Patients must have received 4 or more cycles of one of the following prior systemic induction chemotherapy regimens:\r\n* Rituximab, cyclophosphamide, doxorubicin hydrochloride (hydroxydaunomycin), vincristine sulfate (Oncovin), prednisone (R-CHOP) (with or without cytarabine-containing cycles, including “Nordic” and European Mantle Cell Lymphoma Network [MCL-NET] protocols) with or without autologous (auto) stem cell transplant (SCT)\r\n* R-Hyper-cyclophosphamide, vincristine sulfate, doxorubicin hydrochloride (adriamycin), dexamethasone (CVAD) with or without auto SCT\r\n* Bendamustine + rituximab with or without auto SCT\r\n** Please note:\r\n*** Patients are allowed to receive combinations of the above regimens\r\n*** At the time of registration, patients must be at least 14 days out from last dose of cytotoxic chemotherapy, but no more than 120 days; if a patient underwent auto SCT, he/she must demonstrate engraftment (per treating investigator's discretion) and meet all other hematological requirements as outlined below\r\n*** Patients who progress during induction therapy are not eligible to enroll in this study
Patients who have had a prior allogeneic stem cell transplant are not eligible\r\n* NOTE: if a patient underwent auto SCT, he/she must demonstrate engraftment (per treating investigator’s discretion) and meet all other hematological requirements
Autologous stem cell transplantation (SCT) within 100 days prior to first infusion
Completion of autologous SCT within 100 days prior to Day 1 of Cycle 1
Prior allogeneic stem-cell transplantation (SCT), or autologous SCT within 100 days prior to Day 1 of Cycle 1
Stem Cell Transplant (SCT): No evidence of active graft versus host disease. For allogeneic SCT, greater than or equal to 6 months must have elapsed.
Any patient, regardless of age or sex, with Epstein-Barr virus (EBV)-positive lymphoma, or lymphoepithelioma regardless of the histological subtype or EBV (associated)-T/natural killer (NK)-lymphoproliferative disorder (LPD) all confirmed on any tissue sample\r\n* Primary refractory lymphoma or in second or subsequent relapse including after autologous or syngeneic stem cell transplant OR patients at a high risk for relapse defined as: (i) patients with primary refractory lymphoma or multiply relapsed lymphoma who are in remission but not eligible for autologous stem cell transplant (SCT) or (ii) patients with relapsed lymphoma after autologous SCT who are in remission but not eligible for allogeneic SCT (Group A) OR\r\n* Any patient who has received an allogeneic SCT for EBV lymphoma or EBV (associated)-T/NK-LPD or lymphoepithelioma (Group B)
In view of the principal investigator (PI) and the primary oncologist, there must be no available alternative curative therapies or subject has declined to pursue alternative therapy; 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\r\n* Chemotherapy refractory disease in subjects with B-ALL is defined as progression or stable disease after two lines of therapies\r\n* Recurrence of disease after achieving a complete response (CR)\r\n* Subjects with persistent or relapsed minimal residual disease (MRD) (by flow cytometry, polymerase chain reaction [PCR], fluorescence in situ hybridization [FISH], or next generation sequencing) require verification of MRD positivity on two occasions at least 4 weeks apart\r\n* Subjects with Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ALL) subjects are eligible if they progressed, had stable disease or relapsed after two lines of therapy, including tyrosine kinase inhibitors (TKIs)\r\n* Subjects with recurrence of isolated central nervous system (CNS) relapse after achieving complete remission (CR); if relapsed with MRD, will require verification of MRD positivity on two occasions at least 4 weeks apart
Subjects who have undergone autologous SCT with disease progression or relapse following SCT will be eligible if all other eligibility criteria are met; subjects who have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, they are at least 100 days post-transplant, they have no evidence of active graft versus host disease (GVHD) and have been without immunosuppressive agents for at least 30 days
Who have received autologous stem cell transplant (SCT) 60 days before first infusion of TAK-573 or participants who have received allogeneic SCT 6 months before first infusion. Graft-versus-host disease that is active or requires ongoing systemic immunosuppression.
Prior allogeneic stem cell transplantation (SCT), or autologous SCT within 100 days prior to Day 1 of Cycle 1
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
Prior stem-cell transplantation (SCT).
Must have undergone an allogeneic SCT (regardless of stem cell source)
Prior autologous or allogeneic stem cell transplant (SCT)
Administration of chemotherapy, biological, immunotherapy, or investigational agent (therapeutic or diagnostic) within 3 weeks before enrollment (14 days for non-myelosuppressive therapy). Subjects should be 6 weeks from last dose of nitrosourea, nitrogen mustards or monoclonal antibody, 12 weeks from autologous stem cell transplantation (SCT), and 16 weeks from allogeneic SCT
Patient must have a B cell ALL (inclusive of chronic myeloid leukemia [CML] with ALL transformation) 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; patients who have undergone autologous SCT will be eligible, and patients that have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, they have no evidence of graft versus host disease (GVHD) and have been without immunosuppressive agents for at least 30 days; patients with Philadelphia chromosome + ALL must have failed prior tyrosine kinase inhibitor; patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry
Relapse after SCT is allowed but no active graft-versus-host disease (GVHD) as per treating physician; also must not exceed the number of prior induction regimens listed above; SCT does not count as line of therapy
Relapsed and/or refractory disease as defined by: a. Clonal relapse after at least one previous line of therapy or high-dose chemotherapy and autologous stem cell transplantation OR b. Refractory disease to prior therapy defined as less than a hematologic very good partial response (VGPR). If previous therapy was autologous stem cell transplant (SCT), must be >= 3 months after SCT
Subjects who have undergone autologous stem cell transplantation (SCT) with disease progression or relapse following SCT are eligible; subjects who have undergone allogeneic SCT will be eligible if, in addition to meeting other eligibility criteria, they are at least 100 days post transplant, they have no evidence of graft versus host disease (GVHD) and have been without immunosuppressive agents for at least 30 days
Be able to start the drug therapy between 42 to 100 days following allogeneic SCT;\r\n* No more than 1 prior allogeneic SCT\r\n* Post-transplant bone marrow consistent with complete remission with no evidence of minimal residual disease by flow-cytometry or cytogenetics or molecular testing\r\n* Adequate engraftment within 14 days prior to starting study drug: absolute neutrophil count (ANC) >= 1.0 x 10^9/L without daily use of myeloid growth factor; and, platelet >= 50 x 10^9/L without platelet transfusion within 1 week
No further chemotherapy or stem cell transplant (SCT) planned at the time of enrollment
Patients must be eligible for one of two cohorts: cohort 1 (FLT3 and/or FLT3-D835 inhibitor failure cohort) in FLT3-ITD and/or FLT3-D835 mutated relapsed/refractory AML who have failed therapy with up to two prior salvage regimens (stem cell transplant [SCT] or stem cell therapy for patients who previously underwent SCT/stem cell therapy in remission will not be considered a salvage regimen) and have previously been exposed at least one prior FLT3 inhibitor; cohort 2 (FLT3 inhibitor naive cohort) in FLT3-ITD and/or FLT3-D835 mutated relapsed/refractory who have failed therapy with up to two prior salvage regimens (SCT or stem cell therapy for patients who previously underwent SCT/stem cell therapy in remission will not be considered a salvage regimen) with no prior exposure to any FLT3 inhibitor
Prior autologous stem cell transplant (SCT) in the prior 12 months
Stem cell transplant (SCT): at least 8 weeks following autologous SCT and 12 weeks for allogeneic SCT
TREATMENT: Diagnosis of myeloma after receiving at least one treatment regimen; if patient has received an autologous or syngeneic stem cell transplant (SCT) they must be > 90 days post-transplant (Group A) OR\r\nfollowing autologous or syngeneic SCT (as adjuvant therapy) and < 90 days post-transplant (Group B)
Patients should have received the autologous SCT within 12 months of their diagnosis of myeloma to be eligible for the study
Prior allogeneic SCT
Prior autologous SCT in last 12 months
Subjects with CD19+ B cell lymphomas with no available curative treatment options (such as autologous or allogeneic stem cell transplant [SCT]) who have a limited prognosis (several months to < 2 year survival) with currently available therapies
Mantle cell lymphoma\r\n* Beyond 1st CR with relapsed disease, progressive disease during first line rituximab-chemotherapy combination, or persistent disease after first line rituximab-chemotherapy combination and not eligible or appropriate for conventional allogeneic or autologous SCT\r\n* Relapsed after prior autologous SCT
Diffuse large B cell lymphoma, previously identified as CD19+\r\n* Residual disease after primary therapy and not eligible for autologous SCT\r\n* Relapsed or persistent disease after prior autologous SCT\r\n* Beyond 1st CR with relapsed or persistent disease and not eligible or appropriate for conventional allogeneic or autologous SCT\r\n* Patients with an antecedent history of follicular lymphoma or chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) are eligible
Any relapse after prior autologous SCT will make patient eligible regardless of other prior therapy
Prior autologous stem-cell transplant (SCT) in the prior 3 months
Prior allogeneic hematopoietic SCT within the last 12 months or reduced-intensity transplant within the past 6 months
Patients with lymphomas: prior allogeneic SCT
Patient requiring allogeneic SCT
Allogeneic SCT recipient requiring additional cellular therapy
Prior autologous or allogeneic hematopoietic cell transplantation (other than autologous SCT 60-120 days prior to registration)
Known or suspected progressive disease following autologous SCT
Additional treatment for NHL administered from time of autologous SCT through registration
Are planning to undergo SCT prior to PD on this study (ie, these participants should not be enrolled in order to reduce disease burden prior to transplant).
Has received autologous SCT within 12 weeks before the date of study treatment.
Subjects with a history of autologous SCT, are eligible for study participation provided the following eligibility criteria are met: Autologous SCT was >100 days prior to study enrollment; No active bacterial, viral, or fungal infection(s) present; Subject meets the remainder of the eligibility criteria.
Prior treatment with any of the following: allogeneic or syngeneic SCT within 16 weeks prior to randomization; or autologous SCT within 12 weeks prior to randomization.
Stem cell transplant (SCT): no evidence of active graft vs. host disease for at least 4 weeks; for allogeneic SCT patients, >= 3 months must have elapsed since transplant\r\n* Must have received no more than 1 prior autologous or allogeneic stem cell transplant.\r\n* Patients must be off all systemic immunosuppressive therapy for at least 2 weeks, excluding hydrocortisone for physiologic cortisol replacement
Patient must have a CD19-expressing B cell acute lymphoblastic leukemia (ALL) or lymphoma and must have relapsed or refractory disease after at least one standard chemotherapy 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, or have disease activity that prohibits SCT at this time
Multiple myeloma\r\n* Primary treatment failure\r\n* Relapse after autologous SCT or for consolidation after autologous SCT\r\n* Non-CR after salvage regimen
Ineligible to receive treatment with auto-SCT due to age (?65 years old) or any significant coexisting medical condition (cardiac, renal, pulmonary or hepatic dysfunction), likely to have a negative impact on tolerability of auto-SCT. Participants <65 years of age who refuse auto-SCT are not eligible for this study.
Has relapsed after autologous stem cell transplant (auto-SCT) or has failed to achieve a Complete Response or Partial Response within 60 days of auto-SCT. Participants may have received intervening therapy after auto-SCT for relapsed or refractory disease, in which case they must have relapsed after or be refractory to their last treatment. OR
Any BM relapse after allogeneic SCT and must be > 6 months from SCT at the time of CTL019 infusion OR
Ineligible for allogeneic SCT
Has received autologous stem cell transplant (auto-SCT) within 12 weeks before the first infusion or is planning for or is eligible for auto-SCT
Have had at least 60 days between prior hematopoietic stem cell transplantation (SCT) and first dose of study drug.
Any BM relapse after allogeneic stem cell transplantation (SCT) and must be ? 6 months from SCT at the time of CTL019 infusion OR.
Ineligible for allogeneic SCT.
Completion of autologous stem cell transplant (SCT) within 100 days prior study start
Prior allogeneic SCT
Eligibility for autologous SCT (participants with r/r DLBCL)
Completion of autologous SCT within 100 days prior to Day (D) 1 of Cycle (C) 1
Autologous stem cell transplantation (SCT) within 100 days prior to study drug, or any prior allogeneic SCT or solid organ transplantation
Prior allogeneic stem cell transplantation (SCT), completion of autologous SCT within 100 days prior to Day 1 of Cycle 1 (D1C1)
Participant may have failed to achieve a response to, progressed after, or be ineligible for autologous stem cell transplant (auto-SCT)
Prior allogeneic stem cell transplant (SCT) within 16 weeks or autologous SCT within 8 weeks of initiation of therapy (patients that require immunosuppressive therapy are not eligible within 60 days of therapy)
Subject is a candidate for high-dose therapy and autologous SCT based on standard criteria at the institution where this treatment will be administered
Prior allogeneic stem cell transplant (SCT) within 16 weeks or autologous SCT within 8 weeks of initiation of therapy; (patients that require immunosuppressive therapy are not eligible within 60 days of therapy)
Autologous SCT within 8 weeks and allogeneic SCT within 16 weeks prior to initiation of study treatment. Patients with prior allogeneic SCT should not have evidence of moderate-to-severe graft-versus-host disease (as defined in Filipovich 2005).
May include prior auto-SCT but not prior allo-SCT Patients who have failed second or third line therapy and beyond, such as DPACE, and who are experiencing a partial response rather than progressive disease are also eligible.
Immunotherapy/standard myeloma therapy within 2 weeks; prior stem cell transplant (SCT) therapy (autologous SCT within the prior 8 weeks; allogeneic SCT within the prior 16 weeks)
Any relapse after prior autologous SCT will make patient eligible regardless of other prior therapy
Patient must be determined fit to undergo auto-SCT procedure by a study physician
Autologous SCT within 12 weeks prior to study entry (Arms A and D only)
Prior allogeneic SCT or organ transplant (Arms A and D only)
Prior allogeneic stem cell transplantation (SCT), or autologous SCT within 100 days prior to Day 1 of Cycle 1
Prior autologous or allogeneic stem cell transplant (SCT)/bone marrow transplant within 12 months of signing the ICD. Subjects who received allogeneic SCT ? 12 months before signing the ICD may be eligible provided there is no ongoing graft-versus-host disease and no ongoing immune suppression therapy.
frontline cytotoxic systemic therapy, for patients who are ineligible for stem cell transplant (SCT).
Completion of autologous stem cell transplant (SCT) within 100 days prior to Cycle 1 Day 1
Prior allogeneic SCT
Eligibility for autologous SCT
Prior autologous or allogeneic SCT
Is indicated with standard melphalan prednisone (MP) treatment and is not a candidate for high-dose therapy plus stem cell transplantation (HDT-SCT) for 1 of the following reasons: the participant is 65 years of age or older OR the participant is less than 65 years of age but has significant comorbid condition(s) that are likely to have a negative impact on tolerability of HDT-SCT
PRE-STEM CELL TRANSPLANT (SCT)
PRE-SCT
Prior allogeneic SCT
Be planning to receive a conditioning regimen for stem cell transplant (SCT) consisting of cyclophosphamide and total body irradiation and must meet inclusion criteria for SCT which include:
Patients with a prior stem cell transplant (SCT) must have failed the SCT
Non-allogeneic (e.g. autologous) or syngeneic hematopoietic stem cell transplant (SCT) recipients
Non-allogeneic (e.g. autologous) or syngeneic hematopoietic stem cell transplant (SCT) recipients
Patients who have previously undergone hematopoietic stem cell transplantation (SCT) or who are scheduled for SCT
Prior autologous or allogeneic stem cell transplantation (SCT) within 12 weeks of initiation of study treatment
Disease progression or recurrence less than or equal to 12 months of prior autologous SCT