[c09aa8]: / clusters / 9knumclustersv2 / clust_2190.txt

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Criteria for Solid Tumor Expansion and Lymphoma Cohorts:\r\n* Inclusion and exclusion criteria for this cohort are the same as above, with the following rule for CD count based on tolerability in Phase I; if, participants with lymphocyte T CD count between -/mm^ (Stratum ) are shown to tolerate treatment in the Phase I dose de-escalation portion at the same dose level as those with CD counts > /mm^ (Stratum ), participants in the expansion cohort with CD counts >= /mm^ are permitted; otherwise, the expansion is open to all solid tumor patients except those whose tumors are known not to respond to nivolumab (pancreas, prostate and MSS colon cancer); for the relapsed refractory HIV-cHL cohort, participants with CD count >= /mm^ are permitted
CD count >= cells/ul
HIV positive with CD count < cells/microliter within days prior to registration
Patients who have BCR-ABL fusion transcript determined by fluorescence in situ hybridization (FISH) or real time-polymerase chain reaction (RT-PCR) or t(;)(q;q) by cytogenetics are not eligible and should be considered for enrollment on studies that incorporate imatinib during induction; please note: patients must also be assessed for CD positivity and other markers; positivity for CD and CD is defined as baseline expression of the CD or CD antigen in more than % of leukemic cells using local multiparameter flow-cytometric immunophenotyping with the use of CD expression as a marker to gate the ALL blast population, according to recommendations from the European LeukemiaNet
Participants must have a CD count performed within days of enrollment
ELIGIBILITY CRITERIA - PHASE II (ARM D): Patient cannot have poorly controlled HIV, or CD < ; HIV positive patients are allowed on this study if they have a CD count >= , and are on a stable antiviral regimen
Dose Expansion Cohort # - Patients will have relapse of CD+ BPDCN. Patients with prior CD-targeting agents will be allowed as long as the blasts still have detectable CD expression.
Histologically documented CD-positive lymphoma
Known CD-negative status at relapse or progression
Clinical and phenotypic verification of B cell CLL/ SLL/ or monoclonal B-cell lymphocytosis (MBL) and measurable disease; immunophenotyping of the leukemic cells (blood, lymph node, or bone marrow) must demonstrate a monoclonal (kappa or lambda light chain restricted) B cell population with immunophenotype diagnostic for CLL (e.g.: co-expressing CD and CD)
Histologically documented CD-positive B-cell lymphoma as determined by the local laboratory
Known CD-negative status at relapse or progression
ADJUVANT COHORT: Derived benefit from PD in the neoadjuvant setting in this trial; this includes the patients who achieved complete cell cycle arrest only after the addition of PD (CD Ki > .% and CD Ki =< .%) from the main study (PIKCA WT, mutant, or unknown cohorts) as well as any patients who have a Ki =< % on CD biopsy in the endocrine resistant cohort
Patient with C-kit (CD) positive tumour detected immuno-histochemically
Obtained within days prior to CD: HCV NA analysis negative
>= % of CD-positivity by immunohistochemistry confirmed by hematopathology review at the participating institution
Known CD-negative status at relapse or progression
Residual disease at the time of transplant or post-transplant relapse is defined as polymerase chain reaction (PCR) positivity, specific cytogenetic abnormalities, an abnormal population on flow cytometry, or increased blasts on bone marrow biopsy or in the peripheral blood; minimal residual disease (MRD) will be defined as detection in blood or marrow of any of the following:\r\n* Any leukemia-specific marker (such as t(;); t(;) or t(;)) documented in the patients leukemia cells pre-transplant on a post-transplant evaluation\r\n* A leukemia-specific phenotype (e.g. expression of markers including CD and/or CD or CD and/or CD or CD) post-transplant at a level of ? .%\r\n* Mixed donor chimerism (> %)
Presence of lymphadenopathy and/or splenomegaly with histopathological evaluation of a lymph node biopsy consistent with CLL. Clonality of the circulating B-lymphocytes should be confirmed at screening. Previously confirmed immunohistological diagnosis with a characteristic CD+/CD+ B--cell immunophenotype according to WHO criteria. CLL diagnosis requires an absolute peripheral blood monoclonal CD+/CD+ B-lymphocyte count ? cells/?L for the duration of at least months. Part :
Diagnosis of CLL according to the National Cancer Institute (NCI) criteria or SLL according to the World Health Organization (WHO) criteria; this includes previous documentation of:\r\n* Biopsy-proven small lymphocytic lymphoma or\r\n* Diagnosis of CLL according to NCI working group criteria as evidenced by all of the following:\r\n** Peripheral blood B cell count of > x ^/L consisting of small to moderate size lymphocytes\r\n** Immunophenotyping consistent with CLL defined as:\r\n*** The predominant population of lymphocytes share both B-cell antigens (cluster of differentiation [CD], CD [typically dim expression] or CD) as well as CD in the absence of other pan-T-cell markers (CD, CD, etc.)\r\n*** Clonality as evidenced by kappa or lambda light chain expression (typically dim immunoglobulin expression) or other genetic method (e.g. immunoglobulin heavy chain variable [IGHV] analysis)\r\n*** NOTE: splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL\r\n** Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescent in situ hybridization (FISH) analysis for t(;)(immunoglobulin H [IgH]/cyclin D [CCND]) on peripheral blood or tissue biopsy or negative immunohistochemical stains for cyclin D on involved tissue biopsy
Clinical and phenotypic verification of B cell CLL and measurable disease; immunophenotyping of the leukemic cells (blood or marrow) must demonstrate a monoclonal (or light chain positive) with immunophenotype consistent with B cell population (e.g., co-expressing cluster of differentiation [CD] and CD)
CD+ leukemia
Patients must have measurable or evaluable disease; patients with > % of the peripheral blood mononuclear cells (PBMCs) having the characteristic abnormal (i.e., cluster of differentiation [CD]dim, CD+ CD+ expressing) fluorescence-activated cell sorting (FACS) profile for circulating ATL cells will be considered to have evaluable disease
Patients must have histologically confirmed B-lineage acute lymphoblastic leukemia (ALL) at diagnosis and either evidence of relapse/refractory disease based on a bone marrow/peripheral blood examination or evidence by cytogenetic studies or polymerase chain reaction (PCR) amplification; patients with only extramedullary disease in the absence of bone marrow or blood involvement are not eligible; patients with L (Burkitt's) are not eligible; for ALL in marrow or peripheral blood, immunophenotyping of the blood or marrow lymphoblasts must be performed to determine lineage (B cell, T-cell, or mixed B/T cell); NOTE: appropriate marker studies including CD (B cell), CD, CD, and CD (T cell) must be performed; co-expression of myeloid antigens (CD and CD) will not exclude patients; if possible, the lineage specific markers cytoplasmic CD or CDa (B cells), cytoplasmic CD (T cells) and cytoplasmic myeloperoxidase (MPO) (myeloid cells) must be determined; patients with mixed lineage ALL (ML-ALL) as defined by a lack of cytochemical markers of myeloid differentiation, and by the presence of immunophenotypic markers suggesting both lymphoid and myeloid differentiation, are allowed
CD and/or CD must be expressed on at least % of the lymphoblasts
Subjects must be diagnosed with CLL/SLL (chronic lymphocytic leukemia/small lymphocytic lymphoma) based on the standard histologic and immunophenotypic criteria described in the World Health Organization (WHO) classification of lymphoid malignancies, including immunophenotypic confirmation that the tumor cells co-express B cell antigens cluster of differentiation (CD)/ and CD; mantle cell lymphoma should be excluded based on positive staining of the tumor cells for CD, or the absence of staining of the tumor cells for cyclin D or the absence of t(;); this diagnosis should be confirmed at a Dana-Farber Harvard Cancer Center institution (Dana-Farber Cancer Institute [DFCI], Brigham and Women's Hospital [BWH], Massachusetts General Hospital [MGH], Beth Israel Deaconess Medical Center [BIDMC]) within approximately one month after the subject is registered; any question on histology confirmation should be brought to the attention of the Principal Investigator
Evidence of HCL by flow cytometry, reviewed by the Laboratory of Pathology, National Cancer Institute (NCI), including positivity for CD, CD, CD, and CDc
TREATMENT WITH SJCAR: Available SJCAR product with >= % expression of the CD-chimeric antigen receptor (CAR), and killing of CD+ targets >= % in an in vitro cytotoxicity assay
Prior treatment with a therapeutic agent targeting CD and/or CD (e.g. gemtuzumab ozogamicin, SGN-CDA or AMG ).
Radiotherapy within the last days prior to CD (limited field palliative radiation is allowed if ? days prior to CD);
Clinical and phenotypic verification of B cell CLL or SLL and measurable disease. Immunophenotyping of the leukemic cells (blood, lymph node, or bone marrow) must demonstrate a monoclonal (or light chain positive) B cell population with immunophenotype consistent with CLL (e.g.: co-expressing CD, CD, and CD)
Evidence of at least one measurable lesion on imaging with the following exceptions\r\n* Patients treated with interim chemotherapy for disease control between enrollment and ETL-ARTEMIS T cell infusion who do not have measurable disease at re-screening are still eligible\r\n* CLL/SLL with documented B-cell absolute lymphocytosis > x ^ cells/L peripheral blood or infiltration of lymph nodes and/or bone marrow infiltration by CLL phenotype cells defined as clonal B cells with majority population co-expressing CD and CD, with surface immunoglobulin (sIg, kappa or lambda but not both) and CD (dim), CD+ (if CD or sIg are bright or if CD is dim or negative [atypical CLL phenotype] then fluorescence in situ hybridization (FISH) for : translocation must be performed to differentiate from mantle cell lymphoma)\r\n* Lesions previously irradiated will be considered measurable only if progression has been documented following completion of radiation therapy\r\n** Measurable lesions are nodes/nodal masses > . cm, extranodal masses > . cm or positron emission tomography (PET) avid lesions consistent with lymphoma
CD++ leukemia
Subjects must NOT have an active malignancy other than CD+CD+ leukemia
CD count > /uL
Previous treatment with CD-targeted CAR T cells
Documentation of CD+ status
Histologically confirmed CD-positive lymphoma with cutaneous presentation
Prior to lymphodepletion on protocol PLAT-, total CD antigen load in the bone marrow is <% of cells analyzed by flow cytometry (CD antigen load includes both CD+ leukemia cells and non-malignant B cells)
Patients not in remission must have CD-expressing leukemic blasts; patients in remission do not require phenotyping and may have leukemia previously documented to be CD negative
Documentation of CD expression on any prior or current tumor biopsy; patients who have received previous CD-targeted therapy must have CD-positive disease confirmed on a biopsy since completing the prior CD-targeted therapy
CD count >= in the dose-finding cohort; once the dose-finding cohort is complete and if safety is established, participants with any CD count, including CD count < , will be allowed in the dose-escalation phase
Participants who have received previous CD-targeted therapy must have CD-positive lymphoma confirmed on a biopsy since completing the prior CD-targeted therapy.
Subjects who had a thromboembolic event ? weeks of CD must be receiving adequate anticoagulation treatment for at least weeks before CD and must continue as clinically indicated post first dose
Sufficient baseline tumor tissue available to perform tumor infiltrating CD+ T-cell density assessment; (NOTE: The actual CD+ T-cell density assessment does not need to be performed prior to registration, however the slides must be reviewed prior to registration to ensure that adequate tissue will be available for the pre-treatment tumor infiltrating CD+ T-cell density assessment)
Measurable unresectable cancer expressing CD as assessed by immunohistochemistry of resected tissue (>= + CD positive on >= % of cancer cells, or >= + CD positive on >= % of cancer cells)
ELIGIBILITY FOR TREATMENT WITH TCRC-TRANSDUCED CD+ CELLS
EXCLUSION FOR TREATMENT WITH TCRC-TRANSDUCED CD+ CELLS
CD negative B-cell leukaemia
Subjects must have a diagnosis of relapsed or refractory mantle cell lymphoma as follows:\r\n* Diagnosis of mantle cell lymphoma (MCL) must include morphology and expression of either cyclin D in association with other relevant markers (eg, CD, CD, CD) or evidence of t(;) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR)\r\n* Relapsed or refractory disease is defined as no response or progressive disease to prior treatment if the prior treatment comprised any of the following:\r\n** regimen containing an anti-CD antibody administered for >= doses, and/or\r\n** >= regimen containing cytotoxic agent (e.g., bendamustine, chlorambucil, cyclophosphamide, cytarabine, doxorubicin) administered for cycles
Prior treatment with programmed cell death (PD)-, PD-ligand (L), cytotoxic T lymphocyte-associated protein (CTLA ) targeted therapy, or tumor necrosis factor receptor superfamily (TNFRSF) agonists including CD (OX), CD, CD (-BB), and CD (glucocorticoid-induced tumor necrosis factor receptor family-related protein [GITR])
PRIOR TO CELL PROCUREMENT: CD+ disease (result can be pending at the time of cell procurement, but must be confirmed prior to treatment with ATLCAR.CD cells); NOTE: CD+ disease requires documented CD expression by immunohistochemistry based on the institutional hematopathology standard
PRIOR TO LYMPHODEPLETION: CD+ disease (result can be pending at the time of cell procurement, but must be confirmed prior to lymphodepletion); NOTE: CD+ disease requires documented CD expression by immunohistochemistry based on the institutional hematopathology standard
Patients must have measurable or evaluable disease; NOTE: All patients with greater than % abnormal CD+ homogeneous CD^low strongly CD+ expressing cells, or greater than % Sezary/T-PLL cells, among the peripheral blood mononuclear cells (PBMCs) in the peripheral blood will be deemed to have evaluable disease
CD count >= cells/uL if HIV-infected
PATIENT CRITERIA FOR PROCEEDING WITH CD+ MEMORY T-CELL INFUSION:
Patients must have evidence of mixed CD T-cell chimerism based on the day + (+/- days) blood sample showing >= % and =< % donor type cells
Patients must have a Karnofsky performance status of >= % at the time of the CD+ memory T-cell infusion
Subjects must be on a prophylactic regimen for Pneumocystis jiroveci pneumonia, or agree to begin such treatment, if CD+ cell counts are observed to be =< /ul in peripheral blood
Diagnosis of CLL: monoclonal B-cells co-expressing >= one B-cell marker (cluster of differentiation [CD], CD, or CD) and CD in peripheral blood or lymph node
DONOR: Cell yield goal (post CD determination): > - x^ CD+ cells/kg recipient
CD-positive tumor
Patients should have a confirmed diagnosis of chronic lymphocytic leukemia defined as all of the following:\r\n* Absolute lymphocyte count (ALC) > \r\n* Positive for either CD or CD together with CD and CD\r\n* Less than % atypical cells
Patients must have histological confirmation of the diagnosis (it is recommended that the immunohistochemical panel includes: CD, CD, CD, CD, CD, BCL, BCL, MUM-), and in addition have a dominant mass within the anterior mediastinum.
Previous infusion of CD CAR T cells at another institution
CD positive tumor (can be pending at this time)
Diagnosis - CD+ HL or CD+ NHL
After Dose Escalation: any patient (children or adults) with relapsed CD+ HL or CD+ NHL or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory CD+ HL or CD+ NHL with a treatment plan that will include high dose therapy and autologous stem cell transplantation
CD positive tumor
Recipients (patients with B-cell malignancy) must have received an human leukocyte antigen (HLA)-identical sibling allogeneic hematopoietic stem cell transplant, or a >= /-matched unrelated donor (URD) alloHSCT for any CD+ B-cell malignancy; haploidentical donors will not be used in this protocol; patients with any CD+ B-cell malignancy that is persistent or relapsed after all of the following interventions are eligible:\r\n* Donor T cell engraftment after alloHSCT (> % donor chimerism of the T cell compartment and a peripheral blood T cell number from the National Institutes of Health (NIH), Clinical center (CC) clinical lab of at least CD+ cells/uL)\r\n* A trial of withdrawal of immunosuppressive therapy\r\n* At least one donor cell infusion (DCI) with a minimum T cell dose of x CD+ cells/kg; Exception: prior DCI (donor lymphocyte infusion [DLI]) is not an eligibility requirement for patients with acute lymphopblastic leukemia (ALL), Burkitt lymphoma, ALL-like high-grade lymphomas, or diffuse large B-cell lymphoma\r\n** NOTE: at least days must have elapsed since the latest trial of withdraw of immunosuppression or DCI until the patient can be deemed to have persistent disease
Evidence of HCL by flow cytometry of blood or a solid (lymph node) mass, confirmed by the Laboratory of Pathology, National Cancer Institute (NCI), including positivity for CD, CD, CD, and CDc; patients with flow cytometry consistent with HCL variant (HCLv) are eligible, including those with CD and/or CD negative disease
Patients must have a confirmed diagnosis of CLL as defined by the International Workshop on CLL (iwCLL) criteria below:\r\n* Presence of at least x ^ B lymphocytes/L (/uL) in the peripheral blood\r\n* Morphologically, the lymphocytes must appear of small to moderate size with < % prolymphocytes, atypical lymphocytes or lymphoblasts\r\n* The clonality and immunophenotype of the circulating B-lymphocytes must be confirmed by flow cytometry to express cluster of differentiation (CD), CD, CD, CD, CD and either kappa or lambda light chain
Diagnosis of:\r\n* Biopsy-proven small lymphocytic lymphoma (SLL) , or\r\n* Diagnosis of chronic lymphocytic leukemia (CLL) with a clonal B-cell population in the peripheral blood with immunophenotyping consistent with CLL as follows:\r\n** The population of lymphocytes share both B-cell antigens (CD, CD [typically dim expression], or CD) as well as CD in the absence of other pan-T-cell markers (CD, CD, etc.)\r\n** Clonality as evidenced by kappa or lambda light chain expression (typically dim immunoglobulin expression) or other genetic method (e.g. IGHV analysis)\r\n** Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescence in situ hybridization (FISH) analysis for t(;)(IgH/CCND)
CD-positivity by immunohistochemistry of >= %
Confirmed diagnosis of MCL with CD and cyclin D positivity in tissue biopsy.
Patients must have newly diagnosed T-lymphoblastic leukemia (T-ALL) or T-lymphoblastic lymphoma (T-LLy) stages II-IV \r\n* Note: a diagnosis of T-ALL is established when leukemic blasts lack myeloperoxidase or evidence of B-lineage derivation (cluster of differentiation [CD]/CD/CD), and express either surface or cytoplasmic CD or two or more of the antigens CD, CD, CD, CD, CD or CDa, and are present either in peripheral blood or > % in the bone marrow; if surface CD is expressed on all leukemic cells, additional markers of immaturity, including terminal deoxynucleotidyl transferase (TdT), CD or CD will be assessed for expression; cases with uncertain expression will receive additional review within the appropriate Children's Oncology Group (COG) reference laboratory\r\n* For T-LLy patients with tissue available for flow cytometry, the criterion for diagnosis should be analogous to T-ALL; for tissue processed by other means (i.e. paraffin blocks), the methodology and criteria for immunophenotypic analysis to establish the diagnosis of T-LLy defined by the submitting institution will be accepted
Subjects must be on a prophylactic regimen for pneumocystis carinii pneumonia, or agree to begin such treatment, if CD+ cell counts are observed to be =< /ul in peripheral blood
Patients must have histologically or flow cytometry confirmed diagnosis of B-cell chronic lymphocytic leukemia/small lymphocytic lymphoma (B-CLL/SLL) according to the IWCLL criteria. The malignant B cells must co-express CD with CD or CD. Patients who lack CD expression on their leukemia cells should be examined for (and found NOT to have) either t(;) or cyclin D overexpression, to rule out mantle cell lymphoma.
Severe CD as defined by one of the following:\r\n* CDAI >= \r\n* Need for total parenteral nutrition to maintain weight\r\n* Recurrent intestinal inflammation caused by CD following surgical resection
Subjects must be on a prophylactic regimen for Pneumocystis carinii pneumonia, or agree to begin such treatment, if the CD counts are < cells/uL
Diagnosis of CD- positive GCT; CD expression will be tested by immunohistochemistry (IHC) in archival or fresh tumor tissue as is routinely done for diagnosis
At least % of the cells obtained from lymph node, or extranodal sites must react with anti-CD (anti-Tac) on immunofluorescent or immunoperoxidase staining; patients with CD-positive infiltrating T cells will be eligible even if their Hodgkins (Reed-Sternberg) cells are CD-negative
Patients must have a histologically confirmed diagnosis of B-NHL, T-NHL, or HL; CD antigen expression must be documented on tumor specimens in all cases except HL, in whom histologic demonstration of CD+ cells adjacent to the Reed Sternberg cells is required
Histopathological evidence of CD+ HCL confirmed by the National Institutes of Health (NIH) pathology department; this will require a monoclonal population of peripheral malignant lymphocytes that are CD positive by fluorescence activated cell sorting (FACS) with anti-CD antibody; positive expression in a FACS assay is defined as more than times the mean fluorescence intensity (MFI) of the control antibody by FACS; HCLv (HCL variant) is usually CD negative, and eligibility would require CD+ HCLv
Prior treatment with CD directed agents unless CD expression is confirmed after completion of CD-directed treatment
Patients who have an option for any treatment with proven clinical benefit for CD-positive AML or CD-positive ALL at current state of disease.
CD+ T-cell count >= cells/uL
Histologically documented CD-positive lymphoma as determined by the local laboratory
Known CD-negative status at relapse or progression
Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective; previously treated, pathologically confirmed chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) that requires as per the National Cancer Institute (NCI) Working Group Guidelines for the treatment of CLL; the diagnosis of CLL is defined by the presence of x ^ clonal B-lymphocytes/L in the peripheral blood; clonality of the lymphocyte population is established with flow cytometry and the demonstration of the following surface markers: CD, CD, CD, CD and the presence of either kappa or lambda immunoglobulins; the diagnosis of SLL may be made with the demonstration of < x ^ clonal B-lymphocytes/L in the peripheral blood, with the clinical or radiographic features of enlarged lymph nodes or organomegaly, and the demonstration of SLL cells in the lymph node biopsy; institutional flow cytometry or immunohistochemistry must confirm CD antigen expression; patients may not have had a history of Richters transformation
CD immunohistochemical staining using the anti-CD Becton Dickinson monoclonal (BerH) antibody must be available on the most recent biopsy specimen; during dose escalation, patients can be either CD positive or CD negative; during dose expansion, patients must be CD positive and patients must be CD negative
Immunotherapy within months of CD
Prior treatment with a therapeutic agent targeting CD and/or CD
Patients must be diagnosed with CLL in accordance with International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria that includes all of the following:\r\n* >= x ^ B lymphocytes (/uL) in the peripheral blood\r\n* On morphologic review, the leukemic cells must be small mature lymphocytes, and prolymphocytes must not exceed % of the blood lymphocytes\r\n* CLL cells on immunophenotype (performed locally) must reveal a clonal B-cell population, which express the B cell surface markers of cluster of differentiation (CD) and CD, as well as the T-cell antigen CD; patients with bright surface immunoglobulin expression or lack of CD expression in > % of cells must lack t(;) translocation by interphase cytogenetics
Diagnosis of recurrent CD+ HL or CD+ NHL, or newly diagnosed patients unable to receive or complete standard therapy OR diagnosis of relapsed/refractory CD+ HL or CD+ NHL with a treatment plan that will include high dose therapy and stem cell transplantation
CD positive tumor (result can be pending at this time)
Diagnosis - CD+ HL or CD+ NHL:\r\n* During the dose escalation phase: only adult patients with active disease failing standard therapy\r\n* After dose escalation: any patient (children or adults) newly diagnosed, unable to receive or complete standard therapy OR diagnosis of relapsed/refractory CD+ HL or CD+ NHL with a treatment plan that will include high dose therapy and autologous stem cell transplantation
CD positive tumor
Clinical and phenotypic verification of B cell chronic lymphocytic leukemia (CLL) and measurable disease; immunophenotyping of the leukemic cells (blood or marrow) must demonstrate a monoclonal (or light chain positive) B cell population with immunophenotype consistent with CLL (e.g., co-expressing CD and CD)
Known CD-negative status at relapse or progression; CNS lymphoma or leptomeningeal infiltration
Uncontrolled angina within months before CD.
Diagnosis of CLL including:\r\n* Monoclonal B-cells co-expressing >= one B-cell marker (cluster of differentiation [CD], CD, or CD) and CD in peripheral blood or lymph node
Prior treatment with TNFRSF agonists including OX, CD, CD (-BB), CD (GITR) .
Subjects must have CLL/SLL, as documented by a history at some point in time of an absolute peripheral blood B cell count > /ul, with a monoclonal B cell population co-expressing cluster of differentiation (CD), CD, and CD, or if CD negative, then documentation of the absence of t(;) or cyclin D overexpression; alternatively patients with lymphadenopathy in the absence of circulating disease will also be eligible for this study if lymph node biopsy or bone marrow biopsy establishes the diagnosis of CLL with the above immunophenotype
Immune compromised patients including but not limited to: systemic immune suppressive medications within weeks of enrolling; HIV-positive and below normal CD lymphocytes (less than cells per microliter). Patients must be tested for HIV seropositivity and CD lymphocyte count to be eligible for the study
Diagnosis of CLL according to the National Cancer Institute (NCI)/Internal Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria or small lymphocytic lymphoma (SLL) according to the World Health Organization (WHO) criteria; this includes previous documentation of:\r\n* Biopsy-proven small lymphocytic lymphoma or\r\n* Diagnosis of CLL according to the NCI/IWCLL criteria as evidenced by all of the following:\r\n** Peripheral blood lymphocyte count of greater than x ^/L\r\n** Immunophenotype consistent with CLL defined as:\r\n*** The predominant population of lymphocytes share both B-cell antigens (cluster of differentiation [CD], CD [typically dim expression], or CD) as well as CD in the absence of other pan-T-cell markers (CD, CD, etc)\r\n*** Clonality as evidenced by kappa or lambda light chain restriction (typically dim immunoglobulin expression)\r\n* Negative FISH analysis for t(;)(immunoglobulin heavy locus [IgH]/cyclin D [CCND]) on peripheral blood or tissue biopsy (e.g. marrow aspirate) or negative immunohistochemical stains for cyclin D staining on involved tissue biopsy (e.g. marrow aspirate or lymph node biopsy)
SLL (lymphadenopathy and/or splenomegaly and < ^ CD+ CD+ clonal B lymphocytes/L [< /L] in the peripheral blood at diagnosis with measurable disease that is biopsy-proven SLL)
If prior CD-targeted therapy has been administered, subject must have CD-positive disease confirmed by immunohistochemistry or flow cytometry since completing the prior CD-targeted therapy.
CD negative HL
Current diagnosis of primary cutaneous CD-positive T-cell lymphoproliferative disorders and lymphomas or mycosis fungoides
Prior peripheral ASCT within weeks of CD
Tumors must be CD+ on prior pathologic analysis
Tumor cell negative for CD
Patients must have histologically or cytologically confirmed cluster of differentiation (CD) positive (+)/CD+ B-cell chronic lymphocytic leukemia or small lymphocytic lymphoma; the diagnosis of CLL is based upon the National Comprehensive Cancer Network (NCCN) guidelines; any outside pathology slides used as inclusion criteria for the patient will be reviewed at this institution to confirm the diagnosis; the patient must meet all of the following CLL criteria to participate in this study: \r\n* Absolute lymphocyte count > /uL \r\n* CD+ and CD+ \r\n* Bone marrow lymphocytes >= % \r\n* Or previous confirmed diagnosis of CLL/SLL with less than /ul or less than % lymphocytes in bone marrow (BM)
Histologically confirmed diagnosis of mantle cell Non-Hodgkin's Lymphoma with cyclin D overexpression by immunohistochemistry, and a characteristic immunophenotypic profile with CD(+), CD(-), CD(+), and CD(-). In tumor tissues with negative cyclin D, evidence of cyclin D or D overexpression by immunohistochemistry will be acceptable.
Patients must have a biopsy confirmed diagnosis based on a combination of histological and clinical criteria of CD+ lymphomatoid papulosis, CD+ primary cutaneous anaplastic large T-cell lymphoma (pc-ALCL), or CD+ mycosis fungoides for the phase II trial; there is no specific limit or validated amount other than positive cells on immunohistochemistry (IHC) cells in tumor cells
Diagnosis of chronic lymphocytic leukemia:\r\n* Lymphocytosis of >= , cells/ul; AND\r\n* Marrow aspirate with >= % of mononuclear cells being lymphocytes; AND\r\n* Flow cytometry demonstrating monoclonal B-cells co-expressing >= one B cell marker (cluster of differentiation [CD], CD, or CD) and CD
Patients with less than % donor CD peripheral blood chimerism on two separate, consecutive evaluations; the two evaluations must be at least days apart OR patients with absolute decreases of donor CD peripheral blood chimerism of >= % if the second test shows < % donor CD cells; the two evaluations must be at least days apart
Patients must have persistent donor CD cells (>= % donor CD cells by a deoxyribonucleic acid [DNA]-based assay that compares the profile of amplified fragment length polymorphisms [ampFLP] [or fluorescent in situ hybridization (FISH) studies or variable number of tandem repeats (VNTR)])
Chemotherapy within days prior to CD
CD-detectable leukemia
Participants must have available archival or fresh tumor tissue or both to submit to a central laboratory for CD assay. Expression of CD is measured by immunohistochemistry on fresh or archived tumor sample by central assessment using a CD investigational IHC assay under development: a) Stage : participants whose tumors are more than or equal to (>=) percent (%) positive for CD, b) Stage : participant has less than (<) % CD+ or greater than (>) % CD+ depending on the distribution of CD expression of enrolled participants during Stage . The sponsor will advise on which eligibility criterion is permitted during the enrollment period
CD immunophenotyping performed ? years prior to randomization
Confirmed diagnosis of PTCL expressing CD receptor; diagnosis will be based on identification of PTCL in biopsy specimens characterized (negative) to % (positive) immunohistochemistry staining with CD in the malignant cell population; following PTCL subtypes will be eligible: \r\n* Peripheral T-cell lymphoma, not otherwise specified (NOS) \r\n* Angioimmunoblastic T-cell lymphoma \r\n* Subcutaneous panniculitis like T-cell lymphoma \r\n* Hepatosplenic gamma/delta T-cell lymphoma \r\n* Extranodal natural killer (NK) T-cell lymphoma, nasal type \r\n* Enteropathy-associated T-cell lymphoma \r\n* Adult T-cell leukemia/lymphoma \r\n* T-cell prolymphocytic leukemia \r\n* Primary cutaneous gamma-delta T-cell lymphoma \r\n* Aggressive NK cell leukemia \r\n* Aggressive subtype of T cell large granular lymphocyte (LGL) leukemia or transformed LGL leukemia\r\n* Epstein-Barr virus (EBV)-positive T-cell lymphoproliferative disorders of childhood \r\n* Transformed mycosis fungoides who have progressed following treatment with at least one systemic therapy\r\n* Sezary syndrome \r\nImmunophenotyping of lymphomas will be performed with panels of monoclonal antibodies targeting surface markers and assisting in differential diagnosis of PTCL according to National Comprehensive Cancer Network (NCCN) guidelines version (V) ; CD, CD, CD, CD, CD, CD, CD, CD, CD, beta-Framework (F), activin receptor-like kinase- (ALK-), Epstein-Barr virus encoded ribonucleic acid (RNA) (EBER), TIA cytotoxic granule-associated RNA binding protein (Tia-), granzyme B, cartesian genetic programming (CGP), perforin, CD, B-cell chronic lymphocytic leukemia/lymphoma (bcl-), programmed cell death (PD-); proliferation index will also be evaluated using antibodies against mindbomb E ubiquitin protein ligase (Mib-)/ marker of proliferation Ki- (Ki-); clonality studies with T-cell receptor (TCR) gene rearrangement of beta and gamma genes will also be included; pathology sample must be adequate for a complete immunohistochemical analysis
Primary cutaneous CD+ aggressive epidermic cytotoxic TCL
Primary cutaneous CD+ disorders: ALCL and lymphomatoid papulosis
Known CD-negative status at relapse or progression
Diagnosis of B-cell CLL/SLL including:\r\n* Lymphocytosis of monoclonal B-cells co-expressing >= one B-cell marker (CD, CD, or CD) and CD in peripheral blood or lymph node AND\r\n* Bone marrow with >= % mononuclear cells having the CLL/SLL phenotype
CD CAR-T cells based therapies
Diagnosis of:\r\na) CLL according to the National Cancer Institute (NCI) criteria\r\nb) Small lymphocytic lymphoma (SLL) according to the World Health Organization (WHO) criteria\r\nc) MBL according to the consensus criteria\r\n* This includes previous documentation of:\r\n** Biopsy-proven small lymphocytic lymphoma or\r\n** Diagnosis of CLL or MBL as evidenced by all of the following:\r\n*** Clonal B-cell population in the peripheral blood with immunophenotyping consistent with CLL defined as:\r\n**** The population of lymphocytes share both B-cell antigens (cluster of differentiation [CD], CD [typically dim expression], or CD) as well as CD in the absence of other pan-T-cell markers (CD, CD, etc)\r\n**** Clonality as evidenced by k (kappa) or lambda light chain expression (typically dim immunoglobulin expression) or other genetic method (e.g. immunoglobulin heavy chain variable [IGHV] analysis)\r\nNOTE: splenomegaly, hepatomegaly, or lymphadenopathy are not required for the diagnosis of CLL \r\n*** Patients with a peripheral blood B-cell lymphocyte count of < x ^/L and no evidence of lymphadenopathy or organomegaly will be classified as MBL; patients with a peripheral blood B-cell lymphocyte count of < x ^/L who have evidence of lymphadenopathy will be classified as SLL; patients with a peripheral blood B-cell lymphocyte count >= x ^/L will be considered to have CLL\r\n*** Before diagnosing MBL, CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescence in situ hybridization (FISH) analysis for t(;)(IgH/cyclin D [CCND]) on peripheral blood or tissue biopsy or negative immunohistochemical stains for cyclin D on involved tissue biopsy
have not been treated with a taxane within six months of CD, AND
Is within months of transplant from CD
Diffuse DLBCL with activating mutations in CD (A or B subunits) or ABC-subtype DLBCL (CD wildtype or CD mutant). DLBCL that arose from transformed indolent lymphoma is allowed.
B-cell lymphoma with comprehensive immunohistochemistry (IHC) panel establishing lineage (cluster of differentiation [CD], CD) and cell of origin (CD, B-cell chronic lymphocytic leukemia [CLL]/lymphoma [BCL] and melanoma associated antigen [mutated] [MUM]) in addition to proliferative/prognostic markers (proliferation-related Ki- antigen [Ki-], C-myc and B-cell CLL/lymphoma [BCL]); DHL will be identified using cytogenetics and/or immunohistochemistry as detailed in DHL defined below
A diagnosis of CLL defined by a circulating B-lymphocyte count of greater than or equal to ,/uL at study entry or at any time in the past and flow cytometry confirmation of immunophenotype with CD, CD, CD, CD, CDb, and surface Ig prior to first dose of study treatment.
Have FSH levels indicative of postmenopausal state (i.e., - IU/L) documented within days of CD.
Recurrent disease:\r\n* Patient > years old (yo) must have recovered CD count to > cells/mm OR have disease free interval > one year from completion of cytotoxic therapy\r\n* Patients < yo must have recovered CD count to > cells/mm OR have disease free interval > six months from completion of cytotoxic therapy
Multiple recurrences are allowable as long as CD count or disease-free intervals have been met
Histologically-confirmed CD-positive disease; tissue from the most recent post diagnostic biopsy of relapsed/refractory disease must be available for confirmation of CD expression via slides or tumor block.
Predominant donor chimerisms as measured by CD and CD (or other myeloid marker)
Alemtuzumab or any equivalent in vivo T-cell depleting agent (or CD+ selection)
Greater than % of blasts must be CD positive.
Greater than % of blasts must be CD positive.
Possession of a CD/DVD player or ability to play a CD
Recipients of CD selected grafts or other manipulated grafts (with any form of ex vivo T cell depletion) will be eligible to enroll if they have a CD count > ; (please note: post-transplant Cytoxan for haploidentical transplants is allowable)
FOR THE SUBJECTS ENROLLED IN YEAR : Recipients of CD selected grafts or other manipulated grafts (with any form of ex vivo T cell depletion) will be eligible to enroll if they have a CD count > ; (please note: post-transplant cytoxan for haploidentical transplants is allowable)
CD selection or total cell depletion outside haploidentical transplants
CD count < cells/mm^ within months of entry\r\n* Note: This refers to any CD obtained for routine care; documentation of CD is not required prior to entry
CD+ disease (result can be pending at the time of cell procurement, but must be confirmed prior to treatment with ATLCAR.CD cells); NOTE: CD + disease requires documented CD expression by immunohistochemistry based on the institutional hematopathology standard
Study - CLL/SLL\r\n* Newly diagnosed (< months from pre-registration on this study) CLL according to the National Cancer Institute (NCI) criteria or SLL according to the World Health Organization (WHO) criteria; this includes previous documentation of:\r\n** Biopsy-proven small lymphocytic lymphoma\r\n** Diagnosis of CLL according to NCI working group criteria as evidenced by all of the following:\r\n*** Peripheral blood lymphocyte count of > ,/mm^; if present, prolymphocytes should be < %\r\n*** Immunophenotyping consistent with CLL defined as:\r\n**** The predominant population of lymphocytes share both B-cell antigens (cluster of differentiation [CD], CD, or CD) as well as CD in the absence of other pan-T-cell markers (CD, CD, etc.)\r\n**** Dim surface immunoglobulin expression\r\n**** Restricted surface kappa or lambda light chain expression\r\n*** Before diagnosing CLL or SLL, mantle cell lymphoma must be excluded by demonstrating a negative fluorescent in situ hybridization (FISH) analysis for t(;)(immunoglobulin H [IgH]/cyclin D [CCND]) on peripheral blood or tissue biopsy or negative immunohistochemical stains for cyclin D on involved tissue biopsy\r\n* Rai stage or \r\n* Previously untreated\r\n* Asymptomatic with the plan for observation\r\n* Life expectancy of at least months\r\n* Willing to provide tissue for correlative research purposes
Phenotypic studies (obtained within weeks prior to study drug administration) from peripheral blood showing CD+, CD+ cells >/mm or CD+ cells >/mm.
Pathologically confirmed MCL (in tumor tissue), with documentation of either overexpression of cyclin D in association with other relevant markers (eg, CD, CD, PAX, CD) or evidence of t(;) as assessed by cytogenetics, fluorescent in situ hybridization (FISH), or polymerase chain reaction (PCR)
Adequate hematopoietic function within days prior to CD
Radiation, chemotherapy, or immunotherapy or any other anticancer therapy (including investigational therapies) ? weeks prior to CD. Localized radiation to a single site at least week before CD is permitted. Glucocorticoids within weeks of CD are permitted. Patients on long-term glucocorticoids during Screening do not require a washout period but must be able to tolerate the specified dexamethasone dose in this study.
Patients must have histologically or cytologically confirmed by the local institution CD+ precursor B-acute lymphoblastic leukemia (pre-B cell ALL) OR CD+ mixed phenotype acute leukemia (MPAL): a) with relapse following or refractory to at least one prior line of therapy if older than years; b) in second or higher relapse or refractory to at least two prior lines of therapy if years old and younger (-); c) or they must have a new diagnosis of pre-B cell ALL or CD+ MPAL but are >= years old and are either not a candidate for or do not wish to receive traditional induction chemotherapy
Patients who were treated with blinatumomab in the past will be allowed on the study as long as they have persistent CD expression on leukemia cells and did not experience unacceptable toxicities with prior blinatumomab administration; patients who were treated with chimeric antigen receptor (CAR)-modified T cells targeting CD in the past will be allowed on the study as long as they have persistent CD expression on leukemia cells
Clinical and phenotypic verification of B cell CLL or small lymphocytic lymphoma (SLL) and measurable disease; immunophenotyping of the leukemic cells (blood, lymph node, or bone marrow) must demonstrate a monoclonal (or light chain positive) B cell population with immunophenotype consistent with CLL (e.g.: co-expressing CD, CD, and CD)