Participants must have pathologically confirmed, newly diagnosed high-risk acute myeloid leukemia, as defined by at least one of the following criteria:\r\n* Age >= 65 years\r\n* Age >= 18 years with adverse risk karyotype, as per European Leukemia Net Guidelines\r\n* Age >= 18 years with antecedent or underlying myelodysplastic syndrome, chronic myelomonocytic leukemia (CMML) or myeloproliferative neoplasm\r\n* Age >=18 years with acute myeloid leukemia (AML) with myelodysplastic syndrome (MDS)-related changes\r\n** Note: For patients in category A, a sample to evaluate patient cytogenetics will be sent at the time of diagnosis per standard clinical care and the absence of favorable risk cytogenetics must be confirmed by day 8; if the cytogenetic analysis reveals that the patient harbors favorable risk cytogenetics, or if the cytogenetic results are not received prior to day 8, the participant will be removed from the study; patients removed due to presence of favorable cytogenetics would be considered to be inevaluable and will be replaced; in addition, patients who receive less than half of their total alisertib dose during induction would be considered to be inevaluable and will be replaced
Acute myeloid leukemia (AML): must have < 5% marrow blasts at the time of transplant
Relapsed or refractory acute myeloid leukemia
Diagnosis of acute myeloid leukemia (i.e. >= 20% peripheral or marrow blasts)
Relapsed or refractory acute myelocytic leukemia (AML) with nucleophosmin-1 (NPM1) mutations and no available therapies.
Relapsed and refractory acute myeloid leukemia (Cohort 1)
Newly diagnosed acute myeloid leukemia in older patients (>= 65 years) not candidates for intensive induction chemotherapy (Cohort 2)
Known prior progression to acute myeloid leukemia (AML), defined by at least 20% blasts in the blood or bone marrow.
Acute Myeloid Leukemia (AML) or Acute Lymphoblastic Leukemia (ALL) in first or second remission. Remission is defined as the absence of blasts in the peripheral circulation at the time of enrollment, < 5% blasts in the bone marrow and absence of extramedullary disease including CNS involvement.
Known prior progression to acute myeloid leukemia (AML) defined by at least 20% blasts in the blood or bone marrow.
Very high risk pediatric/young adult patients with acute myeloid leukemia (AML): Patients =< 25 years, however, are eligible with (M2 marrow) with =< 25% blasts in marrow after having failed one or more cycles of chemotherapy; this group of patients will be analyzed separately
Confirmed diagnosis of relapsed or refractory acute leukemia (acute myeloid leukemia, acute lymphoblastic leukemia, blast crisis of chronic myeloid leukemia [CML], secondary AML from prior myelodysplastic syndrome [MDS] / myeloproliferative neoplasm [MPN]); minimum of 5% blasts in the bone marrow or 10% blasts in circulation
This study is open to patients with acute myeloid leukemia (AML) evaluated within 30 days of the start of conditioning regimen and in first or second complete remission (CR)
Diagnosis of relapsed or refractory (R/R) acute myeloid leukemia (AML)
Patients can be in chronic phase (CP) with bone marrow (BM) blast count =< 10% or after progression to acute myeloid leukemia (AML) and achieved =< 5% BM blasts (morphologic complete remission [CR] prior to transplant);
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 the following: a. Favorable risk cytogenetics such as t(8;21), inv(16) or t(16;16) or t(15;17) as per the National Comprehensive Cancer Network (NCCN) Guidelines Version 2, 2016 for Acute Myeloid Leukemia.
Relapsed acute myeloid leukemia
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
Acute myeloid leukemia (AML) – must have < 5% marrow blasts at the time of transplant
Patients ?18 and ?75 years old with relapsed or primary refractory acute myeloid leukemia.
Patients with a diagnosis of histologically confirmed relapsed or refractory (R/R) acute myeloid leukemia or R/R acute lymphoblastic leukemia for which no available standard therapies are indicated or anticipated to result in a durable response
Patients can be in chronic phase (CP) with bone marrow (BM) blast count =< 10% or after progression to acute myeloid leukemia (AML) and achieved =< 5% BM blasts (morphologic complete remission [CR] prior to transplant)
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)
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
Prior therapy with hydroxyurea, interferon, anagrelide, ruxolitinib, hypomethylating agents, revlimid, thalidomide, steroids, other JAK inhibitors is allowed; for acute myeloid leukemia (AML) patients who are back in chronic phase myeloproliferative neoplasm (MPN), prior induction therapy is allowed
Pathological confirmation by bone marrow documenting the following:\r\n* Acute myeloid leukemia (AML) which has relapsed after complete remission\r\n* AML which has been refractory to two prior induction attempts\r\n* Acute lymphoblastic leukemia (ALL) which has relapsed after complete remission\r\n* ALL which has been refractory to two prior induction attempts
Relapsed ALL, biphenotypic/bilineal leukemia, or acute myeloid leukemia (AML) with =< 10% blasts in the bone marrow prior to transplantation
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 histologically or cytologically documented relapsed and/or refractory acute myeloid leukemia or granulocytic sarcoma
Acute myelogenous leukemia\r\n* In first complete remission (CR1) in addition to one of the criteria outlined\r\n* Second or greater complete remission\r\n* Secondary acute myeloid leukemia (AML) from antecedent myeloid neoplasm, myelodysplasia, or previous chemotherapy (chemo) or radiotherapy
Patients must have histologically or cytologically documented relapsed and/or refractory acute myeloid leukemia
Patients with the following diseases: acute myeloid leukemia (AML) and high risk myelodysplastic syndrome (MDS) undergoing second or above allogeneic (allo)-stem cell transplant (SCT) using the same donor or different donor for disease relapse; patients with other hematologic malignancies, including acute lymphoblastic leukemia (ALL), will be at the discretion of the investigators with discussion with the principal investigator (PI)
For salvage cohort: patients with previously treated, relapsed or refractory AML, acute biphenotypic leukemia, or CML in myeloid blast phase are eligible
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)
Acute myeloid leukemia in first remission with any of the following high risk features defined as:\r\n* Adverse cytogenetics: -5, deletion (del) 5q, -7, del7q, abnormalities involving 3q, 9q, 11q, 20q, 21q, 17, +8 or complex karyotype (> 3 abnormalities)\r\n* Preceding myelodysplastic or myeloproliferative syndrome\r\n* Presence of high risk molecular abnormalities including FLT3 mutations, DNMT3A, TET2; ras; kit\r\n* French–American–British (FAB) monosomy (M)6 or M7 classification\r\n* Treatment related acute myeloid leukemia (AML)\r\n* Residual cytogenetic or molecular abnormalities
Patients with >= 18 years of age with relapsed/refractory leukemia with a confirmed diagnosis of acute myelogenous leukemia (AML) or acute lymphoblastic leukemia (ALL) who meet the following criteria: \r\n* Age 18-64: Salvage treatment failures only - defined as relapsed or refractory to after least 1 cycle of salvage therapy\r\n* Age >= 65: Refractory to or have relapsed after induction chemotherapy defined as no response to initial therapy\r\n** Given the clinical activity and use of hypomethylating agents in AML patients, for all AML populations, initial therapy and salvage therapy may include hypomethylating agents; furthermore, patients >= 65 with hematologic malignancies including chronic myelomonocytic leukemia (CMML) or myelodysplasia (MDS) that transform to acute leukemia while actively receiving hypomethylating agents (i.e. decitabine or azacytidine) will be considered induction failures and thus are eligible; for Philadelphia positive (Ph+) ALL, initial therapy and salvage therapy may include steroids and imatinib or dasatinib or nilotinib
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
Acute myeloid leukemia as defined by WHO criteria
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: AML arising from myelodysplastic syndrome (MDS) or a myeloproliferative disorder, or secondary AML; presence of fms-related tyrosine kinase 3 (Flt3) internal tandem duplications; poor-risk cytogenetics: complex karyotype [>= 3 abnormalities], inv(3), t(3;3), t(6;9), myeloid/lymphoid or mixed-lineage leukemia (MLL) rearrangement with the exception of t(9;11), or abnormalities of chromosome 5 or 7; primary refractory disease\r\n* Acute lymphoblastic leukemia (ALL) (leukemia and/or lymphoma) with at least one of the following: adverse cytogenetics such as t(9;22), t(1;19), t(4;11), or MLL rearrangement; clear evidence of hypodiploidy; primary refractory disease\r\n* Biphenotypic leukemia
Acute myeloid leukemia (AML) after first relapse or with primary refractory disease
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 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
Bone marrow blasts ?20%, indicating a diagnosis of acute myeloid leukemia (AML).
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
Patients must have newly diagnosed, previously untreated acute myeloid leukemia (AML) (excluding M3)
Myeloid malignancies requiring allogeneic hematopoietic cell transplantation\r\n* Acute myeloid leukemia (AML) and acute leukemia of mixed or undetermined or ambiguous lineage\r\n* Myelodysplastic syndrome (MDS), myeloproliferative disorders (MPD) (chronic myeloid leukemia [CML], primary myelofibrosis, post-polycythemic/post-thrombocythemic myelofibrosis), chronic myelomonocytic leukemia (CMMoL) and acute blastic transformation of these conditions
Patients in 1st or 2nd remission with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), who are eligible for stem cell transplant; remission defined as no circulating blasts, < 5% blasts in the bone marrow, normalization of previously detected cytogenetic abnormalities, no extramedullary disease
Patients must have histologically or cytologically documented relapsed and/or refractory acute myeloid leukemia
Subject has Relapsed or Refractory Acute Myeloid Leukemia (rrAML) after at least 2 prior induction attempts:
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.
Central confirmation of intermediate or poor risk status, based on Cytogenetics for Acute Myeloid Leukemia.
Acute myeloid leukemia associated with inv(16), t(8;21), t(16;16), t(15;17) karyotypes or molecular evidence of such translocations if not associated with a c-Kit mutation.
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
Patients presenting with an AHNMD requiring immediate cytoreductive therapy or targeted drugs (e.g. acute myeloid leukemia [AML])
Relapsed acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) >= 60 days after allogeneic stem cell transplant (SCT)
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 < 20% bone marrow blasts are eligible if they have: \r\n* A karyotypic abnormality characteristic of de novo AML (t(8;21)(q22;q22), inv(16)(p13q22) or t(16;16)(p13;q22) or 11q23 abnormalities\r\n* The unequivocal presence of megakaryoblasts, or\r\n* Biopsy proven isolated myeloid sarcoma (myeloblastoma; chloroma, including leukemia cutis)
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.
Acute myeloid leukemia (AML) diagnosed by morphologic, histochemical or cell surface marker criteria.
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
Histologically or cytologically confirmed advanced and/or aggressive hematologic malignancy (including acute myeloid leukemia [AML] in complete remission [CR] and myelodysplastic syndrome with < 10% blasts in the bone marrow) unlikely to be cured by alternative therapies
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
Untreated histologically confirmed acute myeloid leukemia OR advanced myelodysplastic syndrome (intermediate [INT]-2 or High risk) not previously treated with anthracycline-based chemotherapy OR a therapy-related myeloid neoplasm
Patients with the diagnosis of Acute Myeloid or Lymphocytic Leukemia (AML or ALL) in first or second complete remission.
Acute myeloid leukemia (AML) must have < 5% marrow blasts at the time of HCT
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
Relapsed/refractory acute myeloid leukemia following at least 2 but no more than 3 prior regimens
Relapsed/refractory acute myeloid leukemia (AML) except for acute promyelocytic leukemia
Patients with CD56 expressing hematological malignancy, as follows: cohort 1: CD56 expressing hematological malignancies including but not limited to acute myeloid leukemia (AML), high-risk myelodysplastic syndrome (MDS), natural-killer leukemia, acute lymphoblastic leukemia, accelerated and blast-phase chronic myeloid leukemia (CML) who have failed prior therapy or for which no standard therapy exists; cohort 2: patients with MF (either primary MF, post-polycythemia MF, or post-essential thrombocythemia MF) and CD56 expression who have been on ruxolitinib or JAK-inhibitor therapy for at least 12 weeks and deemed refractory or sub-optimal responders in the opinion of the treating physician; cohort 3: patients with pathological diagnosis of BPDCN with CD56 expression (frontline and relapsed/refractory)
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 myeloid leukemia (AML), except those patients with RAEB-t who are not candidates for intensive AML therapy.
Have an unequivocal histologic diagnosis of acute myeloid leukemia (AML) (including secondary AML)
Not meeting WHO criteria for Polycythemia Vera (PV), Chronic Myeloid Leukemia (CML), Myledysplastic Syndrome (MDS), or other myeloid neoplasm
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.
Expression of CD33 on more than 30% of bone marrow blasts at screening for patients with refractory or relapsed acute myeloid leukemia is required. CD33 positive expression of bone marrow blasts at the time of initial acute myeloid leukemia diagnosis is sufficient for those patients in complete remission with high risk to relapse.
Patients with refractory or relapsed acute myeloid leukemia > 5.000 blasts in the peripheral blood.
Anti-leukemia therapy within two weeks before first treatment with BI 836858, 4 weeks for biologics. Parallel treatment with Hydroxyurea ia allowed with refractory or relapsed acute myeloid leukemia patients.
Patients who are candidates for allogeneic stem cell transplantation (for patients with refractory or relapsed acute myeloid 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
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
Diagnosis: Patients must have documented relapsed/refractory ALL, AML, or acute leukemia of ambiguous lineage and meet the following criteria:
Acute myeloid leukemia, positive for CD33
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
> 10% blasts or biopsy-documented leukemia cutis or myeloid sarcoma.
Previous diagnosis of CD123+ acute myeloid leukemia (AML), de novo or secondary.
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
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)
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])
Poor risk disease/disease status including: chronic myeloid leukemia (CML) in blast crisis, acute myeloid leukemia (AML)/acute lymphoblastic leukemia (ALL) beyond 2nd remission, multiple myeloma, and aplastic anemia
Patient must fit 1 of the following 2 categories:                          \r\n* Chemotherapy patients                \r\n** Planned to receive at least 2 consecutive cycles (not required to be the first 2 cycles) of intensive chemotherapy for either:\r\n*** De novo, relapsed or secondary acute myeloid leukemia (AML), or acute leukemia of ambiguous lineage treated with standard AML therapy\r\n*** Relapsed acute lymphoblastic leukemia (ALL)\r\n*** For the purposes of this study, “intensive chemotherapy” is defined as regimens that are predicted by the local investigator to cause neutropenia for > 7 days; examples include, but are not limited to, treatment with “4-drug induction” (anthracycline, vincristine, asparaginase, and steroid), high dose cytarabine, anthracycline/cytarabine, ifosfamide/etoposide, and clofarabine-containing regimens\r\n* Stem cell transplantation patients                \r\n** Planned to receive at least 1 myeloablative autologous or allogeneic HSCT\r\n** For the purposes of this study, myeloablative autologous and allogeneic HSCT are those in which the conditioning regimen is predicted by the local Investigator to cause neutropenia for > 7 days
Newly Diagnosed Acute Myeloid Leukemia (AML)
Relapsed/refractory acute myeloid leukemia (AML) patients who received standard of care cytarabine and mitoxantrone as their chemotherapy regimen
Acute myeloid leukemia arising de novo (per European LeukemiaNet)
Transformed acute myeloid leukemia (AML) with marrow fibrosis is allowed, if AML is in complete remission after induction therapy
Acute myeloid leukemia
Acute myeloid leukemia (AML) – must have < 5% marrow blasts at the time of transplant
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
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.