Diagnosis of World Health Organization (WHO) diffuse large B-cell lymphoma, high grade B-cell lymphoma not otherwise specified, or B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma
Participant must have a histologic diagnosis of a mature B cell lymphoma (e.g., Burkitt lymphoma/leukemia, atypical Burkitt lymphoma, diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma, mature B-cell lymphoma not-otherwise specified [NOS]) as defined in the World Health Organization (WHO) classification
PARTICIPANTS FROM COLLABORATING SITES PARTICIPATING IN BIOLOGICAL OBJECTIVES ONLY: Participant must have a histologic diagnosis of a mature B cell lymphoma (e.g., Burkitt lymphoma/leukemia, atypical Burkitt lymphoma, diffuse large B-cell lymphoma, mediastinal large B-cell lymphoma, mature B-cell lymphoma NOS) as defined in the WHO classification
Anaplastic large cell lymphoma (ALCL); or
Known histological transformation from indolent NHL to diffuse large B-cell lymphoma.
Relapsed or refractory diffuse large B cell lymphoma with measurable disease as determined by Non-Hodgkin's Lymphoma Cheson response criteria (2014)
History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL)
Patients must have a histological diagnosis of any of the following (all stages allowed):\r\n* Diffuse large b-cell lymphoma (DLBCL) (including transformation from a previously indolent non-Hodgkin lymphoma [NHL], so long as no prior systemic treatment was given for the indolent NHL)\r\n* B-cell lymphoma, unclassifiable\r\n* Burkitt lymphoma\r\n* MYC+ plasmablastic lymphoma by histology
Anaplastic large cell lymphoma (ALCL), ALK positive
Primary cutaneous type anaplastic large cell lymphoma
Primary mediastinal (thymic) large B-cell lymphoma (PMBL)
1. Diffuse Large Cell Lymphoma (NOT primary mediastinal B-cell lymphoma) -2. Burkitt's Lymphoma
Histologically confirmed diagnosis of a histiocyte/dendritic cell neoplasm or relapsed/refractory aggressive lymphoma with at least one of the following features (with review required at a participating study center):\r\n* Diffuse large B cell lymphoma with Epstein-Barr virus (EBV) positive tumor cells (defined as positive EBV-encoded ribonucleic acid [RNA] in tumor cells)\r\n* Plasmablastic lymphoma\r\n* T cell/histiocyte rich diffuse large B-cell lymphoma (DLBCL)\r\n* EBV+ T cell lymphoma of any histology; note, patients with angioimmunoblastic T cell lymphoma will be eligible regardless of EBV status\r\n* Histiocytic sarcoma\r\n* Follicular dendritic cell sarcoma\r\n* Interdigitating dendritic cell sarcoma
History or diagnosis of mantle cell lymphoma or anaplastic large cell lymphoma.
Diffuse large B cell lymphoma (DLBCL). Histology based upon bone marrow biopsies and/or fine needle aspirates as the sole means of diagnosis are not acceptable.
A histologically confirmed diagnosis of mantle cell lymphoma (MCL) or diffuse large B-cell lymphoma (DLBCL) de novo or in the setting of transformation from an indolent lymphoma (including DLBCL not otherwise specified) according to the World Health Organization criteria for diagnosis of NHL; AND
Untreated ALK+ anaplastic large cell lymphoma (ALCL)
Patients with large cell transformation of cutaneous T cell lymphoma are eligible
Histologically confirmed relapsed or refractory extranodal NK/T-cell lymphoma (ENKTL), nasal type, or EBV-associated diffuse large B cell lymphomas
Pathologically proven diffuse large B-cell lymphoma
Patients with large cell transformation of cutaneous T cell lymphoma are eligible
Histologically confirmed NHL: diffuse large B-cell lymphoma and follicular lymphoma (Grade 1-3A) that has progressed following at least 1 line of prior anticancer therapy.
Patients with peripheral T-cell lymphoma (including but not limited to peripheral T-cell lymphoma, not otherwise specified [PTCL-NOS], angioimmunoblastic T-cell lymphoma, anaplastic large T-cell lymphoma). Patients with mycosis fungoides with large cell transformation with measurable disease is eligible.
Patients must have B-cell non-Hodgkin lymphoma, including mantle cell, follicular, lymphoplasmacytic, marginal zone, transformed indolent B cell lymphoma (including transformed chromic lymphoid leukemia [CLL]), or diffuse large B cell lymphoma that has relapsed after a response to at least one prior therapy regimen or is refractory to prior therapy; patients with de novo diffuse large B-cell lymphoma (DLBCL) must meet one of the following criteria:\r\n* Biopsy-proven refractory disease after a frontline regimen containing both an anthracycline and rituximab or other anti-CD20 antibody (i.e. “primary refractory”), where any disease recurring within 6 months of completion of the regimen is considered refractory\r\n* Relapsed or refractory disease after at least one of the following:\r\n** At least 2 lines of therapy (including at least one with an anthracycline and anti-CD20 antibody)\r\n** Autologous stem cell transplant\r\n** Allogeneic stem cell transplant
Patients must have a diagnosis of B-cell lymphoma confirmed by Laboratory of Pathology, National Cancer Institute (NCI), that is relapsed from or refractory to prior therapy as follows:\r\n* Cohort 1: B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and classical Hodgkin lymphoma (i.e., Gray-zone lymphoma or GZL)\r\n* Cohort 2: Extranodal diffuse large B-cell lymphoma involving one or more of the specified extranodal sites (i.e., extranodal DLBCL); the following subtypes are included (they do not have to be confirmed as non-germinal center B-cell [GCB] subtype for study entry):\r\n** Primary central nervous system (CNS) lymphoma (PCNSL)\r\n** Primary testicular lymphoma (PTL)\r\n** Primary breast lymphoma (PBL)\r\n** Primary cutaneous DLBCL, leg-type\r\n** Intravascular large B-cell lymphoma (IVBCL)\r\n** Diffuse large B-cell, not otherwise specified (NOS), activated B-cell type, involving 1 or more extranodal site\r\n* NOTE: For GZL, diagnosis will be in accordance with the 2016 World Health Organization classification of lymphoid malignancies; patients diagnosed with other extranodal DLBCL subtypes or that are not otherwise specified (NOS) must involved at least 1 extranodal site and must be considered non-GCB by local immunohistochemistry algorithms; cases that are non-GCB by the Hans criteria are considered eligible as well as cases of DLBCL that are both CD10+ and MUM1+
Have a histologically confirmed diagnosis of follicular lymphoma, diffuse large B-cell lymphoma, or classical Hodgkin lymphoma according to the World Health Organization (WHO) classification, with hematopathology review at the participating institution\r\n* FL: grade 1, 2, 3A, or 3B are eligible\r\n* DBLCL: transformed indolent lymphomas (TIL), primary mediastinal large B-cell lymphoma (PMBCL), and aggressive B-cell lymphoma unclassified (BCL-U) are eligible\r\n* HL: all classical HL subtypes are eligible except for nodular lymphocyte predominant Hodgkin lymphoma, which is excluded
Phase 1 Part: Patients with pathologically confirmed advanced stage B-cell NHL (Ann Arbor stage 3 or 4) for whom R-CHOP is considered appropriate therapy; newly diagnosed DLBCL, newly diagnosed low grade B cell NHL, and previously treated low grade B cell NHL patients in first relapse after a prior treatment with non-anthracycline containing chemotherapy are allowed; double hit and transformed diffuse large B cell lymphoma are allowed\r\n* Allowed low grade B cell lymphomas will include follicular lymphoma any grade, marginal zone lymphoma including mucosa-associated lymphoid tissue (MALT) lymphoma, indolent mantle cell lymphoma and Waldenstrom's macroglobulinemia
Phase 2 Part: Patients with pathologically confirmed newly diagnosed diffuse large B cell lymphoma (Ann Arbor stage 3 or 4); newly diagnosed double hit and transformed diffuse large B cell lymphoma are allowed
Patients with de novo diffuse large B-cell lymphoma
Histologically confirmed diagnosis of CD19 positive diffuse large B-cell lymphoma (DLBCL) or transformed large cell lymphoma from low grade lymphoma
Patients must have Hodgkin lymphoma, anaplastic large cell lymphoma, peripheral T-cell lymphoma not otherwise specified, diffuse large B-cell lymphoma not otherwise specified, primary mediastinal B-cell lymphoma, gray zone lymphoma, enteropathy-associated T-cell lymphoma, or extranodal natural killer (NK)/T-cell lymphoma, nasal type
For the purpose of this study, aggressive B-cell NHL will be deemed any lymphoma belonging to one of the following groups according to the 2016 revision of the World Health Organization (WHO) classification of lymphoid neoplasms\r\n* For the purposes of stratification, diagnoses are grouped into 2 categories:\r\n** Category A\r\n*** Burkitt lymphoma\r\n*** Burkitt-like lymphoma with 11q aberration\r\n*** High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements\r\n*** High-grade B-cell lymphoma, not otherwise specified (NOS)\r\n** Category B\r\n*** Diffuse large B-cell lymphoma (DLBCL), NOS\r\n*** Diffuse large B-cell lymphoma (DLBCL), NOS; germinal center B-cell type\r\n*** Diffuse large B-cell lymphoma (DLBCL), NOS; activated B-cell type\r\n*** Large B-cell lymphoma with IRF4 rearrangement\r\n*** T-cell/histiocyte-rich large B-cell lymphoma\r\n*** Primary DLBCL of the central nervous system (CNS)\r\n*** Primary cutaneous DLBCL, leg type\r\n*** Epstein-Barr virus (EBV)+ DLBCL, NOS\r\n*** EBV+ mucocutaneous ulcer\r\n*** DLBCL associated with chronic inflammation\r\n*** Lymphomatoid granulomatosis\r\n*** Primary mediastinal (thymic) large B-cell lymphoma\r\n*** Intravascular large B-cell lymphoma\r\n*** ALK+ large B-cell lymphoma\r\n*** Plasmablastic lymphoma\r\n*** Primary effusion lymphoma\r\n*** Human herpesvirus (HHV)-8+ DLBCL, NOS\r\n*** B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma
Previously untreated participants with cluster of differentiation 20 (CD20)-positive DLBCL, including one of the following diagnoses by 2016 World Health Organization (WHO) classification of lymphoid neoplasms: DLBCL, not otherwise specified (NOS) including germinal center B-cell type, activated B-cell type; T-cell/histiocyte-rich large B-cell lymphoma; Epstein-Barr virus-positive DLBCL, NOS; anaplastic lymphoma kinase (ALK)-positive large B-cell lymphoma; human herpesvirus-8 (HHV8)-positive DLBCL, NOS; High-grade B-cell lymphoma with MYC and B-cell lymphoma 2 (BCL2) and/or B-cell lymphoma 6 (BCL6) rearrangements (double-hit or triple-hit lymphoma); High-grade B-cell lymphoma, NOS
Primary mediastinal (thymic) large B-cell lymphoma
Participants must have histologically (via at least a core or ideally, incisional or excisional biopsy) documented CD20 positive or negative diffuse large B-cell lymphoma (DLBCL)
Patients with B-cell lymphoma who are candidates to autologous stem-cell transplantation: \r\n* Primary refractory or relapsed diffuse large B-cell lymphoma in response to salvage treatment\r\n* Primary refractory or relapsed follicular lymphoma or other indolent B-cell histology in response to salvage treatment\r\n* Chemosensitive mantle-cell lymphoma in first or later line of treatment
Histologically confirmed B-cell non-Hodgkin’s lymphoma (NHL) of any of the following subtypes recognized by the World Health Organization (WHO) classification: Burkitt lymphoma, B-cell lymphoma unclassifiable with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma, diffuse large B-cell lymphoma, marginal zone lymphoma, or follicular lymphoma; patients with evidence of histological transformation to diffuse large B-cell lymphoma from indolent NHL are eligible
Cohort A will enroll 10 patients with a diagnosis of diffuse large B-cell lymphoma; B-cell lymphoma unclassifiable with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma (double hit lymphoma), Burkitt lymphoma, and transformed lymphoma
Relapsed large-cell lymphoma, mantle-cell lymphoma and Hodgkin lymphoma that is chemotherapy sensitive and has failed or ineligible for an autologous transplant
Phase II patients who have received any prior therapy for PEL or KSHV-associated large cell lymphoma
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high grade B cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements; primary mediastinal B-cell lymphoma (PMBCL); or DLBCL transformed from indolent histology with one of the following:\r\n* Persistent disease after first-line chemo-immunotherapy\r\n* Relapse after first-line chemo-immunotherapy and not eligible for autologous hematopoietic stem cell transplant (HCT)\r\n* Relapse or persistent disease after at least two lines of therapy or after autologous HCT
Histologically confirmed follicular lymphoma grade 1-3A, diffuse large B cell lymphoma, and mantle cell lymphoma by World Health Organization (WHO) 2009 classification
Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade 3 follicular lymphoma
Patients must have a histologically confirmed diagnosis of lymphoma expressing the CD20 antigen and generally must have failed at least one prior standard systemic therapy; the exception will be mantle cell lymphoma (MCL) patients, who may be enrolled while in first complete remission (CR) as well as other select high-risk lymphomas (e.g., Burkitt’s, double hit diffuse large B-cell lymphoma [DLBCL], transformed indolent B-cell non-Hodgkin lymphoma [B-NHL], etc.) in accordance with current transplant standard of care for these patients
Patients must have newly diagnosed, previously untreated diffuse large B-cell lymphoma, mantle cell lymphoma, grade 3B follicular lymphoma, Burkitt lymphoma, peripheral T cell lymphoma not otherwise specified (NOS), natural killer (NK)/T cell lymphoma, or transformed lymphoma
Diffuse large B-cell lymphoma, follicular large cell lymphoma, mantle cell lymphoma, anaplastic large cell lymphoma\r\n* Primary refractory disease\r\n* Relapse/progression after autologous HSCT\r\n* Non-CR after salvage regimen
Previously untreated primary mediastinal diffuse large B-cell lymphoma, CD20 positive.
Patients must have a histologically confirmed diagnosis of aggressive B-cell lymphoma (diffuse large B-cell lymphoma [DLBCL], Burkitt lymphoma [BL], etc.) expressing the CD20 antigen and have failed at least one prior standard systemic therapy
(Monotherapy - Parts A, B, C, D, G, H, J, and K) -- Histologically confirmed advanced malignancy, either: (a) Metastatic or unresectable solid malignancy; or (b) Classical Hodgkin lymphoma (HL), or diffuse large B-cell lymphoma (DLBCL), or indolent lymphoma (including follicular lymphoma [FL])
Aggressive non-Hodgkin lymphoma as follows, provided there is stable disease or better to last therapy:\r\n* Natural killer (NK) or NK-T cell lymphoma, peripheral T-cell lymphoma (including angioimmunoblastic T-cell lymphoma, hepatosplenic T-cell lymphoma, subcutaneous panniculitic T-cell lymphoma, and other variants), T-cell prolymphocytic leukemia, or blastic/blastoid variant of mantle cell lymphoma; or\r\n* Hodgkin or aggressive non-Hodgkin lymphoma that has failed at least one multiagent regimen, and the patient is either ineligible for autologous BMT or autologous BMT is not recommended; eligible subtypes of aggressive non-Hodgkin lymphoma include: mantle cell lymphoma; follicular grade 3 lymphoma; diffuse large B-cell lymphoma or its subtypes, excluding primary central nervous system (CNS) lymphoma; primary mediastinal large B-cell lymphoma; large B-cell lymphoma, unspecified; anaplastic large cell lymphoma, excluding skin-only disease; Burkitt’s lymphoma or atypical Burkitt’s lymphoma (high-grade B-cell lymphoma, unclassifiable, with features intermediate between diffuse large B-cell lymphoma and Burkitt’s), in complete remission
Have histologically confirmed Diffuse Large B Cell Lymphoma that is either:
History of lymphoid malignancy other than FL (eg, diffuse large B-cell lymphoma)
Documented history of immunohistochemistry (IHC)-confirmed CD20-positive (with no subsequent history of CD20-negativity) B-cell, NHL, including diffuse large B cell (DLBCL), mantle cell, marginal zone, lymphoplasmacytic, follicular, transformed follicular, or primary mediastinal B cell lymphoma
Men and women with recurrent surface immunoglobulin positive B cell non-Hodgkin's lymphoma (NHL) according to WHO classification (including, but not limited to, CLL/SLL, Waldenström's macroglobulinemia [WM], mantle cell lymphoma [MCL], and diffuse large B cell lymphoma [DLBCL) who have met requirements for roll over from their parent protocol and want to continue study drug.
Patients must have a histopathologically confirmed diagnosis of diffuse large B-cell lymphoma (DBLCL) or primary mediastinal large B-cell lymphoma
Confirmation of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma of the following histology at relapse: diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS; de novo or transformed follicular lymphoma [tFL]), high-grade B-cell lymphoma with MYC and BCL2 and/or BCL6 rearrangements with DLBCL histology (double/triple hit lymphoma [DHL/THL]), and follicular lymphoma Grade 3B per WHO 2016 classification
COHORT 1: patients undergoing high dose chemotherapy with autologous stem cell rescue and “high-risk” disease as defined below:\r\n* Diffuse large cell lymphoma or peripheral T cell lymphoma (including specified World Health Organization [WHO] subtypes) not in computed tomography (CT)-positron emission tomography (PET) complete remission at time of high dose therapy\r\n* Diffuse large cell lymphoma with “double hit” or “double expressor” features\r\n* Diffuse large cell lymphoma or peripheral T cell lymphoma (including WHO specified subtypes) refractory to standard induction therapy OR relapsing within 1 year of treatment OR in greater that second complete remission (CR)\r\n* Mantle cell lymphoma not in CR1\r\n* Multiple myeloma with ONE (or more) of the following high risk features:\r\n** Less than very good partial remission at time of high dose therapy \r\n** High Revised-International Staging System (R-ISS) (stage III – 2 microglobulin >= 5.5 plus lactate dehydrogenase [LDH] > upper limit of normal [ULN] and/or del17p, t(4;14), t(14;16)) at time of diagnosis\r\n** Cytogenetics or fluorescent in situ hybridization (FISH) del17p
Known current or previous histologic transformation from indolent non-Hodgkin lymphoma to diffuse large B-cell lymphoma or other aggressive lymphoma histology.
Relapsed or refractory primary central nervous system (CNS) diffuse large B cell lymphoma (PCNSDLBCL) with a CNS lesion, with cerebrospinal fluid (CSF) relapse with positive CSF cytology, or with ocular relapse with positive ocular tissue biopsy; NOTE: tissue biopsy is not absolutely necessary for CNS tumor unless clinical and radiologic findings strongly suggest other etiologies as per treating physician; initial diagnosis must be made by tissue biopsy; NOTE: patients with B-cell lymphoma with features intermediate between diffuse large B-cell lymphoma and Burkitt lymphoma are also eligible for the protocol as long as they meet other criteria; patients with typical Burkitt lymphoma are not eligible
Subjects must have histologically confirmed relapsed or refractory non-Hodgkin lymphoma that is not a candidate for standard curative therapy; non-Hodgkin lymphoma (NHL) subtypes include: diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, plasmablastic lymphomas, peripheral T-cell lymphomas, and follicular lymphoma of any grade; cutaneous T-cell and B-cell lymphomas will also be eligible in the dose-escalation phase only
Patients must have histologically or cytologically confirmed primary central nervous system diffuse large B-cell lymphoma; only patients with relapsed or refractory disease are eligible; patients with PCNSL that is only extracranial will not be eligible
Follicular lymphoma with large cell transformation
Biopsy proven lymphoma for which rituximab, etoposide, prednisone, vincristine sulfate, cyclophosphamide, and doxorubicin hydrochloride (R-EPOCH) is appropriate frontline therapy, e.g., Burkitt lymphoma or diffuse large B-cell lymphoma (DLBCL) NHL, including plasmablastic lymphoma and primary effusion lymphoma but not T-cell lymphoma; tissue histology will be reviewed at the treating institution
Patients must have histologically or cytologically confirmed Hodgkin lymphoma, Burkitt’s lymphoma, double-hit lymphoma, other c-Myc positive B-cell lymphoma, diffuse large-B cell lymphoma including those patients with history of transformed follicular lymphoma, mantle cell lymphoma, or peripheral T-cell lymphoma
Patient with newly diagnosed, histologically confirmed, group B or C Burkitt lymphoma or leukemia (acute lymphoblastic leukemia, L3 subtype); diffuse large B-cell lymphoma; or primary mediastinal B-cell lymphoma; patients with group B/C post transplant lymphoproliferative disorder are eligible for the study regardless of whether disease is newly diagnosed
Patients with relapsed diffuse large B-cell lymphoma (DLBCL) or HL that have achieved a positron emission tomography (PET)-negative CR following first salvage chemotherapy
Participants with histologically or cytologically documented diffuse large B-cell lymphoma (DLBCL) must meet at least 1 of the following risk criteria:\r\n* Age-adjusted International Prognostic Index (IPI) score: 2-3 \r\n* Ki-67 >= 80%\r\n* Histologically, or cytologically documented activated B-cell-like (ABC, also known as post-GCB) subtype \r\n* Double hit variant, defined as having v-myc avian myelocytomatosis viral oncogene homolog (MYC) gene rearrangement in the presence of B-cell chronic lymphocytic leukemia (CLL)/lymphoma (BCL) 2 or BCL6 gene rearrangement \r\n** Other aggressive non-DLBCL non-Burkitt non-Hodgkin B-cell lymphoma variants as defined by the 2008 World Health Organization (WHO) classification, including rare CD20 negative B-cell lymphomas (i.e. plasmablastic lymphoma, and primary effusion lymphoma) are also eligible; grade 3B follicular lymphoma is also eligible as long as one the above risk criteria is met
Diagnosis of non-Hodgkin’s lymphoma, transformed B-cell lymphoma, follicular lymphoma, mantle cell lymphoma, diffuse large B-cell or T-cell lymphoma, and deemed a candidate for autologous transplant
Histologically proven Diffuse Large B-Cell Lymphoma of the Activated B-Cell type
Newly diagnosed, previously untreated Diffuse Large B-Cell Lymphoma
Diagnosis of lymphoma histologies other than Diffuse Large B-Cell Lymphoma
History of malignancies, other than Diffuse Large B-Cell Lymphoma, unless the patient has been disease free for 5 years or more
Patients must have biopsy-proven de-novo diffuse large B-cell lymphoma (DLBCL) \r\n* Patients with primary mediastinal lymphoma or testicular lymphoma are not eligible\r\n* Patients with prior or simultaneous diagnosis of indolent lymphoma are not eligible\r\n* Post-transplant lymphoproliferative disorder with DLBCL morphology is ineligible
Diagnosis of relapsed or refractory primary mediastinal large B-cell lymphoma AND
Relapsed/refractory diffuse large B cell lymphoma (DLBCL), relapsed/refractory peripheral T cell lymphoma (PTCL) (all subtypes excluding anaplastic large cell lymphoma), relapsed/refractory Cutaneous T cell lymphoma (CTCL) mycosis fungoides/sezary syndrome (MF/SS), relapsed/refractory primary mediastinal B lymphoma (PMBL), and relapsed/refractory mediastinal gray zone lymphoma (MGZL)
Phase 1 (Cohort T2): Participants with diffuse large B-cell lymphoma (DLBCL), regardless of PIK3CA mutation status
Has confirmed diagnosis of relapse or refractory Multiple Myeloma (enrollment completed), Primary mediastinal Large B cell Lymphoma, non-Hodgkin lymphoma (NHL), Follicular Lymphoma, Diffuse Large B cell lymphoma (enrollment discontinued), Hodgkin lymphoma or Myelodysplastic syndrome (enrollment completed).
Has histologically confirmed diffuse large B-cell lymphoma (DLBCL), primary mediastinal B-cell lymphoma (PMBCL), marginal zone lymphoma (MZL), mantle cell lymphoma (MCL) or histologically and/or cytologically confirmed advanced or metastatic solid tumor and have relapsed or refractory disease following at least two lines of prior standard therapy, including alkylator/anthracycline (unless anthracycline-based chemotherapy is contraindicated)/anti-CD20-based therapy (R-CHOP; rituximab, doxorubicin, cyclophosphamide, vincristine, and prednisolone or prednisone, or equivalent) AND must be considered unable to benefit from intensification treatment with autologous hematopoietic stem cell transplantation (ASCT), as defined by meeting at least one of the following criteria:
Patients must have Burkitt lymphoma; effective with Amendment J (version date: 06/24/2014), the following histologies were removed: B-cell lymphoma: unclassifiable with features intermediate between diffuse large B–cell lymphoma and Burkitt lymphoma; c-MYC + DLBCL and c-MYC+ plasmablastic lymphoma\r\n* If questions arise related to diagnosis, please contact the National Cancer Institute (NCI) principle investigator, Dr. Mark Roschewski or the NCI study coordinator, A. Nicole Lucas
Primary mediastinal (thymic) large B-cell lymphoma.
History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL)
Histologically proven diffuse large B-cell non-Hodgkin's lymphoma
Follicular lymphoma with evidence of diffuse large B-cell transformation
Patient has histologically confirmed diagnosis of diffuse large B cell lymphoma or follicular lymphoma harboring mutations in CREB binding protein (CREBBP) or E1A binding protein p300 (EP300) with relapsed or refractory disease
Patients with either diffuse large B cell lymphoma or follicular lymphoma will be allowed to enroll after receiving only 1 prior therapy if they are felt to not be a candidate for further systemic chemotherapy
Patients who have undergone high-dose therapy and autologous PBSCT for treatment of CD20+; NOTE: Based on historical experience of the Indiana University (IU) Bone Marrow and Stem Cell Transplantation Program, it is expected that the vast majority of patients will have been transplanted for diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, or mantle cell lymphoma; however, any patient transplanted for CD20+ lymphoma will be considered potentially eligible
Part II: Subjects must have relapsed or refractory aggressive B cell NHL including follicular lymphoma (FL) grade 3, diffuse large B cell lymphoma (DLBCL), transformed NHL, mantle cell lymphoma (MCL), or other aggressive B cell NHL histology as per the World Health Organization (WHO) 2008 criteria
Primary mediastinal (thymic) large B-cell lymphoma.
Histologically confirmed diagnosis with review of the diagnostic pathology specimen at one of the participating institutions; eligible histologies are:\r\n* For Arm A: diffuse large B cell lymphoma; patients with a prior history of indolent B-cell non-Hodgkin lymphoma (NHL) are eligible, as long as they have histologically confirmed diffuse large B cell lymphoma (DLBCL) prior to their pretransplant salvage treatment; patients with mediastinal large B cell lymphoma are also eligible\r\n* For Arm B: classical Hodgkin lymphoma (patients with nodular lymphocyte predominant Hodgkin lymphoma [NLPHL] are NOT eligible)\r\nFor Arm C: peripheral T cell lymphoma – eligible subtypes will include peripheral T-cell lymphoma (PTCL), not otherwise specified (NOS); angioimmunoblastic T cell lymphoma (AITL); ALK-negative anaplastic large cell lymphoma (ALCL); enteropathy-associated T-cell lymphoma (EATL) and monomorphic epitheliotropic intestinal T-cell lymphoma (MEITL); and extranodal NK/T-cell lymphoma (ENKTL); patients with other PTCL histologies, including ALK-positive PTCL, and cutaneous T-cell lymphoma will not be eligible
CD20+Diffuse Large B-Cell Lymphoma.
Diagnosis of lymphoma other than Diffuse Large B-Cell Lymphoma.
Patient has histologically confirmed diagnosis of R/R mantle cell lymphoma, follicular lymphoma or diffuse large B cell lymphoma\r\n* Diffuse large B cell lymphoma patients has received at least 1 prior regimen and received, declined, or is ineligible for autologous or allogeneic stem cell transplant\r\n* Follicular lymphoma patients have received at least 2 lines of therapy\r\n* Mantle cell lymphoma patients has received at least 1 line of therapy\r\n* Allogeneic stem cell transplant recipients be greater than 6 months post transplant, not on immunosuppression for prevention of graft versus host disease for > 3 months and without active graft versus host disease are eligible\r\n* Autologous stem cell transplant recipients must have adequate bone marrow recovery and transfusion independent\r\n* Transformed histologies are permitted
Confirmed treatment-naive de novo cluster of differentiation (CD)20 positive (+) diffuse large B cell lymphoma (DLBCL), regardless of cell of origin, with stage II-IV disease, or stage I disease if 6 cycles of chemotherapy are planned
Phase 1 and Phase 2: confirmed diagnosis of previously treated relapsed and/or refractory mantle cell lymphoma, diffuse large B-cell lymphoma and/or transformed large cell lymphoma (TLCL)
Pathologically documented relapsed or refractory diffuse large B-cell lymphoma (DLBCL) or follicular lymphoma (FL)
Known central nervous system (CNS) disease (NHL, diffuse large B cell lymphoma [DLBCL])
Research participants enrolled are patients with an indication to be considered for HSCT, who are diagnosed with intermediate or high grade B-cell non-Hodgkin lymphoma (NHL) (e.g. diffuse large B-cell lymphoma [DLBCL], mantle cell lymphoma [MCL], or transformed NHL), and that have either (1) recurrence/progression following prior therapy, or (2) verification of high-risk disease in first or subsequent remission
Patients must have histologically confirmed B-cell NHL; acceptable subtypes of B-cell NHL include follicular lymphoma (grades 1, 2, or 3a), marginal zone lymphoma, or lymphoplasmacytic lymphoma/Waldenstrom‘s macroglobulinemia; patients with mantle cell lymphoma must have a documented t(11;14) or overexpression of cyclin D1 by immunohistochemical evaluation; patients with diffuse large B cell lymphoma must have activated B cell subtype as defined by the Hans criteria; however, patients with a history of large cell transformation are eligible provided that there is no current clinical evidence of active transformed lymphoma
Exploratory Cohort: Patients with histologically confirmed relapsed or refractory germinal center (GC)-derived B-Cell lymphoma (diffuse large B-cell [DLBCL] and follicular lymphoma [FL]) defined by the WHO and Hans criteria with no accepted curative options
Histologically confirmed B-cell non-Hodgkin’s lymphoma (NHL) of any of the following subtypes recognized by the World Health Organization (WHO) classification: diffuse large B-cell lymphoma, mantle cell lymphoma, marginal zone lymphoma, lymphoplasmacytic lymphoma, or follicular lymphoma; patients with evidence of histological transformation to diffuse large B-cell lymphoma from indolent NHL are eligible
Curative therapy must have been exhausted or not feasible to administer; patients with diffuse large B-cell lymphoma, germinal center subtype should only enroll on the study if there are no other potentially effective therapeutic options
No prior treatment for diffuse B-cell lymphoma (DLBCL)
Participants must have histologically confirmed Hodgkin lymphoma or non-Hodgkin lymphoma, (including, but not limited to, diffuse large B-cell lymphoma [DLBCL] or primary mediastinal B-cell lymphoma [PMBCL], Ann Arbor stage I-II disease, or stage III-IV disease with a dominant presenting mass within the mediastinum); pathology must be reviewed and confirmed at Massachusetts General Hospital (MGH) or other Dana-Farber (DF)/Harvard Cancer Center (HCC) institution
Patients must have previously treated relapsed and/or refractory MCL, follicular lymphoma grade 1-3, marginal zone lymphoma, or non-germinal center B-cell diffuse large B-cell lymphoma with 1-4 prior lines of therapy; (prior anthracycline, rituximab or stem cell transplant [autologous (auto) or allogeneic (allo)] are acceptable)
Histologically confirmed diagnosis of grade 3b follicular lymphoma (FL), transformed indolent lymphoma, diffuse large B-cell lymphoma (DLBCL), mediastinal large B-cell lymphoma, mantle cell lymphoma (MCL), peripheral T-cell lymphoma unspecified, or anaplastic large cell lymphoma primary systemic type, or angioimmunoblastic T cell lymphoma.
Subject (non-diffuse large B-cell lymphoma) must have relapsed or refractory non-Hodgkin's lymphoma, and require treatment in the opinion of the investigator.
Subject has refractory diffuse large B-cell lymphoma, defined as meeting any of the following criteria:
Diagnosis of refractory or relapsed biopsy-proven CD20+ diffuse large B-cell lymphoma or primary mediastinal B-cell lymphoma
Histologically or cytologically proven B-cell malignancies, either Burkitt lymphoma or B-AL (=Burkitt leukaemia = L3-AL) or diffuse large B-cell NHL or aggressive mature B-cell NHL non other specified or specifiable.
Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell lymphoma
The following disease types are eligible: transformed lymphomas: diffuse large B cell lymphoma, mantle cell lymphoma, follicular lymphoma grade III; precursor B lymphoblastic leukemia/lymphoma; mediastinal (thymic) large B-cell lymphoma; Burkitt lymphoma/leukemia; precursor T-lymphoblastic leukemia/lymphoma; primary cutaneous anaplastic large cell lymphoma; anaplastic large cell lymphoma – primary systemic type; small lymphocytic lymphoma/chronic lymphocytic leukemia; follicular lymphoma, grades 1, 2; extranodal marginal zone B-cell lymphoma of mucosa-associated lymphatic tissue (MALT) type; nodal marginal zone B-cell lymphoma; splenic marginal zone B-cell lymphoma; peripheral T cell lymphoma, unspecified; anaplastic large cell lymphoma (T and null cell type); lymphoplasmacytic lymphoma (Waldenstrom Macroglobulinemia); CNS lymphoma; post transplant lymphoproliferative disorders; mycosis fungoides/Sezary syndrome; primary effusion lymphoma; blastic natural killer (NK)-cell lymphoma; adult T-cell leukemia/lymphoma; extranodal NK/T-cell lymphoma, nasal type; enteropathy-type T-cell lymphoma; hepatosplenic T-cell lymphoma; subcutaneous panniculitis-like T-cell lymphoma; angioimmunoblastic T-cell lymphoma; anaplastic large cell lymphoma – primary cutaneous type; T-cell prolymphocytic lymphoma
Histologic documentation of diffuse large B-cell lymphoma, or any of its variants as defined in the World Health Organization (WHO) classification, including but not limited to any of the following:\r\n* Diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS)\r\n* Primary mediastinal DLBCL\r\n* T cell/histiocyte-rich large B-cell lymphoma
Central nervous system lymphoma or prior diffuse large B-cell lymphoma (DLBCL), histological evidence of transformation to high grade or diffuse large B-cell lymphoma
Patient must have a CD19-expressing B cell lymphoma; patients with diffuse large B-cell lymphoma, primary mediastinal B-cell lymphoma, and diffuse large B-cell lymphoma transformed from follicular lymphoma must have measurable disease after at least two prior chemotherapy regimens one of which must have contained doxorubicin and rituximab
Diffuse large B-cell lymphoma, follicular large cell lymphoma, peripheral T-cell lymphoma, mantle cell lymphoma, anaplastic large cell lymphoma\r\n* Primary refractory disease\r\n* Relapse/progression after autologous HSCT after autologous HSCT\r\n* Stable disease or better response to last therapy
Histologically or cytologically documented newly diagnosed (stages II, III or IV) Myc-positive diffuse large B-cell lymphoma (DLBCL), transformed follicular lymphoma, or high-grade unclassifiable with features intermediate between DLBCL and Burkitt lymphoma (per the 2008 World Health Organization [WHO] classification of lymphoid neoplasm) OR histologically or cytologically-documented newly diagnosed (stages II, III or IV) DLBCL not otherwise specified (NOS) or high-grade B-cell lymphoma with Myc and B-cell lymphoma 2 (Bcl2) and/or B-cell lymphoma 6 (Bcl6) (per the 2016 revision of the WHO classification of lymphoid neoplasms)
Treatment-naive patients with systemic de novo or transformed diffuse large B cell lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade 3b
Diffuse Large B Cell Lymphoma (DLBCL)
Primary Mediastinal Large B Cell Lymphoma (PMBCL)
Relapsed/refractory diffuse large B cell lymphoma (DLBCL) is allowed if the patient is not eligible for, or refuses, hematopoietic stem cell transplant
Metastatic renal cell carcinoma, mantle cell lymphoma, or diffuse large B-cell lymphoma including Grade 3b follicular lymphoma
Diagnosis of mantle or diffuse large-cell lymphoma, Grade 3B follicular lymphoma [Harris, Swerdlow et al. 2008] or gastric mucosa-associated lymphoid tissue (MALT) lymphoma
Evidence of transformation to a high grade or diffuse large B-cell lymphoma
Known histological transformation from iNHL to diffuse large B-cell lymphoma.
Diagnosis of Primary Mediastinal Large B-cell Lymphoma
Group 3: Individuals with lymphoma are limited to diffuse large B-cell lymphoma and peripheral T-cell lymphoma that are refractory to or intolerant of standard therapy or for which no standard therapy is available
Patients with mantle cell lymphoma, T-cell lymphoma, and diffuse large B-cell lymphoma within 6 months post autologous transplantation and without relapse
Patients must have histologically proven relapsed or refractory B-cell NHL of the following World Health Organization (WHO) classification subtypes: follicular lymphoma (FL), mantle cell lymphoma (MCL), lymphoplasmacytic lymphoma/Waldenström’s macroglobulinemia (LPL/WM), marginal zone lymphoma (MZL), diffuse large B-cell lymphoma (DLBCL), Burkitt’s lymphoma (BL), and B-cell lymphoma with features unclassifiable between Burkitt’s and large cell lymphoma; alternatively, patients with histologically proven, newly diagnosed transformed non-Hodgkin’s lymphoma (tNHL) are eligible
Patient has a histologically confirmed diagnosis of mantle cell lymphoma, follicular lymphoma, or diffuse large B cell lymphoma.
Patients must have biopsy confirmed, cluster of differentiation (CD)20 positive diffuse large B-cell lymphoma, mantel cell, high grade-B-cell or anaplastic large B cell non-Hodgkin lymphoma (NHL); AND bone marrow must show =< 20% CD20+ B-cells with >= 15% cellularity within 42 days of study registration
Untreated, histological diagnosis of CD20-positive diffuse large B-cell lymphoma
Histologically confirmed relapsed or refractory CD20+ DLBCL, transformed indolent lymphoma (follicular or other), or primary mediastinal large B-cell lymphoma;
PHASE II: Histological confirmation of transformation of FL lymphoma to diffuse large B cell lymphoma or aggressive lymphoma
Histologically documented PCNSL or histologically documented systemic diffuse large B-cell lymphoma (DLBCL)
Subjects with a diagnosis of lymphoma falling into the following categories:\r\n* Diffuse large B-cell lymphoma (DLBCL) who have received 1 cycle of anthracycline-based chemotherapy\r\n* DLBCL in complete remission and within 12 months after completion of anthracycline-based chemotherapy\r\n* Chronic lymphocytic leukemia (CLL) or mantle cell lymphoma (MCL) receiving ibrutinib for at least 1 month\r\n* Follicular lymphoma (FL) in remission and on surveillance for 6 or more months\r\n* Aggressive peripheral T-cell lymphoma (PTCL) who have received 1 cycle of chemotherapy
Patients with aggressive non-Hodgkin’s lymphoma (NHL), including diffuse large cell lymphoma, mediastinal B-cell lymphoma, transformed lymphoma, mantle cell lymphoma, and peripheral T cell lymphoma, who also have one of the following criteria:\r\n* Failure to achieve complete remission to primary induction therapy\r\n* Relapsed and refractory to at least one line of salvage systemic therapy\r\n* Failed stem cell collection
Non-Hodgkin lymphoma (NHL) subjects with anaplastic lymphoma kinase (ALK) negative CD30+ anaplastic large-cell lymphomas (ALCL), CD30+ ALCL regardless of ALK status, with chemotherapy-sensitive relapse, CD30+ high-risk diffuse large B-cell lymphoma (DLBCL), CD30+ cutaneous T cell lymphoma, or CD30+ mycosis fungoides who are otherwise eligible for transplant, are eligible for this study
Study 1 - Aggressive lymphoma\r\n* Newly diagnosed de-novo DLBCL or primary mediastinal B-cell lymphoma that will be treated with an anthracycline-containing regimen (rituximab-cyclophosphamide, doxorubicin hydrochloride, prednisone [R-CHOP] or equivalent) \r\n* Patients with composite lymphomas (low grade and large cell; marginal and large cell; nodular lymphocyte predominant [LP] Hodgkin and large cell, etc) at the time of original diagnosis can also be enrolled as long as they have large cell component and will be treated with an anthracycline\r\n* Patients with high-grade B-cell lymphoma with rearrangements of MYC and BCL2 and/or BCL6 (formerly DLBCL with double or triple hit), high-grade B-cell lymphoma, not otherwise specified (NOS), B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma, and post-transplant DLBCL are also eligible as long as they meet other criteria and are receiving RCHOP-based therapy\r\n** NOTE: patients can be enrolled up through day 1 of cycle 3 of therapy; the patient is permitted to participate in any other therapeutic therapy for their disease as long as it does not concern vitamin D; patients can begin their chemotherapy while awaiting vitamin D results and treatment arm assignment or\r\n* Newly diagnosed untreated peripheral T-cell non-Hodgkin lymphoma (NHL) that will be treated with chemotherapy; NOTE: patients can be enrolled up through day 1 of cycle 3 of therapy; this includes the following disease types:\r\n** Peripheral T cell lymphoma, unspecified\r\n** Anaplastic large cell lymphoma (T and null cell type)\r\n** Extranodal NK/T-cell lymphoma, nasal type\r\n** Enteropathy-type T-cell lymphoma\r\n** Hepatosplenic T-cell lymphoma\r\n** Subcutaneous panniculitis-like T-cell lymphoma\r\n** Angioimmunoblastic T-cell lymphoma\r\n** Anaplastic large cell lymphoma – primary cutaneous type and\r\n* Willing to provide tissue for correlative research purposes
Patients who previously had indolent lymphoma and now at a separate episode have large cell NHL (i.e. transformation)
Diffuse large B-cell lymphoma (DLBCL) Not otherwise specified (NOS) including transformed indolent Non-Hodgkin lymphoma (NHL)
T cell/histiocyte-rich large B-cell lymphoma
Primary mediastinal (thymic) large B-cell lymphoma
Diffuse Large B Cell Lymphoma (DLBCL)