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
+Diagnosis of acute myeloid leukemia (AML) by World Health Organization criteria excluding acute promyelocytic leukemia (APL)-M3.
+Acute promyelocytic leukemia (APL)
+Acute promyelocytic leukemia
+Patients must have histologically or cytologically documented newly diagnosed acute myeloid leukemia (non-acute promyelocytic leukemia [APL]) that has not yet been treated; hydroxyurea (Hydrea) and tretinoin (ATRA) previous treatments are acceptable
+Patients with myelodysplastic syndrome(MDS)/acute myeloid leukemia (AML) or with features suggestive of MDS/AML.
+EXPANSION COHORT: Patients must have a diagnosis of newly diagnosed AML with any of the following:\r\n* Confirmed translocation involving 11q23\r\n* Partial tandem duplication (PTD) of the MLL gene (on 11q23)\r\n* FLT3-ITD (internal tandem duplication)\r\n* Increased Fgf2 in serum (2 standard deviations above control serum samples)\r\n* HOX(A9/A10) over-expression in bone marrow (2 standard deviations above control values in CD34+ cells from normal subjects)\r\n* Note: Patients with secondary AML are eligible for enrollment into the trial (in both cohorts); secondary AML is defined as AML that has developed in a person with a history of antecedent blood count abnormalities, or myelodysplastic syndromes (MDS), or a myeloproliferative disorder (excluding chronic myeloid leukemia); or a history of prior chemotherapy or radiation therapy for a disease other than AML
+Patients with acute promyelocytic leukemia (APL) are not eligible
+Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML).
+Patients must have relapsed/refractory disease; patients with secondary AML (including those progressing from MDS or myeloproliferative neoplasm [MPN], and those with AML secondary to chemotherapy or radiotherapy for other malignancies) are eligible whether they have received prior therapy for AML or not
+Patients must have one of the following diagnoses:\r\n* Acute myeloid leukemia fulfilling the criteria of the World Health Organization (WHO) classification, or\r\n* > 5% but < 20% marrow myeloblasts and evidence of a clonal de novo AML genetic abnormality [e.g., t(8;21), inv(16), t(9;11)], or\r\n* Myeloid sarcoma (also referred to as extramedullary myeloid tumor, granulocytic sarcoma, or chloroma), with or without evidence of a leukemia process in the bone marrow or peripheral blood, with confirmation of myeloid differentiation, or\r\n* High grade myelodysplastic syndrome (MDS) with greater than 5% blasts, or\r\n* Patients with treatment related myeloid neoplasms including AML and MDS, provided their cumulative anthracycline dose has not exceeded 230 mg/m^2 doxorubicin equivalents
+Acute promyelocytic leukemia (APL)
+Cohort Inclusion Criteria - Group A: Subjects must have previously untreated acute myeloid leukemia (AML) according to the WHO classification with no prior treatment other than hydroxyurea. Prior therapy for myelodysplastic syndrome (MDS), myeloproliferative syndromes (MPD), or aplastic anemia is permitted but not with hypomethylating agents.
+Acute promyelocytic leukemia
+Participants with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML)
+Patients with acute promyelocytic leukemia (French-American-British [FAB] class M3 AML)
+Patients with acute promyelocytic leukemia (APL) confirmed either by the presence of t(15;17)(q22;q21) or promyelocytic leukemia (PML)/retinoic acid receptor (RAR) alpha transcripts will be excluded
+Patients with secondary AML are eligible for enrollment onto the trial; secondary AML is defined as AML that has developed in a person with a history of antecedent blood count abnormalities, or myelodysplastic syndrome (MDS), or a myeloproliferative disorder (excluding chronic myeloid leukemia); or a history of prior chemotherapy or radiation therapy for a disease other than AML\r\n* NOTE: Prior therapy of MDS with decitabine, low-dose cytarabine, or azacitidine is excluded
+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-M3 (acute promyelocytic leukemia) was being ruled out, and which has been discontinued, will be eligible
+A diagnosis of acute myeloid leukemia (AML) according to the World Health Organization 2008 criteria with relapsed or refractory disease and ineligible for or have exhausted standard therapeutic options
+Acute promyelocytic leukemia
+Subject has a diagnosis of acute promyelocytic leukemia
+TREATMENT: Patients with treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic syndrome (MDS), or with features suggestive of AML/MDS, or who have had prior allogeneic bone marrow transplant or double umbilical cord blood transplantation, should not receive veliparib due to reports of MDS and leukemia secondary to oncology therapy on Cancer Therapy Evaluation Program (CTEP)-sponsored studies utilizing veliparib
+No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear
+Patients with myelodysplastic syndrome/acute myeloid leukemia or with features suggestive of MDS/AML
+No features suggestive of myelodysplastic syndrome (MDS)/acute myeloid leukemia (AML) on peripheral blood smear
+>= 55 years of age with AML of any risk classification, or 18-54 years of age with high-risk AML disease based on one of the following:\r\n* Antecedent hematologic disorder including myelodysplasia (MDS)-related AML (MDS/AML) and prior myeloproliferative disorder (MPD)\r\n* Treatment-related myeloid neoplasms (t-AML/t-MDS)\r\n* AML with FLT3-ITD\r\n* Myeloid sarcoma\r\n* AML with multilineage dysplasia (AML-MLD)\r\n* Adverse cytogenetics (defined as -5/-5q; -7/-7q; abnormal 3q, 9q, 11q, 20q, 21q or 17p; t(6;9); t(9;22); trisomy 8; trisomy 13; trisomy 21; complex karyotypes (>= 3 clonal abnormalities); monosomal karyotypes
+Patients with acute promyelocytic leukemia (APL) as diagnosed by morphologic criteria, flow cytometric characteristics, and rapid cytogenetics or FISH or molecular testing
+Patients with secondary AML or therapy related disease (t-AML) are eligible
+Acute Promyelocytic Leukemia
+No features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy
+Patients with newly diagnosed or relapsed/refractory AML, except acute promyelocytic leukemia (APL), requiring intensive induction chemotherapy
+Patients must have newly diagnosed, previously untreated acute myeloid leukemia (AML) (excluding M3)
+Patients with acute promyelocytic leukemia confirmed with t(15;17) (French-American-British Classification [FAB] subtype M3 and M3 variant)
+AML, other than acute promyelocytic leukemia (APL), in first or second remission or with minimal residual disease
+Patients with acute promyelocytic leukemia
+Patients must have histologically or cytologically confirmed acute myeloid leukemia (AML) by World Health Organization (WHO) criteria in the blood and/or marrow AND age >= 60 and not candidates/refuse standard induction treatment OR who have one of the following: poor risk cytogenetics, AML following antecedent hematologic disorder, or therapy-related AML
+Diagnosis of acute myeloid leukemia (AML) as defined by the World Health Organization
+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(8;21), inv(16), t(16;16), or t(15;17)identified by metaphase karyotype\r\n* The absence of t(8;21), inv(16), t(16;16), or t(15;17) identified by fluorescent in situ hybridization(FISH)\r\n* The absence of the corresponding fusion transcripts, AML1-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] M3)
+Subjects with untreated AML, if not candidates for standard induction chemotherapy or with poor risk AML (i.e. preceding myelodysplastic syndromes [MDS], myeloproliferative syndromes, leukemia due to cytotoxic chemotherapy for another condition, adverse cytogenetics or complex karyotype), acute promyelocytic leukemia (French-American-British [FAB] M3) is excluded
+Acute promyelocytic leukemia (FAB M3)
+Patients with evidence of myelodysplastic syndromes (MDS)/acute myeloid leukemia (AML) or abnormal cytogenetics analysis indicative of MDS on the pre-transplant bone marrow examination
+Subject has a diagnosis of primary acute myeloid leukemia (AML) or AML secondary to myelodysplastic syndrome (MDS) according to WHO classification (2008) as determined by pathology review at the treating institute.
+Subject was diagnosed as acute promyelocytic leukemia (APL).
+Morphologically documented primary Acute Myeloid Leukemia (AML) or AML secondary to Myelodysplastic Syndrome (MDS), as defined by World Health Organization (WHO) criteria, as determined by pathology review at the study site.
+Acute Promyelocytic Leukemia (AML subtype M3).
+AML secondary to prior chemotherapy for other neoplasms, except AML secondary to prior Myelodysplastic Syndrome (MDS).
+Subject has French-American-British classification (FAB) type M3 leukemia (acute promyelocytic leukemia) or identification of t(15;17).
+Known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML)
+Patients must not have known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML).
+Subjects must have confirmation of Acute Myeloid Leukemia (AML) by WHO criteria and be ineligible for treatment with a standard cytarabine and anthracycline induction regimen due to co-morbidity or other factors.
+Subject has acute promyelocytic leukemia.
+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 M3]) 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 M3]) or confirmed by hematopathology (BPDCN)
+The patient has a diagnosis of acute promyelocytic leukemia (APL; FAB M3).
+Diagnosis of AML according to WHO criteria 2016.
+Acute promyelocytic leukemia (FAB M3 classification)
+AML (including secondary AML) diagnosed as per WHO criteria
+Acute promyelocytic leukemia
+Newly diagnosed, histologically confirmed de novo AML or AML secondary to prior myelodysplastic disease or CMML (Chronic myelomonocytic leukemia)
+AML secondary to prior MDS, or
+Suspected or proven acute promyelocytic leukemia (French-American-British (FAB) M3) based on morphology, immunophenotype, molecular assay, or karyotype; AML associated with t(9;22) karyotype, biphenotypic acute leukemia or AML with previous hematologic disorder such as chronic myelogenous leukemia or myeloproliferative neoplasms.
+For patients registered to the relapsed/refractory cohort (Cohort 2), patients must have a previous morphologically confirmed diagnosis of acute myeloid leukemia (AML)\r\n* For patients registered to the myelodysplastic syndromes (MDS) transformed to AML cohort (Cohort 1), patients must have a previous morphologically confirmed diagnosis of MDS/chronic myelomonocytic leukemia (CMML); patients may have received previous non-intensive therapy (e.g. azacitidine, decitabine, low-dose cytarabine [LDAC], lenalidomide) given for treatment of MDS/CMML (with up to 20% blasts); at the time of registration they must have a morphologically confirmed diagnosis of AML\r\n* Note: This protocol uses the World Health Organization (WHO) diagnostic criteria for AML; patients with acute promyelocytic leukemia (APL, French American British [FAB], M3) or blastic transformation of chronic myelogenous leukemia are not eligible
+Diagnosis of acute promyelocytic leukemia (APL)
+Acute Promyelocytic Leukemia
+Acute myeloid leukemia (AML)
+No Patients with treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic syndrome (MDS) or with features suggestive of AML/MDS
+A history of other primary invasive malignancy that has not been in remission for at least 3 years or a current diagnosis of myelodysplastic syndrome (MDS) or an immature leukemia such as acute myeloid leukemia (AML)
+CD30 expressing acute myeloid leukemia (AML), as identified by flow cytometric analysis, or by immunohistochemistry when 2+ or 3+ staining is present in greater than or equal to 20% of the myeloblasts in the bone marrow specimen
+Diagnosis of acute promyelocytic leukemia
+The diagnosis of AML-M3 (acute promyelocytic leukemia) characterized by translocations involving the retinoic acid receptor-alpha (RAR-alpha) gene
+AML patients include de novo AML, AML evolving from MDS or other AHD and AML after previous cytotoxic therapy or radiation (secondary AML)
+AML M3 Acute Promyelocytic Leukemia (APL) or patients with a t(9:22) cytogenetic translocation.
+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], M3) or blastic transformation of chronic myelogenous leukemia (CML) are not eligible
+Patients who have received prior induction chemotherapy for AML or myelodysplastic syndrome (MDS); temporary prior measures such as apheresis or hydroxyurea are allowed; patients who have received a limited and short-term exposure of ATRA (all trans retinoic acid) while AML-M3 (acute promyelocytic leukemia) was being ruled out, and which has been discontinued, will be eligible
+Patients presenting with an AHNMD requiring immediate cytoreductive therapy or targeted drugs (e.g. acute myeloid leukemia [AML])
+Patients with myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) who received therapy for the MDS or CMML and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML; the World Health Organization (WHO) classification will be used for AML
+Acute promyelocytic leukemia (APL)
+Patients with secondary AML or therapy related disease (t-AML) are eligible; patients who received decitabine or 5-azacytidine as prior treatment for myelodysplastic syndrome (MDS) remain eligible
+Pathological diagnosis of AML according to World Health Organization (WHO) criteria (with at least 20% 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
+Patients with acute promyelocytic leukemia are excluded
+For patients with newly diagnosed disease: diagnosis of “high-risk” myelodysplastic syndrome (MDS) (>= 10% blasts) or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2008 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 M3 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 patient’s age not fit for standard therapy
+Patients with any of the following oncologic diagnoses are not eligible:\r\n* Any concurrent malignancy\r\n* Juvenile myelomonocytic leukemia (JMML)\r\n* Philadelphia chromosome positive AML\r\n* Biphenotypic or bilineal acute leukemia\r\n* Acute promyelocytic leukemia\r\n* Acute myeloid leukemia arising from myelodysplasia\r\n* Therapy-related myeloid neoplasms\r\nNote: enrollment may occur pending results of clinically indicated studies to exclude these conditions
+Acute promyelocytic leukemia with t(15;17)(q22;q12) and/or PML-RARA molecular rearrangement
+Patients with myelodysplastic syndrome (MDS)/ treatment-related acute myeloid leukemia (t-AML) or with features suggestive of MDS/AML
+Subject was diagnosed as acute promyelocytic leukemia (APL).
+Dose Escalation: Acute Promyelocytic Leukemia
+Have acute promyelocytic leukemia and the associated cytogenic translocation t:(15/17)
+Diagnosis of AML (AML de novo and post-MDS) or DLBCL
+Has acute promyelocytic leukemia, clinically uncontrolled disseminated intravascular coagulation, or peripheral cytopenia
+“High-risk SMM” per Mayo Clinic or Spanish PETHEMA (Treatment of Newly Diagnosed Patients with Acute Promyelocytic Leukemia) criteria
+Untreated, histological confirmed acute myeloid leukemia (AML) based on World Health Organization (WHO) 2008 criteria with either/or both:\r\n* FLT3 ITD mutation\r\n* FLT3 TKD mutation
+Diagnosis of AML-M3 (or acute promyelocytic leukemia)
+Acute promyelocytic leukemia (AML with t[15;17][q22;q11] and variants)
+Participants may not have any features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated
+Participant has acute promyelocytic leukemia (French-American-British Class M3 AML).
+Diagnosis of acute promyelocytic leukemia
+Acute promyelocytic leukemia (APL, M3) unless failed regimens that included tretinoin, arsenic trioxide, anthracyclines and cytarabine and currently NOT candidates for stem cell transplantation
+Patients with relapsed or refractory AML
+Patients with secondary AML or therapy related disease (t?AML) are eligible; patients who received decitabine or 5?azacytidine as prior treatment for myelodysplastic syndrome (MDS) or AML remain eligible; however, none of these agents is permitted within 6 months of study entry
+Patients with acute promyelocytic leukemia (French-American-British Cooperative group [FAB] M3)
+Acute promyelocytic leukemia [t(15;17)]
+Subject has a diagnosis of previously-untreated de novo acute myeloid leukemia (AML) according to WHO classification (2008) documented within 28 days prior to enrollment.
+Subject was diagnosed as acute promyelocytic leukemia (APL) or AML with good risk cytogenetics; t(8;21), inv(16) or t(16;16). (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 ASP2215 and be taken off trial).
+Treatment-related AML or acute promyelocytic leukemia (APL)
+Diagnosis of acute myelogenous leukemia (AML) according to World Health Organization (WHO) criteria;
+Acute myeloid leukemia (AML) diagnosed by morphologic, histochemical or cell surface marker criteria.
+Patients with AML must have either: (a) relapsed or refractory leukemia after receiving at least one prior conventional induction therapy. Those in early first relapse must not have a matched donor and/or they must not be a candidate for allogeneic stem cell transplantation (usually this would mean the patient is too ill, obese, has a co-morbid condition or is over the age of 55 years) or (b) poor-risk AML as defined below: (i) Treatment related AML, except if it is associated with favorable cytogenetics (e.g., inversion 16, t(16;16), t(8;21), t(15;17), and not a candidate for stem cell transplantation, or (ii) AML with an antecedent hematologic disease (e.g., MDS, myelofibrosis, polycythemia vera, etc.), and not a candidate for stem cell transplantation. (iii) De novo AML > 70 years of age. (iv) AML with unfavorable cytogenetics regardless of age (>18 years), if patients are not candidates for allogeneic transplantation. Unfavorable cytogenetics are the following: complex (>3 abnormalities), -7, -5, 7q-, 5q-, abnormalities of 11q23 excluding t(9;11), t(9;22), inversion 3, t(3;3), t(6;9). (c) Patients older than 60 years of age who had AML (i.e., > 20% bone marrow blasts) and no prior therapy for AML
+Acute promyelocytic leukemia (APL)
+Patients with relapsed/refractory disease must have morphologic proof (from bone marrow aspirate, smears or touch preps of bone marrow biopsy) of AML with >= 10% blasts within two weeks (14 days) prior to initiation of therapy\r\n* All immunophenotype and cytogenetic/molecular groups are eligible for participation except for acute promyelocytic leukemia (APL) (as proven by the presence of promyelocytic leukemia/retinoic acid receptor alpha [PML-retinoic acid-receptor-[RAR] alpha])
+Newly diagnosed AML (according to the World Health Organization [WHO] 2008 classification) except t(15;17), including:\r\n* De novo AML\r\n* Secondary AML\r\n* Secondary AML arising from previously diagnosed myelodysplastic syndromes (MDS) or other antecedent hematologic malignancy treated with deoxyribonucleic acid (DNA) methyltransferase inhibitor (DNMTi) (i.e., decitabine or azacitidine)
+Diagnosis of acute promyelocytic leukemia (APL)
+Patients with acute promyelocytic leukemia
+Patients must have histologic evidence of newly diagnosed acute myeloid leukemia (non-M3 AML) as documented by the presence of > 20% myeloid blasts in the bone marrow or a pathological diagnosis of granulocytic sarcoma, leukemia cutis or other pathologically confirmed extramedullary involvement of AML
+Subjects with acute promyelocytic leukemia (APL) - French-American-British Cooperative group (FAB) M3 (t(15;17)(q22;q21)[promyelocytic leukemia (PML)-retinoic acid receptor (RAR)]) are not eligible
+Untreated, histological confirmed acute myeloid leukemia (AML) based on World Health Organization (WHO) 2008 criteria with Kit expression (CD 117) of myeloblasts >= 20% by flow cytometry from bone marrow aspirate at diagnosis
+Diagnosis of AML-M3 (or acute promyelocytic leukemia)
+Cytologically/histologically confirmed acute myeloid leukaemia (AML) according to WHO classification; (except for acute promyelocytic leukaemia (APL).
+Acute promyelocytic leukaemia (French-American-British (FAB) classification subtype M3).
+Patient has acute promyelocytic leukemia (APL).
+Patients must have a diagnosis of AML or acute leukemia of ambiguous lineage according to World Health Organization (WHO) classification with >= 5% of disease in bone marrow (BM); patients with blast count < 5% are eligible if immunophenotype, molecular or cytogenetic signature are consistent with AML as determined by primary treating oncologist; patients with extramedullary disease, or biopsy-proven isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia cutis) are eligible regardless of marrow involvement
+AML or acute leukemia of ambiguous lineage:\r\n* If relapse AML or acute leukemia of ambiguous lineage:\r\n** Must have a prior diagnosis of AML or acute leukemia of ambiguous lineage and be in 1st or greater relapse as evidenced by morphology, immunophenotype, molecular or cytogenetic signature\r\n** Must not have received prior reinduction therapy for this relapse\r\n* If primary refractory AML or acute leukemia of ambiguous lineage:\r\n** Must have had a prior diagnosis of AML or acute leukemia of ambiguous lineage and\r\n** Must not have received more than 3 previous induction attempts\r\n* If primary AML or acute leukemia of ambiguous lineage newly diagnosed or in remission\r\n** Primary treating oncologist must have deemed patient unable to complete standard treatment therapy and selected FLAG as appropriate alternative regimen\r\n* If prior diagnosis of acute lymphoblastic leukemia must have evidence of transformation to AML or acute leukemia of ambiguous lineage as evidenced by morphology, immunophenotype, molecular or cytogenetic signature\r\n* Patients meeting above criteria are eligible regardless of central nervous system (CNS) classification
+Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16 if known at the time of randomization.
+Prior treatment intended for induction therapy of AML; only hydroxyurea is permitted for control of blood counts. For example, a patient with MDS that changes HMA dose and schedule after the diagnosis of AML is excluded. AML-type therapy, such as cytarabine alone (>1g/m2/day) or cytarabine plus an anthracycline as well as prior HSCT are also excluded.
+Patient must have non-M3 AML or MDS
+The patient must not have acute promyelocytic leukemia or t(15;17) observed by FISH
+Acute promyelocytic leukemia
+Confirmed primary AML relapsed or refractory after prior therapy, AML secondary to antecedent chemotherapy or radiation therapy, or AML due to prior myelodysplastic syndrome (MDS)/ myeloproliferative neoplasm (MPN) as defined by WHO criteria with presence of either FLT3 ITD and/or other FLT3 activating mutations
+For the phase II Portion of the study, only patients who are previously untreated for AML. 1. Patients with history of MDS who received therapy for MDS and progressed to AML are eligible at the time of diagnosis of AML. Only induction chemotherapy administered for AML will be considered for considerations of eligibility regarding prior therapy. Patients who received therapy for MDS before transforming to AML (e.g., with hypomethylating agents or lenalidomide) are eligible.
+Patients with treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic syndrome (MDS) or with features suggestive of AML/MDS. Prior allogeneic bone marrow transplant or double umbilical cord blood transplantation
+Acute promyelocytic leukemia (French-American-British [FAB] M3 AML)
+Patients with the diagnosis of Acute Myeloid or Lymphocytic Leukemia (AML or ALL) in first or second complete remission.
+Confirmed diagnosis of MDS using the World Health Organization (WHO) classification or a diagnosis of WHO myelodysplastic/ myeloproliferative neoplasm (MDS/MPN) or MDS refractory anemia with excess blast in transformation (RAEB-t) by French American British (FAB) classification (acute myeloid leukemia [AML] with 20-30% myeloblasts by WHO classification)
+Key Inclusion Criteria (Phase 1):\n\n        - Confirmed hematologic malignancy, including Acute Myeloid Leukemia (AML), Chronic\n        Lymphocytic Leukemia (CLL), Chronic Myelogenous Leukemia (CML), Acute Lymphocytic Leukemia\n        (ALL), Myelodysplastic Syndrome (MDS), Multiple Myeloma (MM), Myelofibrosis (MF),\n        Myeloproliferative Neoplasms (MPN) or MDS/MPN overlap diseases. (Once Phase 2 has started\n        subjects with AML will be eligible for inclusion in the Phase 1 portion of the study only\n        if their malignancy has been shown to have c-Cbl mutation, trisomy 3, trisomy 11, inv(16),\n        or elevated FLT3. [Other AML and subjects with MDS will no longer be eligible for\n        inclusion in the Phase 1 portion of the study]).\n\n        Key Inclusion Criteria (Phase 2):\n\n          -  Part A: AML or MDS patients with an acceptable level of EphA3 expression\n\n          -  Part B: MF patients with an acceptable level of EphA3 expression\n\n        Key Inclusion Criteria (Both Phases):\n\n          -  Confirmed hematologic malignancy refractory to or progressed following standard\n             treatments, or subjects not considered medically suitable to receive standard of care\n             treatment or who refuse standard of care treatment\n\n          -  Acceptable level of EphA3 expression\n\n          -  Eastern Cooperative Oncology Group (ECOG) ?1\n\n          -  Acceptable laboratory results\n\n        Key Exclusion Criteria (Both Phases):\n\n          -  For subjects with AML, more than 2 prior therapies for AML (induction and\n             consolidation with or without a hypomethylating agent given in a maintenance setting\n             are considered 1 therapy)\n\n          -  History of or current central nervous system (CNS) involvement that may increase risk\n             of bleeding\n\n          -  Recent major surgery\n\n          -  Ongoing surgical or wound healing complications\n\n          -  Active clinically significant bleeding\n\n          -  Uncontrolled hypertension\n\n          -  Significant intercurrent illness\n\n          -  Known history of prolonged bleeding times or platelet dysfunction\n\n          -  Active infection requiring IV antibiotics, IV antifungals, or IV antivirals within 2\n             weeks prior to Cycle 1, Day 1
+Key Inclusion Criteria (Phase 1):\n\n        - Confirmed hematologic malignancy, including Acute Myeloid Leukemia (AML), Chronic\n        Lymphocytic Leukemia (CLL), Chronic Myelogenous Leukemia (CML), Acute Lymphocytic Leukemia\n        (ALL), Myelodysplastic Syndrome (MDS), Multiple Myeloma (MM), Myelofibrosis (MF),\n        Myeloproliferative Neoplasms (MPN) or MDS/MPN overlap diseases. (Once Phase 2 has started\n        subjects with AML will be eligible for inclusion in the Phase 1 portion of the study only\n        if their malignancy has been shown to have c-Cbl mutation, trisomy 3, trisomy 11, inv(16),\n        or elevated FLT3. [Other AML and subjects with MDS will no longer be eligible for\n        inclusion in the Phase 1 portion of the study]).\n\n        Key Inclusion Criteria (Phase 2):\n\n          -  Part A: AML or MDS patients with an acceptable level of EphA3 expression\n\n          -  Part B: MF patients with an acceptable level of EphA3 expression\n\n        Key Inclusion Criteria (Both Phases):\n\n          -  Confirmed hematologic malignancy refractory to or progressed following standard\n             treatments, or subjects not considered medically suitable to receive standard of care\n             treatment or who refuse standard of care treatment\n\n          -  Acceptable level of EphA3 expression\n\n          -  Eastern Cooperative Oncology Group (ECOG) ?1\n\n          -  Acceptable laboratory results\n\n        Key Exclusion Criteria (Both Phases):\n\n          -  For subjects with AML, more than 2 prior therapies for AML (induction and\n             consolidation with or without a hypomethylating agent given in a maintenance setting\n             are considered 1 therapy)\n\n          -  History of or current central nervous system (CNS) involvement that may increase risk\n             of bleeding\n\n          -  Recent major surgery\n\n          -  Ongoing surgical or wound healing complications\n\n          -  Active clinically significant bleeding\n\n          -  Uncontrolled hypertension\n\n          -  Significant intercurrent illness\n\n          -  Known history of prolonged bleeding times or platelet dysfunction\n\n          -  Active infection requiring IV antibiotics, IV antifungals, or IV antivirals within 2\n             weeks prior to Cycle 1, Day 1
+AML-associated inv(16)/t(16;16)/del(16q), t(15;17) (i.e. promyelocytic leukemia) with/without secondary aberrations; t(8;21) lacking del (9q) or complex karyotypes
+Subjects with MDS/AML or with features suggestive of MDS/AML;
+No features suggestive of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML) on peripheral blood smear or bone marrow biopsy, if clinically indicated
+Confirmed diagnosis of non-acute promyelocytic leukemia (APL) AML (World Health Organization [WHO] criteria)
+Subjects with a diagnosis of Acute Promyelocytic Leukemia
+Patients with a diagnosis of acute myeloid leukemia (AML) (World Health Organization classification: >= 20% blasts in the bone marrow and/or peripheral blood) or myelodysplastic syndrome (MDS) (International Prognostic Scoring System intermediate-1 or higher) that at the time of allogeneic transplantation were in: - induction failure, relapsed disease or second or greater remission; patients in first complete remission that required more than 1 cycle of treatment to achieve the remission, or that have AML evolving from MDS, or that had the following abnormalities: FLT3 mutation, deletion of chromosome 5 or 7, mixed-lineage leukemia (MLL) gene rearrangement, or more than or equal to 3 cytogenetics abnormalities; patients with de novo or therapy-related MDS, chronic myelomonocytic leukemia (CMML) or AML are also eligible, regardless of cytogenetics or molecular rearrangements
+Patients must have one of the following three characteristics:\r\n* Acute myeloid leukemia fulfilling the criteria of the World Health Organization (WHO) classification\r\n* < 20% marrow myeloblasts and evidence of a clonal de novo AML genetic abnormality [e.g., t(8;21), inv(16), t(9;11)] \r\n* Myeloid sarcoma (also referred to as extramedullary myeloid tumor, granulocytic sarcoma, or chloroma), with or without evidence of a leukemic process in the bone marrow or peripheral blood, with confirmation of myeloid differentiation\r\n* Patients with secondary AML following treatment of primary malignancy are eligible
+Acute promyelocytic leukemia (APL)
+Newly diagnosed, previously untreated, cytologically/histologically confirmed de novo or secondary AML according to World Health Organization (WHO) classification (except for acute promyelocytic leukemia (APL))
+Promyelocytic leukemia
+Patients with a new diagnosis of histologically confirmed (according to World Health Organization [WHO] classification 2008) acute myeloid leukemia (either primary or secondary AML) are included
+Patients with a diagnosis of acute promyelocytic leukemia (according to WHO classification 2008)
+Secondary AML
+New diagnosis of AML, other than acute promyelocytic leukemia (APL) or poor-risk AML
+Patients with known acute promyelocytic leukemia (French-American-British class M3-AML)
+Relapsed/refractory acute myeloid leukemia (AML) except for acute promyelocytic leukemia
+Patients must have one of the following, histologically or cytologically confirmed:\r\n* Acute myeloid leukemia (AML) [non- acute promyelocytic leukemia (APL) AML]\r\n** If previously treated:\r\n*** AML that is relapsed or refractory to at least one prior line of therapy\r\n** If previously untreated, must meet all of the following:\r\n*** >= 60 years of age\r\n*** Secondary or therapy-related AML\r\n*** Does NOT bear favorable cytogenetic and/or molecular features, eg, core-binding factor abnormalities, FLT3 Internal Tandem Duplication (FLT3-ITD) negative/NPM1 mutated, biallelic CCAAT/enhancer binding protein alpha (CEBPA) mutation without FLT3-ITD\r\n* Chronic myeloid leukemia blast crisis (CML-BC)\r\n** Relapsed or refractory to at least one Bcr-Abl-TKI-containing regimen\r\n* Myelodysplastic syndrome (MDS), must meet all of the following:\r\n** Higher risk MDS [intermediate-2 or high risk by the original International Prognostic Scoring System (IPSS)]\r\n** Relapsed, refractory, or intolerant to at least one prior line of therapy containing hypomethylating agents (deoxyribonucleic acid [DNA] methyltransferase inhibitors)
+Acute promyelocytic leukemia (APL, M3)
+Acute promyelocytic leukemia (French-American-British Class M3 AML).
+Diagnosis of acute promyelocytic leukemia (APL, French-American-British [FAB] classification M3 or World Health Organization [WHO] classification of APL with t[15;17][q22;q12]), (progressive multifocal leukoencephalopathy [PML]/retinoic acid receptor alpha [RARa] and variants)
+Relapsed or refractory AML
+Acute myeloid leukemia (AML), except those patients with RAEB-t who are not candidates for intensive AML therapy.
+Acute promyelocytic leukemia (APL)
+Histologically proven non-M3 AML:\r\n* Refractory/relapsed AML OR\r\n* Initial diagnosis of AML in patient >= 60 years old
+Prior morphological diagnosis of AML other than acute promyelocytic leukemia according to the 2001 World Health Organization (WHO) diagnostic criteria; patients with biphenotypic, RAS-mutated acute leukemia are also eligible
+have diagnosis of AML French-American-British (FAB) classification (FAB) M3 (acute promyelocytic leukemia (APL))
+Have an unequivocal histologic diagnosis of acute myeloid leukemia (AML) (including secondary AML)
+Subjects with the diagnosis of acute promyelocytic leukemia (t[15;17])
+Patients eligible include those with diagnosis of AML other than acute promyelocytic leukemia by World Health Organization (WHO) criteria with relapsed disease after induction therapy or refractory to induction chemotherapy, as determined by morphology on bone marrow biopsy; also eligible are patients unwilling to receive standard induction chemotherapy
+Patients must have histologically or cytologically confirmed non–acute promyelocytic leukemia (APL) acute myeloid leukemia (AML)
+AML patients must either:\r\n* Be ineligible to receive standard intensive induction chemotherapy (based upon judgement of the treating physician, based on parameters such as comorbidities, cytogenetic studies as well as), or\r\n* Have relapsed or refractory disease to previous chemotherapy (induction and/or consolidation) for acute myeloid leukemia; patients must have recovered from acute toxicities of AML chemotherapy
+Diagnosis of acute promyelocytic leukemia (APL)
+Age ? 60 years with relapsed/refractory AML of any type except for acute promyelocytic leukemia (APL; AML M3), after at least 1 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.
+In blast transformation of chronic myeloid leukemia (CML). Prior myelodysplastic syndrome (MDS) is acceptable; prior treatment for MDS does not count as an AML therapy.
+Treatment Group B (TGB): Acute Leukemia (Part 3 - acute myeloid leukemia [AML] only), myelodysplastic syndrome (MDS), myelodysplastic /myeloproliferative neoplasms (MDS/MPN) and myelofibrosis (MF)
+All subtypes of Acute Myeloid leukemia (except for acute promyelocytic leukemia)
+Diagnosis of acute promyelocytic leukemia
+Diagnosis of relapsed or refractory AML with at least one prior treatment for acute myeloid leukemia and patients with diagnosis of acute myeloid leukemia in complete remission with high risk to relapse.
+Patients with acute promyelocytic leukemia according to WHO definition.
+Diagnosis of AML or MDS according to the WHO criteria
+Acute promyelocytic leukemia or AML with a t(15;17) (q22;q12) cytogenetic abnormality or Bcr/Abl positive leukemia
+Acute promyelocytic leukemia
+Morphologically confirmed acute myeloid leukemia (AML), except acute promyelocytic leukemia (APL), including leukemia secondary to prior therapy or antecedent hematologic disorder (e.g., MDS or myeloproliferative disorders), who have failed to achieve CR or who have relapsed after prior therapy and are not candidates for potentially curative therapy
+Patients with acute promyelocytic leukemia (APL)
+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 WT1 transcript for AML, or CA-125 for ovarian carcinoma) advanced stage malignancies: non-small cell lung, ovarian, glioblastoma, and AML (not including acute promyelocytic leukemia), known to overexpress the WT1 protein.
+Patient must have histologically or cytologically documented measurable (may be measurable by tumor markers only, such as quantitative RT-PCR for WT1 transcript for AML) advanced stage glioblastoma or AML (not including acute promyelocytic leukemia), known to overexpress the WT1 protein. Note: Determination of WT1 expression will not be assessed prior to patient enrollment.
+Diagnosis of newly diagnosed AML (other than acute promyelocytic leukemia [APL]) or high-risk (intermediate-2 high by International Prognostic Scoring System [IPSS] or > 10% blasts, including chronic myelomonocytic leukemia [CMML]) MDS; prior therapy with Hydrea and the use of a single or a two day dose of cytarabine (up to 3 g/m^2) for emergency use up to 24 hours prior to start of study therapy is allowed; prior therapy for MDS or other antecedent hematologic disease (AHD) is not allowed
+Acute promyelocytic leukemia (APL)
+A diagnosis of acute myeloid leukemia (AML) based on World Health Organization (WHO) classification (>= 20% myeloblasts in peripheral blood or bone marrow)
+A diagnosis of acute promyelocytic leukemia (APL); the study does not require to rule APL out for every subject; however, if there is clinical suspicion for APL, such diagnosis has to be ruled out before initiation of treatment
+De novo or secondary acute myeloid leukemia (AML) (post myelodysplastic syndrome [MDS] or myeloproliferative neoplasm [MPN] or after leukemogenic chemotherapy) according to WHO 2008 criteria For Part A:
+Acute promyelocytic leukemia with t(15;17), or its molecular equivalent (PML-RARalpha)
+Patients with secondary AML or therapy related disease (t-AML) are eligible
+Participant has a relapsed or refractory hematologic malignancy (with any measurable disease) with FLT3-ITD or TKD mutations and one of the following diagnoses:\r\n* Acute myeloid leukemia (AML)\r\n* AML with prior myelodysplastic syndrome (MDS)\r\n* Myeloperoxidase (MPO)-positive mixed phenotype acute leukemia
+Newly Diagnosed De novo AML according to WHO criteria except for Acute Promyelocytic Leukemia or patients with known favorable cytogenetics (see exclusion)
+Newly diagnosed patients with Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16
+Diagnosis: Patients must have documented relapsed/refractory ALL, AML, or acute leukemia of ambiguous lineage and meet the following criteria:
+Histologically or cytologically confirmed AML, other than acute promyelocytic leukemia, as defined by the 2008 World Health Organization (WHO) criteria that is relapsed or refractory to standard chemotherapy; Note: newly-diagnosed AML patients who are 60 years or older and are not candidates for or have refused standard chemotherapy are also eligible for this trial
+Subject was diagnosed as acute promyelocytic leukemia (APL).
+Diagnosed with AML according to the WHO 2008 classification. Note: subjects with secondary AML following Myelodysplastic syndrome or secondary to previous leukemogenic therapy are allowed provided that a record of previous MDS history or leukemogenic therapy history is available.
+A diagnosis of acute promyelocytic (M3) or acute megakaryocytic leukaemia (M7).
+Acute promyelocytic leukemia.
+Diagnosis of untreated “high-risk” MDS (>= 10% blasts) or AML other than acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) or variants according to the 2008 World Health Organization (WHO) classification; patients with biphenotypic AML are eligible; outside diagnostic material is acceptable as long as peripheral blood and/or bone marrow slides are reviewed at the study institution and cytogenetic/molecular information is available\r\n* Prior hydroxyurea for AML is permitted but should be discontinued prior to start of CPX-351 treatment\r\n* Azacitidine, decitabine, lenalidomide, and growth factors are permitted for low-risk MDS (< 10% blasts); all treatments for MDS should be discontinued prior to start of CPX-351 treatment
+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], M3) or blastic transformation of chronic myelogenous leukemia (CML) are not eligible; patients with known core binding factor (CBF) or fms-like tyrosine kinase 3 (FLT3) 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
+Diagnosis of acute myeloid leukemia (AML) (other than acute promyelocytic leukemia) with refractory/relapsed disease; (patients must be primary refractory, in relapse 1, or in relapse 2); NOTE: patients with AML arising from prior myelodysplastic syndrome (MDS) or myeloproliferative neoplasm (MPN) would be eligible even if they have not received treatment for the AML; NOTE: patients with relapsed/refractory acute lymphocytic leukemia (ALL) would also be eligible for the phase II part of the study; NOTE: use of hydroxyurea and/or up to 4 doses of cytarabine, for emergent cytoreduction is allowed
+Documented/confirmed acute myelogenous leukemia (AML), except for acute promyelocytic leukemia
+World Health Organization (WHO)-confirmed AML, other than acute promyelocytic leukemia (APL)
+Prior diagnosis of “high-risk” myelodysplastic syndrome (MDS) (>= 10% blasts) or AML other than acute promyelocytic leukemia (APL) with t(15;17) (q22;q12) or variants according to the 2008 World Health Organization (WHO) classification; patients with biphenotypic AML are eligible
+Patients with secondary MDS/AML
+Patient has any known history or current diagnosis of myelodysplastic syndrome (MDS) or acute myelogenous leukemia (AML).
+Known history of MDS or AML
+Previous diagnosis of CD123+ acute myeloid leukemia (AML), de novo or secondary.
+Diagnosis of acute promyelocytic leukemia (APL).
+Acute myelogenous leukemia (AML) in 1st or subsequent remission
+Morphologically documented primary AML, prior-chemotherapy-related AML or AML secondary to an antecedent hematologic disorder (e.g., Myelodysplastic Syndrome) as defined by WHO criteria, confirmed by pathology review. For Cohort Expansion Phase (Part 2) only: Bone marrow involvement is required.
+Diagnosis of acute promyelocytic leukemia
+Poor-risk acute leukemia in first remission, with remission defined as < 5% bone marrow blasts morphologically:\r\n* Acute myeloid leukemia (AML) with at least one of the following:\r\n** AML arising from myelodysplastic syndromes (MDS) or a myeloproliferative disorder, or secondary AML\r\n** Presence of FMS-like tyrosine kinase-3 (Flt3) internal tandem duplications\r\n** Poor-risk cytogenetics\r\n** Primary refractory disease\r\n* Acute lymphoblastic leukemia (ALL) (leukemia and/or lymphoma) with at least one of the following:\r\n** Poor-risk cytogenetics\r\n** Clear evidence of hypodiploidy\r\n** Primary refractory disease\r\n* Biphenotypic leukemia
+The leukemia is a de novo or secondary AML.
+The patient has acute promyelocytic leukemia with t(15;17) (q22;q12), (PML/RAR?) or variants.
+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 1 or more courses of induction or reinduction chemotherapy\r\n* First or greater relapse after allogeneic hematopoietic stem cell transplantation (HSCT)
+Diagnosis of acute promyelocytic leukemia
+The patient has cytologically proven AML, as defined by the WHO classification. The pretreatment AML karyotype should be documented.
+The leukemia could be a de novo or secondary AML.
+The patient has acute promyelocytic leukemia with t(15;17)(q22;q12), (PML/RAR?) or variants.
+Clonal cytogenetic abnormalities associated with myelodysplastic syndrome (MDS) or acute myeloid leukemia (AML) on marrow examination
+Newly Diagnosed De novo AML according to WHO criteria except for Acute Promyelocytic Leukemia or patients with known favorable cytogenetics
+Newly diagnosed patients with Acute promyelocytic leukemia [t(15;17)] or favorable cytogenetics, including t(8;21) or inv16
+Patients should have a diagnosis of AML (de novo or transformed from hematologic malignancies), myelodysplastic syndrome (MDS) or chronic myelomonocytic leukemia (CMML) with one of the following features: (A) patients with MDS or CMML should have failed prior therapy with a hypomethylating agent and/or with lenalidomide (cohorts 2 and 3); (B) patients with AML should have failed any prior therapy or have relapsed after prior therapy (cohorts 2 and 3); for patients in cohort 3 prior therapy should have included a FLT3 inhibitor; (C) patients with MDS or CMML who received therapy with a hypomethylating agent and progress to AML are eligible at the time of diagnosis of AML regardless any prior therapy for AML; the World Health Organization (WHO) classification will be used for AML; these patients will be assigned to cohort 1; patients with MDS, CMML or AML who have received no prior therapy are eligible if age 65 and greater or if, at the time of enrollment, are not candidates to receive or refuse standard therapy (cohort 1 only)
+Acute promyelocytic leukemia (APL)
+A diagnosis of acute promyelocytic leukemia (APML)
+Acute promyelocytic leukemia
+Patients may have had prior treatment for myelodysplastic syndrome (MDS) or AML, including prior lenalidomide for MDS or AML or another condition
+Patients with acute promyelocytic leukemia
+Acute leukemia patients (acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], acute promyelocytic leukemia [APL], therapy-related myeloid neoplasm [tMN], high grade myelodysplastic syndrome [MDS])
+All categories of AML will be included except for acute promyelocytic leukemia (APL) (AML-M3 as defined by 1976 French-American-British [FAB] classification, or APL with t(15;17)(q22;q12); PML-RARA as defined by the revised 2008 World Health Organization [WHO] classification of myeloid neoplasms and acute leukemias), acute megakaryocytic leukemia (AML-M7 type as per FAB or AML [megakaryoblastic] with t(1;22)(p13;q13); RBM15-MKL1 as per WHO 2008 revised classification) and acute leukemias of ambiguous lineage (as per WHO 2008 revised classification), undergoing 7 + 3 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 7 days prior to entry into the study
+Patients with secondary AML arising out of myelodysplastic syndrome (MDS) (all subtypes under WHO classification), chronic myelomonocytic leukemia (CMML); therapy-related AML and those with a prior autologous hematopoietic cell transplantation are eligible
+Secondary AML arising out of myeloproliferative neoplasms (as per the revised 2008 WHO classification of myeloid neoplasms and acute leukemias) and MDS/myeloproliferative (MPD) neoplasms other than CMML (as per the revised 2008 WHO classification of myeloid neoplasms and acute leukemias); refractory anemia with ringed sideroblasts with thrombocytosis (RARS-T) classified as MDS/myeloproliferative neoplasm (MPN) neoplasm, unclassifiable will be excluded; AML patients with presenting features suspicious of underlying unrecognized MPD such as marked splenomegaly (>= 20 cm) and or thrombocytosis (> 400,000 per microliter) will be excluded; patients with relapsed or refractory AML will be excluded
+Patients must have one of the following diagnoses and/or treatment plans:\r\n* Newly diagnosed de novo AML\r\n* First or subsequent relapse of AML\r\n* Secondary AML\r\n* Treatment with institutional standard AML therapy in those without AML (for example, myelodysplastic syndrome, bone marrow blasts > 5% or biphenotypia)\r\n* Note: Patients with a history of prolonged antifungal therapy (example, relapsed AML) are eligible
+Patients with the following diagnoses are not eligible:\r\n* Acute promyelocytic leukemia (APL)\r\n* Down syndrome\r\n* Juvenile myelomonocytic leukemia (JMML)
+Diagnosis of acute promyelocytic leukemia (APL), French-American-British classification M3 or WHO classification of APL with translocation, t(15;17)(q22;q12), or breakpoint cluster region-Abelson murine leukemia viral oncogene homolog 1 (BCR-ABL) positive leukemia (ie, chronic myelogenous leukemia in blast crisis); subjects who undergo diagnostic workup for APL and treatment with all-trans retinoic acid (ATRA), but who are found not to have APL, are eligible (treatment with ATRA must be discontinued before starting induction chemotherapy).
+Patients with acute promyelocytic leukemia
+Newly Diagnosed Acute Myeloid Leukemia (AML)
+Acute promyelocytic leukemia
+Relapsed/refractory acute myeloid leukemia (AML) patients who received standard of care cytarabine and mitoxantrone as their chemotherapy regimen
+Patients with a diagnosis of acute promyelocytic leukemia
+AML subtype M3 (promyelocytic leukemia)
+Transformed acute myeloid leukemia (AML) with marrow fibrosis is allowed, if AML is in complete remission after induction therapy
+Untreated de novo or secondary acute myeloid leukemia (AML), including AML that has progressed from myelodysplastic syndrome (MDS), and histologically documented diagnosis
+Acute promyelocytic leukemia (APL) with PML-RARA
+Patients must have a documented Unequivocal diagnosis of AML according to WHO 2008 classification (>20% blasts in the bone marrow), excluding M3 (acute promyelocytic leukemia).
+Patients with either newly diagnosed AML or MDS who have either begun (within 4 days of starting study drug) or are planned to begin specific treatment for their AML/MDS; patients who are participating in other therapeutic clinical trials for their AML/MDS may participate in this trial
+Participants with a previously documented diagnosis of myelodysplastic syndrome (or any dysplastic leukocyte morphology suggestive of myelodysplastic syndromes [MDS]) or acute myeloid leukemia
+Subjects with treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic syndrome (MDS) or with features suggestive of AML/MDS
+Acute myeloid leukemia (AML)
+Patients must not have acute promyelocytic leukemia (APL) and must not have evidence of t(15;17)(q22;q21)
+Patients with newly diagnosed AML or acute promyelocytic leukemia (APL)
+Patients with secondary or relapsed AML or APL should be excluded
+Acute myocardial infarctions or acute coronary syndromes
+Acute promyelocytic leukemia.
+Histologically confirmed diagnosis of acute myeloid leukemia (AML) or myelodysplastic syndrome (MDS) per 2016 World Health Organization (WHO) criteria
+Diagnosis of acute promyelocytic leukemia
+Subject has confirmed morphologically documented AML, excluding acute promyelocytic leukemia (APL), in CR1 (including CRp and CRi). For the purposes of enrollment, CR will be defined as < 5% 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.
+Confirmed diagnosis of Myelodysplastic Syndromes (MDS), Chronic Myelomonocytic Leukemia (CMML), or Acute Myeloid Leukemia (AML).
+DONOR: Patient with acute myeloid leukemia (AML) undergoing screening for potential URD HCT
+DONOR: Potential URD undergoing screening to provide a HCT graft to a patient with acute myeloid leukemia (AML) at a participating institution
+Acute promyelocytic leukemia (M3 classification).
+diagnosis of AML
+Diagnosis of MDS or AML other than APL with t(15;17)(q22;q12), (promyelocytic leukemia[PML]/retinoic acid receptor [RAR]), or variants according to the 2008 World Health Organization (WHO) classification
+Acute promyelocytic leukemia
+Relapsed or refractory AML (Acute Myeloid Leukemia) (Parts A and B) or relapsed or refractory high-risk MDS (Myelodysplastic Syndrome) (Part B only) as defined by World Health Organization criteria who are not suitable for other established therapies.
+Subjects with acute promyelocytic leukemia (APL)
+Primary or secondary AML (including erythroleukemia and eosinophilic leukemia, but excluding acute promyelocytic leukemia)
+Diagnosis of promyelocytic leukemia
+Patients with treatment-related acute myeloid leukemia (AML) (t-AML)/myelodysplastic syndrome (MDS), or with features suggestive of AML/MDS, or who have had prior allogeneic bone marrow transplant or double umbilical cord blood transplantation, should not receive veliparib due to reports of MDS and leukemia secondary to oncology therapy on Cancer Therapy Evaluation Program (CTEP)-sponsored studies utilizing veliparib