Patients with myelodysplastic syndrome/acute myeloid leukemia
CNS3 leukemia
Patient must be CNS (cerebrospinal fluid [CSF]) negative for leukemia
Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia); patients with Down syndrome are also eligible
Patients with Burkitt leukemia/lymphoma or mature B-cell leukemia are not eligible
Patients with T-lymphoblastic leukemia (T-ALL)/lymphoblastic lymphoma (T-LL) are not eligible
Patients must have newly diagnosed B lymphoblastic leukemia (2008 World Health Organization [WHO] classification) (also termed B-precursor acute lymphoblastic leukemia) or acute leukemia of ambiguous lineage (ALUL), which includes mixed phenotype acute leukemia (MPAL); for patients with ALUL, the morphology and immunophenotype must be at least 50% B lymphoblastic
Patients with known absence of KMT2A-rearrangement leukemia prior to enrollment
Patients with secondary B acute lymphoblastic leukemia (B-ALL) that developed after treatment of a prior malignancy with cytotoxic chemotherapy
Known history of chronic myelogenous leukemia (CML)
Newly diagnosed patients with CD-22 positive B-cell acute lymphoblastic leukemia (World Health Organization [WHO] criteria) are eligible; patients with Burkitt type ALL are NOT eligible
Patients with acute bilineal/biphenotypic leukemia
leukemia refractory to ? 2 induction attempts,
leukemia in 2nd or higher relapse,
Patients must have a diagnosis of relapsed or refractory CD22-positive acute leukemia including B-ALL, mixed phenotype leukemia (biphenotypic), or Burkitt’s leukemia based on World Health Organization (WHO) classification; patients with bilineal leukemia are excluded
Patients with a diagnosis of chronic myelomonocytic leukemia (CMML)
Patients with prior myelodysplastic syndrome or acute myeloid leukemia
Patients with previously untreated acute lymphoblastic leukemia (B-cell or T-cell)
Relapsed or refractory acute myeloid leukemia
Diagnosis of acute promyelocytc leukemia
Primary or secondary plasma cell leukemia
Concurrent symptomatic amyloidosis or plasma cell leukemia
Relapsed or refractory chronic myelomonocytic leukemia (CMML), and other MDS/myeloproliferative neoplasm (MPN) overlap syndromes, with no available therapies
Pathologic confirmation of the diagnosis of AML, ALL (acute lymphoblastic leukemia), or blast-phase CML (chronic myelogenous leukemia)
Relapsed and refractory acute myeloid leukemia (Cohort 1)
Known leukemia or lymphoma
Have current acute leukemia.
A diagnosis of acute promyelocytic leukemia (APL) or chronic myeloid leukemia (CML) in blast crisis.
Plasma cell leukemia
Diagnosis of acute leukemia or any patient that has been treated with fludarabine.
Patients with hematologic malignancies (includes patients with myelodysplastic syndrome/acute myeloid leukemia)
For expansion, subjects may have a pathologically confirmed diagnosis of MF or PV as noted above; there are two expansion cohorts for patients with myelodysplasia/myeloproliferative neoplasm (MDS/MPN) (chronic myelomonocytic leukemia [CMML], atypical chronic myelogenous leukemia [aCML], refractory anemia with ringed sideroblasts and thrombocytosis [RARS-T] or MDS/MPN-unclassifiable [U]) which warrants treatment; patients with these diagnoses may be eligible, provided they are able to obtain ruxolitinib from commercial supply
T-cell prolymphocytic leukemia
T-cell large granular lymphocytic leukemia
Diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma as defined by the World Health Organization
NK cell leukemia.
Lymphoid blastic crisis of chronic myelogenous leukemia
Plasma cell leukemia
Current diagnosis of plasma cell leukemia
Acute lymphoblastic leukemia (ALL):
Any acute leukemia with marrow aplasia or without adequate count recovery.
Mixed phenotype acute leukemia MRD > 1% after consolidation
Participants must have a diagnosis of AML or acute leukemia of ambiguous lineage (acute undifferentiated leukemia or mixed phenotype acute leukemia) and meet the criteria below:\r\n* Refractory leukemia, defined as persistent leukemia after at least two courses of induction chemotherapy, OR\r\n* Early relapsed leukemia, defined as the re-appearance of leukemia after the achievement of remission and within one year of diagnosis, OR\r\n* Relapsed leukemia that is refractory to at least one course of salvage therapy (i.e., therapy given after the relapse has occurred), OR\r\n* Second or greater relapse\r\nPatients in all categories above must have >= 5% blasts in the bone marrow as assessed by morphology or flow cytometry; however, if an adequate bone marrow sample cannot be obtained, patients may be enrolled if there is unequivocal evidence of leukemia with >= 5% blasts in the peripheral blood; in addition, patients in all categories must not be eligible to undergo curative therapy, such as immediate stem cell transplantation (SCT)
Participants with a history of myelodysplastic syndrome or acute myeloid leukemia
Subject has BCR-ABL-positive leukemia (Chronic myeloid leukemia [CML] in blast crisis).
Diagnosis of acute leukemia
Patient has newly diagnosed acute lymphoblastic leukemia (ALL) or acute undifferentiated leukemia with >= 25% blasts in the bone marrow (M3), with or without extramedullary disease; patients with T-cell ALL are eligible; patients with bilineage or biphenotypic acute leukemia are eligible, provided the morphology and immunophenotype are predominantly lymphoid
Plasma cell leukemia (defined by plasma cell >20%, and/or an absolute plasma cell count of >2 x 10e9/L in peripheral blood).
Active or prior plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 10^9/L).
Have current hematologic malignancies, acute or chronic leukemia.
Diagnosis of T-acute lymphoblastic leukemia/ lymphoblastic lymphoma according to World Health Organization (WHO) criteria which has relapsed or is refractory to chemotherapy
Total bilirubin =< 2 x institutional upper limit of normal (IULN) except for Gilbert’s disease or when in the opinion of treating physician elevated levels are due to direct involvement of leukemia (e.g., hepatic infiltration or biliary obstruction due to leukemia)
Leukemia other than CMML
leukemia
High grade lymphomas (Burkitts or lymphoblastic), plasma cell leukemia.
Patient must have a B cell acute lymphoblastic leukemia (ALL) (inclusive of ALL blast transformation from chronic myelogenous leukemia [CML]) or lymphoma and must have relapsed or refractory disease after at least one standard chemotherapy regimen and one salvage regimen; in view of the principal investigator (PI) and the primary oncologist, there must be no available alternative curative therapies and subjects must be either ineligible for allogeneic stem cell transplant (SCT), have refused SCT, recurred after SCT, or have disease activity that prohibits SCT at the time of enrollment
Acute lymphoblastic leukemia, excluding known mature B-cell ALL by the presence of any of the following: surface immunoglobulin, L3 morphology, t(8;14)(q24;q32), t(8;22), or t(2;8)
Patients who are considered appropriate candidates for allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses:\r\n* Acute lymphocytic leukemia in first or subsequent remission\r\n* Acute myeloid leukemia in first or subsequent remission \r\n* Acute lymphocytic leukemia in relapse or primary refractory disease with a circulating blast count of no more than 10,000/mm^3 (Arms A or C only)\r\n* Acute myeloid leukemia in relapse or primary refractory disease with a circulating blast count of no more than 10,000/mm^3 (Arms A or C only)\r\n* Refractory anemia with excess blasts (RAEB-1 and RAEB-2) (if the patient has received previous induction chemotherapy within 60 days)\r\n* Chronic myelogenous leukemia with a history of accelerated phase or blast crisis (if the patient has received at least one course of induction chemotherapy)\r\n* Other acute leukemia or related neoplasm (including but not limited to ‘biphenotypic’, ‘undifferentiated’ or ‘ambiguous lineage’ acute leukemia, blastic plasmacytoid dendritic cell neoplasm or lymphoblastic lymphoma)
Presence of active central nervous system (CNS) leukemia. Subjects adequately treated for CNS leukemia documented by 2 consecutive cerebrospinal fluid samples negative for leukemia cells are eligible. Subjects with no history of CNS leukemia will not be required to undergo cerebrospinal fluid sampling for eligibility.
Group A: CD19+ B-acute lymphoblastic leukemia (ALL) undergoing allogeneic HSCT or
CD19+ leukemia
Patients with pathologically confirmed smoldering or chronic adult T- cell leukemia as defined by Shimoyama
Must have relapsed or refractory precursor B-cell acute lymphoblastic leukemia or acute lymphoblastic lymphoma
Have known acute or chronic leukemia or current hematologic malignancies (except iNHL for patients in Part B5) that, in the judgment of the investigator and sponsor, may affect the interpretation of results
Chronic myelogenous leukemia excluding refractory blast crisis; to be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate
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
Patients with myeloid diseases (AML, myeloid blast crisis of CML) will be eligible for arm A with cytarabine; patients with lymphoid diseases (ALL, lymphoid blast crisis of CML) will be eligible for arm B with liposomal vincristine; patients with leukemia of ambiguous lineage or bi-phenotypic leukemia (e.g. B/myeloid) may be treated on either arm A or B, at discretion of treating physician
Patients with first relapsed/refractory B-cell acute lymphoblastic leukemia (ALL)
Patients with Philadelphia chromosome (Ph)-positive ALL or Burkitt leukemia
Concurrent symptomatic amyloidosis or plasma cell leukemia
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.
Patients with a known diagnosis of plasma cell leukemia
Active plasma cell leukemia and/or leukemic manifestations of lymphoma
Chronic lymphocytic leukemia and Richter's transformation, and prolymphocytic leukemia (NHL subjects)
Patients with symptomatic CNS leukemia or patients with poorly controlled CNS leukemia
Patients with symptomatic CNS leukemia or patients with poorly controlled CNS leukemia.
Patients with Plasma Cell Leukemia
Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
Diagnosis of acute leukemias, accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma.
CD19+22+ leukemia
Central nervous system (CNS) leukemia (including leukemia detectable in the cerebrospinal fluid and/or solid chloromas) refractory to intrathecal chemotherapy and/or craniospinal radiation
History of or active bone marrow disorders expected to interfere with study therapy (e.g. acute leukemias, accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma)
Relapsed acute myeloid leukemia
POEMS syndrome or active plasma cell leukemia;
Has morphologically confirmed diagnosis of myelodysplastic syndromes (MDS) or nonproliferative chronic myelomonocytic leukemia (CMML) (i.e., with white blood cell [WBC] <13,000/?L) or low-blast acute myelogenous leukemia (AML).
A diagnosis or suspicion of myelodysplastic syndrome/acute myeloid leukemia.
Patients with a diagnosis of chronic myelomonocytic leukemia (CMML) who have not received induction chemotherapy
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
Patients ?18 and ?75 years old with relapsed or primary refractory acute myeloid leukemia.
Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis; cirrhosis; fatty liver; and inherited liver disease. Patients with acute leukemias, accelerated/blast phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma
Relapsed or refractory CD19-positive B-lineage acute lymphoblastic leukemia having received at least 1 prior line of therapy
Philadelphia chromosome/BCR-ABL1-positive B-lineage acute lymphoblastic leukemia (ALL) must have failed at least 1 second or third generation tyrosine kinase inhibitor (TKI) or be intolerant to TKIs
Burkitt lymphoma/leukemia
Chronic myelomonocytic leukemia (CMML)
Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (Lead-in and Phase 2)
Relapsed and/or refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia/lymphoma or “double-hit” leukemia/lymphoma (2 separate cohorts, phase II only)
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
PHASE I: Diagnosis of CD22-positive acute lymphoblastic leukemia
PHASE II: Diagnosis of CD22-positive acute lymphoblastic 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.
Plasma cell leukemia
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 acute leukemias, accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma
Patients with acute leukemias, accelerated/blast phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma
Patients with Burkitt lymphoma/leukemia
Plasma cell leukemia (greater than 2,000 cells/mcL of circulating plasma cells by standard differential)
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)
Patients with myelodysplastic syndrome/acute myeloid leukemia
Patients with acute leukemias, accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma
Myeloid blast crisis of chronic myeloid leukemia (CML), unless patient is not considered candidate for tyrosine kinase inhibitor treatment
Diagnosis of T acute lymphoblastic leukemia (T-ALL) or Burkitt’s leukemia/lymphoma
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
MRD positive leukemia (AML, ALL or accelerated/blast phase chronic myelogenous leukemia [CML]); selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status
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
Plasma cell leukemia
Plasma cell leukemia
Patients with symptomatic CNS leukemia or patients with poorly controlled CNS leukemia
Patients with myelodysplastic syndrome/acute myeloid leukemia
Have acute leukemia.
Isolated extramedullary leukemia without also meeting bone marrow criteria for leukemia
Myeloid blast crisis of chronic myeloid leukemia (CML), unless patient is not considered candidate for tyrosine kinase inhibitor treatment
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
Acute biphenotypic or bilineal leukemia in first or greater complete remission
Chronic myelomonocytic leukemia (CMML)
Chronic myeloid leukemia (CML) who have failed or are intolerant to BCR-ABL tyrosine kinase inhibitors
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)
Chronic myeloid leukemia (CML) in any phase
PHASE I AND II SCLC AND UROTHELIAL CARCINOMA EXPANSION COHORT: Patients with myelodysplastic syndrome/acute myeloid leukemia or pneumonitis; or baseline features suggestive of myelodysplastic syndrome or acute myelogenous leukemia on peripheral blood smear or bone marrow biopsy, if clinically indicated
Philadelphia chromosome positive acute lymphoblastic leukemia
Myeloid blast crisis of chronic myeloid leukemia (CML), unless patient is not considered candidate for CML-directed tyrosine kinase inhibitor treatment (excluding sorafenib)
Chronic myelogenous leukemia in chronic or accelerated phase, or chronic myelogenous leukemia (CML) blast crisis in morphological remission (< 5% blasts): chronic phase patients must have failed at least two tyrosine kinase inhibitors been intolerant to all available tyrosine kinase inhibitors (TKIs) or have T315I mutation
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.
Newly diagnosed, previously untreated chronic phase chronic myeloid leukemia (CP-CML) (by World Health Organization [WHO] definition) (hydroxyurea permitted up to 7 days prior to enrollment)
Chronic myeloid leukemia (CML) in AP or BP
Patients diagnosed with a leukemia or lymphoma as follows:\r\n* Chronic or acute leukemia forms of HTLV-1 associated adult T-cell leukemia;\r\n* Peripheral T-cell lymphoma (angioimmunoblastic, hepatosplenic, or not otherwise specified); or,\r\n* Cutaneous T-cell lymphoma stage III or IV with circulating monoclonal cells (B1 or B2) and/or erythrodermia (T4)\r\n* T-cell prolymphocytic leukemia (T-PLL)\r\n* NOTE: Diagnosis must be validated by the Pathology Department, National Cancer Institute (NCI)
Chronic myelogenous leukemia excluding refractory blast crisis: To be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate
Plasma cell leukemia after initial therapy, who achieved at least a partial remission
Chronic myeloid leukemia (CML) in refractory blast crisis
Active plasma cell leukemia (defined as either 20% of peripheral white blood cells comprised of plasma/CD138+ cells or an absolute plasma cell count of 2 x 10^9/L)
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
Patients with a known history or prior diagnosis of optic neuritis or other immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment
Multiple myeloma specific:\r\n* Active or prior plasma cell leukemia (defined as either 20% of peripheral white blood cell [WBC] comprised of plasma/cluster of differentiation [CD]138+ cells or an absolute count of 2 x 10^9/L)\r\n* Solitary bone or solitary extramedullary plasmacytoma as the only evidence of plasma cell dyscrasia
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
PHASE I: No features suggestive of myelodysplastic syndrome/ acute myeloid leukemia
PHASE II: No features suggestive of myelodysplastic syndrome/ acute myeloid leukemia
A diagnosis of chronic myelomonocytic leukemia (CMML), unless in morphologic CR
Diagnosis of acute leukemia by World Health Organization (WHO) criteria (e.g.-acute myeloid leukemia, acute lymphoblastic leukemia, acute leukemia of ambiguous origin)
Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia or Richter's Transformation
Patients who are in blast transformation of chronic myeloid leukemia (CML); prior MDS or CMML is acceptable
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
Participants with non-secretory or oligo-secretory myeloma, plasma cell leukemia or Waldenström's macroglobulinemia
Histologically confirmed diagnosis of relapsed or refractory acute lymphoblastic leukemia (ALL) (including Burkitt leukemia), acute myeloid leukemia (AML), mixed lineage leukemia, biphenotypic leukemia, or chronic myelogenous leukemia (CML) in blast crisis\r\n* Refractory disease defined as: persistent disease after at least two induction cycles\r\n* Relapsed disease: second or subsequent relapse, any relapse refractory to salvage chemotherapy
Individuals with CNS 3 leukemia
Plasma cell leukemia
Must have relapsed or refractory acute lymphoblastic leukemia (ALL) or relapsed or refractory lymphoblastic lymphoma (LL). Refractory is defined as persistent disease after at least 2 courses of chemotherapy.
Newly diagnosed or relapsed chronic myelogenous leukemia (CML) in lymphoid blast crisis
Patients with myelodysplastic syndrome/acute myeloid leukemia
Patients must have histologically or cytologically documented relapsed and/or refractory acute myeloid leukemia or granulocytic sarcoma
Acute leukemia not in remission
Chronic myelogenous leukemia (CML)
Patients with symptomatic CNS leukemia or patients with poorly controlled CNS leukemia
In order to prevent tumor lysis syndrome, acute leukemia patients must have a peripheral blast count under 50 x 10^9/L; this should be achieved with hydroxyurea cytoreduction, prior to starting DT2219
Chronic myelogenous leukemia\r\n* Chronic phase chronic myelogenous leukemia (CML) having progressed after treatment with breakpoint cluster region (BCR)-ABL proto-oncogene 1, non-receptor tyrosine kinase (ABL) kinase inhibitor or with evidence of T315I BCR-ABL mutation\r\n* Accelerated or blast phase CML\r\n* Not eligible for myeloablative allogeneic HSCT
WHO classification defined B-lymphoid malignancy, with the exception of Burkitt lymphoma/leukemia, plasma cell myeloma, acute lymphoblastic leukemia, lymphoblastic lymphoma, and plasmablastic lymphoma.
Patients must have histologically or cytologically documented relapsed and/or refractory acute myeloid leukemia
Patients with a known diagnosis of plasma cell 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)
Patients with biopsy-proven acute myeloid leukemia or myelodysplastic syndrome with persistent disease or in remission
Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood)
Disease status must be complete remission by standard criteria for lymphoma and acute leukemia patients
Burkitt’s or Burkitt-like leukemia/lymphoma, either previously untreated, or relapsed/refractory, or human immunodeficiency virus (HIV)-related; patients HIV positive will be described and reported separately or relapsed/refractory acute lymphoblastic leukemia (ALL)
Research participants with precursor B-cell acute lymphoblastic leukemia/lymphoma or plasma cell dyscrasias
Newly diagnosed or relapsed mixed phenotype acute leukemia (MPAL), which for this protocol, will be defined as follows: bone marrow result interpreted by the reading pathologist (or tissue biopsy for cases of extramedullary disease) as: biphenotypic leukemia, bilineal leukemia, undifferentiated leukemia, mixed lineage leukemia, leukemia of ambiguous lineage, T/myeloid leukemia, B/myeloid leukemia, or other diagnosis indicating the presence of multiple lineages within the cell population
For salvage cohort: patients with previously treated, relapsed or refractory AML, acute biphenotypic leukemia, or CML in myeloid blast phase are eligible
Patients with biopsy-proven acute lymphoblastic leukemia, acute myeloid leukemia, or myelodysplastic syndrome in remission or relapse
Patients with non-measurable MM or primary plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
Diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma
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
Chronic myeloid leukemia (CML) which:\r\n* Failed to achieve a cytogenetic remission to tyrosine kinase inhibitor treatment or has a cytogenetic relapse\r\n* Has ever been in accelerated phase or blast crisis
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
Plasma cell leukemia
Patients with plasma cell leukemia who are transplant candidates
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
Chronic myelomonocytic leukemia (CMML): CMML-1 and CMML-2
Patients will be excluded if they have isolated extra-medullary relapse of acute lymphoblastic leukemia (ALL)
MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN
BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
Active plasma cell leukemia
Acute myeloid leukemia as defined by WHO criteria
Patients with a myeloid hematologic malignancy (acute myelogenous leukemia, secondary myelogenous leukemia or myelodysplastic syndrome) unlikely to be cure by standard chemotherapy; this includes patients who have relapsed after standard chemotherapy treatments and patients in first remission with unfavorable prognostics features
Relapsed or refractory acute leukemia (acute myeloid leukemia or acute lymphoblastic leukemia or lymphoma) in second or subsequent remission, with remission defined as < 5% bone marrow blasts morphologically
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
Interferon- or imatinib-refractory chronic myelogenous leukemia (CML) in first chronic phase, or non-blast crisis CML beyond first chronic phase
Chronic myelomonocytic leukemia
Juvenile myelomonocytic leukemia
Chronic myelomonocytic leukemia: CMML-1 and CMML-2
Plasma cell leukemia: after induction chemotherapy
Subjects with leukemia are not eligible for study participation
Chronic myelogenous leukemia: All types, except refractory blast crisis; chronic phase patients must have failed or been intolerant to Gleevec or other tyrosine kinase inhibitors
Acute myeloid leukemia/acute lymphoblastic leukemia, including biphenotypic acute leukemia or mixed-lineage leukemia: Must have < 5% morphologic marrow blasts in an evaluable marrow (> 25% of normal cellularity for age) collected less than one month prior to start of conditioning; patients persistently aplastic for greater than one month since completing last chemotherapy are also eligible with the approval of the PI or designee
Chronic myelogenous leukemia (CML) in chronic or accelerated phase; prior therapies allowed
Hematologic malignancy (e.g. acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], B cell non-Hodgkin's lymphoma [B-NHL])
Diagnosis of chronic lymphocytic leukemia with no history of previous treatments with monoclonal antibodies or chemotherapy.
Chronic myelogenous leukemia in chronic or accelerated phase
Myelodysplastic/myeloproliferative disease\r\n* Juvenile myelomonocytic leukemia (JMML)\r\n* Myelodysplastic syndrome and/or pre-leukemia at any stage
Diagnosis of acute lymphoblastic leukemia (ALL) or biphenotypic leukemia meeting the following criteria:
Based on European Group for the Classification of Acute Leukemia (EGIL) diagnostic criteria
CNS or testicular leukemia at diagnosis allowed
Chronic myelogenous leukemia (CML)
Chronic myelogenous leukemia excluding refractory blast crisis; to be eligible in first chronic phase (CP1) patient must have failed or be intolerant to imatinib mesylate
Plasma Cell leukemia after initial therapy, who achieved at least a partial remission
Chronic myelogenous leukemia: all types except refractory blast crisis; chronic phase patients must have failed or been intolerant to Gleevec
Chronic myelogenous leukemia (CML) in refractory blast crisis
Documented acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL) as defined by the criteria below:
Confirmed diagnosis of B-cell Chronic Lymphocytic Leukemia
Chronic myelogenous leukemia excluding refractory blast crisis: to be eligible in first chronic phase (CP1) patient must have failed or be intolerant to one or more tyrosine kinase inhibitors
Plasma cell leukemia after initial therapy, in patients who have achieved at least a partial remission
Juvenile myelomonocytic leukemia
MRD positive leukemia (AML, ALL or accelerated/blast phase chronic myeloid leukemia [CML]); selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status
Secondary immune thrombocytopenia from any cause including lymphoma, chronic lymphocytic leukemia, and drug-induced thrombocytopenia
Criteria 4 Plasma cell leukemia (> 2.0 x 109/L circulating plasma cells by standard differential)
Diagnosis of chronic myelogenous leukemia in blast crisis;
Extramedullary leukemia allowed except CNS disease
CNS leukemia
Must not have acute leukemia
Plasma cell leukemia
Chronic myelomonocytic leukemia (CMML)
Plasma cell leukemia (plasma cells > 2000/cubic mm)
TdT-positive leukemia (ALL, AML, or blastic CML) that has failed at least one standard treatment regimen and for which no standard therapies are expected to result in durable remission. Leukemia is minimally defined as at least 20% blast cells present in marrow or peripheral blood. TdT must be expressed in at least 20% of blast cells present and documented either immunologically or biochemically;
Diagnosis of refractory or relapsed ALL (acute lymphocytic leukemia)
History of Richter's transformation or prolymphocytic leukemia
Myeloid blast crisis of chronic myeloid leukemia (CML), unless patient is not considered candidate for tyrosine kinase inhibitor treatment
Diagnosis of mature B-cell ALL (Burkitt’s leukemia) according to World Health Organization (WHO) classification, or lymphoid blast crisis of chronic myelogenous leukemia (CML)
Patients with myelodysplastic syndrome/acute myeloid leukemia
Known history of primary plasma cell leukemia or evidence of primary or secondary plasma cell leukemia at the time of screening
Patients with acute leukemias, accelerated/blast phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma.
Patients with known extramedullary leukemia are not eligible
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 < 5% 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)-2 or high risk (i.e., RAEB, RAEBt) or refractory anemia with severe pancytopenia or high risk cytogenetics; blasts must be < 10% by a representative bone marrow aspirate morphology\r\n* Chronic Myeloid Leukemia excluding refractory blast crisis; to be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy
The subject must have precursor B-cell or T-cell acute lymphoblastic leukemia. B-cell: relapsed or refractory after first or subsequent salvage therapy; or T-cell: relapsed or refractory with first remission duration less than or equal to 12 months in first salvage; or relapsed or refractory after first or subsequent salvage therapy
Patients with a diagnosis of relapsed or refractory hematologic malignancy including, but not limited to acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), Burkitt’s leukemia/lymphoma, prolymphocytic leukemia, biphenotypic acute leukemia, blast-phase of chronic myeloid leukemia (CML), B-cell lymphoma, or Richter’s transformation of chronic lymphocytic leukemia (CLL)
Patients must have a confirmed diagnosis of either B- or T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma that is either:\r\n* Arm A: Initially diagnosed at age 40 or later, OR\r\n* Arm B: Relapsed after or failed to respond to >= 1 previous chemotherapy regimen
Patients with Burkitt lymphoma/leukemia
Patients with any of the following diagnoses are eligible: 1) high-risk MDS (i.e. refractory anemia with excess blasts [RAEB-1 or RAEB-2] by World Health Organization [WHO] classification, or any WHO subset with International Prognostic Scoring System [IPSS] intermediate-2 or high, or any patients that has failed prior therapy with hypomethylating agents); 2) chronic myelomonocytic leukemia (CMML); 3) acute myeloid leukemia (AML) by WHO classification; 4) chronic myeloid leukemia in blast phase (CML-BP); patients with myelofibrosis are also eligible
BCR-ABL1 chronic myeloid leukemia in blast crisis (CML-BC)
Juvenile myelomonocytic leukemia (JMML)
Patients with a history of or active bone marrow disorders expected to interfere with study therapy (e.g. acute leukemias, accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma)
Plasma cell leukemia defined as peripheral plasma cell count > 2000/cubic millimeter (mm^3)
Participants whose leukemia meets WHO diagnostic criteria of mixed phenotype acute leukemia (MPAL) or leukemia of ambiguous lineage are not eligible
Plasma cell leukemia
Patients must not have blastic transformation of chronic myelogenous leukemia
Diagnosed with plasma cell leukemia, POEMS syndrome or amyloidosis.
Patients must have an initial diagnosis of AML, biphenotypic acute leukemia, or APL or chronic myelogenous leukemia (CML) in blast crisis
Plasma cell 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
Extremely radiosensitive tumor (lymphoma, leukemia)
Chronic myelogenous leukemia (accelerated, blast or second chronic phase)
Confirmed diagnosis of acute lymphoblastic leukemia or lymphoblastic lymphoma
For acute lymphoblastic leukemia: diagnosis should be made by bone marrow aspirate or biopsy demonstrating >= 30% 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
Plasma cell leukemia
Chronic myelogenous leukemia all types except blast crisis (note treated blast crisis in chronic phase is eligible)
Chronic myelogenous leukemia (CML) in refractory blast crisis
Patients with acute leukemias, accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia (except Rai-stage I), Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma
Patients who are in the blast phase of chronic myeloid leukemia
Bi-phenotypic acute leukemia
Diagnosis of plasma cell leukemia
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
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 who are currently receiving other anti-cancer agents are not eligible (except leukemia patients receiving hydroxyurea, which may be continued until 24 hours prior to start of protocol therapy); patients with acute lymphoblastic leukemia may receive intrathecal therapy
Relapse after previous allogeneic stem cell transplant for one of the following hematologic malignancies - acute myelogenous leukemia, acute lymphoblastic leukemia, myelodysplastic syndromes (MDS), lymphoma, myeloma, chronic lymphocytic leukemia, chronic myelogenous leukemia meeting the following:\r\n* For non-chronic myelogenous leukemia (CML), relapse will be defined based on disease specific morphologic criteria from a bone marrow biopsy and aspirate or recurrence of disease specific cytogenetics; relapse can be determined morphologically; equivocal results for relapse should result in a repeated test after an appropriate time interval (suggested 1 month) to determine eligibility\r\n* For CML, relapse will be defined as any cytogenetic evidence of a Philadelphia chromosome or persistence of breakpoint cluster region (BCR)/c-abl oncogene 1, non-receptor tyrosine kinase (ABL) rearrangements by molecular testing on at least two measurements over a 6 month interval; if cytogenetics are normal and there is polymerase chain reaction (PCR) evidence of a BCR/ABL fusion, patients will be eligible if they have evidence of a quantitative increase in CML measured either by quantitative PCR or by fluorescent in situ hybridization (FISH)\r\n* For chronic phase CML patients only:\r\n** Must have failed (no response in 3 months or incomplete response at 6 months) or refused treatment with a tyrosine-kinase inhibitor (TKI)\r\n** Must have failed (defined as incomplete response or relapse) or refused donor lymphocyte infusion (DLI)
Patients with chronic myelomonocytic leukemia (CMML) are allowed to be enrolled
Diagnosis of plasma cell leukemia
Patients must have histologically or cytologically documented relapsed and/or refractory acute myeloid leukemia
Patients must have chronic phase chronic myeloid leukemia (CML); they must also be under treatment with nilotinib as either first, second or third-line therapy
Patients with acute leukemia must have chemotherapy sensitive disease, as defined by at least a 50% reduction in circulating absolute blast count due to the most proximal regimen
Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
Subjects who have plasma cell leukemia or clinically significant amyloidosis
Subject has Relapsed or Refractory Acute Myeloid Leukemia (rrAML) after at least 2 prior induction attempts:
Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell [surface Immunoglobulin (sIg) positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)
Known CNS lymphoma or leukemia.
Known CNS lymphoma or leukemia.
Active CNS leukemia
The patient has known active or suspected CNS leukemia. If suspected, CNS leukemia should be ruled out with relevant imaging and/or examination of cerebrospinal fluid.
Plasma cell leukemia, primary amyloidosis or POEMS syndrome
Active plasma cell leukemia
Have acute T-cell lymphoblastic leukemia (T-ALL) or T-cell lymphoblastic lymphoma (T-LBL).
Patients with Burkitt's lymphoma/leukemia (i.e. patients with mature B-cell ALL, leukemia with B-cell [sIg positive and kappa or lambda restricted positivity] ALL, with FAB L3 morphology and /or a MYC translocation)
Acute leukemia of ambiguous lineage (biphenotypic leukemia)
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.
Active plasma cell leukemia
POEMS syndrome, Plasma cell leukemia, Waldenstrom's macroglobulinemia or Amyloidosis
Diagnosis of Burkitt's Leukemia, or lymphoid blast crisis of chronic myelogenous leukemia (CML)
Cohort 4: Participants must have chronic lymphocytic leukemia.
Patients must not have proliferative (WBC >= 12,000/mcL) chronic myelomonocytic leukemia (CMML); WBC must be < 12,000/mcL
Atypical chronic myeloid leukemia (CML): Philadelphia chromosome-negative patients with a diagnosis of atypical CML
Plasma cell leukemia, primary amyloidosis or POEMS syndrome
Primary cancer is leukemia, lymphoma, or myeloma
Patient has concurrent symptomatic amyloidosis or plasma cell leukemia
EXCLUSION FOR TREATMENT: Active central nervous system (CNS) leukemia, as defined by unequivocal morphologic evidence of lymphoblasts in the cerebrospinal fluid (CSF) or symptomatic CNS leukemia (i.e. cranial nerve palsies or other significant neurologic dysfunction) within 28 days of treatment; prophylactic intrathecal medication is not a reason for exclusion\r\n* If the lumbar puncture (LP) is traumatic (containing red blood cells [RBCs]) and cannot be repeated the Steinherz/Bleyer ratio will be used to determined unequivocal evidence of CSF leukemia at the discretion of the treating physician
Pathologically confirmed, relapsed or refractory acute myelogenous leukemia
B-ALL patients with testicular leukemia are not eligible for AALL0932
Subject with lymphoma who has measurable disease (? 2.0 cm in its longest dimension by computed tomography) or chronic lymphocytic leukemia in need of treatment.
Patients with symptomatic CNS leukemia or patients with poorly controlled CNS leukemia
Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
Relapsed acute myeloid leukemia (AML) or acute lymphoblastic leukemia (ALL) >= 60 days after allogeneic stem cell transplant (SCT)
Patients with central nervous system (CNS) leukemia are eligible as long as they have received treatment and most recent cerebrospinal fluid (CSF) analysis is negative for leukemia
Patients with acute lymphoblastic leukemia (ALL), acute myelogenous leukemia (AML), chronic myelogenous leukemia (CML) with relapsed or refractory disease who are not eligible for stem cell transplantation or other standard therapies
Myeloid blast crisis of chronic myeloid leukemia (CML), unless patient is not considered candidate for tyrosine kinase inhibitor treatment
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
Patients must not have any history of Richter’s transformation or prolymphocytic leukemia (prolymphocytes in blood > 55%)
Subject has leukemia or lymphoma
Patients with a history of or active bone marrow disorders expected to interfere with study therapy (e.g. acute leukemias, accelerated/blast-phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma)
Acute Leukemias or T lymphoblastic lymphoma in 1st or subsequent complete remission (CR): Acute lymphoblastic leukemia (ALL)/T lymphoblastic lymphoma; acute myelogenous leukemia (AML); acute biphenotypic leukemia (ABL); acute undifferentiated leukemia (AUL)
Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
Diagnosis of Burkitt's leukemia/lymphoma according to WHO classification or chronic myelogenous leukemia lymphoid blast crisis
Plasma cell leukemia
Patients with acute leukemias, accelerated/blast phase chronic myelogenous leukemia, chronic lymphocytic leukemia, Burkitt lymphoma, plasma cell leukemia, or non-secretory myeloma
Patients with one of the following diagnoses:\r\n* Acute myeloid leukemia (AML)\r\n* Acute lymphoblastic leukemia (ALL)\r\n* Juvenile myelomonocytic leukemia (JMML)\r\n* Myelodysplastic syndrome (MDS)
Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) =< 2 x IULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g. hepatic infiltration or biliary obstruction due to leukemia) or Gilbert's disease
Total bilirubin =< 2 x IULN except when in the opinion of treating physician is due to direct involvement of leukemia (e.g. hepatic infiltration or biliary obstruction due to leukemia) or Gilbert’s disease
Plasma cell leukemia (> 2.0 × 109/L circulating plasma cells by standard differential)
Subject has a history of myeloproliferative neoplasm (MPN) including polycythemia vera, myelofibrosis, essential thrombocythemia, or chronic myelogenous leukemia.
Active refractory or relapsed acute leukemia
Confirmed Philadelphia Chromosome positive Chronic Myeloid Leukemia or Confirmed BCR-ABL1 (Abelson-break point cluster) Positive if Philadelphia Chromosome negative Chronic Myeloid Leukemia (from initial diagnosis).
Any Chronic Myeloid Leukemia disease phase, as long as the patient is unable to receive treatment with imatinib, dasatinib and/or nilotinib for any reason.
Smoldering myeloma, monoclonal gammopathy of undetermined significance (MGUS), or plasma cell leukemia
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)
Richter's Syndrome and Prolymphocytic Leukemia Transformation only: biopsy proven DLBCL Richter's transformation or prolymphocytic leukemia transformation.
No plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
History of Richter's transformation or prolymphocytic leukemia
Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
Plasma cell leukemia (> 20% circulating plasma cells) during screening studies
Patients with myelodysplastic syndrome/acute leukemia or with features suggestive thereof.
Plasma cell leukemia
Patients who are considered appropriate candidates for allogeneic hematopoietic stem cell transplantation and have one of the following diagnoses:\r\n* Acute lymphocytic leukemia in first or subsequent remission\r\n* Acute myeloid leukemia in first or subsequent remission \r\n* Acute lymphocytic leukemia in relapse or primary refractory disease with a circulating blast count of no more than 10,000/mm^3\r\n* Acute myeloid leukemia in relapse or primary refractory disease with a circulating blast count of no more than 10,000/mm^3 \r\n* Refractory anemia with excess blasts (RAEB-1 and RAEB-2) \r\n* Chronic myelogenous leukemia with a history of accelerated phase or blast crisis\r\n* Other acute leukemia (including but not limited to ‘biphenotypic’, ‘undifferentiated’ or ‘ambiguous lineage’ acute leukemia)
Patients with chronic myelogenous leukemia (CML) in myeloid blast crisis are eligible if their disease has failed to respond, and/or they are intolerant, to the available tyrosine kinase inhibitors (TKIs)
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.
Plasma cell leukemia
Spine disease from leukemia, lymphoma or myeloma
Absence of CNS involvement by leukemia.
Disease associated with secondary MF such as metastatic carcinoma, lymphoma, myelodysplasia, hairy cell leukemia, mast cell disease or acute leukemia (including M7 disease or acute panmyelosis with MF)
Chronic myelogenous leukemia excluding refractory blast crisis; to be eligible in first chronic phase (CP1) patient must have failed or be intolerant to tyrosine kinase inhibitor therapy
Diagnosis of relapsing/refractory or previously untreated chronic lymphocytic leukemia
Acute myelogenous leukemia diagnosed by World Health Organization (WHO) criteria with one of the following:\r\n* Primary refractory disease following >= 1 cycle of induction chemotherapy\r\n* First relapse or higher; patients with primary or secondary acute myelogenous leukemia are eligible; patients with biphenotypic leukemia are eligible
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
Subjects with plasma cell leukemia (PCL)
Active disease meeting at least 1 of the International Workshop on Chronic Lymphocytic Leukemia 2008 criteria for requiring treatment
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
Documented plasma cell leukemia or known amyloidosis. (Plasma cell leukemia is defined as the presence of >20% plasma cells in the peripheral blood and an absolute plasma cell count of ?2000 muL
Current acute or chronic myelogenous leukemia
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
FAB subtype M0 (minimally differentiated acute myeloblastic leukemia), M6 (acute erythroid leukemias, including erythroleukemia (M6a) and pure erythroid leukemia (M6b)), or M7 (acute megakaryoblastic leukemia)
Patients with chronic lymphocytic leukemia requiring treatment age >65 at the time of signing informed consent.
Patients with documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood).
Prior treatment for chronic lymphocytic leukemia.
Participants must have a diagnosis of chronic myelogenous leukemia as confirmed by fluorescent in situ hybridization (FISH) for BCR/ABL translocation and/or standard cytogenetics analysis
Have an acute leukemia
Myeloproliferative disorders to be included:\r\n* Idiopathic myelofibrosis\r\n* Polycythemia vera\r\n* Essential thrombocythemia\r\n* Chronic myelomonocytic leukemia\r\n* Chronic neutrophilic leukemia\r\n* Chronic eosinophilic leukemia\r\n* Philadelphia chromosome-negative chronic myelogenous leukemia (CML)\r\n* Hypereosinophilic syndrome\r\n* Systemic mastocytosis
Bi-phenotypic acute leukemia
Plasma cell leukemia at time of study entry.
Biphenotypic leukemia
Patients of all ages with newly diagnosed, previously untreated CD-20+ acute lymphoblastic leukemia (ALL), or lymphoblastic lymphoma, Burkitt leukemia/lymphoma or having achieved complete remission (CR) with one course of induction chemotherapy
Chronic myelomonocytic leukemia
Active plasma cell leukemia
Patients with a diagnosis of chronic myelomonocytic leukemia (CMML)
A diagnosis of refractory or relapsed AML, or Ph+ CML (in chronic, accelerated or blast phase, or acute lymphoblastic leukemia, or myelodysplastic syndrome. One of the following parameters is required to meet criteria for accelerated phase CML:
Patients with plasma cell leukemia
Plasma cell leukemia
Patients must have CD19+ acute lymphoblastic leukemia (ALL) as confirmed by flow cytometry and/or immunohistochemistry
Liver function tests (LFTs) (bilirubin, AST, and/or ALT) may be acceptable if the elevation is secondary to leukemia infiltration or leukemia therapy with tyrosine kinase inhibitors
Disease transformation [i.e. Richter's Syndrome (lymphomas) or prolymphocytic leukemia]
Biphenotypic leukemia
Chronic lymphocytic leukemia that has failed induction therapy or Rai stages 2-4
Any patient regardless of sex or age with CD19+ B-acute lymphoblastic leukemia (ALL) undergoing allogeneic HSCT (Group A); OR any patient regardless of sex or age with CD19+ B-chronic lymphocytic leukemia (CLL) or non-Hodgkin lymphoma (NHL) undergoing allogeneic HSCT (Group B)
MRD will be defined as detection in blood or marrow of:\r\n* Any leukemia specific marker (such as t[9:22] or t[4:11]) documented in the patient’s leukemia cells pre transplant on a post-transplant evaluation\r\n* A T-cell receptor (TCR) or immune globulin rearrangement known to be a disease marker for this patient post-transplant\r\n* A leukemia specific phenotype post-transplant at a level of >= 0.01%\r\n* Mixed donor chimerism; OR\r\n* With no evidence of ALL or CLL/NHL post-HSCT (to be included in the phase II extension)
Patients with a diagnosis of chronic myelomonocytic leukemia (CMML)
Disease transformation (active) (ie, Richter's Syndrome, prolymphocytic leukemia)
Juvenile myelomonocytic leukemia (JMML)
Patients who have already received an allogeneic hematopoietic cell transplant and have either a documented relapse of leukemia or MDS or have recurrent persistent minimal residual disease as documented by at least 2 sequential testings, separated by 1 week, demonstrating molecular evidence of leukemia or MDS by fluorescence in situ hybridization (FISH), cytogenetics or fluorescent immunocytometry
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
For patients with chronic phase chronic myelogenous leukemia, patient’s disease must have evidence of never responded to or progressed after receiving a tyrosine-kinase inhibitor (e.g. imatinib mesylate)
Patients with acute leukemia or myelodysplastic syndrome or chronic myelomonocytic leukemia must be in a hematologic remission, defined as < 5% blasts present in both blood and marrow to be referred for evaluation; should a patient have > 5% blasts or a donor not be available by the time the patient is ready for enrollment, the patient will be referred back to their primary hematologist-oncologist for treatment; patients with diseases other than acute leukemia including but not limited to Hodgkin’s and Non-Hodgkin’s lymphoma, CLL/SLL, natural killer T-cell lymphoma (NKTCL), peripheral T-cell lymphoma (PTCL), must have stable disease to their most recent regimen received within 8 weeks if chemo/radiotherapy or within 12 weeks after prior autologous stem cell transplantation; should a patient in either of these scenarios have progressive disease or a donor not be available after enrollment, the patient will be referred back to their primary hematologist-oncologist for treatment; if either of these scenarios are not in the best interest of the patient according to the clinical judgment of the PI, then the patient may receive standard treatment for the malignant disease under the current study; if under either of these settings, it becomes apparent that the patient will not be able to proceed to transplant, then he/she must come off study; recipient-subjects receiving a standard therapy will be told about the therapy, associated risks, benefits alternatives of the proposed therapy, and availability of receiving the same treatment elsewhere, outside of a research protocol
Relapsed or refractory Chronic Lymphocytic Leukemia and require treatment in opinion of investigator
Relapsed/refractory acute myeloid leukemia following at least 2 but no more than 3 prior regimens
CD123-detectable leukemia
Previously untreated Philadelphia chromosome negative acute lymphoblastic leukemia/lymphoma
Lymphoblastic crisis of chronic myelogenous leukemia (CML)
Burkitt's lymphoma/leukemia or chronic myelogenous leukemia lymphoid blast crisis (p210 BCR-ABL+)
Participants must have relapsed or refractory acute lymphoblastic leukemia or lymphoma:\r\n* Stratum I: T-cell lymphoblastic leukemia or lymphoma in first relapse or refractory to one or two courses of frontline induction therapy\r\n* Stratum II: B-cell or T-cell lymphoblastic leukemia or lymphoma in second or third relapse or refractory to 2 or 3 induction or re-induction attempts; patients with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL) must be refractory or relapsed after treatment with a regimen that included a tyrosine kinase inhibitor (TKI)
Isolated extramedullary relapse (leukemia) or isolated CNS lymphoma
Acute lymphoblastic leukemia (ALL)/lymphocytic leukemia (LL) in 1st remission with clinical or molecular features indicating a high risk for relapse; or ALL > second (2nd) remission
Chronic myelomonocytic leukemia (CMML)-1 and CMML-2, advanced polycythemia vera, and myelofibrosis\r\n* Patients must have a healthy human leukocyte antigen (HLA) compatible (8/8 molecularly matched related, or unrelated) donor willing to undergo bone marrow (BM) harvesting or peripheral blood stem cell (PBSC) apheresis after filgrastim (G-CSF) administration; BM will be the preferred graft source\r\n* Patients diagnosed with any form of acute leukemia must have received induction and at least one course of consolidation chemotherapy pretransplant
Patients with plasma cell leukemia in >= partial remission are eligible
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 precursor-B lymphoblastic leukemia or lymphoma
Acute Lymphoblastic Leukemia (ALL) in CR
NK cell lymphoblastic leukemia in any CR
Chronic Myelogenous Leukemia (CML) All subjects with evidence of CNS leukemia must be treated and be in CNS CR to be eligible for trial.
Richter's transformation or prolymphocytic leukemia
History of chronic leukemias (eg, chronic lymphocytic leukemia).
Subjects with leukemia are excluded, with the exception of chronic lymphocytic leukemia (CLL), who are allowed in the dose escalation phase. Subjects with Burkitt lymphoma, plasma cell leukemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal gammopathy, and skin changes), or amyloidosis are also excluded.
Proliferative type chronic myelomonocytic leukemia with white blood cell count >12 Gi/L at any time during the 28 days before Day 1
Burkitt’s or mixed lineage leukemia, T cell ALL
have one of the following disease states: Acute Myeloid Leukemia (AML) (age <60 years) with relapsed/refractory disease; •Chronic Lymphocytic Leukemia (CLL) with relapsed disease following a fludarabine-based regimen or relapsed disease following an alkylator-based regimen
Patients with a diagnosis of leukemia, lymphoma, or myeloma
Not meeting WHO criteria for Polycythemia Vera (PV), Chronic Myeloid Leukemia (CML), Myledysplastic Syndrome (MDS), or other myeloid neoplasm
History of amyloid, plasma cell leukemia or CNS involvement.
Adult T-cell lymphoma (TCL)/leukemia (human T-cell leukemia virus 1+)
T cell prolymphocytic leukemia
T cell large granular lymphocytic leukemia
Philadelphia positive Chronic Myeloid Leukemia (CML) in chronic phase
Plasma cell leukemia
Have known acute or chronic leukemia or current hematologic malignancies that, in the judgment of the investigator and sponsor, may affect the interpretation of results.
Adults with pathologically confirmed, relapsed or refractory acute myelogenous leukemia OR those 70 and older who are not candidates for, or decline, conventional frontline chemotherapy
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 with chronic lymphocytic leukemia, prolymphocytic leukemia, or Richter's transformation who are eligible for allogeneic transplantation and are not eligible for protocols of higher priority.
Current CNS Leukemia
Have current acute or chronic leukemia.
Participant with acute leukemia must meet one of the following criteria:\r\n* Relapsing acute lymphoblastic leukemia (ALL), acute myeloid leukemia (AML), or acute biphenotypic leukemia in 2nd or greater relapse, or\r\n* Refractory ALL, AML, or acute biphenotypic leukemia failing to achieve CR with >= 2 induction or re-induction attempts
Isolated extramedullary disease (leukemia)
Patient must have relapsed/refractory acute myelogenous leukemia (AML) with ? 5% blast in the bone marrow or biopsy confirmed chloroma. Patient may have CNS 1, 2 or 3 disease. Isolated CNS relapse is not eligible.
Patients with leukemia must not be known to be refractory to red blood cell or platelet transfusions.
Uncontrolled meningeal leukemia
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)
Must not have leukemia.
Patients must have at least received an appropriate induction therapy regimen. Patients with persistent leukemia after induction therapy, or with recurrence of leukemia at any time during the course of treatment (including allogeneic HSCT) are eligible;
Past or current plasma cell leukemia.
Plasma cell leukemia
Subject has BCR-ABL-positive leukemia (chronic myelogenous leukemia in blast crisis).
Past or current plasma cell leukemia.
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: < 5% marrow blasts with no morphologic evidence of leukemia, no peripheral blasts, marrow > 20% cellular, and peripheral absolute neutrophil count > 1000/uL (platelet recovery is not required)\r\n* Myelodysplasia (MDS) and chronic myeloid leukemia (CML): must have < 5% marrow blasts\r\n* Myeloproliferative neoplasms (MPN): must have < 5% peripheral/marrow blasts
Plasma cell leukemia or circulating plasma cells >= 2 X 10^9/L
Acute myeloid leukemia, positive for CD33
Plasma cell leukemia or circulating plasma cells >= 2 × 10^9/L
Patients with chronic myelogenous leukemia (CML) in myeloid blasts crisis
Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
Refractory/relapsing blast crisis of chronic myelogenous leukemia (CML)
Pathologically confirmed diagnosis of B-lineage acute lymphoblastic leukemia, Burkitt leukemia or lymphoma, or B-lineage lymphoblastic lymphoma
Survivor of childhood acute lymphoblastic leukemia (ALL) or non-Hodgkins's lymphoma (NHL) (treated for ALL or NHL before the age of 21 years old and ?5 years post-treatment)
Refractory/relapsing myeloid blast crisis of chronic myeloid leukemia (CML), unless patient is not considered candidate for tyrosine kinase inhibitor treatment
Plasma cell leukemia
Burkitt and/or precursor lymphoblastic leukemia/lymphoma
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)
Plasma cell leukemia or circulating plasma cells ? 2 × 10^9/L.
Acute lymphoblastic leukemia (ALL) in 1st or subsequent remission
Chronic myelogenous leukemia (CML)
Active plasma cell leukemia
Subjects with T-cell acute lymphoblastic leukemia or T-cell lymphoblastic lymphoma refractory to or relapsed from standard therapies
Diagnosis of chronic myelogenous leukemia in blast crisis
Chronic myelomonocytic leukemia
Juvenile myelomonocytic leukemia
Patients receiving corticosteroids aside from dexamethasone treatment directed at leukemia
Acute or chronic leukemia.
Have current acute or chronic leukemia
Plasma cell leukemia
Have known current hematologic malignancies or acute or chronic leukemia
Plasma cell leukemia (> 2.0 × 10^9/L circulating plasma cells by standard differential)
Patients must have a diagnosis of leukemia/lymphoma undergoing active treatment or following HSCT for any indication. Leukemia/lymphoma will be defined according to the National Cancer Institute Surveillance Epidemiology and End Results Collaborative Staging Manual including those conditions defined as borderline such as myelodysplastic syndromes. All forms of HSCT will be eligible, allogeneic as well as autologous.
Patients with biopsy-proven acute lymphoblastic leukemia, acute lymphoblastic lymphoma, or acute biphenotypic leukemia in remission or relapse
Active or prior plasma cell leukemia (defined as either 20% of peripheral WBC comprised of plasma/CD138+ cells or an absolute count of 2 x 10^9/L).
CNS leukemia.
Active plasma cell leukemia.
PARENT/CAREGIVER: Adult primary caregiver of children treated for acute lymphoblastic leukemia (ALL) or acute myeloid leukemia (AML) or lymphoblastic lymphoma (LL) and daily contact with the child
Have a diagnosis of lung cancer (both small cell and non-small cell), central nervous system tumors, acute myeloid leukemia, and acute lymphoblastic leukemia will be excluded
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)
Acute or chronic thrombocytopenia in patients with acute leukemia (myeloblastic or lymphoblastic) receiving induction or re-induction chemotherapy that is expected to induce marrow aplasia for at least 2 weeks; or
Expected chronic thrombocytopenia in patients with newly diagnosed marrow failure syndromes, myelodysplastic syndromes, aplastic anemia, chronic myelomonocytic leukemia or myelofibrosis or;
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
Acute myelogenous leukemia diagnosed by World Health Organization (WHO) criteria with one of the following (patients with biphenotypic leukemia are eligible, provided that the treating physician determines an acute myeloid leukemia (AML) treatment regimen is appropriate)\r\n* Primary refractory disease following >= 1 cycle of induction chemotherapy\r\n* First relapse or higher; patients with primary or secondary acute myelogenous leukemia are eligible
Subject has MDS/MPN including chronic myelomonocytic leukemia (CMML), atypical chronic myeloid leukemia (CML), juvenile myelomonocytic leukemia (JMML) and unclassifiable MDS/MPN.
Currently enrolled and receiving treatment for acute lymphoblastic leukemia (ALL) on the TOTXVI therapy protocol at St. Jude Children’s Research Hospital
Phase I: Hematologic malignancy diagnosis including any subset of myeloma, lymphoma, leukemia, or myelodysplastic syndrome
PATIENTS: Refractory or recurrent hematologic malignancy (lymphoma, leukemia, or myeloma, amyloidosis and chronic myelogenous leukemia [CML] - CML can only be accelerated or blast phase).
PATIENTS: Chronic myeloid leukemia (CML) except accelerated or blast phase.
Acute or chronic leukemia diagnosis
Patients with lymphoproliferative disorders such as chronic lymphocytic leukemia and indolent non-Hodgkin’s lymphoma who are in remission or asymptomatic after initial treatment and are being followed with active surveillance will be eligible.
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
Those with acute leukemia must be in remission at the time of transplant
Known relapsed acute leukemia or myelodysplastic syndrome
Patients with:\r\n* Acute lymphoblastic leukemia/lymphoma \r\n* Malignant brain tumor \r\n* Non-central nervous system (CNS) solid tumors \r\n* Acute myeloblastic leukemia\r\n* Non-Hodgkin’s lymphoma \r\n* Hodgkin’s disease\r\n* Head and neck tumors
Any patient with non-acute promyelocytic leukemia (APL) acute leukemia (acute myeloid leukemia [AML], acute lymphoblastic leukemia [ALL], biphenotypic leukemia) undergoing curative intent chemotherapy OR any patient undergoing allogeneic hematopoietic stem cell transplantation (HSCT) for a hematologic disorder (including acute leukemia as above, chronic myelogenous leukemia [CML], chronic lymphocytic leukemia [CLL], myelodysplastic syndrome [MDS], primary or secondary myelofibrosis, hypereosinophilic syndromes, plasma cell disorders, B-cell or T-cell lymphoma)
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)
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
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 acute myelogenous leukemia (AML) or relapsed acute lymphoblastic leukemia (ALL) that will receive chemotherapy with/without transplant must have, or be scheduled to have, an external tunneled CVC (Broviacs, Hickmans, tunneled PICCs, etc.) and/or non-tunneled PICC that is expected to remain in place for an additional >= 3 months
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
Subjects with any of the following will NOT be eligible for study:\r\n* Bone marrow involvement\r\n* Active myelogenous leukemia, or history of myelogenous leukemia\r\n* Pregnancy
Be diagnosed with chronic phase chronic myelogenous leukemia (CML)
Patients with history of hematologic malignancies, including leukemia, myeloma, myeloproliferative disease, lymphoma, or myelodysplastic diseases
Patients with a hematologic malignancy other than aplastic anemia or primary myelofibrosis, scheduled to undergo RIC allogeneic SCT with a peripheral blood stem cell graft from an unrelated donor, using fludarabine phosphate (Flu)/busulfan (Bu) conditioning and tacrolimus (Tac)/methotrexate (MTX) GVHD prophylaxis; the following diagnoses are included:\r\n* Acute leukemia - acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL) or acute biphenotypic leukemia; patients will have documentation of complete remission within 6 weeks prior to their transplant; complete remission is defined as < 5% blasts on a bone marrow biopsy and absence of any known extramedullary disease\r\n* Chronic myelogenous leukemia in any stage, but with documentation of < 5% blasts on a bone marrow biopsy within 6 weeks prior to transplant\r\n* Myelodysplastic syndrome of any subtype, but with documentation of < 5% blasts on a bone marrow biopsy within 6 weeks prior to transplant\r\n* Myeloproliferative disorders other than primary myelofibrosis\r\n* Lymphoma - all types of lymphoma are eligible\r\n* Chronic lymphocytic leukemia (CLL) and prolymphocytic leukemia (PLL)
Plasma cell leukemia
Plasma cell leukemia
Documented prolymphocytic leukemia (prolymphocytes more than 55% in the blood) or Richter's transformation
Acute leukemia receiving induction chemotherapy
Acute myeloid leukemia arising de novo (per European LeukemiaNet)
Diagnosis of lymphoma or leukemia as documented in medical record
All acute myelogenous leukemia and high-risk myelodysplastic leukemia patients who are admitted to the leukemia service and those who are referred from other services (i.e. pediatrics, medical oncology, etc.) will be eligible for the study
Leukemia, lymphoma, and myeloma
Intensive induction chemotherapy for a new diagnosis of acute myelogenous leukemia, acute lymphocytic leukemia, or myelodysplastic syndrome receiving standard anthracycline based chemotherapy
Re-induction of acute myelogenous or lymphocytic leukemia after primary relapse
Chronic myelogenous leukemia: all types except refractory blast crisis; chronic phase patients must have failed or been intolerant to at least one tyrosine-kinase inhibitor
New diagnosis of de novo ALL, lymphomas (T or B cell), or mixed-phenotype acute leukemia
Acute myeloid leukemia
Acute lymphoblastic leukemia, including T lymphoblastic lymphoma with a history of marrow involvement
Chronic Myelogenous leukemia
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
Diagnosis of acute myeloid leukemia (AML), acute biphenotypic leukemia, or acute lymphoblastic leukemia (ALL); CML transformed to blast crisis is eligible
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
Chronic myeloid leukemia, primary myelofibrosis, chronic myelomonocytic leukemia
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
Acute leukemia (acute myeloid leukemia [AML] or acute lymphoblastic leukemia [ALL]) must be in complete remission defined as: < 5% marrow blasts with no morphologic evidence of leukemia, no peripheral blasts, marrow > 20% cellular, and peripheral absolute neutrophil count > 1000/uL (platelet recovery is not required)
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
Prior diagnosis of an acute leukemia or lymphoma or any receipt of HCT for a malignant condition.
Chronic myelogenous leukemia: all types except refractory blast crisis; chronic phase patients must have failed at least two different tyrosine-kinase inhibitors (TKIs), or been intolerant to all available TKIs or have T315I mutation
Chronic myelogenous leukemia (CML) in blast crisis
Active myeloproliferative neoplasms (MPN) and chronic myelomonocytic leukemia (CMML)
Clinical Diagnosis of one of the following: Acute Lymphoblastic Leukemia, Acute Myelogenous Leukemia, Lymphoma
Known history of primary plasma cell leukemia or evidence of primary or secondary plasma cell leukemia at the time of screening
Acute lymphoblastic leukemia (ALL)
Acute undifferentiated leukemia (AUL)
Acute biphenotypic leukemia
Chronic myelogenous leukemia (CML)
Patients with secondary acute myeloid leukemia arising from myeloproliferative disease, including Chronic myelomonocytic leukemia (CMML), with evidence of active myeloproliferative features or myelofibrosis in the background.
COHORT 1: RELAPSED/REFRACTORY LEUKEMIA \r\n* Acute lymphoblastic leukemia, first or greater relapse\r\n* Acute myeloid leukemia, first or greater relapse\r\n* Leukemia refractory to induction chemotherapy\r\n* Other recurrent leukemia\r\n* Myelodysplastic syndrome (MDS), first or greater relapse, or refractory to initial therapy
COHORT 2: NEW DIAGNOSIS\r\n* Acute myeloid leukemia, new diagnosis\r\n* New diagnosis infant mixed-lineage leukemia (MLL)-rearranged acute lymphoblastic leukemia (ALL) or low hypodiploid (< 40 chromosomes) ALL\r\n* Rare leukemia- e.g., juvenile myelomonocytic leukemia (JMML), leukemia of ambiguous lineage\r\n* Secondary leukemia\r\n* Myelodysplastic syndrome (MDS) not eligible for stem cell transplant
Patients with known extramedullary leukemia
Active plasma cell leukemia.
Concurrent symptomatic amyloidosis or plasma cell leukemia
Plasma cell leukemia (> 2.0 X109/L circulating plasma cells by standard differential).
Diagnosis of a core binding factor leukemia (t(8;21), t(16;16) or inv(16)).
Have lymphoma or leukemia
Patient has a diagnosis of chronic lymphocytic leukemia
Multiple myeloma/plasma cell leukemia or B cell acute lymphoblastic leukemia
Patients must have histologically or cytologically confirmed by the local institution CD19+ precursor B-acute lymphoblastic leukemia (pre-B cell ALL) OR CD19+ mixed phenotype acute leukemia (MPAL): a) with relapse following or refractory to at least one prior line of therapy if older than 21 years; b) in second or higher relapse or refractory to at least two prior lines of therapy if 21 years old and younger (16-21); c) or they must have a new diagnosis of pre-B cell ALL or CD19+ MPAL but are >= 60 years old and are either not a candidate for or do not wish to receive traditional induction chemotherapy
Active leukemia in the testes or isolated extramedullary relapse; patients with a history of treated leukemia in testes but no active disease at the time of enrollment are eligible
CNS leukemia
Patients with Burkitt's leukemia/lymphoma.