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
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 ()
History of transformation of indolent disease to diffuse large B-cell lymphoma (DLBCL)
Anaplastic large cell lymphoma (ALCL), ALK positive
Primary cutaneous type anaplastic large cell lymphoma
Primary mediastinal (thymic) large B-cell lymphoma (PMBL)
. Diffuse Large Cell Lymphoma (NOT primary mediastinal B-cell lymphoma) -. 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
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
Diagnosis of Non-Hodgkin's Lymphoma including Diffuse Large B-cell Lymphoma, Follicular, Small Lymphocytic and Marginal Zone Lymphoma
Histologically or cytologically confirmed relapsed cluster of differentiation (CD)+ non-Hodgkin lymphoma (NHL) (included in this category are follicular grade I, II, III, marginal zone, mantle cell, gray zone, primary mediastinal, Burkitt's, diffuse large B cell, small lymphocytic lymphoma)
Histologically confirmed diagnosis of rel/ref DLBCL, or diffuse large B cell lymphoma transformed from an indolent lymphoma\r\n* Since the endpoint of the phase I portion is safety, any B-cell NHL can be enrolled; however, the progression-free survival (PFS) endpoint varies greatly amongst different types of lymphoma; in order to accurately interpret the survival data, a homogeneous cohort of patients with DLBCL will be evaluated; DLBCL is the most aggressive B-NHL with limited options; other B-NHLs are generally more indolent and have more options available to them
Patient must have known pathologic diagnosis of diffuse large B cell lymphoma (DLBCL), and evidence of persistent disease on PET/CT or CT.
Histologically confirmed NHL: diffuse large B-cell lymphoma and follicular lymphoma (Grade -A) that has progressed following at least line of prior anticancer therapy.
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.
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-CD antibody (i.e. primary refractory), where any disease recurring within 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 lines of therapy (including at least one with an anthracycline and anti-CD 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 : 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 : 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 or more extranodal site\r\n* NOTE: For GZL, diagnosis will be in accordance with the 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 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 CD+ and MUM+
For DLBCL\r\n* Histologically confirmed aggressive B cell non-Hodgkin lymphoma (NHL) including the following types defined by World Health Organization (WHO) : \r\n** DLBCL not otherwise specified; T cell/histiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR \r\n** Primary mediastinal (thymic) large B cell lymphoma \r\n** Transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia to DLBCL will also be included\r\n* Subjects with DLBCL must have progressed, had stable disease (SD), or recurred after initial treatment regimens that include an anthracycline and an anti CD monoclonal antibody; subjects who relapse >= months after therapy should have progressed after autologous transplant or been ineligible for autologous transplant
Phase Part: Patients with pathologically confirmed newly diagnosed diffuse large B cell lymphoma (Ann Arbor stage or ); newly diagnosed double hit and transformed diffuse large B cell lymphoma are allowed
Patients with de novo diffuse large B-cell lymphoma
Must have a diagnosis of a solid tumor (except primary brain tumors), acute myeloid leukemia (AML), or non-Hodgkin lymphoma (NHL); NHL may be of any subtype for Dose Escalation but is limited to diffuse large B-cell lymphoma (DLBCL) for those enrolled to the cohort evaluating the combination of ABBV- and venetoclax. Subjects in the Dose Optimization solid tumor cohorts must have either colorectal cancer with documented KRAS mutations (as determined by local testing), or pancreatic cancer (irrespective of mutational status).
Histologically confirmed diagnosis of CD positive diffuse large B-cell lymphoma (DLBCL) or transformed large cell lymphoma from low grade lymphoma
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 revision of the World Health Organization (WHO) classification of lymphoid neoplasms\r\n* For the purposes of stratification, diagnoses are grouped into categories:\r\n** Category A\r\n*** Burkitt lymphoma\r\n*** Burkitt-like lymphoma with q aberration\r\n*** High-grade B-cell lymphoma, with MYC and BCL and/or BCL 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 IRF 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)-+ DLBCL, NOS\r\n*** B-cell lymphoma, unclassifiable, with features intermediate between DLBCL and classical Hodgkin lymphoma
Primary mediastinal (thymic) large B-cell lymphoma
Participants must have histologically (via at least a core or ideally, incisional or excisional biopsy) documented CD positive or negative diffuse large B-cell lymphoma (DLBCL)
Histologically confirmed B-cell non-Hodgkins 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 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
Phase I or II patients who have received prior dose-adjusted EPOCH for treatment for PEL or KSHV-associated large cell lymphoma
Phase II patients who have received any prior therapy for PEL or KSHV-associated large cell lymphoma
Histologically confirmed diffuse large B-cell lymphoma (DLBCL) or transformed DLBCL
PHASE II: Patients must have histologically confirmed R/R NHL (as defined by World Health Organization [WHO] criteria); in addition, patients with NHL other than diffuse large B cell lymphomas (DLBCL) must have received at least prior therapies; patients with DLBCL will be eligible if there is no available standard therapy
Relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified (NOS); high grade B cell lymphoma with MYC and BCL and/or BCL 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 -A, diffuse large B cell lymphoma, and mantle cell lymphoma by World Health Organization (WHO) classification
Patients with ABC (determined by immunohistochemistry using the Hans algorithm) diffuse large B-cell lymphoma (DLBCL) with primary refractory disease, relapse < months after initial therapy, secondary International Prognostic Index (IPI) > , less than partial response to salvage treatment or exposure to > salvage regimens
Patients with aggressive B cell lymphoma histology, including diffuse large B cell lymphoma (DLBCL) and grade follicular 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
Histologically or cytologically confirmed relapsed cluster of differentiation (CD)+ non-Hodgkin's lymphoma (NHL) (included in this category are follicular grade I, II, III, marginal zone, mantle cell, diffuse large B cell, small lymphocytic lymphoma) for which standard curative therapy does not exist or is no longer effective; this includes patients who have failed or are not eligible for autologous transplants
Previously untreated primary mediastinal diffuse large B-cell lymphoma, CD 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 CD 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])
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 CD-positive (with no subsequent history of CD-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, Waldenstrm'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
COHORT : 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 year of treatment OR in greater that second complete remission (CR)\r\n* Mantle cell lymphoma not in CR\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 microglobulin >= . plus lactate dehydrogenase [LDH] > upper limit of normal [ULN] and/or delp, t(;), t(;)) at time of diagnosis\r\n** Cytogenetics or fluorescent in situ hybridization (FISH) delp
Known current or previous histologic transformation from indolent non-Hodgkin lymphoma to diffuse large B-cell lymphoma or other aggressive lymphoma histology.
DLBCL Phase cohort: De novo or transformed diffuse large B-cell lymphoma (DLBCL), relapsed or refractory to frontline or second line treatment or autologous hematopoietic cell transplantation
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
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
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
Pathologically confirmed diagnosis of relapsed or refractory diffuse large B-cell lymphoma (DLBCL; including de novo and transformed DLBCL) or Grade b follicular lymphoma
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 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
Diagnosis of relapsed/refractory diffuse large B-cell lymphoma (DLBCL) as documented by medical records and with histology based on criteria established by The World Health Organization (WHO):
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 (Cohort T): Participants with diffuse large B-cell lymphoma (DLBCL), regardless of PIKCA 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).
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 EA binding protein p (EP) with relapsed or refractory disease
Patients with either diffuse large B cell lymphoma or follicular lymphoma will be allowed to enroll after receiving only prior therapy if they are felt to not be a candidate for further systemic chemotherapy
Part II: Subjects must have relapsed or refractory aggressive B cell NHL including follicular lymphoma (FL) grade , 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) criteria
Primary mediastinal (thymic) large B-cell lymphoma.
CD+Diffuse Large B-Cell Lymphoma.
Diagnosis of lymphoma other than Diffuse Large B-Cell Lymphoma.
Evidence of diffuse large B-cell transformation
Confirmed treatment-naive de novo cluster of differentiation (CD) positive (+) diffuse large B cell lymphoma (DLBCL), regardless of cell of origin, with stage II-IV disease, or stage I disease if cycles of chemotherapy are planned
Phase and Phase : 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 () recurrence/progression following prior therapy, or () verification of high-risk disease in first or subsequent remission
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-Hodgkins 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)
Patients must have previously treated relapsed and/or refractory MCL, follicular lymphoma grade -, marginal zone lymphoma, or non-germinal center B-cell diffuse large B-cell lymphoma with - prior lines of therapy; (prior anthracycline, rituximab or stem cell transplant [autologous (auto) or allogeneic (allo)] are acceptable)
Histologically confirmed diagnosis of grade b 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:
Male or female participants years or older with diagnosis of mycosis fungoides (MF) or primary cutaneous anaplastic large cell lymphoma (pcALCL)
Diagnosis of refractory or relapsed biopsy-proven CD+ diffuse large B-cell lymphoma or primary mediastinal B-cell lymphoma
Central nervous system lymphoma, leptomeningeal lymphoma, or histological evidence of transformation to a high-grade or diffuse large B-cell 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
Evidence of diffuse large B-cell transformation.
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 CD-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
High-grade transformation from earlier diagnosis of low-grade lymphoma; patients with de novo transformed diffuse large B-cell lymphoma (DLBCL), defined as DLBCL only on lymph node biopsy and a discordant marrow with para-trabecular small cells at first diagnosis of lymphoma, are eligible if adherent to all other selection criteria
Germinal Center B cell Diffuse large B cell lymphoma (GCB-DLBCL) relapsed or refractory to at least one prior regimen (e.g., rituximab, cyclophosphamide, doxorubicin, vincristine, prednisone [R-CHOP]) AND not a candidate for standard salvage regimens or autologous or allogeneic stem cell transplant. Local confirmation of lymphoma subtype (e.g. GCB-DLBCL) is allowed for enrollment but must be confirmed through central laboratory testing.
Treatment-naive patients with systemic de novo or transformed diffuse large B cell lymphoma (DLBCL) or follicular non-Hodgkin lymphoma (NHL) grade b
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
Co-existent diffuse large B-cell lymphoma (Richter's transformation)
Metastatic renal cell carcinoma, mantle cell lymphoma, or diffuse large B-cell lymphoma including Grade b follicular 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 : 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 must have a diagnosis of Diffuse Large B Cell Lymphoma (DLBCL) of non-GCB subtype, established according to the World Health Organization (WHO) criteria that has been tested for the MyD LP mutation.
Patients with mantle cell lymphoma, T-cell lymphoma, and diffuse large B-cell lymphoma within months post autologous transplantation and without relapse
Subjects in Expansion cohorts are restricted to relapsed/refractory diffuse large B-cell lymphoma (DLBCL) or Follicular Lymphoma (FL) subjects who are either relapsed or refractory to prior rituximab or ritxumab-containing chemotherapy regimens
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) 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 =< % CD+ B-cells with >= % cellularity within days of study registration
Untreated, histological diagnosis of CD-positive diffuse large B-cell lymphoma
Treatment-naive CD-positive mature T-cell and NK-cell neoplasms, including systemic anaplastic large 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)
Non-Hodgkin lymphoma (NHL) subjects with anaplastic lymphoma kinase (ALK) negative CD+ anaplastic large-cell lymphomas (ALCL), CD+ ALCL regardless of ALK status, with chemotherapy-sensitive relapse, CD+ high-risk diffuse large B-cell lymphoma (DLBCL), CD+ cutaneous T cell lymphoma, or CD+ mycosis fungoides who are otherwise eligible for transplant, are eligible for this study
Part /Other BCMA positive Hematologic Malignancies cohort: Subject with one of the following lymphomas: Diffuse Large B-cell Lymphoma (DLBCL) or follicular lymphoma (FL) that exhibits positive BCMA expression on tumor cells as determined by a central laboratory using a validated Immunohistochemistry (IHC) assay. Eligible subjects with BCMA positive malignancies must also fulfill the prior treatment requirements as follows: DLBCL: at least prior lines of systemic therapy containing at least one line of chemo-immunotherapy with anti-CD antibody, and either has undergone stem cell transplant or is considered transplant ineligible. FL: at least prior lines of systemic therapy.
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)