Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia are not eligible
Known leukemia or lymphoma
Subjects must have histologically documented acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), myeloproliferative disorders (MPD), chronic myeloid leukemia (CML), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL) or multiple myeloma (MM) as follows:\r\n* Acute myeloid leukemia (AML) with one or more of the following criteria:\r\n** Poor risk cytogenetics, including -5, 5q-, -7, 7q-, t(9;22); complex cytogenetics (>= 3 abnormalities); or normal cytogenetics with Fms-like tyrosine kinase 3 (Flt3) internal tandem duplications (ITD), in first or subsequent complete remission (CR)\r\n** Relapsed or primary refractory AML with =< 10% blasts in the peripheral blood\r\n** Subjects in CR1 who required two cycles of induction to achieve remission may be included at the discretion of the treating physician\r\n** Standard risk or intermediate risk cytogenetics in second or subsequent CR (enrolled at the discretion of the treating physician)\r\n* Acute lymphoblastic leukemia (ALL) with one of the following criteria:\r\n** Second or subsequent CR\r\n** Any partial remission (PR) (no circulating blasts)\r\n** High-risk ALL in first CR including (Philadelphia chromosome positive [Ph+], t(4:11)), complex karyotype, hypodiploidy (< 44 chromosomes), positive minimal residual disease (MRD) after induction, and other high risk features in adults per treating physician\r\n* Myelodysplasia, intermediate-2 (score 1.5-2.0) or high risk (score > 2.5) by the International Prognostic Score System\r\n* Myeloproliferative disorders (include chronic myelomonocytic leukemia [CMML], agnogenic myeloid metaplasia [AMM] or idiopathic myelofibrosis, and juvenile myelomonocytic leukemia [JMML]) with excess blasts (> 5%)\r\n* Chronic myeloid leukemia (CML) with one of the following criteria:\r\n** Second or subsequent chronic phase\r\n** Accelerated phase\r\n** Blast crisis\r\n* Non-Hodgkin's lymphoma (NHL) meeting one of the following criteria:\r\n** Relapse after autologous stem cell transplantation with evidence of responsive disease\r\n** Subject with chemosensitive relapse who have no option for autologous stem cell transplantation due to blood or marrow involvement or failure to mobilize autologous stem cells or are not considered eligible for autologous transplant by their treating physician\r\n* Hodgkin’s lymphoma: relapse after autologous hematopoietic cell transplant (HCT), chemorefractory disease\r\n* Multiple myeloma: per National Comprehensive Cancer Network (NCCN) guidelines
The patient must have a disease (listed below) with treatment-responsiveness that the treating transplant physician believes will benefit from an allogeneic stem cell transplant. The diseases include:\r\n* Acute leukemia – Acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL)\r\n* Chronic leukemia – Chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL)\r\n* Myelodysplasia\r\n* Myeloproliferative disorder\r\n* Myelofibrosis\r\n* Lymphoma – Non-Hodgkin lymphoma (NHL) or Hodgkin’s disease\r\n* Plasma cell disorder, including myeloma, Waldenstrom’s macroglobulinemia.
The patient must have a diagnosis of one of the following (one must be yes):\r\n* Bone marrow failure disorders:\r\n** Acquired bone marrow failure disorders include aplastic anemia, paroxysmal nocturnal hemoglobinuria (PNH):\r\n*** SAA must have failed at least one cycle of standard immunosuppressive therapy with calcineurin inhibitor plus anti-thymocyte globulin (ATG)\r\n*** PNH must have failed treatment or not tolerated treatment with eculizumab or progressed during or after treatment with eculizumab\r\n** Hereditary bone marrow failure disorders include Diamond-Blackfan anemia, Shwachman-Diamond syndrome, Kostmann syndrome, and congenital amegakaryocytic thrombocytopenia\r\n* Other non-malignant hematologic or immunologic disorders that require transplantation:\r\n** Quantitative or qualitative congenital platelet disorders (including but not limited to congenital amegakaryocytopenia, absent-radii syndrome, Glanzmann’s thrombasthenia)\r\n** Quantitative or qualitative congenital neutrophil disorders (including but not limited to chronic granulomatous disease, congenital neutropenia)\r\n** Congenital primary immunodeficiencies (including but not limited to severe combined immunodeficiency syndrome, Wiskott-Aldrich syndrome, CD40 ligand deficiency, T-cell deficiencies)\r\n** Hemoglobinopathies (including sickle cell disease and thalassemia)\r\n* Acute leukemias:\r\n** Acute myeloid leukemia (AML) - antecedent myelodysplastic syndrome, secondary\r\nAML, intermediate cytogenetics, high risk cytogenetic abnormalities or normal cytogenetics with high-risk\r\nmolecular mutations (including but not limiting to Flt3-ITD mutation), or other high risk features as per clinical judgment of the study principal investigator (PI) (or in the absence of the study PI, another equally qualified clinician)\r\n** Acute lymphoblastic leukemia (ALL) - B cell or T cell\r\n* Chronic myelocytic leukemia (CML):\r\n** Chronic phase (intolerant or unresponsive to imatinib and/or tyrosine kinase inhibitors)\r\n** Second chronic phase or accelerated phase who are ineligible for conventional myeloablative transplantation\r\n* Myeloproliferative and myelodysplasia syndromes:\r\n** Myelofibrosis (with/without splenectomy) with intermediate to high risk features\r\n** Advanced polycythemia vera not responding to therapy\r\n** Myelodysplastic syndrome (MDS) with an Revised International Prognostic Scoring System (IPSS-R) score of intermediate or higher\r\n** Secondary MDS with any IPSS score\r\n** Chronic myelomonocytic leukemia (CMML)\r\n* Lymphoproliferative disease:\r\n** Chronic lymphocytic leukemia (CLL), low-grade non-Hodgkin lymphoma (NHL) (recurrent or persistent) cytotoxic therapy refractory or with less than 6 months duration of complete response (CR) between courses of conventional therapy\r\n** Multiple myeloma (MM) progressive disease after auto bone marrow transplantation (BMT), tandem allo after prior auto\r\n** Waldenstrom’s macroglobulinemia (failed one standard regimen)\r\n** T or B cell lymphoma with poor risk features\r\n** Hodgkin disease:\r\n*** Received and failed frontline therapy\r\n*** Failed or not eligible for autologous transplantation
Diagnosis of hematologic malignancy (i.e. acute myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, Hodgkin’s lymphoma, non-Hodgkin’s lymphoma) in complete remission at the time of transplant
Burkitt lymphoma/leukemia
Must have one of the following hematologic malignancies: a. Acute myelogenous leukemia (AML), induction failure, high-risk for relapse first remission (with intermediate-risk or high-risk cytogenetics, flt3 mutation positive and/or evidence of minimal residual disease by flow cytometry), secondary leukemia from prior chemotherapy and/or arising from myelodysplastic syndrome (MDS), Langerhan's cell histiocytosis, any disease beyond first remission. b. Myelodysplastic syndrome (MDS): MDS International Prognostic Scoring System (IPSS) INT-1 will be enrolled only if the subjects have failed previous leukemia treatments and are transfusion-dependent. MDS may be primary or therapy related, including patients that will be considered for transplant. Including the following categories: 1) Revised IPSS intermediate and high risk groups, 2) MDS with transfusion dependency, 3) Failure to respond or progression of disease on hypomethylating agents, 4) Refractory anemia with excess of blasts, 5) Transformation to acute leukemia, 6) Chronic myelomonocytic leukemia, 7) Atypical MDS/myeloproliferative syndromes, 8) Complex karyotype, abn(3g), -5/5g-, -7/7g-, abn(12p), abn(17p). c. Acute lymphoblastic leukemia (ALL) patients with the following will be considered: induction failure, primary refractory to treatment (do not achieve complete remission after first course of therapy) or are beyond first remission including second or greater remission or active disease. Patients in first remission are eligible if they are considered high risk, defined as any of the following detected at any time: with translocations 9;22 or 4;11, hypodiploidy, complex karyotype, secondary leukemia developing after cytotoxic drug exposure, and/or evidence of minimal residual disease, or acute biphenotypic leukemia which excludes > 7 chromosomal abnormalities, or double hit non-Hodgkin's lymphoma. Non-Hodgkin's lymphoma (NHL) in second or third complete remission or relapse (including relapse post autologous hematopoietic stem cell transplant), or relapsed double hit lymphoma. Small lymphocytic lymphoma (SLL), or chronic lymphocytic leukemia (CLL) with progressive disease with progression after standard of care therapy or have failed/been intolerant to ibrutinib. Chronic myelogenous leukemia (CML) second chronic phase or accelerated phase. Hodgkin's disease (HD): Induction failure after the first complete remission, or relapse (including relapse post autologous hematopoietic stem cell transplant), or those with active disease.
Patients with history of CD 19 positive B-lymphoid malignancies (acute lymphoblastic leukemia [ALL], chronic lymphocytic leukemia [CLL], non-Hodgkin's lymphoma [NHL]) who have received at least 2 lines of standard chemoimmunotherapy or targeted therapy and have persistent disease.
Patients with Burkitt lymphoma/leukemia
The following malignancies will be considered eligible if progressive or persistent:\r\n* Chronic lymphocytic leukemia (CLL)\r\n* Non-Hodgkin lymphoma (NHL)\r\n* Hodgkin lymphoma (HL)\r\n* Multiple myeloma (MM)\r\n* Acute leukemia (acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL])\r\n* Myelodysplastic syndrome (MDS)\r\n* Myeloproliferative neoplasms (MPN)\r\n* Chronic myeloid leukemia (CML)
Diagnosed with one of the following high-risk malignancies, which require hematopoietic cell transplant (HCT) but do not have an available human leukocyte antigen (HLA)-matched (8/8) related or unrelated donor\r\n* High risk acute lymphoblastic leukemia (ALL) in first complete remission (CR1) or greater\r\n* High risk acute myelogenous leukemia (AML) in CR1 or greater\r\n* High risk undifferentiated acute leukemia\r\n* High risk myelodysplastic syndrome (MDS)\r\n* Chronic myelogenous leukemia (CML) failing or intolerant to tyrosine kinase inhibitors (TKIs) or in accelerated, blastic phase, or in second or subsequent chronic phase\r\n* Juvenile myelomonocytic leukemia (JMML)\r\n* Lymphoma, (Hodgkin and non-Hodgkin lymphoma [NHL] including marginal zone, follicular lymphoma, chemotherapy-sensitive large-cell, mantle cell lymphoma, gray zone, and Burkitt’s lymphoma in remission)
IMMUNE RECONSTITUTION STUDY ONLY: Diagnosed with one of the following high-risk malignancies, which require HCT but do not have an available HLA-matched (8/8) related or unrelated donor\r\n* High risk acute lymphoblastic leukemia (ALL) in CR1 or greater\r\n* High risk acute myelogenous leukemia (AML) in CR1 or greater\r\n* High risk myelodysplastic syndrome (MDS)\r\n* Chronic myelogenous leukemia (CML) failing or intolerant to TKIs or in accelerated, blastic phase, or in second or subsequent chronic phase\r\n* Juvenile myelomonocytic leukemia (JMML)\r\n* Lymphoma, (Hodgkin and NHL including marginal zone, follicular lymphoma, chemotherapy-sensitive large-cell, mantle cell lymphoma, gray zone, and Burkitt's lymphoma in remission
Patients with high risk myeloid or lymphoid malignancies prior to stem cell transplant with increased risk of disease relapse after stem cell transplant, including but not limited to conditions listed below\r\n* Refractory acute myelogenous or lymphoid leukemia\r\n* Relapsed acute myelogenous or lymphoid leukemia\r\n* Myelodysplastic syndromes with 5% or more blasts or with residual dysplastic changes prior to stem cell transplant, or with poor risk cytogenetic changes, such as -5, -7 or complex karyotype, or with poor molecular mutations, especially p53 mutation\r\n* Chronic myelogenous leukemia in chronic phase 3 or more, blast phase presently, or second accelerated phase\r\n* Recurrent or refractory malignant lymphoma or Hodgkin’s disease with high risk relapse features or not in complete remission\r\n* High risk chronic lymphocytic leukemia not in complete remission or with high risk relapse features, such as p53 mutation, or 17p deletion et al.\r\n* Acute leukemia (including AML, ALL) with minimal residual disease determined by accepted methods, including multiple color flow cytometry; next generation sequencing (NGS) or molecular testing\r\n* Acute leukemia with poor risk cytogenetic changes
The patient must have a disease (listed below) with treatment-responsiveness that the treating transplant physician believes will benefit from an allogeneic stem cell transplant. The diseases include:\r\n* Acute leukemia – acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL)\r\n* Chronic leukemia – chronic myelogenous leukemia (CML), chronic lymphocytic leukemia (CLL)\r\n* Myelodysplasia\r\n* Myelofibrosis\r\n* Lymphoma – non-Hodgkin's lymphoma (NHL) and Hodgkin’s disease\r\n* Plasma cell disorder, including myeloma, Waldenstrom’s macroglobulinemia
Patients with high-risk hematologic malignancies with anticipated poor prognosis with non transplant therapy, including those in remission or with induction failure and after treated or untreated relapse; Diagnoses to be included a) Acute myeloid leukemia; b) Acute lymphocytic leukemia; c) Chronic myeloid leukemia; d) Chronic lymphoproliferative disorder; e) Myelodysplastic syndrome; f) Myeloproliferative syndromes; g) Non-Hodgkin's lymphoma; h) Hodgkin's Lymphoma; i) Multiple myeloma
Any of the following hematologic malignancies that has relapsed or remains refractory after prior allogeneic hematopoietic cell transplantation (HCT) (this includes any stage of disease - such as refractory due to induction failure, refractory in relapse, or in any complete remission (CR) - as long as the hematologic malignancy remained persistent or returned after a previous allogeneic HCT): acute lymphoblastic leukemia (ALL), acute myeloblastic leukemia (AML), myeloid sarcoma, chronic myelogenous leukemia (CML), juvenile myelomonocytic leukemia (JMML), myelodysplastic syndrome (MDS), non-Hodgkin lymphoma (NHL)
Patients at least eighteen (18) years of age with histologically or cytologically proven Multiple Myeloma (MM), Hodgkins Disease (HD), Non-Hodgkins Lymphoma (NHL), Chronic Myelogenous Leukemia (CML), Acute Lymphocytic Leukemia (ALL), Acute Myelogenous Leukemia (AML) and Chronic Lymphocytic Leukemia (CLL), who have responded to standard, first-line antineoplastic therapy, as defined using standard response criteria for the specific hematologic malignancy (HM), and have no additional potentially curative therapeutic intervention available, will be eligible to participate in this study.
One of the following diagnoses:\r\n* Acute myelogenous leukemia (AML) in 1st or subsequent remission\r\n* Acute lymphoblastic leukemia (ALL) in 1st or subsequent remission\r\n* Chronic myelogenous leukemia (CML) in chronic or accelerated phase\r\n* Non-Hodgkin lymphoma (NHL) or Hodgkin’s disease (HD) in 2nd or greater complete remission, partial remission\r\n* Chronic lymphocytic leukemia (CLL)\r\n* Multiple myeloma (MM)\r\n* Myelodysplastic syndrome (MDS)\r\n* Myeloproliferative neoplasm (MPN) excluding primary or secondary myelofibrosis
Any of the following high risk or recurrent hematological malignancies: \r\n* Hodgkin lymphoma (HL) \r\n* Non-Hodgkin lymphoma (NHL) \r\n* Chronic lymphocytic leukemia (CLL) \r\n* Multiple myeloma (MM) \r\n* Acute myelogenous leukemia (AML) \r\n* Acute lymphocytic leukemia (ALL)\r\n* Chronic myelogenous leukemia (CML)\r\n* Myelodysplastic syndrome (MDS)\r\n** Note: determination that the malignancy is high risk will be made by the investigator
Patients with a history of CD19+ lymphoid malignancy defined as acute lymphoblastic leukemia, acute biphenotypic leukemia, non-Hodgkin’s lymphoma, small lymphocytic lymphoma, or chronic lymphocytic leukemia with active disease defined by presence of > 5% malignant blasts in bone marrow and/or peripheral blood, and/or minimal residual disease by flow cytometry or molecular analysis for fusion proteins, and/or positive imaging for extramedullary disease; patients must have measurable disease at time of study treatment
Has a myeloid or lymphoid malignant disease that is treated with TLI and ATG reduced-intensity conditioning for allogeneic transplant (any of the following: acute myeloid leukemia [AML]; chronic lymphocytic leukemia [CLL]; B or T cell non-Hodgkin lymphoma [NHL]; Hodgkin lymphoma [HL]; myelodysplastic syndrome (MDS); or myeloproliferative disease syndrome [MPD])
Patients with neoplastic hematological disorders with indication of allogeneic transplant according to the National Comprehensive Cancer Network (NCCN) or other standard guidelines as follows:\r\n* Acute lymphoblastic leukemia (ALL) with high-risk features or relapsed disease.\r\n* Hodgkin or non-Hodgkin lymphoma (HL or NHL): relapsed disease where remission duration is less than 1 year, relapse after previous autologous transplant, or failure to achieve complete remission (CR) with chemotherapy\r\n* Myeloid malignancy (acute myeloid leukemia [AML] with intermediate/high-risk features [per NCCN criteria] or relapsed disease, OR chronic myeloid leukemia [CML] in hematological remission or chronic phase)
INCLUSIONS FOR SCREENING AND LEUKAPHERESIS:\r\n* Patients with CD19 expressing acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL) or non-Hodgkin lymphoma (NHL)\r\n* Ability to understand and provide informed consent\r\n* Not human immunodeficiency virus (HIV) infected
By definition, patients with hematological malignancies or dyscrasias that require HSCT as part of cure-directed therapy are by definition high-risk and can be treated on this protocol; examples of high risk patients include but are not limited to: \r\n* Acute myeloid leukemia with high risk features as defined by: \r\n** Age greater than or equal to 60 \r\n** Secondary acute myeloid leukemia (AML) (prior therapy or hematologic malignancy) \r\n** Normal cytogenetics but fms-related tyrosine kinase 3 (FLT3)/internal tandem duplication (ITD) positive \r\n** Any relapse or primary refractory disease \r\n** Greater than 3 cytogenetic abnormalities or any one of the following cytogenetic abnormalities: -5/del(5q), -7/del(7q), Abn(9q), (11q), (3q), (21q), (17p), t(6;9), t(6;11), t(11;19), +8, del(12p), inv(3), t(10;11), -17, 11q 23 \r\n** Any single autosomal monosomy\r\n* Acute lymphoid leukemia in 1st or 2nd morphological remission; ALL with any morphological evidence of disease will not be eligible\r\n* Myelodysplasia (MDS) other than refractory anemia (RA), refractory anemia with rare sideroblasts (RARS), or isolated 5q- syndrome subtypes\r\n* Hodgkin’s or Non-Hodgkin’s lymphoma in 2nd or greater remission or with persistent disease\r\n* Myeloma with evidence of persistent disease after front-line therapy\r\n* Chronic myeloid leukemia (CML) resistant to signal transducer inhibitor (STI) therapy \r\n* Myelofibrosis and chronic myelomonocytic leukemia (CMML) \r\n* Essential thrombocytopenia or polycythemia vera with current or past evidence of evolution to acute leukemia\r\n* Patients with chronic lymphocytic leukemia (CLL), follicular non-Hodgkin lymphoma (NHL), or other lymphoid malignancies who have highly adverse cytogenetics (such as p53 deletion), are chemo-insensitive, are not responsive to highly effective novel treatments such as chimeric antigen receptor T-lymphocytes (CART) or Ibrutinib, or who have transformed disease\r\n* Any hematological malignancy not cited above which is thought to be high-risk with increased chance of post HSCT relapse\r\n* Any patient who has an aggressive disease that would normally be treated on a myeloablative study, but is prevented from doing so by factors in their past medical history; examples are patients with previous treatment with radiation therapy precluding TBI, or a past history of myeloablative therapy, precluding a 2nd myeloablative regimen\r\n* Patients with aplastic anemia may be treated on this protocol, with outcomes reported descriptively
Any patient with a hematologic or oncologic diagnosis in which allogeneic HSCT is thought to be beneficial, and in whom front-line therapy has already been applied; patients will be considered high-risk if they have any of the following:\r\n* Eastern Cooperative Oncology Group (ECOG) performance status of =< 2\r\n* Acute leukemia: requiring more than one chemotherapy regimen to obtain 1st complete remission (CR); second or greater CR, 1st relapse; any Philadelphia chromosome-positive (Ph+) acute lymphoblastic leukemia (ALL)\r\n* Chronic myelogenous leukemia (CML) 2nd chronic phase, accelerated phase, or blastic phase\r\n* Myelodysplastic syndromes (MDS) with International Prognostic Scoring System (IPSS) of intermediate 2 or greater\r\n* Any myeloproliferative disorder\r\n* Hodgkin lymphoma: relapsed, refractory, or primary induction failure\r\n* Non-Hodgkin lymphoma: relapsed, refractory, primary treatment failure, or not eligible for an autologous HSCT\r\n* Other conditions not listed will be assessed as high-risk by the principal investigator (PI)
Hematologic malignancy (e.g. acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], B cell non-Hodgkin's lymphoma [B-NHL])
Patients with Burkitt lymphoma/leukemia
Patients must have histologic confirmation of relapsed and or refractory hematologic malignancy, locally advanced or metastatic colon/rectal carcinoma, or refractory and/or relapsed soft tissue sarcomas and have failed at least one standard line of therapy; patients will be eligible if they have either declined standard treatment regimens or if there is no standard approach to curative salvage therapy per National Comprehensive Cancer Network (NCCN) guidelines in the setting of relapsed/refractory disease; in addition, patients for whom a potential 29-day delay in treatment will not interfere with the subject’s potential therapeutic options can be eligible per the treating physician's discretion\r\nMalignancies can include:\r\n* Acute myeloid leukemia\r\n* Myelodysplastic syndrome\r\n* Acute lymphoblastic leukemia\r\n* Chronic myeloid leukemia\r\n* Chronic lymphocytic leukemia\r\n* Non Hodgkin lymphoma\r\n* Hodgkin lymphoma\r\n* Myeloproliferative syndromes\r\n* Plasma cell myeloma\r\n* Colon/rectal carcinoma\r\n* Sarcomas including but not limited to Ewing’s sarcoma and rhabdomyosarcoma
Non-Hodgkin lymphoma (NHL), Hodgkins, chronic lymphocytic leukemia, multiple myeloma demonstrating chemosensitive disease
Lymphoid malignancies requiring allogeneic hematopoietic cell transplantation\r\n* Multiple myeloma including primary or secondary plasma cell leukemia and secondary amyloidosis\r\n* Lymphomas and related chronic lymphoid proliferative disorders: Hodgkin’s lymphoma, non-Hodgkin’s lymphoma of any types (B-cell, T-cell, null/natural killer [NK]-cell type), chronic lymphocytic leukemia (CLL), pro-lymphocytic leukemia (PLL), hairy-cell leukemia, large granular lymphocytic leukemia\r\n* Waldenstrom’s macroglobulinemia/lymphoplasmacytic lymphoma\r\n* Acute lymphoblastic leukemia (ALL) of any types
Primary cancer is leukemia, lymphoma, or myeloma
INCLUDING: any non-Hodgkin's B cell malignancy such as chronic lymphocytic leukemia (CLL) and rare non-Hodgkin's B- cell subtypes such as hairy cell leukemia, Waldenström macroglobulinemia (WM), mantle cell leukemia (MCL), and transformed NHL histologies
Subject has leukemia or lymphoma
Eligible diagnoses:\r\n* Myelodysplastic syndrome (MDS) including chronic myelomonocytic leukemia (CMML) with at least one of the following poor-risk features:\r\n** Poor-risk cytogenetics\r\n** International Prognostic Scoring System (IPSS) score of intermediate (INT)-2 of greater\r\n** Treatment-related or secondary MDS\r\n** MDS diagnosed before age 21\r\n** Progression on or lack of response to standard deoxyribonucleic acid (DNA)-methyltransferase inhibitor therapy\r\n** Life-threatening cytopenias, including those requiring frequent transfusions\r\n* Small lymphocytic lymphoma (SLL) or chronic lymphocytic leukemia (CLL) with 17p deletion, or with progression < 6 months after second or greater treatment regimen; must have the following to be an acceptable candidate as well:\r\n** =< 20% of bone marrow cellularity involved by SLL/CLL (to lower risk of graft rejection)\r\n** No lymph nodes >= 5 cm in any dimension\r\n** No massive splenomegaly, defined as > 6 cm below the left costal margin\r\n* T-cell prolymphocytic leukemia (PLL) in partial remission (PR) or better prior to transplantation; must also have =< 20% of bone marrow cellularity involved by PLL (to lower risk of graft rejection)\r\n* Interferon- or tyrosine kinase-refractory chronic myelogenous leukemia (CML) in first chronic phase, tyrosine kinase inhibitor (TKI)-intolerant CML in first chronic phase, or CML in second or subsequent chronic phase\r\n* Philadelphia chromosome negative myeloproliferative disease (including myelofibrosis)\r\n** Intermediate-2 or high risk score by Dynamic International Prognostic Scoring System (DIPSS) plus is required for a diagnosis of myelofibrosis\r\n* Multiple myeloma or plasma cell leukemia with a PR or better to the last treatment regimen, based on the International Myeloma Working Group (IMWG) criteria\r\n* Hematologic malignancy in complete remission with minimal residual disease (MRD) non detectable OR detectable by conventional cytogenetics, fluorescence in situ hybridization (FISH), flow cytometry, or molecular testing or hematologic malignancies in partial remission
Refractory or relapsed chronic lymphocytic leukemia (CLL), prolymphocytic leukemia (PLL), hairy cell leukemia (HCL) or non-Hodgkin lymphoma (NHL) (including those of T cell origin)
Patients with high risk myeloid or lymphoid malignancies at stem cell transplant following American Society for Blood and Marrow Transplantation (ASBMT) criteria, including but not limited to conditions listed; these criteria apply BEFORE cyto-reductive therapy given within 28 days of planned conditioning:\r\n* Refractory acute myelogenous or lymphoid leukemia\r\n* Relapsed acute myelogenous or lymphoid leukemia\r\n* Myelodysplastic syndromes with 5% or more blasts\r\n* Chronic myelogenous leukemia in chronic phase 3 or more, blast phase presently, or second accelerated phase\r\n* Recurrent or refractory malignant lymphoma or Hodgkin’s disease with less than a partial response at transplant\r\n* High risk chronic lymphocytic leukemia defined as no response or stable disease to the most recent treatment regimen\r\n* Diseases in response or remission at high risk of relapse at the discretion of the attending physician: some examples include but are not limited to:\r\n** Acute myeloid leukemia (AML) in remission with monosomy 5 or 7, deletion of 5q or 7q, 11q23 mixed-lineage leukemia (MLL) rearrangement or complex karyotype (>= 3 chromosome abnormalities)\r\n** Non-Hodgkin's lymphoma (NHL) in response that is double hit or triple hit (which are characterized by a recurrent chromosome translocation in combination with a v-myc avian myelocytomatosis viral oncogene homolog [MYC]/8q24 breakpoint; these include but not limited to B-cell chronic lymphocytic leukemia [CLL]/lymphoma [BCL]2+/MYC+; BCL6+/MYC+; cyclin D1 (CCND1)+/MYC+; and BCL2+/BCL6+/MYC+)\r\n** Bi-phenotypic lineage leukemia\r\n** CLL with 17p deletion\r\n** Acute lymphoblastic leukemia (ALL) with t(4,11) et al.
Diagnosis of high risk hematological malignancy:\r\n* Any acute leukemia in first complete remission (CR) considered at high risk for relapse, or second or third CR, or relapse/refractory less than 10% blasts in bone marrow, or aplasia post-therapy; this includes de novo acute leukemia or acute leukemia that is therapy related or arising from an antecedent hematologic disorder including myelodysplasia (MDS), chronic myeloid leukemia (CML) or other myeloproliferative disorder\r\n* Juvenile myelomonocytic leukemia (JMML) in CR, or relapse with less than 10% bone marrow blasts \r\n* CML with tyrosine kinase inhibitor failure in chronic or accelerated phase or evolved to acute leukemia (blast crisis, see above)\r\n* MDS or other myeloproliferative disorder with life-threatening cytopenia(s), and/or red blood cell or platelet transfusion dependence, or patients with aplasia, or patients with excess blasts less than 10% blasts in the bone marrow at work-up\r\n* Aggressive lymphoma: patients in first complete remission (CR1) with disease at high risk of relapse or CR2-3 \r\n* Indolent lymphoma or chronic lymphocytic leukemia (CLL): any disease status provided any transformed component is in CR\r\n* Hodgkin lymphoma that is primary refractory or relapsed not suitable for other therapy and in partial remission (PR) or CR or small volume stable disease
Recipients of first ASCT from related or unrelated donor for the treatment of hematologic malignancies (acute myeloid leukemia, chronic myeloid leukemia, acute lymphoblastic leukemia, chronic lymphocytic leukemia, myelodysplastic syndrome, Hodgkin and non-Hodgkin lymphoma) who are 1-antigen or 1-allele mismatched or fully matched at human leukocyte antigen (HLA)-A, -B, -C and –DR as defined by high resolution typing
Patients who are considered candidates for an allogeneic stem cell transplantation as treatment for any of the following hematologic disorders:\r\n* Acute leukemia\r\n* Myelodysplastic syndrome\r\n* Other myeloproliferative disorder (i.e. myelofibrosis, chronic myelomonocytic leukemia, or chronic myelogenous leukemia)\r\n* Non Hodgkin's lymphoma\r\n* Hodgkin's disease\r\n* Multiple myeloma
Patients with high-risk hematologic malignancies with anticipated poor prognosis with non-transplant therapy, including those in remission or with induction failure and after treated or untreated relapse; diagnoses to be included are:\r\n* Acute myeloid leukemia\r\n* Acute lymphocytic leukemia\r\n* Chronic myeloid leukemia\r\n* Chronic lymphocytic leukemia\r\n* Myelodysplastic syndrome \r\n* Myeloproliferative syndromes\r\n* Non-Hodgkin lymphoma\r\n* Hodgkin lymphoma\r\n* Multiple myeloma
The following diseases will be permitted although other diagnoses can be considered if approved by Patient Care Conference (PCC) or the participating institutions’ patient review committees and the principal investigators\r\n* Aggressive non-Hodgkin lymphomas (NHL) and other histologies such as diffuse large B cell NHL: not eligible for autologous HCT, not eligible for high-dose allogeneic HCT, or after failed autologous HCT\r\n* Mantle cell NHL: may be treated in first complete remission (CR); (diagnostic lumbar puncture [LP] required pre-transplant)\r\n* Low grade NHL: with < 6 month duration of CR between courses of conventional therapy\r\n* CLL: must have either: \r\n** Failed to meet National Cancer Institute (NCI) Working Group criteria for complete or partial response after therapy with a regimen containing FLU (or another nucleoside analog, e.g. 2-Chlorodeoxyadenosine [2-CDA], pentostatin) or experience disease relapse within 12 months after completing therapy with a regimen containing FLU (or another nucleoside analog); \r\n** Failed FLU-cyclophosphamide (CY)-Rituximab (FCR) combination chemotherapy at any time point; or \r\n** Have “17p deletion” cytogenetic abnormality; patients should have received induction chemotherapy but could be transplanted in 1st CR; or\r\n** Patients with a diagnosis of CLL (or small lymphocytic lymphoma) or diagnosis of CLL that progresses to prolymphocytic leukemia (PLL), or T-cell CLL or PLL\r\n* Hodgkin lymphoma: must have received and failed frontline therapy\r\n* Multiple myeloma: must have received prior chemotherapy; consolidation of chemotherapy by autografting prior to nonmyeloablative HCT is permitted\r\n* Acute myeloid leukemia (AML): must have < 5% marrow blasts at the time of transplant\r\n* Acute lymphocytic leukemia (ALL): must have < 5% marrow blasts at the time of transplant\r\n* Chronic myeloid leukemia (CML): patients in 1st chronic phase (CP1) must have failed or be intolerant of tyrosine-kinase inhibitors (TKI); patients beyond CP1 will be accepted if they have < 5% marrow blasts at time of transplant  \r\n* Myelodysplasia (MDS)/myeloproliferative syndrome (MPS): patients must have < 5% marrow blasts at time of transplant \r\n* Waldenstrom’s macroglobulinemia: must have failed 2 courses of therapy
Patients who are to receive an allogeneic hematopoietic cell transplant as treatment for a leukemia or myelodysplastic syndrome that has an expected risk of relapse exceeding 30% will be eligible to have donor-derived WT1 peptide sensitized T cells generated prior to or at the time of transplant for immediate use post transplant at such time that the patient is found to have minimal residual disease or relapse; this includes patients with:\r\n* Acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), or MDS refractory to primary induction therapy\r\n* ALL or AML at any stage later than first (1 degree) relapse\r\n* Chronic myelogenous leukemia (CML) secondary (2 degree) or greater chronic phase after chemotherapy\r\n* CML in persistent accelerated phase or blast crisis\r\n* High risk MDS (refractory anemia with excess blasts [RAEB] and RAEB in transformation [T]) which has failed to respond or has recurred following induction chemotherapy
Patients with a diagnosis of leukemia, lymphoma, or myeloma
One of the following hematologic malignancies that has relapsed or remains refractory after prior allogeneic HCT: acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), myeloid sarcoma, chronic myelogenous leukemia (CML), juvenile myelomonocytic leukemia (JMML), myelodysplastic syndrome (MDS), non-Hodgkin lymphoma (NHL)
One of the following hematologic malignancies that has relapsed or remains refractory after prior allogeneic HCT: \r\n* Acute lymphoblastic leukemia (ALL)\r\n* Acute myeloid leukemia (AML) (including myeloid sarcoma)\r\n* Chronic myelogenous leukemia (CML), juvenile myelomonocytic leukemia (JMML), myelodysplastic syndrome (MDS), Hodgkin or non-Hodgkin lymphoma (NHL)
Allogeneic hematopoietic cell transplant for hematologic malignancy (i.e. leukemia, lymphoma including acute lymphoblastic leukemia [ALL], acute myeloid leukemia [AML], chronic myelogenous leukemia [CML], non-Hodgkin lymphoma [NHL], Hodgkin lymphoma [HL]) in complete remission; myelodysplastic syndrome (active dysplasia and/or blasts are permitted, but must not have active leukemia) or idiopathic severe aplastic anemia (SAA)
Patients must have one of the following documented diseases:\r\n* Chronic myelogenous leukemia\r\n* Chronic lymphocytic leukemia\r\n* Multiple myeloma\r\n* Myelodysplasia\r\n* Myeloproliferative disorder\r\n* Non-Hodgkin's lymphoma\r\n* Hodgkin's disease\r\n* Acute myelogenous leukemia\r\n* Acute lymphoblastic leukemia\r\n* Acute biphenotypic leukemia
Patients must meet diagnostic criteria of acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), chronic myeloid leukemia (CML), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL), myelodysplastic syndrome (MDS), myelofibrosis, or severe aplastic anemia; patients will be allowed on study if they are deemed eligible for allogeneic (allo) HCT regardless of remission status
Planned peripheral blood stem cell (PBSC) or bone marrow (BM) HCT for the treatment of the following hematologic malignancies:\r\n* Lymphoma (Hodgkin and non-Hodgkin)\r\n* Myelodysplastic syndrome\r\n* Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood; persistent lymphadenopathy on computed tomography [CT] or CT/positron emission tomography [PET] scan without progression is allowed)\r\n* Acute myeloid leukemia in first or second remission\r\n* Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase\r\n* Other hematologic malignancies judged appropriate by the clinical principal investigators (PIs), including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis; patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded\r\n** Adult cases of multiple myeloma (MM) are excluded; adults with aplastic anemia are excluded; patients undergoing a second haploHCT are not eligible (patients who have undergone a previous autologous HCT are eligible)
Planned HCT for the treatment of the following hematologic malignancies:\r\n* Lymphoma (Hodgkin and non-Hodgkin)\r\n* Myelodysplastic syndrome\r\n* Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status needs to be in hematologic remission by bone marrow and peripheral blood; persistent lymphadenopathy on computed tomography [CT] or CT/positron emission tomography [PET] scan without progression is allowed)\r\n* Acute myeloid leukemia in first or second remission\r\n* Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase\r\n* Other hematologic malignancies including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis; patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded
Planned HCT for the treatment of the following hematologic malignancies:\r\n* Lymphoma (Hodgkin and non-Hodgkin)\r\n* Myelodysplastic syndrome\r\n* Acute lymphoblastic leukemia in first or second remission (for acute lymphoblastic leukemia/lymphoblastic lymphoma, the disease status must be in hematologic remission by bone marrow and peripheral blood; persistent lymphadenopathy on computed tomography [CT] or CT/positron emission tomography [PET] scan without progression is allowed)\r\n* Acute myeloid leukemia in first or second remission\r\n* Chronic myelogenous leukemia in first chronic or accelerated phase, or in second chronic phase\r\n* Other hematologic malignancies including chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis; patients with multiple myeloma and those with non-malignant disease such as aplastic anemia are excluded\r\n* Patients undergoing a second allogeneic (allo) HCT are not eligible (patients who have undergone a previous autologous HCT are eligible)
Patients with history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic diseases
Diagnosis of lymphoma or leukemia as documented in medical record
Leukemia, lymphoma, and myeloma
Patients that are high risk for TLS or potential/intermediate risk for TLS as described below:\r\n* High risk: Hyperuricemia of malignancy (uric acid levels > 7.5); or diagnosis of very aggressive lymphoma/leukemia based on Revised European-American Lymphoma (REAL) classification; acute myeloid leukemia, chronic myelogenous leukemia (CML) in blast crisis; high grade myelodysplastic syndrome only if they have > 10% bone marrow blast involvement and given aggressive treatment similar to acute myeloid leukemia (AML)\r\n* Potential risk: Diagnosis of aggressive lymphoma/leukemia based on (REAL) classification; plus one or more of the following criteria: lactate dehydrogenase (LDH) >= 2 x upper limit of normal (UNL); stage III-IV disease; stage I-II disease with at least 1 lymph node/tumor > 5 cm in diameter; for patients with potential/intermediate risk for TLS-only those planned to receive alternating regimens (or non-standard regimens) in 2 cycles (example; rituximab-hyperfractionated cyclophosphamide-vincristine [vincristine sulfate]-Adriamycin [doxorubicin hydrochloride]-dexamethasone [R-Hyper-CVAD] alternating with methotrexate/arabinofuranosyl cytidine [cytarabine] [MTX/ARA-C]) will be eligible
RECIPIENT: Planned HCT for the treatment of the following hematologic malignancies: lymphoma (Hodgkin and non?Hodgkin), myelodysplastic syndrome, acute lymphoblastic leukemia in first or second remission, acute myeloid leukemia in first or second remission, chronic myelogenous leukemia (in first chronic or accelerated phase, or in second chronic phase), chronic lymphocytic leukemia, myeloproliferative disorders and myelofibrosis (City of Hope [COH] only). Patients with multiple myeloma are excluded
The patient must have a diagnosis of one of the following (one must be yes):\r\n* Acute myeloid leukemia (AML)\r\n* Acute lymphoblastic leukemia (ALL)\r\n* Chronic myelogenous leukemia (CML) (chronic phase intolerant or unresponsive to tyrosine kinase inhibitors, accelerated phase, history of blast crisis)\r\n* Myelodysplastic syndrome (MDS)\r\n* Myeloproliferative neoplasm (MPN)\r\n* Chronic myelomonocytic leukemia (CMML)\r\n* Non-Hodgkin lymphoma (NHL)\r\n* Hodgkin lymphoma (HL) (received and failed frontline therapy or failed autologous transplantation or inability to collect enough peripheral blood stem cells [PBSC] for autologous hematopoietic cell transplant [auto-HCT])\r\n* Multiple myeloma (MM)\r\n* Waldenstrom’s macroglobulinemia\r\n* Severe aplastic anemia
Acute myeloid leukemia, myelodysplasia, acute lymphoblastic leukemia, chronic myeloid leukemia, chronic lymphocytic leukemia, myeloproliferative neoplasms, Hodgkin lymphoma, or non-Hodgkin lymphoma requiring a matched allogeneic HSCT
Subjects must have one of the following disease categories:\r\n* Acute myeloid leukemia (AML) beyond 2nd remission or relapsed/refractory disease\r\n* Acute lymphoblastic leukemia (ALL) beyond 2nd remission or relapsed/refractory disease\r\n* Chronic myeloid leukemia (CML) beyond 2nd chronic phase or in blast crises\r\n* Myelodysplastic syndrome (MDS)\r\n* Myeloproliferative disorders including myeloid metaplasia and myelofibrosis\r\n* High risk non-Hodgkin’s lymphoma (NHL) in first remission\r\n* Relapsed or refractory NHL\r\n* Hodgkin’s lymphoma (HL) beyond first remission
Malignant disorders:\r\n* Chronic myeloid leukemia (CML) (chronic phase, accelerated phase or blast crisis)\r\n* Acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), juvenile myelomonocytic leukemia (JMML)\r\n* Acute lymphoblastic leukemia (ALL)\r\n* Lymphoma (Hodgkin’s and non-Hodgkin’s)
Hematologic malignancies - Acute myelogenous leukemia (AML), acute lymphoblastic leukemia (ALL), myelodysplastic syndrome (MDS), chronic lymphocytic leukemia (CLL), non-Hodgkin lymphoma (NHL), Hodgkin lymphoma (HL), multiple myeloma (MM) - in complete remission (CR)\r\n* Complete remission is defined per morphologic, cytogenetic, fluorescence in situ hybridization (FISH), molecular, and radiographic imaging studies appropriate for each condition listed
Have lymphoma or leukemia
Patients with Burkitt's leukemia/lymphoma.