REGISTRATION STEP -RANDOMIZATION: Patients must have morphologically confirmed, previously untreated acute myeloid leukemia (AML) or MDS with excess blasts- (MDS-EB-)\r\n* Patients with acute promyelocytic leukemia (APL), biphenotypic leukemia, blastic transformation of chronic myelogenous leukemia (CML or BCR/ABL), are not eligible\r\n* Patients must have disease present in the blood or bone marrow; patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible\r\n* All tests for establishing baseline disease status eligibility must be based on blood and/or bone marrow examination performed within days prior to randomization (registration Step )
Patients with isolated myeloid sarcoma (myeloblastoma, chloroma, including leukemia cutis) but without evidence of APL by bone marrow or peripheral blood morphology are excluded
Acute myeloid leukemia (AML): must have < % marrow blasts at the time of transplant
Relapsed or refractory acute myeloid leukemia
Diagnosis of acute myeloid leukemia (i.e. >= % peripheral or marrow blasts)
Relapsed and refractory acute myeloid leukemia (Cohort )
Known prior progression to acute myeloid leukemia (AML), defined by at least % 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, < % 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 % blasts in the blood or bone marrow.
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 % blasts in the bone marrow or % blasts in circulation
This study is open to patients with acute myeloid leukemia (AML) evaluated within 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 =< % or after progression to acute myeloid leukemia (AML) and achieved =< % BM blasts (morphologic complete remission [CR] prior to transplant);
Experimental therapies for MDS or Acute Myeloid Leukemia (AML).
Participant has the following: a. Favorable risk cytogenetics such as t(;), inv() or t(;) or t(;) as per the National Comprehensive Cancer Network (NCCN) Guidelines Version , for Acute Myeloid Leukemia.
Relapsed acute myeloid leukemia
Acute myeloid leukemia (AML) must have < % marrow blasts at the time of transplant
Patients ? and ? years old with relapsed or primary refractory acute myeloid leukemia.
Patients can be in chronic phase (CP) with bone marrow (BM) blast count =< % or after progression to acute myeloid leukemia (AML) and achieved =< % BM blasts (morphologic complete remission [CR] prior to transplant)
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 =< % 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 [Int-] 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 (CR) 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
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[;], inv , or t[;]) and/or molecular profile (nucleophosmin [NPM])
Acute myeloid leukemia who fail to achieve complete remission with one course of induction chemotherapy or after relapse; patients must have less than % bone marrow or peripheral blood blasts
Acute myeloid leukemia (AML) in st remission for patients whose AML does not have good risk cytogenetic features (i.e. t;, t;, inv )
Acute myeloid leukemia as defined by WHO criteria
Relapsed or refractory acute leukemia (acute myeloid leukemia or acute lymphoblastic leukemia or lymphoma) in second or subsequent remission, with remission defined as < % bone marrow blasts morphologically
Acute myeloid leukemia/acute lymphoblastic leukemia, including biphenotypic acute leukemia or mixed-lineage leukemia: Must have < % morphologic marrow blasts in an evaluable marrow sample (> % of normal cellularity for age collected less than one month prior to start of conditioning; patients in which adequate marrow/biopsy specimens cannot be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible; reasonable attempts must be made to obtain an adequate specimen for morphologic assessment, including possible repeat procedures; these patients must be discussed with the principal investigator prior to enrollment; patients persistently aplastic for greater than one month since completing last chemotherapy are also eligible with principal investigator (PI) approval
Acute myeloid leukemia (AML) after first relapse or with primary refractory disease
Malignancies included are:\r\n* Acute leukemia, including Acute myeloid leukemia (AML), biphenotypic acute leukemia or mixed-lineage leukemia, acute lymphoblastic leukemia (ALL); all patients must be in complete response (CR) as defined by < % blasts by morphology/flow cytometry in a representative bone marrow sample with adequate cellularity to assess remission status\r\n* Myelodysplasia (MDS) International Prognostic Scoring System (IPSS) intermediate (Int)- or high risk (i.e., RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics; blasts must be < % by a representative bone marrow aspirate morphology\r\n* Chronic Myeloid Leukemia excluding refractory blast crisis; to be eligible in first chronic phase (CP) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy
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* > % but < % marrow myeloblasts and evidence of a clonal de novo AML genetic abnormality [e.g., t(;), inv(), t(;)], 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 % blasts, or\r\n* Patients with treatment related myeloid neoplasms including AML and MDS, provided their cumulative anthracycline dose has not exceeded mg/m^ doxorubicin equivalents
Bone marrow blasts ?%, indicating a diagnosis of acute myeloid leukemia (AML).
Isolated myeloid sarcoma (meaning, patients must have blood or marrow involvement with AML to enter the study)
For acute lymphoblastic leukemia: diagnosis should be made by bone marrow aspirate or biopsy demonstrating >= % involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-precursor or T-ALL phenotype; while myeloid co-expression on blasts determined to be primarily lymphoid is allowed, patients with leukemia of ambiguous lineage are not eligible
Patients must have newly diagnosed, previously untreated acute myeloid leukemia (AML) (excluding M)
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 st or nd remission with acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL), who are eligible for stem cell transplant; remission defined as no circulating blasts, < % 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 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(), t(;), t(;), t(;) karyotypes or molecular evidence of such translocations if not associated with a c-Kit mutation.
Acute myeloid leukemia (AML)
CD expressing acute myeloid leukemia (AML), as identified by flow cytometric analysis, or by immunohistochemistry when + or + staining is present in greater than or equal to % 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) >= days after allogeneic stem cell transplant (SCT)
Patients with < % bone marrow blasts are eligible if they have: \r\n* A karyotypic abnormality characteristic of de novo AML (t(;)(q;q), inv()(pq) or t(;)(p;q) or q 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 () documented within 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-M AML) as documented by the presence of > % 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 < % 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 >= % of disease in bone marrow (BM); patients with blast count < % 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
Acute myeloid leukemia, including biphenotypic acute leukemia or mixed-lineage leukemia\r\n* All patients must have acute myeloid leukemia (AML) that is considered best treated by stem cell transplant by the referring physician and the attending transplant physician\r\n* All patients must be in complete remission (CR) as defined by < % blasts by morphology/flow cytometry in a representative bone marrow sample with cellularity >= % for age\r\n* Patients in which adequate marrow/biopsy specimens cannot be obtained to determine remission status by morphologic assessment, but have fulfilled criteria of remission by flow cytometry, recovery of peripheral blood counts with no circulating blasts, and/or normal cytogenetics (if applicable) may still be eligible; reasonable attempts must be made to obtain an adequate specimen for morphologic assessment, including possible repeat procedures; these patients must be discussed with the principal investigator prior to enrollment
Untreated histologically confirmed acute myeloid leukemia OR advanced myelodysplastic syndrome (intermediate [INT]- 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 < % 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* < % marrow myeloblasts and evidence of a clonal de novo AML genetic abnormality [e.g., t(;), inv(), t(;)] \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 but no more than prior regimens
Relapsed/refractory acute myeloid leukemia (AML) except for acute promyelocytic leukemia
Patients with CD expressing hematological malignancy, as follows: cohort : CD 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 : patients with MF (either primary MF, post-polycythemia MF, or post-essential thrombocythemia MF) and CD expression who have been on ruxolitinib or JAK-inhibitor therapy for at least weeks and deemed refractory or sub-optimal responders in the opinion of the treating physician; cohort : patients with pathological diagnosis of BPDCN with CD expression (frontline and relapsed/refractory)
Acute myeloid leukemia (AML), except those patients with RAEB-t who are not candidates for intensive AML therapy.
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 CD on more than % of bone marrow blasts at screening for patients with refractory or relapsed acute myeloid leukemia is required. CD 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 > . blasts in the peripheral blood.
Anti-leukemia therapy within two weeks before first treatment with BI , 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
Acute myeloid leukemia, myelodysplasia, acute lymphoblastic leukemia, chronic myeloid leukemia, or myeloproliferative neoplasms requiring a matched allogeneic hematopoietic stem cell transplant (HSCT)\r\n* Acute leukemia (acute myeloid leukemia [AML] or acute lymphoblastic leukemia [ALL]) must be in complete remission defined as: < % marrow blasts with no morphologic evidence of leukemia, no peripheral blasts, marrow > % cellular, and peripheral absolute neutrophil count > /uL (platelet recovery is not required)\r\n* Myelodysplasia (MDS) and chronic myeloid leukemia (CML): must have < % marrow blasts\r\n* Myeloproliferative neoplasms (MPN): must have < % peripheral/marrow blasts
Acute myeloid leukemia, positive for CD
Diagnosis of acute myeloid leukemia (AML) (other than acute promyelocytic leukemia) with refractory/relapsed disease; (patients must be primary refractory, in relapse , or in relapse ); 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 doses of cytarabine, for emergent cytoreduction is allowed
> % blasts or biopsy-documented leukemia cutis or myeloid sarcoma.
Previous diagnosis of CD+ acute myeloid leukemia (AML), de novo or secondary.
Poor risk disease/disease status including: chronic myeloid leukemia (CML) in blast crisis, acute myeloid leukemia (AML)/acute lymphoblastic leukemia (ALL) beyond nd remission, multiple myeloma, and aplastic anemia
Patient must fit of the following categories: \r\n* Chemotherapy patients \r\n** Planned to receive at least consecutive cycles (not required to be the first 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 > days; examples include, but are not limited to, treatment with -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 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 > 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 leukemia (acute myeloid leukemia [AML] or acute lymphoblastic leukemia [ALL]) must be in complete remission defined as: < % marrow blasts with no morphologic evidence of leukemia, no peripheral blasts, marrow > % cellular, and peripheral absolute neutrophil count > /uL (platelet recovery is not required)
Acute myeloid leukemia (AML) must have < % marrow blasts at the time of transplant
Acute myeloid leukemia (AML) in first cytomorphological remission (< % blasts in the bone marrow) with Disease Risk Index (DRI) intermediate or above, or in second or higher cytomorphological remission
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