Patients must have histologically or cytologically confirmed relapsed/refractory CD30 low (< 10%) TCL:\r\n* Peripheral TCL not otherwise specified (PTCL NOS)\r\n* Angioimmunoblastic T cell lymphoma (AITL)\r\n* Hepato-splenic T cell lymphoma (HTCL)\r\n* Adult T cell leukemia/lymphoma (ATLL)\r\n* Enteropathy associated T cell lymphoma (EATL)\r\n* Natural killer (NK) T cell lymphoma (NK/TCL)\r\n* Transformed mycosis fungoides
Patients must have histologically confirmed mantle cell lymphoma (MCL)\r\n* Please note: measurable disease is not required, but will be followed if it exists
Histologic diagnosis other than a mature B-cell lymphoma as defined in the WHO classification
Peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS);
Natural-killer/T-cell lymphoma (NKTL)
Relapsed or refractory mantle cell lymphoma (MCL) with no adequate therapies.
Biopsy proven plasmablastic lymphomas, or peripheral T cell lymphoma (with the exception of anaplastic lymphoma kinase positive [ALK+] type in first or second complete remission) (timeline 8 months prior to enrollment)
Cutaneous T cell Lymphoma (CTCL)
NHL SA expansion: Mature B-cell NHL with the following histologies: primary mediastinal lymphoma, DLBCL, and B-cell lymphoma not specified that is R/R to standard therapy and for whom standard treatments are contraindicated or unavailable
Angioimmunoblastic T-cell lymphoma (AITL)
Enteropathy-associated T-cell lymphoma
Extranodal natural killer (NK) T-cell lymphoma, nasal type
Hepatosplenic T-cell lymphoma
Peripheral T-cell lymphoma, no otherwise specified (NOS)
Precursor T-cell lymphoma or leukemia
Adult T-cell lymphoma/leukemia (ATLL)
Histologically confirmed diagnosis of PTCL (using the most recent edition of the World Health Organization [WHO] Classification of Tumors of Hematopoietic and Lymphoid Tissues as guidance) including: \r\n* Anaplastic large cell lymphoma, anaplastic large cell kinase (ALK)-negative \r\n* Angioimmunoblastic T-cell lymphoma \r\n* Enteropathy-type T-cell lymphoma\r\n* Hepatosplenic gamma-delta T-cell lymphoma \r\n* Peripheral T-cell lymphoma, unspecified (not otherwise specified [NOS]) \r\n* Transformed mycosis fungoides\r\n* Subcutaneous panniculitis-like T-cell lymphoma. \r\n* NOTE: patients with adequate archived (well-preserved, formalin-fixed) biopsy tissue remaining will be required to submit a portion for exploratory studies; this is not optional if tissue is available; however, lack of adequate tissue for exploratory studies will not preclude patients from participating
Patients with a diagnosis of any of the following are not eligible:\r\n* Anaplastic large cell lymphoma, ALK-positive \r\n* Adult T-cell lymphoma/leukemia (ATLL)\r\n* Anaplastic large-cell lymphoma, primary cutaneous type\r\n* Precursor T-lymphoblastic lymphoma/leukemia\r\n* Mycosis fungoides/Sezary syndrome (except transformed mycosis fungoides [MF])\r\n* Natural killer (NK)-cell leukemia\r\n* T-cell granular lymphocytic leukemia\r\n* T-cell prolymphocytic leukemia
Patients with T-cell or B cell lymphoblastic lymphoma confirmed by conventional immature T- or pre B cell markers even if the bone marrow is not involved are also eligible
3. High Grade B-cell Lymphoma---Burkitt's like.
Patients with newly diagnosed Group A (low risk) lymphoma. Patients with Group B (intermediate risk) if classified as Murphy Stage III/IV and diagnostic LDH > 2 XULN and patients with primary mediastinal B-cell lymphoma (PMBL).
PROCUREMENT: Diagnosis of Hodgkin’s or non-Hodgkin’s lymphoma:\r\n* GROUP A: \r\n** With active disease \r\n*** In second or subsequent relapse\r\n*** In first relapse for indolent lymphoma after first line therapy for relapse\r\n*** Or first relapse if immunosuppressive chemotherapy contraindicated\r\n*** Primary refractory disease or if persistent disease after first line therapy of relapse\r\n** Or multiply relapsed patients in remission who are at a high risk of relapse or the lymphoma is a second malignancy e.g. a Richter's transformation of chronic lymphocytic leukemia (CLL) after failing frontline therapy OR\r\n* GROUP B:\r\n** After autologous or syngeneic stem cell transplant (SCT) (as adjuvant therapy)
B-CLL or recurrent or refractory B-cell lymphoma (or other B-cell neoplasm) or multiple myeloma monoclonal for Kappa-light chain
Prior therapy must include a BTK inhibitor in diseases for which approved therapy includes a BTK inhibitor (i.e., SLL/CLL, WM, and mantle cell lymphoma). Subjects with DLBCL must have failed, refused, or be ineligible for autologous stem cell transplant. Subjects with low grade lymphoma must be progressing and requiring treatment.
Falls under one of the following subtypes of CD52 positive non-Hodgkin lymphoma (defined as >= 50% positive staining by immunohistochemical staining or flow cytometry by local lab):\r\n* High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements (DHL)\r\n* DLBCL or high-grade B-cell lymphoma NOS or B-cell lymphoma unclassifiable with features intermediate between Burkitt lymphoma and diffuse large B-cell lymphoma with MYC and BCL2 protein over-expression by immunohistochemical (IHC) staining as defined by MYC expression in >= 30% of cells and BCL2 positivity >= 50% (DOL)\r\n* Transformed lymphoma with MYC rearrangement by fluorescence in situ hybridization (FISH) or over-expression by IHC, as above\r\n* CD52 positive mature T-cell lymphoproliferative disorder
Histologically confirmed mature peripheral T-cell or natural killer (NK)-cell lymphoma per World Health Organization (WHO) classification, including: \r\n* Anaplastic lymphoma kinase (ALK)-positive anaplastic large cell lymphoma (ALCL) with international protein index (IPI) of 2 or higher (must have stage III-IV disease)\r\n* ALK-negative ALCL\r\n* PTCL-not otherwise specified (NOS)\r\n* Angioimmunoblastic T-cell lymphoma (AITL)\r\n* Adult T-cell lymphoma/leukemia (ATLL) \r\n* Enteropathy-associated T-cell lymphoma (EATL)\r\n* Hepatosplenic T-cell lymphoma
INCLUSION - PROCUREMENT: Referred patients will initially be consented for procurement of blood for generation of the transduced ATL; eligibility criteria at this stage include:\r\n* Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including angioimmunoblastic T-cell lymphoma [AITL], enteropathy-associated T-cell lymphoma [EATL], monomorphic epitheliotropic intestinal T-cell lymphoma [MEITL], peripheral T-cell lymphoma [PTCL] not otherwise specified [NOS], anaplastic large cell lymphoma [ALCL] adult T-cell leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, extranodal natural killer [NK]/T cell lymphoma, mycosis fungoides/ Sezary syndrome stage IIb or higher)\r\nAND\r\n* suitable for allogeneic hematopoietic stem cell transplant (HSCT)\r\n** with confirmation of an identified eligible allogeneic (allo)-HSCT donor by a Foundation for the Accreditation of Cellular Therapy (FACT) accredited transplant center AND \r\n** with confirmation that the center plans to proceed with transplant if CD5.CAR treatment induces a complete remission\r\n* For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated
INCLUSION - TREATMENT: Diagnosis of recurrent T-cell acute lymphoblastic leukemia (T-ALL), T-cell acute lymphoblastic lymphoma (T-LLy), or T-non-Hodgkin lymphoma (T-NHL, including angioimmunoblastic T-cell lymphoma [AITL], enteropathy-associated T-cell lymphoma [EATL], monomorphic epitheliotropic intestinal T-cell lymphoma [MEITL], peripheral T-cell lymphoma [PTCL] NOS, anaplastic large cell lymphoma [ALCL], adult T-cell leukemia/lymphoma, T cell prolymphocytic leukemia with symptomatic disease, extranodal NK/T cell lymphoma, mycosis fungoides/ Sezary syndrome stage IIB or higher) AND\r\n* suitable for allogeneic hematopoietic stem cell transplant (HSCT) \r\n** with confirmation of an identified eligible allo-HSCT donor by a FACT accredited transplant center AND\r\n** with confirmation that the center plans to proceed with transplant if CD5.CAR treatment induces a complete remission\r\n* For T-NHL subjects, eligibility will be confined to disease stages where allogeneic HSCT is indicated
INCLUSION - PROCUREMENT: Any patient, regardless of age or sex, with measurable EBV-positive Hodgkin’s or non-Hodgkin’s lymphoma, (regardless of the histological subtype) or EBV (associated)-T/natural killer (NK)- or B cell lymphoproliferative disease\r\n* The first 3 patients enrolled will be adults; patients <18 years of age are eligible if those first 3 patients do not experience dose limiting toxicity considered to be primarily related to the EBVST or nivolumab\r\n* Patients with relapsed or refractory lymphoma who failed or are ineligible for an autologous hematopoietic cell transplantation are also eligible for this study
Key Inclusion Criteria:\n\n        -Any of the following as defined by the WHO, 2016 lymphoid neoplasm classifications and\n        histologically confirmed:\n\n          -  Diffuse large B-cell lymphoma (DLBCL), Not Otherwise Specified (NOS): Germinal center\n             B-cell type (GCB), Activated B-cell type (ABC)\n\n          -  High-grade B-cell lymphoma (HGBCL) NOS\n\n          -  HGBCL with MYC and BCL2 and/or BCL6 rearrangements\n\n          -  T-cell histocyte-rich large B-cell lymphoma\n\n          -  EBV+ DLBCL, NOS\n\n          -  HHV8+ DLBCL, NOS\n\n        Relapsed or refractory disease following at least 2 lines (and a maximum of 4 lines) of\n        prior rituximab containing multi-agent chemotherapy which may include an autologous stem\n        cell transplantation unless patients are not considered suitable for intensive second-line\n        chemotherapy or autologous stem cell transplantation. Patients who are ineligible for\n        intensive second line chemotherapy,must have received at least one prior\n        rituximab-containing combination chemotherapy regimen. Patients who are ineligible for\n        intensive second line chemotherapy, must have received at least one prior\n        rituximab-containing combination chemotherapy regimen.\n\n          -  Baseline measurable disease with at least 1 bi dimensional lesion with longest\n             diameter (LDi) >1.5cm on CT scan which is FDG avid on PET scan.\n\n          -  A biopsy (archived or Screening/recent) will be collected at Screening.\n\n          -  At least 18years of age (or ?20 years in Japan).\n\n          -  Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0 or 1.\n\n        Key Exclusion Criteria:\n\n          -  Active central nervous system (CNS) lymphoma.\n\n          -  Prior organ transplantation including prior allogeneic SCT.\n\n          -  Prior therapy with an anti PD 1, anti PD L1, anti PD L2, anti CD137, or anti cytotoxic\n             T lymphocyte associated antigen 4 (CTLA 4) antibody (including ipilimumab,\n             tremelimumab or any other antibody, or drug specifically targeting T cell co\n             stimulatory or immune checkpoint pathways).
Mantle cell lymphoma Any histologies not specifically mentioned must be discussed with medical monitor.For subjects enrolled in the phase 3 portion of study, pathologic samples will be submitted for central confirmation of disease histology.
Pathology confirmed relapsed or refractory T-cell lymphoma (PTCL and stage > IB CTCL) at treating institution
Patients with mature B-cell ALL will be removed from the protocol as soon as that diagnosis is made and should be treated on a B-cell leukemia (Burkitt’s) protocol; NOTE: patients with T-cell surface markers and a t(8;14)(q24;q11) remain eligible
Patients with systemic T cell lymphoma of any stage and any subtypes; patient must have had at least one standard chemotherapy and measurable disease at the time of enrollment
Patients must have relapsed (first or greater relapse) or refractory lymphoma with:\r\n* Lymphoblastic lymphoma or peripheral T-cell lymphoma\r\n* Histologic verification of disease at original diagnosis or subsequent relapse\r\n* Evaluable or measurable disease documented by clinical or radiographic criteria or bone marrow disease present at study entry\r\n* Patient may have CNS 2 status if other sites of leukemia or lymphoma involvement are present
Histologically confirmed mantle cell lymphoma (confirmation of cyclin D1 positivity on diagnostic biopsy)
Subjects with ALK+, anaplastic large cell lymphoma (ALCL) should have been treated with, be ineligible for, or have refuse chemotherapy and brentuximab prior to enrollment on the current study.
Mature T-cell lymphoma\r\n* Chemosensitive T-cell lymphomas including primary T-cell not otherwise specified angioimmunoblastic, and ALK-positive anaplastic large cell, will be eligible after initial therapy, whether or not CR is achieved\r\n* Mycosis fungoides/Sezary syndrome will be eligible in >= CR2/PR2
Relapsed or refractory T-cell lymphoma (TCL) biopsy-proven =< 6 months prior to registration, including the following subtypes:\r\n* Peripheral T-cell lymphoma, not otherwise specified\r\n* Anaplastic large cell lymphoma, anaplastic lymphoma kinase (ALK) negative, primary systemic type\r\n* Angioimmunoblastic T-cell lymphoma\r\n* Extranodal natural killer (NK)/T-cell lymphoma, nasal type\r\n* Adult T-cell lymphoma/leukemia (human T-lymphotropic virus 1 [HTLV1]+)\r\n* Blastic NK-cell lymphoma\r\n* Enteropathy-associated T-cell lymphoma\r\n* Hepatosplenic gamma delta T-cell lymphoma\r\n* Transformed mycosis fungoides\r\n* T/NK-cell lymphoma, unclassifiable
Eligible patients with Hodgkin lymphoma must fulfill one of the following criteria: 1) have received two prior therapies, one of which must be an autologous stem cell transplant, or 2) have received three prior lines of therapy; eligible patients with any of the listed peripheral T cell lymphomas or non-Hodgkin lymphomas must have received two lines of prior therapy, at least one of which must contain cytotoxic chemotherapy; patients with diffuse large B-cell lymphoma or primary mediastinal B-cell lymphoma must have received 2 prior treatment regimens at least 1 of which included an anthracycline and an anti-CD20 monoclonal antibody
Relapsed or refractory:\r\n* Multiple myeloma (MM) previously treated with an immunomodulatory drug (IMID), a proteosome inhibitor and an alkylating agent; OR\r\n* Acute myeloid leukemia (AML), excluding acute promyelocytic leukemia (PML-RARA rearranged- AML-M3); either primary refractory or relapsed/refractory disease after at least two front line chemotherapy regimens (note: induction and consolidation chemotherapy is considered one line of therapy); diagnosis based on 2008 World Health Organization (WHO) criteria; OR\r\n* Relapsed T-cell lymphoma (TCL) or the following types: peripheral T-cell lymphoma-not otherwise specified (PTCL-NOS); angioimmunoblastic T-cell lymphoma (AITL), anaplastic large cell (ALCL), and cutaneous TCL (CTCL) of mycosis fungoides (MF); patients should have failed standard therapy and in the case of PTCL-NOS, AITL, and ALCL either have failed or be ineligible for high-dose therapy with autologous stem cell transplant
CUTANEOUS T-CELL LYMPHOMA (CTCL) ONLY
PERIPHERAL T-CELL LYMPHOMA (PTCL) ONLY
Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy
Mantle cell lymphoma ([MCL] with the exception of aggressive MCL, defined as Ki67 > 30%, or blastoid histology)
Primary disease of hematologic origin, lymphoma, or small cell cancer
Phase I or II patients who have received prior dose-adjusted EPOCH for treatment for PEL or KSHV-associated large cell lymphoma
Primary lesions with the following histologies: small cell carcinoma, germ-cell tumors, lymphoma, leukemia, and multiple myeloma
Histologically or cytologically-proven T- or B-cell lymphoma
Treatment with alemtuzumab or other T cell-depleting antibodies within 6 months of T cell therapy
All subjects must have a diagnosis of ALL of either B-cell, T-cell, or mixed (i.e., B/T lineage)
Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy
Mantle cell lymphoma patients who are beyond first remission and previously treated with chemoimmunotherapy; patients who have relapsed following autologous hematopoietic cell transplant (HCT) are eligible
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)
Patients must have been refractory or relapsed following front line therapy for adult T-cell leukemia (ATL); those with cutaneous T-cell lymphoma (CTCL) or peripheral T-cell lymphoma (PTCL) who have CD30+ disease must have progressed during or after treatment with brentuximab vedotin, or are unable to receive treatment due to allergy or intolerance
Diagnosis of either cutaneous T-cell lymphoma; T-prolymphocytic leukemia; T-large granulocytic leukemia; T-lymphoblastic leukemia/lymphoma; or peripheral T-cell lymphoma, natural killer/T-cell lymphoma for whom allogeneic stem cell transplantation is indicated
Participants with primary mediastinal B-cell lymphoma (PMBCL)
Pathologic diagnosis of one of the following:\r\n* For dose escalation:\r\n** Confirmed diagnosis of peripheral T-cell lymphoma (PTCL) or angioimmunoblastic T-cell lymphoma (AITL) that is refractory to at least one line of therapy; anaplastic large cell lymphoma (ALCL) and natural killer T-cell lymphoma nasal type (NKTCL) are excluded\r\n** Advanced stage cutaneous T-cell lymphoma (CTCL), specifically CTCL NOS, small/medium T-cell lymphoma (SMTCL) and mycosis fungoides (MF) stage IB, IIA, IIB, III and IV that have relapsed after at least one specific prior therapy (e.g. interferon, photopheresis, denileukin difitox, bexarotene, etc); anaplastic cutaneous large cell lymphoma (ACLCL) and lymphomatoid papulopsis are excluded\r\n** Follicular lymphoma grade 1, 2 or 3A that meets the following criteria: \r\n*** Relapsed or refractory to at least 2 lines of therapy AND\r\n*** Relapsed or refractory post autologous cell transplantation (HCT)\r\n* For dose expansion/dose confirmation phase: \r\n** Patients with confirmed diagnosis of peripheral T-cell lymphoma (PTCL) follicular type or angioimmunoblastic T-cell lymphoma (AITL) that is refractory to at least one line of therapy
Patients must have histologically confirmed relapsed/refractory or previously untreated mantle cell lymphoma (any stage)
Primary lesion with radiosensitive histology that includes the following: small cell carcinoma, germ cell tumors, lymphoma, leukemia, or multiple myeloma
Natural killer (NK) cell neoplasms\r\n* First complete remission (CR) for patients with high risk natural killer cell neoplasms including myeloid/NK cell precursor acute leukemia, blastic NK-cell lymphoma, aggressive NK-cell leukemia and nasal-type extranodal NK-cell lymphoma in first complete remission\r\n* Second or greater CR
Patients with a pathologically confirmed diagnosis of systemic mature T-cell non-Hodgkin lymphoma (NHL) with City of Hope pathology review as per World Health Organization (WHO) classification of lymphomas 2008, who are deemed eligible for high dose therapy and AHCT including patients in:\r\n* T-NHL histologies including peripheral T-cell lymphomas (PTCLs), cutaneous T-cell lymphomas (CTCLs) and natural killer (NK)/T cell lymphomas\r\n** First remission after initial first-line therapy (CR1) in PTCL patients, except for anaplastic lymphoma receptor tyrosine kinase (ALK)+ anaplastic large cell lymphoma (ALCL) and CTCL; patients with minimal residual disease after induction therapy may also be eligible at the discretion of the principal investigator (PI)\r\n** Relapsed/refractory disease, stable disease, partial remission (PR) or complete remission (CR), who have received at least 2 lines of therapy, and do not have an adequate allogenetic stem cell transplant option
STEP 1: Within 30 days of study entry: T cell leukemia or lymphoma
COH pathology review confirms that research participant’s diagnostic material is consistent with recurrent/progressive/residual B cell lymphoproliferative neoplasms as listed below AND the research participant is not eligible for or declines COH IRB Protocol No. 13277; additionally, CD19 positivity must be documented in a pathology report if the research participant previously received CD19-targeted therapy; however, it is not a requirement that the CD19 testing be performed by a COH pathologist\r\n* Disease stratum 1 (NHL): Unclassifiable high grade lymphoma, mantle cell lymphoma, follicular lymphoma, diffuse large B-cell lymphoma (DLBCL) and all its subtypes, Burkitt lymphoma (BL), marginal zone B-cell lymphoma, hairy cell leukemia, lymphoplasmacytic lymphoma, B cell lymphoma unclassifiable with features intermediate between DLBCL and BL, B cell lymphoma unclassifiable with features intermediate between DLBCL and classical Hodgkin lymphoma, and those research participants who either declined or were not eligible for COH IRB Protocol No. 13277, or who collected autologous T cells for COH IRB Protocol No. 13277 but then became ineligible for autologous hematopoietic stem cell transplant (HSCT) or participants who have relapsed following prior T cell therapy on either COH IRB Protocol No. 09174 or 12224 may be enrolled on this study\r\n* Disease stratum 2 (CLL/PLL/SLL): chronic lymphocytic leukemia (CLL), and B-cell prolymphocytic leukemia (PLL), and small lymphocytic lymphoma (SLL)
Patients must have histologic or cytologic diagnosis of hematologic malignancies with an indication for allogeneic hematopoietic progenitor cell transplantation, who are ineligible to receive a full ablative conditioning regimen as part of their transplantation, including:\r\n* Acute myeloid leukemia (AML)\r\n** As post-remission therapy in patients with intermediate and high risk cytogenetic and molecular abnormalities, including therapy-related leukemia\r\n** Patients refractory to induction chemotherapy\r\n** Relapsed after complete remission\r\n* Acute lymphocytic leukemia (ALL)\r\n** As post remission therapy in Philadelphia chromosome positive (Ph+) and Philadelphia chromosome negative (Ph-) ALL in complete remission, with or without minimal residual disease in patients older than 55 years of age and those younger than 55 years but ineligible for treatment with fully ablative conditioning regimens\r\n** Relapsed or refractory after prior therapy\r\n* Non Hodgkin lymphoma\r\n** Aggressive lymphoma (Burkitt, diffuse large B cell lymphoma, plasmablastic lymphoma, mantle cell lymphoma) relapsed after autologous hematopoietic progenitor transplantation or patients ineligible to receive autologous hematopoietic progenitor transplantation because of mobilization failure or persistent bone marrow involvement by lymphoma\r\n** Indolent lymphoma (follicular, marginal zone lymphoma, mantle cell lymphoma, etc.) patients are eligible if they have received at least two lines of therapy and have remission of their extramedullary disease\r\n** Indolent and aggressive lymphoma patients with refractory disease to at least two lines of therapy\r\n* Hodgkin lymphoma\r\n** Patients relapsed after autologous hematopoietic progenitor transplantation with remission of at least their extramedullary disease after salvage therapy\r\n** Patients with refractory disease to at least 2 lines of chemotherapy\r\n* Multiple myeloma\r\n** Patients who have presented with relapsed or refractory disease after second line therapy\r\n* Myelodysplastic syndrome\r\n** Patients with International Prognostic Score System Risk rating of: intermediate – 2 and higher, ineligible to receive a fully ablative conditioning regimen for allogeneic hematopoietic progenitor cell transplantation\r\n* Chronic lymphocytic leukemia\r\n** Patients with disease relapsed or refractory after 2 or more lines of therapy, ineligible to receive fully ablative conditioning regimens for allogeneic hematopoietic progenitor cell transplantation\r\n** Patients with disease transformed to aggressive lymphoma (Richter transformation) who have received induction therapy for their aggressive disease\r\n* Chronic myeloid leukemia:\r\n** In chronic phase that has failed therapy with at least 3 different tyrosine kinase inhibitors or has progressed to accelerated or blast phase\r\n** In accelerated or blast crisis\r\n* Myeloproliferative syndromes including myelofibrosis\r\n* Complete remission is not necessary for enrollment in this protocol, however Hodgkin and non Hodgkin lymphoma must have had remission of all extramedullary disease to be eligible to participate in this trial
Patients must have a previously documented histologic diagnosis of multiple myeloma (MM) Hodgkin’s Disease (HD) or non-Hodgkin’s lymphoma (NHL), and be eligible to undergo autologous PBSC transplantation on institutional protocols\r\n* Multiple myeloma should be in first or second partial response or better, as defined by International Myeloma Working Group criteria\r\n* Hodgkin’s Disease should be primary refractory or relapsed (either chemosensitive or refractory)\r\n* Non-Hodgkin’s lymphoma must be in either first or second partial response or better and have any one of the following histologies:\r\n** Diffuse large B cell lymphoma\r\n** Transformed lymphoma\r\n** Mantle cell lymphoma\r\n** Follicular lymphoma (any grade)\r\n** Peripheral T cell lymphoma
Autologous patients can be included anytime within 6 months post-transplant, if they had no signs of progression and meet one of the following criteria: i. leukemia; ii. lymphoma (all types of B and T cell lymphoma); iii. multiple myeloma
PROCUREMENT INCLUSION CRITERIA\r\n* Diagnosis of recurrent aggressive or indolent B-cell lymphoma or CLL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory aggressive B-cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation\r\n* CD19-positive tumor (result can be pending at this time)\r\n* Hemoglobin (Hgb) > 8.0\r\n* If pheresis required to collect blood:\r\n** Creatinine < 1.5 × upper limit normal\r\n** Aspartate aminotransferase (AST) < 1.5 × upper limit normal\r\n** Prothrombin time (PT) and activated partial thromboplastin time (APTT) < 1.5 × upper limit normal\r\n* Informed consent explained to, understood by and signed by patient/guardian (and donor, where applicable); patient/guardian given copy of informed consent
Diagnosis of recurrent aggressive or indolent B-cell lymphoma or CLL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory aggressive B-cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation
No prior treatment for mantle cell lymphoma with the exception of corticosteroids for 7 days or less, or 1 course of involved-field radiation
Patients with primary tumors including germ cell tumor, or lymphoma/leukemia
Pathologically confirmed T-cell lymphomas at the enrolling institution, including stage >= Ib cutaneous T-cell lymphoma (CTCL), which has relapsed or progressed after at least one systemic therapy
Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma);\r\n* Patients with more than one type of lymphoma may be enrolled after discussion with the MSK principal investigator\r\n* Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-cell lymphoma) is permissible after discussion with the MSK principal investigator
The following histologies will need to be confirmed at Memorial Sloan-Kettering Cancer Center (MSK) or locally for participating sites in order to be considered for HDT-ASCT and post-transplant maintenance romidepsin:\r\n* Peripheral T-cell lymphoma (PTCL)\r\n* Angioimmunoblastic T-cell lymphoma (AITL)\r\n* Anaplastic large-cell lymphoma (ALCL)\r\n* Enteropathy-associated T-cell lymphoma (EaTCL)\r\n* Hepatosplenic gamma delta T-cell lymphoma\r\n* Adult T-cell leukemia/lymphoma\r\n* Primary cutaneous gamma/delta T-cell lymphoma\r\n* Extranodal natural killer (NK)/T-cell lymphoma, nasal type\r\n* Primary cutaneous anaplastic large cell lymphoma\r\n* Subcutaneous panniculitis-like T-cell lymphoma\r\n* Mycosis fungoides/Sezary syndrome
Recipients (patients with B-cell malignancy) must have received an human leukocyte antigen (HLA)-identical sibling allogeneic hematopoietic stem cell transplant, or a >= 9/10-matched unrelated donor (URD) alloHSCT for any CD19+ B-cell malignancy; haploidentical donors will not be used in this protocol; patients with any CD19+ B-cell malignancy that is persistent or relapsed after all of the following interventions are eligible:\r\n* Donor T cell engraftment after alloHSCT (> 50% donor chimerism of the T cell compartment and a peripheral blood T cell number from the National Institutes of Health (NIH), Clinical center (CC) clinical lab of at least 50 CD3+ cells/uL)\r\n* A trial of withdrawal of immunosuppressive therapy\r\n* At least one donor cell infusion (DCI) with a minimum T cell dose of 5 x 106 CD3+ cells/kg; Exception: prior DCI (donor lymphocyte infusion [DLI]) is not an eligibility requirement for patients with acute lymphopblastic leukemia (ALL), Burkitt lymphoma, ALL-like high-grade lymphomas, or diffuse large B-cell lymphoma\r\n** NOTE: at least 28 days must have elapsed since the latest trial of withdraw of immunosuppression or DCI until the patient can be deemed to have persistent disease
High risk disease including at least one of the following:\r\n* Relapsed or refractory disease\r\n* Transformed lymphoma\r\n* Aggressive T-cell lymphoma\r\n* Failure to achieve completed remission (CR) following Auto SCT\r\n* Less than a 20% chance of event-free survival from autologous transplant determined by the treating physician and the Principal Investigator
Previously untreated T cell ALL including T cell lymphoblastic lymphoma; failure to one induction course of chemotherapy are eligible; patients in CR after =< 2 courses are also eligible
Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressive on salvage therapy; stable disease is acceptable to move forward provided it is non-bulky
Any stage for mediastinal gray zone lymphoma (MGZL) and primary mediastinal B cell lymphoma (PMBL)
Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy
Any high grade B-cell lymphoma
Histologically confirmed peripheral T-cell lymphoma (PTCL) as defined by the World Health Organization (WHO) criteria 2016, excluding cutaneous T-cell lymphoma (CTCL); transformed mycosis fungoides is allowed
Patients with B-cell lymphoma who are candidates to autologous stem-cell transplantation, including: 1. Primary refractory or relapsed diffuse large B-cell lymphoma in response to salvage treatment. 2. Primary refractory or relapsed follicular lymphoma or other indolent B-cell histology in response to salvage treatment. 3. Chemosensitive mantle-cell lymphoma in first or later line of treatment. 4. Patients with B cell lymphoma (all CD19+ NHL) with progressive or refractory disease who would otherwise not be candidates for autologous stem cell transplantation
Patients must have a histologically documented (either primary or metastatic site) diagnosis of advanced solid tumor cancer (stage IV or unresectable) or aggressive lymphoma (diffuse large B cell lymphoma, mantle cell lymphoma, T cell lymphoma, and natural killer [NK] cell lymphoma)\r\n* NOTE: The following histologies will be excluded: non-small cell lung cancer, squamous cell carcinoma of head and neck, melanoma, renal cell carcinoma, bladder cancer, Hodgkin’s lymphoma, Merkel cell carcinoma, and high-frequency microsatellite instability (MSI-H) colorectal cancer\r\n* NOTE: Patients with deleterious BRCA 1/2 mutated ovarian cancer will be excluded
Have a histologically or cytologically confirmed relapsed/refractory mature T-cell lymphoma that has progressed after a minimum of 1 systemic therapy with any of the following T-cell histologies: peripheral T-cell non-Hodgkin lymphoma (NHL), not otherwise specified (PTCL, NOS); anaplastic large cell T-cell lymphoma (ALCL) anaplastic lymphoma kinase positive or negative; angioimmunoblastic T-cell lymphoma; subcutaneous panniculitis like T-cell lymphoma; primary cutaneous gamma-delta T cell lymphoma; enteropathy associated T-cell lymphoma; hepatosplenic T-cell lymphoma; extranodal NK/T-cell lymphoma, nasal type; adult T-cell leukemia/lymphoma; unclassifiable PTCL; and transformed cutaneous T-cell lymphoma (CTCL) to PTCL with systemic involvement (not local skin transformation)
Biopsy proven NHL, including plasmablastic lymphoma and primary effusion lymphoma but not T-cell lymphoma; tissue histology will be reviewed at City of Hope (COH); patients who have been in remission for >= 1 year post Hodgkin's lymphoma chemotherapy are also considered eligible
Recurrent B cell lymphoma or leukemia (ALL or CLL), or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory intermediate B cell lymphoma with a treatment plan that will include high dose therapy and autologous stem cell transplantation; if the patient is less than age 18, the lymphoma/leukemia is highly aggressive (i.e. lymphoblastic, Burkitt, ALL)
Mature T-cell lymphoma\r\n* T-cell lymphomas including primary T-cell not otherwise specified, angioimmunoblastic, and anaplastic lymphoma kinase (ALK)-positive anaplastic large cell, will be eligible after initial therapy, whether or not CR is achieved\r\n* Mycosis fungoides/Sezary syndrome will be eligible in >= CR2/PR2
Special cases of high-risk lymphoma, including but not limited to: plasma dendritic cell type, hepato-splenic T cell type, gamma delta panniculitic T cell type, muco-cutaneous natural killer (NK) cell type, and stage III-IV nasal NK cell type\r\n* Primary treatment failure\r\n* Relapse after autologous SCT\r\n* Non-CR after salvage regimen\r\n*In first CR or any later CR
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)
Phase 2 subjects with known lymphoma: >=1000 cells/mm3 (>750 cell/mm3 for subjects with lymphoma in bone marrow)
T-cell lymphoma
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)
Cohort 5: Participants must have a mature T cell, B cell, or natural killer (NK) cell neoplasm.
Primary mediastinal B-cell lymphoma
Patients must have histologically confirmed relapsed or refractory mantle cell lymphoma or low grade B-cell non-Hodgkin lymphoma (NHL); patients with evidence of transformation to a high grade histology will not be eligible
Mantle cell lymphoma International Prognostic Index (IPI) (MIPI) score must be calculated and entered in Oncology Patient Enrollment Network (OPEN)\r\n* NOTE: for this calculation white blood cell (WBC) 7,500/mm^3 = 7,500/uL = 7.5 x 10^9/L should be entered as 7500
Pathologically confirmed T or NK cell lymphoma at the enrolling institution; for cutaneous T-cell non-Hodgkin lymphoma (CTCL), patients with stage IB disease or greater are eligible
Previous systemic anti-cancer therapy for T-cell lymphoma must have been discontinued at least 2 weeks prior to treatment;\r\n* Glucocorticoids aimed at controlling lymphoma-related symptoms are allowed as long as they are tapered down to 20 mg or less by the time of ruxolitinib initiation\r\n* Topical steroids for CTCL are permitted
Receiving systemic therapy for another primary malignancy (other than T-cell lymphoma)\r\n* Patients with more than one type of lymphoma may be enrolled after discussion with the Memorial Sloan-Kettering (MSK) principal investigator\r\n* Adjuvant or maintenance therapy to reduce the risk of recurrence of other malignancy (other than T-cell lymphoma) is permissible after discussion with the MSK principal investigator
Any previous chemotherapy or radiation for mantle cell lymphoma; short course of steroids for symptom relief prior to presentation is permissible
Histologically confirmed new diagnosis of stage II, III and IV peripheral T-cell non-Hodgkin’s lymphoma not otherwise specified (NOS), anaplastic large cell lymphoma (ALK negative) (ALK positive if IPI 3, 4, or 5), angioimmunoblastic T-cell lymphoma, enteropathy associated T-cell lymphoma, hepatosplenic gamma delta T-cell lymphoma
Patients with a diagnosis of other peripheral T-cell lymphoma (PTCL) histologies other than those specified in the inclusion criteria
Patients with non-T-cell-based lymphoma of any type or hairy cell leukemia are eligible on the condition that they do not receive active systemic treatment for their hematologic disease and are in complete remission as evidenced by PET/CT scans and bone marrow biopsies for at least 3 months.
Pathologically confirmed B- or T-cell lymphomas at the enrolling institution, including stage >= Ib cutaneous T-cell lymphoma (CTCL), which has relapsed or progressed after at least one systemic therapy\r\n* Hodgkin lymphoma is allowed and will be classified as a B-cell lymphoma in the phase IIA portion
Patients must have a confirmed diagnosis of mantle cell lymphoma with positivity in tissue biopsy
All patients must have a pathologic diagnosis of one of the following malignancies:\r\n* Non-Hodgkin’s lymphoma, including B- and T-cell lymphoma\r\n* Multiple myeloma or another plasma cell dyscrasia (Waldenstrom, Amyloidosis)
Histologically confirmed mantle cell lymphoma (MCL)
Relapse or progression after at least one systemic therapy for mantle cell lymphoma
Inclusion Criteria:\n\n        • Aged 18 years or older, with lymphoid malignancies of B-cell origin as follows:\n\n        *Indolent / aggressive B-cell (NHL) Non- Hodgkin's Lymphoma:\n\n        EXCLUDING: Burkitt lymphoma and precursor B-lymphoblastic leukemia/lymphoma\n\n        INCLUDING: any non-Hodgkin's B-cell malignancy such as CLL and rare non-Hodgkin's B-cell\n        subtypes such as Hairy Cell Leukemia, Waldenstrom macroglobulinemia, Mantle cell lymphoma,\n        transformed NHL histologies, etc.\n\n        *Hodgkin's lymphoma\n\n          -  Life expectancy of 12 weeks or longer.\n\n          -  Subject must have received ? 1 prior treatment regimen.\n\n          -  The subject must not be a candidate for potentially curative therapy, including stem\n             cell transplant.\n\n        Exclusion Criteria:\n\n          -  Received an investigational study drug within 28 days or 5 half-lives (whichever is\n             longer) prior to receiving the first dose of study drug.\n\n          -  Received any approved anticancer medications within 21 days or 5 half-lives (whichever\n             is longer) prior to receiving their first dose of study drug (42 days for\n             nitrosoureas) EXCEPT steroids at ? 10 mg prednisone daily (or equivalent).\n\n          -  Has any unresolved toxicity ? Grade 2 from previous anticancer therapy.\n\n          -  Has history of brain metastases or spinal cord compression, or lymphoma involving the\n             central nervous system.\n\n          -  Has an Eastern Cooperative Oncology Group (ECOG) performance status of ? 3.\n\n          -  Received allogeneic hematopoietic stem cell transplant within the last 6 months, or\n             has active graft versus host disease (GVHD) following allogeneic transplant, or is\n             currently receiving immunosuppressive therapy following allogeneic transplant.\n\n          -  Received autologous hematopoietic stem cell transplant within the last 3 months.\n\n          -  Laboratory parameters not within the protocol-defined range.\n\n          -  Current or recent history (<30 days prior to screening and/or <45 days prior to\n             dosing) of a clinically meaningful bacterial, fungal, parasitic or mycobacterial\n             infection.\n\n          -  Current clinically active viral infection.\n\n          -  Known history of infection with the human immunodeficiency virus (HIV).\n\n          -  History of active hepatitis or positive serology for hepatitis.
Patients with aggressive B-cell non-Hodgkin lymphoma subtypes including, relapsed or refractory diffused large B-cell lymphoma (DLBCL) and transformed follicular lymphoma meeting at least one of the following criteria:\r\n* Bone marrow involvement at the time of relapse or refractory disease and not appropriate for allogeneic transplantation\r\n* Positron emission tomography (PET) positive disease outside of one radiation port, unless single-port disease treated with prior radiotherapy within the port, following >= 2 cycles of salvage chemotherapy, per 1999 International Working Group (IWG) criteria
Diagnosis of islet cell tumor, lymphoma, metastatic lesion, acinar cell (or other atypical pathologic malignancy)
Pathology confirmed lymphoma or multiple myeloma\r\n* Hodgkin lymphoma is eligible for either phase and will be considered a B-cell lymphoma in the phase IIa study\r\n* Phase IIa portion, subjects must have B-cell lymphoma, T-cell lymphoma, or multiple myeloma
Have a clinical diagnosis of cutaneous T cell lymphoma CTCL, including documentation of a skin biopsy within the prior 3 years with histological findings consistent with CTCL (atypical epidermotropic or folliculocentric T-cells)
Indolent B-cell NHL lymphoma (study part B):
Patient with radiosensitive histologies (lymphoma, multiple myeloma, small cell carcinomas, germ cell tumors)
Male or female participants 18 years or older with diagnosis of mycosis fungoides (MF) or primary cutaneous anaplastic large cell lymphoma (pcALCL)
No prior radiation therapy for mantle cell lymphoma
Patients with histologically confirmed aggressive B-cell lymphoid malignancy, such as diffuse large B cell lymphoma (DLBCL), including primary mediastinal large B cell lymphoma, T cell rich B cell lymphoma, \double hit\ DLBCL, mantle cell lymphoma, any transformed low grade B cell lymphomas or grade 3 follicular lymphoma (grade 3a or 3b) who were refractory to rituximab-cyclophosphamide-hydroxydaunorubicin (doxorubicin hydrochloride)-Oncovin (vincristine sulfate)-prednisone (R-CHOP)-like or any anthracycline based chemotherapy or relapsed after at least one prior combination chemotherapeutic regimen and who are deemed candidates for a salvage type chemotherapy\r\n* Relapsed disease:\r\n** Progressive disease after a CR for at least 28 days; progression will be defined according to the Revised Response Criteria for Malignant Lymphoma (Cheson 2007)\r\n* Refractory disease:\r\n** Subjects must meet one of the following criteria:\r\n*** Persistent or progressive lymphoma with a CR of < 28 days duration or with a PR of any duration; subjects must have received at least 3 cycles of RCHOP-like or any anthracycline base chemotherapy or at least 2 full cycles of hyperfractionated cyclophosphamide-vincristine sulfate-Adriamycin (doxorubicin hydrochloride)-dexamethasone (HyperCVAD)-like chemotherapy\r\n*** Persistent lymphoma and stable disease after at least 2 cycles of RCHOP-like or any anthracycline base chemotherapy or at least 1 full cycle of HyperCVAD-like chemotherapy (part A and B)\r\n*** Progressive disease despite at least 1 cycle of RCHOP-like or any anthracycline base chemotherapy or at least 1 cycle (part A or A and B) of HyperCVAD-like chemotherapy
Primary germ cell tumor, small cell carcinoma, or lymphoma
Have confirmed mantle cell lymphoma diagnosis.
Persistent, or relapsed non-Hodgkin's lymphoma (NHL) (any histology) that is chemo-resistant (< a partial response [PR]), subjects who have received >= 3 prior chemotherapy regimens, or subjects with lymphomas that have a high relapse rate following autologous or syngeneic stem cell transplantation (transformed NHL, peripheral T-cell lymphoma [PTCL], mantle cell lymphoma, anaplastic lymphoma kinase [ALK]-negative anaplastic large cell lymphoma [ALCL, alk neg]), intermediate International Prognostic Index (IPI) or high risk IPI or subjects with a positive positron emission tomography (PET) scan prior to transplant, and otherwise eligible for transplantation with adequate end-organ function
Chemosensitive NHL, except subjects receiving >= 3 prior chemotherapy regimens, or subjects having transformed NHL, PTCL, mantle cell lymphoma (MCL) or ALCL, alk neg
NK cell neoplasms\r\n* First complete remission (CR) for patients with high risk natural killer cell neoplasms including myeloid/NK cell precursor acute leukemia, blastic NK-cell lymphoma, aggressive NK-cell leukemia and nasal-type extranodal NK-cell lymphoma in first complete remission\r\n* Primary induction failure\r\n* Second or greater CR
T-cell neoplasm: adult T-cell leukemia/lymphoma, hepatosplenic T-cell lymphoma, and enteropathy associated T-cell lymphoma\r\n* First CR\r\n* Chemotherapy-refractory disease\r\n* Relapse after greater than or equal to 1 prior regimen
For patient with NK cell neoplasms: 1) patients with high risk natural killer cell neoplasms including myeloid/NK cell precursor acute leukemia, blastic NK-cell lymphoma, aggressive NK-cell leukemia and nasal-type extranodal NK-cell lymphoma in first complete remission; 2) all NK cell neoplasms can be transplanted in: a) primary induction failure or b) second or greater complete remission
For patients with T-cell neoplasms including adult T-cell leukemia/lymphoma, hepatosplenic T-cell lymphoma and enteropathy associated T-cell lymphoma\r\n* First CR\r\n* Chemotherapy-refractory disease\r\n* Relapse after greater than or equal to 1 prior regimen
Patients with CD30 positive Hodgkin lymphoma (HL) or anaplastic large cell lymphoma (ALCL) that have undergone allogeneic or haploidentical stem cell transplant (SCT) in the past 60 days (matched related or matched unrelated donors only)
Hodgkin's variant of Richter's lymphoma, accelerated CLL, composite lymphoma, interdigitating dendritic cell sarcoma, sarcoma, EBV-associated lymphoma or prolymphocytic transformation.
Patients must have histologically proven T-cell lymphoma, including the following subtypes:\r\n* Peripheral T-cell lymphoma, not otherwise specified\r\n* Angioimmunoblastic T-cell lymphoma\r\n* Anaplastic large cell lymphoma, anaplastic lymphoma receptor tyrosine kinase (ALK) positive\r\n* Anaplastic large cell lymphoma, ALK negative\r\n* Mycosis fungoides\r\n* Sezary syndrome
T-cell primary CNS lymphoma.
Confirmed diagnosis of mantle cell lymphoma
Confirmed diagnosis of PTCL expressing CD30 receptor; diagnosis will be based on identification of PTCL in biopsy specimens characterized 0 (negative) to 79% (positive) immunohistochemistry staining with CD30 in the malignant cell population; following PTCL subtypes will be eligible: \r\n* Peripheral T-cell lymphoma, not otherwise specified (NOS) \r\n* Angioimmunoblastic T-cell lymphoma \r\n* Subcutaneous panniculitis like T-cell lymphoma \r\n* Hepatosplenic gamma/delta T-cell lymphoma \r\n* Extranodal natural killer (NK) T-cell lymphoma, nasal type \r\n* Enteropathy-associated T-cell lymphoma \r\n* Adult T-cell leukemia/lymphoma \r\n* T-cell prolymphocytic leukemia \r\n* Primary cutaneous gamma-delta T-cell lymphoma \r\n* Aggressive NK cell leukemia \r\n* Aggressive subtype of T cell large granular lymphocyte (LGL) leukemia or transformed LGL leukemia\r\n* Epstein-Barr virus (EBV)-positive T-cell lymphoproliferative disorders of childhood \r\n* Transformed mycosis fungoides who have progressed following treatment with at least one systemic therapy\r\n* Sezary syndrome \r\nImmunophenotyping of lymphomas will be performed with panels of monoclonal antibodies targeting surface markers and assisting in differential diagnosis of PTCL according to National Comprehensive Cancer Network (NCCN) guidelines version (V)2 2012; CD2, CD5, CD7, CD4, CD8, CD10, CD25, CD30, CD56, beta-Framework 1 (F1), activin receptor-like kinase-1 (ALK-1), Epstein-Barr virus encoded ribonucleic acid (RNA) (EBER), TIA1 cytotoxic granule-associated RNA binding protein (Tia-1), granzyme B, cartesian genetic programming (CGP), perforin, CD21, B-cell chronic lymphocytic leukemia/lymphoma 6 (bcl-6), programmed cell death 1 (PD-1); proliferation index will also be evaluated using antibodies against mindbomb E3 ubiquitin protein ligase 1 (Mib-1)/ marker of proliferation Ki-67 (Ki-67); clonality studies with T-cell receptor (TCR) gene rearrangement of beta and gamma genes will also be included; pathology sample must be adequate for a complete immunohistochemical analysis
Biopsy-confirmed relapsed, refractory, or progressive NHL or HL, including cutaneous T-cell lymphoma (CTCL)
Patient has one of the following peripheral T-cell lymphoma (PTCL) subtypes confirmed by an independent central pathology reviewer, using the Revised European American Lymphoma World Health Organization disease classification:
T/natural killer (NK)-cell leukemia/lymphoma
Anaplastic large cell lymphoma (ALCL), primary systemic type, excluding anaplastic lymphoma kinase positive (ALK+) with International Prognostic Index (IPI) score less than 2 at initial diagnosis and complete response (CR) after CHOP-based therapy
Enteropathy-type intestinal lymphoma
Extranodal T/NK-cell lymphoma nasal or nasal type
High grade B-cell lymphoma (HGBCL)
Any T cell lymphoma
In addition, cutaneous B and T cell lymphoma are permitted; cutaneous T cell lymphoma must be refractory to 1 prior systemic therapy (topical therapy, photophoresis, radiation are not considered systemic therapy); transformed B and T cell cutaneous lymphoma are also permitted
Relapsed/refractory nodal, leukemic, and extranodal T cell lymphomas are eligible; subtypes eligible include anaplastic large cell lymphoma, angioimmunoblastic T cell lymphoma, peripheral T-cell lymphoma-not-otherwise specified (PTCL-NOS), nasal or disseminated extranodal T/natural killer (NK) lymphoma, enteropathy-associated T cell lymphoma, hepatosplenic gamma/delta T cell lymphoma, subcutaneous panniculitis-like T cell lymphoma, T-prolymphocytic leukemia, adult T-cell leukemia/lymphoma, large granular lymphocytic leukemia, aggressive NK leukemia
Enteropathy-Associated T cell Lymphoma (EATL)
Primary disease of hematologic origin, lymphoma, or small cell cancer
Patients with non-Hodgkin’s lymphoma and one or more of the following: \r\n* Diffuse large B-cell lymphoma with one or more of the following: \r\n** Primary refractory disease\r\n** Relapse within 12 months of completion of first-line therapy\r\n** Secondary International Prognostic Index (IPI) > 1\r\n** Less than partial remission (PR) to first-line salvage chemotherapy\r\n** Kinetic failure after salvage chemotherapy\r\n** Prior treatment with 3 or more lines of therapy\r\n** Patients with double-hit or triple-hit non-Hodgkin lymphoma (NHL), in any state of the disease\r\n* Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) in any stage of the disease\r\n* Angioimmunoblastic T-cell lymphoma (AITL) in any stage of the disease\r\n* Refractory or recurrent Burkitt¹s lymphoma\r\n* Any other lymphoma that is refractory or relapsed and that does not qualify for treatment protocols of higher priority
Participants must have histologically confirmed peripheral T-cell lymphoma, with the diagnostic specimen reviewed at one of the Dana-Farber Harvard Cancer Center (DFHCC) hematopathology laboratories; eligible histologies include:\r\n* PTCL-not otherwise specified (NOS)\r\n* Systemic T cell/null anaplastic large cell lymphoma (ALCL), regardless of anaplastic lymphoma kinase (Alk)-status\r\n* Angioimmunoblastic T-cell lymphoma (AITL)\r\n* Hepatosplenic (alpha-beta or gamma-delta) lymphoma (HSL)\r\n* Enteropathy-associated T-cell lymphoma (EATL)\r\n* Adult T-cell leukemia/lymphoma (ATLL), lymphomatous subtype\r\n* Subcutaneous panniculitis-like T-cell lymphoma\r\n* T-cell prolymphocytic leukemia (T-PLL)\r\n* Natural killer (NK) cell lymphoma/leukemia
Patients with extranodal NK T-cell lymphoma
B-cell lymphoma with comprehensive immunohistochemistry (IHC) panel establishing lineage (cluster of differentiation [CD]20, CD3) and cell of origin (CD10, B-cell chronic lymphocytic leukemia [CLL]/lymphoma 6 [BCL6] and melanoma associated antigen [mutated] 1 [MUM1]) in addition to proliferative/prognostic markers (proliferation-related Ki-67 antigen [Ki-67], C-myc and B-cell CLL/lymphoma 2 [BCL2]); DHL will be identified using cytogenetics and/or immunohistochemistry as detailed in DHL defined below
One of the following poor-risk lymphomas or plasma cell neoplasms, in PR or better prior to transplantation:\r\n* Transformed lymphoma\r\n* T-cell prolymphocytic leukemia (PLL)\r\n* Peripheral T-cell lymphoma\r\n* Natural killer (NK) or NK/T-cell lymphoma\r\n* Blastic/blastoid mantle cell lymphoma\r\n* Plasma cell leukemia
Treatment-naive CD30-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large cell lymphoma
Current diagnosis of primary cutaneous anaplastic large cell lymphoma, mycosis fungoides, Sezary syndrome or other primary cutaneous lymphomas; extranodal NK/T-cell lymphoma, nasal type
Histologically confirmed cancer with 1-4 brain metastases (except lymphoma or small cell histologies)
mantle cell lymphoma
Meets one of the following need-for-treatment criteria (with the exception of mantle cell lymphoma for which treatment is indicated):
Patients must be newly diagnosed with mantle cell lymphoma, have an accessible disease site for excisional biopsy or have sufficient peripheral blood tumor to leukapheresis at least 1.5 x 10^9 lymphoma cells in a single session
Documentation of diagnosis as evidenced by one or more clinical features consistent with mycosis fungoides cutaneous T-cell lymphoma
Burkitt, mantle cell, follicular, or mucosa-associated lymphoid tissue lymphoma
Previously untreated mantle cell lymphoma patients (at least clinical stage 2)
Platelet count >= 100,000, unless felt to be secondary to underlying mantle cell lymphoma
Patients with mantle cell lymphoma (MCL) with stage 1 or 2 disease
Large cell lymphoma, mantle cell lymphoma and Hodgkin disease that is progressing on salvage therapy
Patients must have histologically or cytologically confirmed (at original diagnosis or subsequent recurrence or progression) lymphoma, chronic lymphocytic lymphoma (CLL) or solid tumor; patients with lymphoma or CLL must have radiologically or clinically evaluable disease, and be refractory to standard therapy as defined by relapse within 6 months of last treatment (see note below); patients with solid tumors must have radiologically or clinically evaluable disease that is metastatic, unresectable, progressive, or recurrent, and for which standard curative measures do not exist or are no longer effective\r\n* Patients with a liver mass, raised alpha-fetoprotein level (>= 500 ng/mL) and positive serology for hepatitis, consistent with a diagnosis of hepatocellular carcinoma will be eligible without the need for pathologic confirmation of the diagnosis\r\n* Patients with prostate cancer, renal cell cancer, neuroendocrine tumors, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are excluded in the normal and mild cohorts due to a lack of efficacy in these tumor types in phase 2 studies; patients with breast, pancreatic, bladder, head and neck cancers, as well as melanoma and other malignancies are eligible\r\n* Note: patients with prostate cancer, renal cell cancer, lung cancer, colorectal cancers, soft tissue sarcomas, glioma and thyroid cancer are allowed to enroll in the moderate and severe cohorts provided the patients:\r\n** Sign a separate consent form which outlines the lack of efficacy observed in prior studies\r\n** Are consented to the study by a protocol-specified designee who is not their longitudinal oncologist; patients with neuroendocrine tumors are still excluded from the moderate and severe cohorts\r\n* Note: as romidepsin is approved for patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) or cutaneous T cell lymphoma (CTCL), these patients would be eligible WITHOUT the requirement of having ‘relapsed within 6 months of last treatment’
High grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple-hit lymphoma)
For the Dose Escalation phase, participants must have histologically confirmed diagnosis of advanced NHL of any histology (with the exception of participants with mantle cell lymphoma [MCL] or chronic lymphoma leukemia [CLL]).
B-cell ALL