Histologically-confirmed B-cell non-Hodgkin’s lymphoma (mantle cell lymphoma, follicular lymphoma, small lymphocytic lymphoma/chronic lymphocytic leukemia, marginal zone lymphoma, diffuse large B-cell lymphoma, and lymphoplasmacytic lymphoma)
Patients must have histologically confirmed transformed diffuse large B-cell lymphoma (DLBCL), including histologic transformation from any indolent lymphoma (e.g. follicular or marginal zone lymphoma); (patients with Richter transformation of chronic lymphocytic leukemia/small lymphocytic lymphoma are excluded)
Biopsy proven aggressive B-cell Non-Hodgkin Lymphoma (B-NHL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), follicular lymphoma Grade 3B, PMBCL, T-cell rich B-cell lymphoma, or DLBCL that represents transformation of indolent non-Hodgkin's Lymphoma (NHL), (including follicular, marginal zone, and lymphoplasmacytoid lymphoma) excluding chronic lymphocytic leukemia or Hodgkin Lymphoma. The following histologies are not eligible:
Diagnosis of follicular lymphoma (FL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia (CLL) (meeting International Workshop on Chronic Lymphocytic Leukemia [IWCLL] Criteria 2008), mantle cell lymphoma (MCL), Waldenstrom's macroglobulinemia (WM), or non-germinal center B-cell lymphoma (GCB) diffuse large B-cell lymphoma (DLBCL) as documented by medical records on WHO criteria
Patients must have histologically confirmed diffuse large B-cell lymphoma (DLBCL); patients with previously diagnosed indolent lymphoma (follicular lymphoma and marginal zone lymphoma but not small lymphocytic lymphoma) who have transformed to DLBCL are eligible only if they have not previously been treated for indolent lymphoma; for the Phase II study, patients must have non-GC DLBCL as determined by Hans Algorithm
Chronic lymphocytic leukemia /small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, lymphoplasmacytic lymphoma or follicular lymphoma that have progressed after at least two different prior therapies; patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant; these patients must be presented at primary care center (PCC) prior to enrollment, given potential competing eligibility on autotransplant protocols
Histologically-confirmed diagnosis of Follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), small lymphocytic lymphoma (SLL), chronic lymphocytic leukemia(CLL), or diffuse large B-cell lymphoma (DLBCL) a. Subjects must have disease that has relapsed or is refractory to 2 or more prior regimens and in need of treatment due to progressive disease
Biopsy confirmed low-grade B-cell lymphoma, including grade 1, 2, or 3A follicular lymphoma, marginal zone lymphoma, small lymphocytic lymphoma, lymphoplasmacytic lymphoma, or indolent mantle cell lymphoma; patients may be newly diagnosed or previously treated
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)19+ 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)
Patients with relapsed/refractory CD19+ non-Hodgkin’s lymphoma of the following subtypes: \r\n* Diffuse large B-cell lymphoma (DLBCL) \r\n* Mantle cell lymphoma (MCL)\r\n* Follicular lymphoma (FL)\r\n* Chronic lymphocytic leukemia and small lymphocytic lymphoma (CLL/SLL)\r\n* Burkitt’s Lymphoma
Patients must have histologically or cytologically confirmed relapsed and/or refractory B-cell lymphoma confirmed by the Laboratory of Pathology, National Cancer Institute (NCI), as follows:\r\n* Aggressive B-cell lymphoma: includes diffuse large B-cell lymphoma (DLBCL) and subtypes, transformed lymphoma, Burkitt lymphoma, as well as high-grade B-cell lymphoma with MYC and/or BCL2 and/or BCL6 rearrangement(s)\r\n* Indolent B-cell lymphoma:\r\n** Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) is excluded\r\n** Mantle cell lymphoma (MCL) is excluded\r\n* NOTE: patients with known active central nervous system (CNS) lymphoma are not eligible
Histologically documented (by history of present illness [HPI] or pathology report) iNHL as defined by follicular lymphoma (FL), marginal zone lymphoma (MZL), lymphoplasmacytic lymphoma/Waldenstrom disease (LPL/WM) and small lymphocytic lymphoma (SLL) or tiNHL as defined by large B cell transformation of any of the above entities including chronic lymphocytic leukemia (CLL)
Histological confirmation of biopsy-proven non-Hodgkin lymphoma, excluding chronic lymphocytic leukemia, primary central nervous system (CNS) lymphoma and Burkitt’s lymphoma; Note: small lymphocytic lymphoma (SLL) is allowed
PHASE I: Histologically confirmed B-cell NHL with any of the following subtypes: DLBCL, mantle cell lymphoma (MCL), FL, marginal zone lymphoma (MZL) and lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia (LL/WM), Burkitt’s lymphoma (BL); patients with histological transformation to DLBCL from indolent lymphoma, primary mediastinal lymphoma and grey zone lymphoma are eligible
Phase I portion of the study: The following types of NHL as documented by medical records and with histology based on criteria established by the World Health Organization (WHO):\r\n* Mantle cell lymphoma (MCL)\r\n* Follicular lymphoma (FL) - grades 1-3a\r\n* Lymphoplasmacytic lymphoma (LPL)\r\n* Marginal zone lymphoma (MZL)\r\n* CLL in Richter’s transformation\r\n* B-cell prolymphocytic leukemia
Relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma, which have progressed within 12 months of achieving a partial or complete remission; patients who had remissions lasting > 12 months, are eligible after at least two prior therapies; patients with bulky disease should be considered for debulking chemotherapy before transplant; patients with refractory disease are eligible, unless bulky disease and an estimated tumor doubling time of less than one month
PART I: Histologically confirmed B-cell NHL with any of the following subtypes: diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), follicular lymphoma (FL), marginal zone lymphoma (MZL) and lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia (LL/WM), Burkitt’s lymphoma (BL); patients with histological transformation to DLBCL from indolent lymphoma, primary mediastinal lymphoma and grey zone lymphoma are eligible
Biopsy-confirmed grade 1 or 2, or 3A follicular lymphoma; mantle cell lymphoma; or marginal zone lymphoma; subjects must have relapsed from or are refractory to prior therapy
Patients with a diagnosis of chronic lymphocytic leukemia (CLL) or other B-cell neoplasms including small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL) and follicular B-cell non-Hodgkin's lymphoma (FL) who have no available approved therapies.
Patients must have histologically confirmed, low-grade B-lymphocyte non-Hodgkin lymphoma (NHL) by the World Health Organization classification:\r\n* Follicular lymphoma grades 1, 2, and 3a\r\n* Marginal zone B-cell lymphoma, including extranodal (mucosa-associated lymphoid tissue [MALT]), nodal and splenic\r\n* Excluding:\r\n** Small lymphocytic lymphoma\r\n** Lymphoplasmacytic lymphoma/Waldenstrom’s macroglobulinemia (WM)
Patients must have a diagnosis of prior treated diffuse large b-cell lymphoma, mantle cell lymphoma, transformed lymphoma, follicular lymphoma (any grade), small lymphocytic lymphoma, marginal zone lymphoma, or Hodgkin lymphoma who do not have curative treatment options
Relapsed chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma which have progressed within 12 months of achieving a partial or complete remission; patients who had remissions lasting > 12 months, are eligible after at least two prior therapies; patients with bulky disease should be considered for debulking chemotherapy before transplant; patients with refractory disease are eligible, unless bulky disease and an estimated tumor doubling time of less than one month
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone b-cell lymphoma or follicular lymphoma are eligible if there was disease progression/relapse within 12 of achieving a partial or complete remission; patients who had remissions lasting > 12 months, are eligible after at least two prior therapies; patients with bulky disease (nodal mass greater than 5 cm) should be considered for de-bulking chemotherapy before transplant
Malignancy criteria:\r\n* Patients with the following malignancies are potentially eligible: any B-cell lymphoma and chronic lymphocytic leukemia (CLL); patients with indolent malignancies that have transformed to diffuse large B-cell lymphoma are eligible\r\n* Clear CD19 expression must be uniformly detected on 75% or more of malignant cells from either bone marrow or a leukemia or lymphoma mass by flow cytometry or immunohistochemistry; these assays must be performed at the National Institutes of Health; it is preferable but not required that the specimen used for CD19 determination comes from a sample that was obtained after the patient’s most recent treatment; if paraffin embedded unstained samples of bone marrow involved with malignancy or a lymphoma mass are available, these can be shipped to the National Institutes of Health (NIH) for CD19 staining; otherwise, new biopsies will need to be performed for determination of CD19 expression\r\n* Diffused large B-cell lymphoma (DLBCL) patients must have received at least two prior chemotherapy-containing regimens at least one of which must have contained doxorubicin and a monoclonal antibody; follicular lymphoma patients must have received at least 2 prior regimens including at least 1 regimen with chemotherapy; all other lymphoma and leukemia patients must have had at least 1 prior chemotherapy-containing regimen; all patients with CLL or small lymphocytic lymphoma must have had prior treatment with ibrutinib or another signal transduction inhibitor\r\n* Patients must have measurable malignancy as defined by at least one of the criteria below\r\n** Lymphoma or leukemia masses that are measurable (minimum 1.5 cm in largest diameter) by computed tomography (CT) scan is required for all diagnoses except CLL; all masses must be less than 10 cm in the largest diameter\r\n** For a lymphoma mass to count as measurable malignancy, it must have abnormally increased metabolic activity when assessed by positron emission tomography (PET) scan\r\n** For CLL and lymphoma with only bone marrow involvement no mass is necessary, but if a mass is not present, bone marrow malignancy must be detectable by flow cytometry in lymphoma and CLL
For an indolent lymphoma histology (follicular lymphoma, small lymphocytic lymphoma [SLL]/chronic lymphocytic leukemia [CLL]) or mantle cell lymphoma, the patient should not have an HLA-matched sibling, who would be an eligible donor, available
Patients with stage I-IV indolent B cell lymphoma, including mucosa-associated lymphoid tissue (MALT) and follicular grade I/II; patients with mantle cell lymphoma will also be included in this study, as mantle cell lymphoma is also radiosensitive, despite it not being an indolent B cell lymphoma; patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) are ineligible
Patients must have a diagnosis of one of the following B-NHL malignancies: chronic lymphocytic leukemia (CLL)/ small lymphocytic lymphoma (SLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), or Waldenstrom macroglobulinemia (WM)/ lymphoplasmacytic lymphoma (LPL); patients with mucosa associated lymphoid tissue (MALT) subtype of MZL may have relapsed or refractory disease after a course of antibiotic therapy; otherwise, patients will not have received standard systemic treatment for their B-NHL before the time of study enrollment; standard systemic therapy is defined by including any of the following agents, representing a comprehensive list of recommended front-line agents used in the treatment of B-NHL: cytotoxic chemotherapies (bendamustine, cyclophosphamide, doxorubicin, vincristine, chlorambucil, cytarabine, gemcitabine, platinum drugs, etoposide); anti-CD20 antibodies (obinutuzumab, ofatumumab, rituximab); lenalidomide; ibritumomab tiuxetan; proteasome inhibitors (bortezomib, carfilzomib); tyrosine kinase inhibitors (ibrutinib, acalabrutinib, idelalisib); alemtuzumab; corticosteroids unless given for an indication other than treating the B-NHL; or other therapy as determined by the principal investigator (PI)\r\n* Disease: CLL/SLL; Criteria for diagnosis: histopathologic or flow cytometric confirmation\r\n* Disease: FL; Criteria for diagnosis: histopathologic confirmation\r\n* Disease: MZL; Criteria for diagnosis: histopathologic confirmation\r\n* Disease: MCL; Criteria for diagnosis: histopathologic confirmation\r\n* Disease: WM/LPL; Criteria for diagnosis: Per World Health Organization (WHO) criteria
A diagnosis of small lymphocytic lymphoma, follicular lymphoma (grades 1-3a), or marginal zone lymphoma
Biopsy-confirmed low-grade B-cell or cutaneous T cell lymphoma; specifically, follicular grade 1, 2, or 3A, marginal zone or small lymphocytic lymphoma, or mycosis fungoides of any initial stage; patients in cohort A must have had no prior systemic therapy and patients in cohort B must be relapsed/refractory after at least one prior systemic therapy
Histologically or cytologically confirmed relapsed cluster of differentiation (CD)20+ 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
Patients with histologically confirmed B-cell NHL including marginal zone lymphoma, follicular lymphoma, or mantle cell lymphoma by WHO criteria.
Marginal zone B-cell lymphoma or follicular lymphoma that has progressed after at least two prior therapies (excluding single agent Rituxan)
Follicular lymphoma, marginal zone B-cell lymphoma, lymphoplasmacytic lymphoma, mantle-cell lymphoma, and indolent T-cell lymphomas: Must have progressed with the most recent remission duration being < 6 months; patients with bulky disease should be considered for debulking chemotherapy before transplant; patients with refractory disease are eligible, unless they have bulky disease and an estimated tumor doubling time of less than one month
Patients must have the following CD19+ B cell leukemia or lymphoma either with relapsed or chemotherapy-refractory disease or with evidence of residual disease following therapy; in all cases, patient’s disease must be confirmed at Memorial Sloan-Kettering Cancer Center (MSKCC)\r\n* Chronic lymphocytic leukemia (CLL): Patients must have a diagnosis of CLL as evidenced by flow cytometry, bone marrow histology, and/or cytogenetics\r\n* Other low grade B-cell neoplasms are eligible for study, such as small lymphocytic lymphoma (SLL), follicular lymphoma, Waldenstrom’s macroglobulinemia, hairy cell leukemia, marginal zone lymphomas, and mantle cell lymphomas
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma or follicular lymphoma are eligible if there was disease progression/relapse within 12 of achieving a partial or complete remission; patients who had remissions lasting > 12 months, are eligible after at least two prior therapies; patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma, which have progressed within 12 months of achieving a partial or complete remission; patients who had remissions lasting > 12 months, are eligible after at least two prior therapies; patients with bulky disease should be considered for debulking chemotherapy before transplant; patients with refractory disease are eligible, unless has bulky disease and an estimated tumor doubling time of less than one month
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma or follicular lymphoma are eligible if there was disease progression/relapse within 12 of achieving a partial or complete remission; patients who had remissions lasting > 12 months, are eligible after at least two prior therapies; patients with bulky disease (nodal mass greater than 5 cm) should be considered for debulking chemotherapy before transplant
103 Biopsy proven B-NHL (biopsy proven at least at primary diagnosis), including DLBCL that represents transformation of indolent NHL (including follicular, marginal zone, and lymphoplasmacytic lymphoma excluding chronic lymphocytic leukemia or Hodgkin Lymphoma), FL, and MCL. Presentations of these histologies with substantial occurrence of malignant cells into the bloodstream (lymphocyte count ? 7 x 10^9/L) including all leukemic presentations are excluded. Subjects with transformation of indolent lymphoma must have received therapy after a diagnosis of transformation that is appropriate for aggressive histology as described in 105. The following histologies are not eligible: Lymphoblastic lymphoma, Burkitt lymphoma. Any histologies not specifically mentioned must be discussed with the medical monitor.
Dose escalation cohort:\r\n* Histologically or flow cytometry confirmed diagnosis of B-CLL/small lymphocytic lymphoma (SLL) according to National Cancer Institute–sponsored Working Group (NCI-WG) 1996 guidelines\r\n* The following types of NHL as documented by medical records and with histology based on criteria established by the World Health Organization (WHO):\r\n** Mantle cell lymphoma (MCL)\r\n** Follicular lymphoma (FL) - grades 1-3a\r\n** Lymphoplasmacytic lymphoma (LPL)\r\n** Marginal zone lymphoma (MZL)\r\n** CLL in Richter’s transformation\r\n** B-cell prolymphocytic leukemia (B-PLL)\r\n** Diffuse large B-cell lymphoma (DLBCL)
Indolent lymphoma Phase 2 cohort: Marginal zone or follicular lymphoma, relapsed or refractory to standard approved therapies
Histologically confirmed previously untreated DLBCL or Grade 3B FL, [double-positive for BCL2 and c-MYC] or transformed lymphoma. Transformed lymphoma from FL or marginal zone lymphoma, but not chronic lymphocytic leukemia (CLL) [Richter Transformation] are allowed as long as no prior anti-lymphoma therapy of any kind has been administered.
Previously untreated, histologically confirmed indolent lymphoma including follicle cell lymphoma, World Health Organization (WHO) classification, grade I or II, and marginal zone lymphoma; bone marrow biopsies as the sole means of diagnosis are not acceptable, but they may be submitted in conjunction with nodal biopsies; fine needle aspirates are not acceptable
Subject who has histologically confirmed and documented B-cell lymphoma (eg, follicular, diffuse large B-cell, mantle cell, small lymphocytic, or Hodgkin lymphoma) and chronic lymphocytic leukemia.
Participants with confirmed mantle cell lymphoma (MCL) or small lymphocytic lymphoma (SLL) Expansion Portion of the Study:
Histologically confirmed marginal zone lymphoma or follicular lymphoma (grade 1, 2 or 3a; CD20+ by flow cytometry or histochemistry).
Histologically confirmed CD20+ follicular lymphoma, grade 1, 2, or 3a or marginal zone lymphoma
Patients with other aggressive B-cell malignancies including, but not limited to: Burkitt lymphoma, transformed chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and transformed marginal zone lymphoma that are not included above in the inclusion criteria
Histologically confirmed diagnosis of follicular lymphoma (FL) grades 1, 2 or 3a, marginal zone lymphoma (including nodal or splenic marginal zone B-cell lymphoma and mucosa-associated lymphoid tissue [MALT] lymphoma), lymphoplasmacytic lymphoma/Waldenström macroglobulinemia, chronic lymphocytic leukemia (CLL).
Subject has been diagnosed with Post-Transplant Lymphoproliferative Disease, Burkitt's lymphoma, Burkitt-like lymphoma, lymphoblastic lymphoma/leukemia, chronic lymphocytic leukemia, small lymphocytic lymphoma or mantle cell lymphoma (MCL).
Patients with the following cluster of differentiation (CD)20+ lymphoid malignancies who are eligible for allogeneic transplantation:\r\n* Relapsed or refractory follicular lymphoma\r\n* Relapsed or refractory or high risk mantle cell lymphoma (hi ki67; blastic)\r\n* Recurrent or refractory marginal zone\r\n* Recurrent or refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma\r\n* Double-hit lymphoma\r\n* Diffuse large B cell lymphoma\r\n* Richter's patients\r\n* Refractory or recurrent Burkitts
Patients must have one of the following relapsed/ refractory lymphoid malignancies: chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL) or B-prolymphocytic leukemia which has been previously treated with a purine analog, and are not candidates for higher priority clinical studies; follicular lymphoma, mantle cell lymphoma, lymphoplasmacytoid lymphoma or marginal zone lymphoma which has been previously treated with autologous or allogeneic stem cell transplantation; T-cell prolymphocytic leukemia, large granular lymphocyte leukemia, mycosis fungoides / Sezary syndrome or peripheral T-cell lymphoma which has been previously treated with at least one line of chemotherapy or monoclonal antibody therapy; T-cell or B-cell acute lymphoblastic leukemia (ALL) which has been previously treated with at least one line of chemotherapy
Indolent lymphoma including Grades 1-3a follicular, small lymphocytic, lymphoplasmacytic, and marginal zone lymphoma; Stages III-IV, or bulky disease, Stage II. Tumor verified CD20+ and CT imaging done at screening verifying disease
Indolent lymphoma including grades 1-3a follicular, small lymphocytic, lymphoplasmacytic, and marginal zone lymphoma; stages III-IV, or bulky disease stage II (i.e. as any single mass > 5 cm in any direction)
CD30 detectable B lineage relapsed refractory NHL including the following histologies: \r\n* Aggressive lymphomas: diffuse large B cell lymphoma, primary mediastinal B cell lymphoma, grey zone lymphomas, high grade B cell lymphomas, and transformed indolent lymphomas\r\n* Indolent lymphoma: follicular lymphoma, marginal zone lymphoma, small lymphocytic lymphoma; indolent lymphoma patients eligible for this trial should have high tumor burden and high risk disease, as defined by:\t\r\n** The Groupe d’Etude des Lymphomes Folliculaires (GELF) criteria\r\n** Intermediate or high risk by Follicular Lymphoma International Prognostic Index (FLIPI) score or elevated lactose dehydrogenase (LDH)/ beta-2 microglobulin (B2M)
Biopsy confirmed low-grade B-cell lymphoma, specifically, follicular grade 1 or 2, or 3A marginal zone or small lymphocytic lymphoma; patients must have relapsed from or are refractory to prior therapy
Clinical evidence of other indolent forms of lymphoma (e.g., marginal zone lymphoma [MZL], small lymphocytic lymphoma [SLL])
Known HIV infection and histologically confirmed B-cell non-Hodgkin lymphoma or B-cell lymphoproliferative disease as follows, as defined by the World Health Organization classification:\r\n* Active B-cell non-Hodgkin lymphoma (cluster of differentiation [CD]20 positive or negative), chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL), or multiple myeloma that has relapsed, progressed, or been refractory to at least one regimen\r\n* Note: Patients with CLL, SLL, or mantle cell lymphoma (MCL) may only be enrolled in Stratum C
Previously treated CLL or other B-cell neoplasm including small lymphocytic lymphoma, hairy cell leukemia, follicular lymphoma, Waldenstrom’s macroglobulinemia, marginal zone lymphomas, mantle cell lymphomas, lymphoplasmacytic lymphoma and diffuse large B-cell lymphoma; patients with composite lymphoma and transformed disease will be included; immunophenotypic (or immunohistochemical) analysis of the malignant lymphocytes should demonstrate that the cells are B-cells
Histological confirmation of biopsy-proven B-cell non-Hodgkin’s lymphoma, excluding chronic lymphocytic leukemia/small lymphocytic lymphoma, primary central nervous system (CNS) lymphoma and Burkitt’s lymphoma
Relapsed/refractory Hodgkin lymphoma or NHL patients (e.g. histologies include: any subtype of Hodgkin lymphoma, chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), any subtype of marginal zone, follicular [grades 1, 2 or 3], diffuse large B-cell lymphoma (DLBCL) [including any morphological variants], transformed lymphoma, mantle cell, lymphoplasmacytic lymphoma and peripheral T-cell lymphoma (PTCL) [but excluding cutaneous T-cell, precursor T-cell or B-cell lymphoma, or Burkitt lymphoma]), who have relapsed or are refractory after receiving a minimum of two prior systemic therapies (i.e., excludes patients who have involved field radiation therapy for limited stage disease); patients who have undergone prior autologous (but not allogeneic) stem cell transplantation are eligible for this study as long as they meet all other required inclusion/exclusion criteria
Non-Hodgkin’s Lymphoma subjects that have received at least one prior treatment (Antibodies and / or chemotherapy); subjects must have one of the following subtypes according to the World Health Organization (WHO)/Revised European American Lymphoma (REAL) Classification(1):\r\n* Follicular lymphoma, diffuse large cell lymphoma, mantle cell lymphoma and small lymphocytic lymphoma / chronic lymphocytic lymphoma
\Indolent lymphoma\ is included, and refers to small lymphocytic lymphoma/B-cell chronic lymphocytic leukemia (SLL/CLL); lymphoplasmacytic lymphoma (with or without Waldenstrom’s macroglobulinemia); hairy cell leukemia; follicular lymphoma (FL) of any grade; marginal zone B-cell lymphoma; or mantle cell lymphoma
Relapsed or refractory NHL including tumor types: Follicular lymphoma (FL), marginal zone lymphoma (MZL)/mucosa-associated lymphoid tissue (MALT), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), chronic lymphocytic leukemia (CLL).
Small lymphocytic, lymphoplasmacytic, marginal zone lymphoma, and follicular lymphoma; Grades 1, 2 and 3a, defined according to World Health organization (WHO) guidelines. [Tefferi, 2008]
Inclusion Criteria:\n\n Each of the following criteria must be met in order for a patient to be considered eligible\n for registration:\n\n - Biopsy proven (with hematopathology review at one of the participating sites to\n confirm correct histology in accordance with World Health Organization) indolent\n lymphoma to include the following diagnoses:\n\n - Grade 1, 2, or 3a follicular lymphoma\n\n - Small lymphocytic lymphoma (CLL excluded)\n\n - Marginal zone lymphoma (nodal or splenic)\n\n - Mucosal-associated lymphoid tissue\n\n - Measurable disease defined by Lugano criteria\n\n - No prior anti-lymphoma systemic therapy; prior radiation therapy allowed\n\n - Age 18 or over\n\n - Ann Arbor stages II, III or IV\n\n - Patients with follicular lymphoma must have PET FDG-avid lymphoma and fulfill Low\n tumor burden by Groupe D'Etude des Lymphomes Folliculaires (GELF) criteria:\n\n - No mass > 7 cm\n\n - < 3 distinct masses of greater than 3 cm\n\n - No B symptoms\n\n - No splenomegaly > 16 cm by computed tomography (CT) scan\n\n - No risk of vital organ compression\n\n - No leukemic phase > 5000/µl circulating lymphocytes (except for in patients with\n splenic marginal zone diagnosis)\n\n - No cytopenias (platelets < 100,000/µl, hemoglobin < 10 g/dl, or absolute\n neutrophil count < 1500/µl)\n\n Exclusion Criteria:\n\n The following criteria will prevent inclusion of an inappropriate subject into the trial:\n\n - Osteoporosis requiring prescription treatment\n\n - Known symptomatic primary hyperparathyroidism\n\n - Hypercalcemia defined as above the institutional normal range (corrected for albumin\n when albumin levels are below normal)\n\n - History of calcium-related kidney stones\n\n - Creatinine > 1.5X above upper limit of normal\n\n - Women who are known to be pregnant or who plan to become pregnant while on rituximab\n treatment
Confirmed diagnosis of B-cell Non-Hodgkin's lymphoma limited to follicular lymphoma (FL), diffuse large B-cell lymphoma (DLBCL), mantle cell lymphoma (MCL), marginal zone lymphoma (MZL), primary mediastinal B-cell lymphoma (PMBL), or chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) that has progressed and for which standard curative measures do not exist or are no longer effective. Prior therapy must have included a rituximab-based regimen.
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-Cell lymphoma, follicular lymphoma, which have progressed within 12 months of achieving a partial or complete remission; patients who had remissions lasting > 12 months, are eligible after at least two prior therapies; patients with bulky disease should be considered for debulking chemotherapy before transplant; patients with refractory disease are eligible, unless has bulky disease and an estimated tumor doubling time of less than one month
Subjects with chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B cell, Hodgkin's lymphoma, or mantle cell lymphoma must have chemosensitive disease at time of transplant.
Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B-cell, Hodgkin lymphoma, or mantle cell lymphoma with chemosensitive disease at time of transplantation; all types of lymphoma are eligible
Chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), marginal zone B-cell lymphoma, follicular lymphoma, which have progressed within 12 months of achieving a partial or complete remission; patients who had remissions lasting > 12 months are eligible after at least two prior therapies; patients with bulky disease should be considered for debulking chemotherapy before transplant; patients with refractory disease are eligible, unless has bulky disease and an estimated tumor doubling time of less than one month
Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma; follicular, marginal zone, diffuse large B-cell or mantle cell lymphoma with chemo-sensitive disease at time of transplant
Patients with chronic lymphocytic leukemia/small lymphocytic lymphoma, follicular, marginal zone, diffuse large B-cell, Hodgkin's Lymphoma,or mantle cell lymphoma with chemosensitive disease at time of transplantation