[c09aa8]: / clusters / final9knumclusters / clust_2196.txt

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All patients are required to be pre-registered to A061402 in order to submit post-radiation therapy (RT) bone marrow aspirate specimens to Roswell Park for MRD detection by flow cytometry; this submission is required prior to registration to confirm eligibility
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Relapsed or refractory B-cell or T-cell ALL after multi-agent chemotherapy (>= 5% marrow lymphoblasts, assessed by morphology and flow cytometry; flow cytometry will be used to confirm immunophenotype and percentage of blasts will be assessed by morphology)
ELIGIBILITY CRITERIA - PHASE II (ARM D): Relapsed or refractory B-cell or T-cell ALL after multi-agent chemotherapy (>= 5% marrow lymphoblasts, assessed by morphology and flow cytometry; flow cytometry will be used to confirm immunophenotype and percentage of blasts will be assessed by morphology)
Participants with > 5% involvement of bone marrow by malignant cells (either by manual count or flow cytometry) prior to stem cell collection
Evidence of myelodysplasia or myeloid leukemia by morphology, immunostains, flow cytometry, or cytogenetics on a bone marrow aspirate or biopsy.
Previously untreated Ph negative precursor B-cell or T-cell ALL confirmed by conventional flow cytometry or immunohistochemical stain; patients who have untreated B-cell or T-cell ALL confirmed by conventional flow cytometry or immunohistochemical stain, but Ph status is unknown, may also enroll
Patients must have measurable disease requiring cytoreduction, defined as a bone marrow myeloblast count >= 5% and < 20% on morphologic examination or by flow cytometry in cases in which adequate morphologic examination is not possible
Available autologous transduced peripheral blood T-cells with >= 15% expression of CAR-Kappa determined by flow-cytometry
CD19 expression is required at any time since diagnosis; if patient has received anti-CD19 targeted therapy (i.e. blinatumomab), then CD19 expression must be subsequently demonstrated. CD19 expression must be detected on greater than 50% of the malignant cells by immunohistochemistry or >= 90% by flow cytometry; the choice of whether to use flow\r\ncytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each subject; in general, immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples
INCLUSION - PROCUREMENT: CD5-positive tumor (result can be pending at this time); > 50% CD5 + blasts by flow cytometry or immunohistochemistry (tissue) assessed by a Clinical Laboratory Improvement Amendments (CLIA) certified flow cytometry/pathology laboratory
INCLUSION - TREATMENT: CD5-positive tumor (> 50%) CD5+ blasts by flow cytometry or immunohistochemistry (tissue) assessed in a CLIA certified flow cytometry/pathology laboratory
INCLUSION - TREATMENT: Available autologous activated peripheral blood T cell products with ? 20% expression of CD5.CAR.28 zeta and < 0.5% gene-modified malignant T blasts by flow cytometry
TREATMENT INCLUSION: Available autologous T cells with ? 15% expression of CD30CAR determined by flow-cytometry
Biopsy-confirmed CD20+ expression of the underlying malignancy by immunohistochemical staining or flow cytometry between the most recent dose of an anti-CD20 monoclonal antibody (mAb) and study enrollment
Patients with any history of relapsed/refractory disease, or who have progressed at any time since beginning induction therapy are not eligible; patients who have evidence of residual disease by FISH, cytogenetics, SNP array, or flow cytometry without any measurable nodal disease or morphologic evidence of disease in the bone marrow or peripheral blood are eligible
Patients will be eligible to receive donor-derived multiTAA-specific T cells following any type of allogeneic HSCT as\r\n* Adjuvant therapy for AML/MDS (Group A); or\r\n* Treatment for refractory/relapsed or minimal residual AML/MDS disease (Group B)\r\n** 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, in the peripheral blood, or any other extramedullary sites\r\n* Minimal residual disease (MRD) will be defined as detection in blood, bone marrow, or other tissues any of the following:\r\n** Any leukemia specific marker such as t(8;21); inv 16; t (15;17), t(9;22) or t(4;11) documented in the patient’s leukemia cells pre-transplant on a post-transplant evaluation\r\n** Expression of a leukemia associated antigen known to be a marker for residual disease like WT1\r\n** A leukemia-specific phenotype (e.g. expression of markers including CD13 and/or CD33 and/or CD117 and/or human leukocyte antigen–antigen D related positive [HLA-DR+]) post-transplant at a level of ? 0.01%\r\n** Mixed donor chimerism (> 20%)
CD22 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 80% by flow cytometry; the choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each patent; in general, immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples
Patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis
Prior CAR therapy within 30 days prior to apheresis or prior CAR therapy at any time with evidence for persistence of CAR T cells in blood samples (circulating levels of genetically modified cells of >= 5% by flow cytometry)
Available allogeneic activated peripheral blood T cell products with ? 15% expression of CD19.CAR-CD28zeta determined by flow cytometry (cell dose is based on total cell numbers and not individual anti-leukemic cell numbers)
Patient’s multiple myeloma cells are positive for CD28 or CD86 expression by flow cytometry or immunohistochemistry (in any proportion)
CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 90% by flow cytometry; the choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each patient; in general, immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples; CD22+ B cell malignancy is required and CD22 expression levels will be documented when available, but a specific level of expression is not an eligibility requirement; it may be documented as positive or negative
Prior CAR therapy within 30 days prior to apheresis or prior CAR therapy at any time with evidence for persistence of CAR T cells in blood samples (circulating levels of genetically modified cells of ? 5% in peripheral blood by flow cytometry)
The patient’s lymphoma must be CD19 positive, either by immunohistochemistry or flow cytometry analysis on the last biopsy available.
Evidence of CD20 expression by immunohistochemistry or flow cytometry on the tumor specimen obtained with the biopsy performed with screening
CD19 expression is required at any time since diagnosis; if patient has received anti-CD19 targeted therapy (i.e. blinatumomab or CD19-CAR T cells), then CD19 expression must be subsequently demonstrated; CD19 expression must be detected on greater than 50% of the malignant cells by immunohistochemistry or >= 90% by flow cytometry; the choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each subject; in general, immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples
AML Blast cell expressing CD123 by flow cytometry performed as per standard practice
After CAR T cell infusion on PLAT-02, the ratio of the % CAR T cells in peripheral blood on day 10 (as measured by flow cytometry) compared to the % CAR T cells in peripheral blood on day 14 is >= 1.5\r\n* Patients meeting above criteria may enroll on Cohort B, but must demonstrate evidence of ongoing B cell aplasia (BCA) in the bone marrow within 7 days prior to planned T-APC test dose, in order to remain on Cohort B; BCA in the bone marrow is defined as < 1% CD19+ cells, as measured by flow cytometry; patients not demonstrating ongoing BCA may be considered for enrollment on Cohort C of this study
Following CAR T cell infusion on PLAT-02, patient initially achieved BCA and has now lost BCA in the bone marrow or peripheral blood, before 6 months; BCA is defined as < 1% CD19+ cells by lymphocyte subset testing, as measured by flow cytometry\r\n* If patient has disease relapse in this setting, disease must remain CD19+
Evidence of CD19 expression via flow cytometry (peripheral blood or bone marrow) or immunohistochemistry (bone marrow biopsy) from a sample obtained from the current relapse
Patients must have received at least 12 months of ibrutinib therapy and have measurable CLL by at least one of the following: Absolute monoclonal lymphocyte count > 4000/microL; OR measurable lymph nodes with at least one node > 1.5 cm in diameter on CT; OR bone marrow with >= 30% lymphocytes on aspirate differential; OR detectable CLL cells using a standardized flow cytometry assay for minimal residual disease
Patients must have bone marrow and peripheral blood studies available for confirmation of diagnosis of AML; CD33 positivity must be confirmed by either flow cytometry or immunohistochemistry; cytogenetics, flow cytometry, and molecular studies (such as FMS-like tyrosine kinase-3 [Flt-3] status) will be obtained as per standard practice.
Diagnosis of B- or T-ALL or LLy by immunophenotyping:\r\n* LLy participants must have < 25% tumor cells in bone marrow and peripheral blood by morphology and flow cytometry; if any of these show >= 25% blasts, patient will be considered to have leukemia
Evidence of CD19 expression by immunohistochemistry or flow cytometry on any prior or current tumor specimen or high likelihood of CD19 expression based on disease histology
CELL PROCUREMENT: CD19 positivity of lymphoblasts confirmed by flow cytometry or immunohistochemistry (IHC) per institutional standards
Phase I portion of the study: Histologically or flow cytometry confirmed diagnosis of B-CLL/SLL according to National Cancer Institute (NCI)-Working Group (WG) 1996 guidelines
Phase II portion of the study - histologically or flow cytometry confirmed diagnosis of BCLL/SLL according to NCI-WG 1996 guidelines; patients who lack CD23 expression on their leukemia cells should be examined for (and found NOT to have) either t(11;14) or cyclin D1 overexpression, to rule out mantle cell lymphoma
Leukemia or myelodysplastic syndrome (MDS) in aplasia; these patients may be taken to transplant if after induction therapy they remain with aplastic bone marrow and no morphological or flow-cytometry evidence of disease >= 28 days post-therapy; these high risk patients will be analyzed separately
Bone marrow and peripheral blood studies must be available for confirmation of diagnosis; cytogenetics, flow cytometry, and molecular studies (such as JAK-2, MPL and CALR mutational status) will be obtained as per standard practice
Response to therapy and completion of at least one cycle of consolidation therapy, and with disease status meeting one of the following criterion\r\n* Minimal residual disease, as defined by detectable disease by flow cytometry but with marrow that is at least 10% cellular with < 5% blasts on morphologic review\r\n* CRi/CRp, as defined by absence of detectable disease by flow cytometry, and marrow that is at least 10% cellular with < 5% blasts on morphologic review, but with neutrophil count < 1000/ul and/or platelet count <100,000/ul. As previously stated, a platelet threshold of < 80,000/ul will be used to define CRp in pediatric patients, as per consensus pediatric response criteria\r\n* Elevated expression above of WT1 in bone marrow or peripheral blood; (increased expression of WT1 will be determined if the number of copies of WT1 divided by the number of copies of ABL x 10^4 is > 250 for bone marrow, or > 50 for peripheral blood)
Minimal residual disease (MRD) positive leukemia (AML, ALL or accelerated/blast phase CML); selected patients in morphologic CR, but with positive immunophenotypic (flow cytometry) or molecular evidence of MRD may be eligible if recent chemotherapy has not resulted in MRD negative status
Leukemia or MDS in aplasia; these patients may be taken to transplant if after induction therapy they remain with aplastic bone marrow and no morphological or flow-cytometry evidence of disease >= 28 days post-therapy; these high risk patients will be analyzed separately
Evidence of ROR1 expression by immunohistochemistry or flow cytometry on any prior or current tumor specimen
PRIOR TO LYMPHODEPLETION: Available autologous T cells with ? 15% expression of CD30CAR determined by flow cytometry required prior to treatment with ATLCAR.CD30 cells
PRIOR TO INFUSION OF ATLCAR.CD30 CELLS: Available autologous T cells with ? 15% expression of CD30CAR determined by flow-cytometry required prior to treatment with ATLCAR.CD30 cells
Abnormal T cells must be CD52+ as assessed by flow cytometry or immunohistochemistry
Cohort 2: Persistence or reappearance of minimal residual disease by flow cytometry or cytogenetic or molecular testing while being in morphological remission after allogeneic stem cell transplantation
Cohort 3: High risk AML and MDS patients who are in complete remission morphologically with no evidence of minimal residual disease by flow cytometry or cytogenetic or molecular testing after allogeneic stem cell transplantation
Please note that tumor samples for patients with MF or SS can be CD30 negative and do not have to be CD30 positive on either flow cytometry or immunohistochemistry for patients to be eligible
Confirmed history of CD19 positivity by flow cytometry for malignant cells
AT THE TIME OF INFUSION: Available autologous transduced T lymphocytes with ? 15% expression of HER2 CAR determined by flow cytometry and killing of HER2-positive targets ? 20% in cytotoxicity assay
Documented genetic lesion(s) known to confer susceptibility to inhibition by either ruxolitinib or dasatinib or cytokine receptor-like factor 2 (CRLF2) positivity by flow cytometry (for the ruxolitinib cohort)
A measurable residual disease at the time of screening defined as at least MRD-positive disease:\r\n* A method of evaluation of MRD is multi-parameter flow cytometry (MFC) performed at the University of Chicago\r\n* Patients who have negative MRD by multi-parameter flow cytometry (MFC) but have residual original monoclonal protein by serum or urine immunofixation may be eligible if they are found to have MRD-positive disease by next generation sequencing (NGS)
Evidence of MRD at the time of screening for this study by multi-color flow cytometry (bone marrow procedure at screening required)
Histologic verification of B-cell lineage leukemia or B cell non-Hodgkin lymphoma and evidence of relapse/refractory disease with the presence of CD19 and/or CD22 by flow cytometry or immunohistochemistry of bone marrow aspirate, peripheral blood or node/tumor biopsy
Evidence of marrow disease by flow and morphology after upfront or salvage cytoreductive therapy and before stem cell mobilization
Patients with T cell acute lymphoblastic leukemia (ALL) must be in complete remission and minimal residual disease (MRD) negative (-) by flow cytometry and molecular studies
FOR BOTH STUDY ARMS: Research participants must have bone marrow and/or peripheral blood samples available for confirmation of diagnosis of AML or BPDCN; CD123 positivity must be confirmed by either flow cytometry or immunohistochemistry within 90 days of study entry; cytogenetics, flow cytometry, and molecular studies (such as FMS-like tyrosine kinase-3 [FLT-3] status) will be obtained as per standard practice; however, for research participants who are at a high risk of recurrence, they must have historical bone marrow and/or peripheral blood samples available for confirmation of diagnosis of AML or BPDCN; CD123 positivity must be confirmed by either flow cytometry or immunohistochemistry prior to start of lymphodepletion
MRD will be defined in this protocol by presence of malignant cells at 0.01% or more by flow cytometry or polymerase chain reaction (PCR) analysis at the completion of initial remission induction therapy
Evidence of CD19 expression by immunohistochemistry or flow cytometry on any prior or current tumor specimen or high likelihood of CD19 expression based on disease histology
Available autologous or syngeneic activated peripheral blood T cell products (CD28zeta and CD28/CD137zeta) with >= 15% expression of CD19.CAR determined by flow cytometry
HLA-A2 positive based on flow cytometry
History of CD19+ malignancy with evidence of relapse or persistent minimal residual disease (MRD) following autologous or allogeneic hematopoietic stem cell transplantation (cohort 1)\r\n* Relapse on this protocol is detection of CD19+ malignancies in bone marrow (>= 5%) or extramedullary lesion by morphology, cytogenetics, molecular, radiographic, and/or flow cytometry\r\n* Persistent minimal residual disease after transplantation must be demonstrated by morphology, karyotype, fluorescent in situ hybridization (FISH), flow cytometry, or reverse transcriptase (RT)-polymerase chain reaction (PCR)
Measurable disease for dose expansion and lead in phases only; measurable disease defined by:\r\n* Revised International Working Group (Cheson, 2007) classification for systemic lymphoma or \r\n* Atypical and or malignant lymphocytes quantifiable by flow cytometry or morphology in blood\r\n* Or bone marrow modified severity weighted assessment tool (mSWAT) > 0 or Sezary count >= 1000 cells/uL
Available autologous transduced EBV-specific cytotoxic T lymphocytes with >= 15% expression of CD30CAR determined by flow-cytometry
HLA-A2 positive based on flow cytometry
CD19 expression must be detected on the majority of the malignant cells by immunohistochemistry or by flow cytometry in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), NIH; definition of which cells are malignant must be determined for each patient by the Laboratory of Pathology using techniques to demonstrate monoclonality such as kappa/lambda restriction (other techniques can be used to determine monoclonality at the discretion of the Laboratory of Pathology); the choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each patient. Immunohistochemistry will be used for lymph node biopsies and bone marrow biopsies; flow cytometry will be used for peripheral blood, fine needle aspirate, and bone marrow aspirate samples
Persistent or rising minimal residual disease (MRD) after standard chemotherapy regimens: patients with evidence of minimal residual disease at the completion of therapy or evidence of rising MRD while on therapy; MRD will be defined by either flow cytometry (> 0.1% residual cells in the blast gate with immune phenotype of original leukemic clone), by molecular techniques (polymerase chain reaction [PCR] or fluorescent in situ hybridization [FISH]) or conventional cytogenetics (g-banding)\r\n* New leukemia subtypes: if new high risk features are identified after the writing of this protocol, patients can be enrolled with the approval of two members of the study committee
AML or MDS relapse following allo-HSCT (morphological relapse, or MRD positive by flow cytometry, cytogenetics, molecular mutations)
Confirmed history of CD19-positivity by flow cytometry for malignant cells.
Expansion cohort - histologically or flow cytometry confirmed diagnosis of B-CLL/SLL according to NCI-WG 1996 guidelines; patients who lack CD23 expression on their leukemia cells should be examined for (and found NOT to have) either t(11;14) or cyclin D1 overexpression, to rule out mantle cell lymphoma
Detectable clonal bone marrow plasma cells by multicolor flow cytometry and less than 10% clonal plasma cells in a bone marrow biopsy by immunohistochemistry, morphology, or flow cytometry
Diagnosis should be made by bone marrow aspirate or biopsy demonstrating >= 25% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-precursor or T-ALL phenotype\r\n* For patients with circulating blasts in the peripheral blood, flow cytometry confirmation of B-ALL or T-ALL phenotype is sufficient for registration onto the study; bone marrow aspirate and/or biopsy should be performed as soon as feasible, preferably prior to the initiation of any therapy\r\n* While myeloid co-expression on blasts determined to be primarily lymphoid is allowed, patients meeting World Health Organization (WHO) diagnostic criteria of mixed phenotype acute leukemia (MPAL) or leukemia of ambiguous lineage are not eligible; patients with mature B-cell phenotype are also not eligible
Pre-registration: Diagnostic bone marrow and peripheral blood specimens must be submitted for eligibility testing by multiparameter flow cytometry; testing will be performed by the Eastern Cooperative Oncology Group (ECOG)-American College of Radiology Imaging Network (ACRIN) Leukemia Translational Studies Laboratory and reported to the institution
Leukemic blasts must demonstrate surface expression of CD22 at the time of relapse by local/institutional flow cytometry of a bone marrow aspirate sample; (assessment of CD22 using a bright fluorophore such as phycoerythrin [PE] is strongly recommended) \r\n* In the case of an inadequate aspirate sample (dry tap) or if bone marrow aspirate is unable to be performed due to patient clinical status, flow cytometry of peripheral blood specimen may be substituted if the patient has at least 1000/uL circulating blasts; alternatively, CD22 expression may be documented by immunohistochemistry of a bone marrow biopsy specimen
For acute lymphoblastic leukemia: diagnosis should be made by bone marrow aspirate or biopsy demonstrating >= 30% involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-precursor or T-ALL phenotype; while myeloid co-expression on blasts determined to be primarily lymphoid is allowed, patients with leukemia of ambiguous lineage are not eligible
For patients with circulating blasts in the peripheral blood, flow cytometry confirmation of B-precursor or T-ALL phenotype is sufficient for registration onto the study; bone marrow aspirate and/or biopsy should be performed as soon as feasible, preferably prior to the initiation of any therapy
Recipient leukocyte infusion (RLI) might involve the infusion of circulating tumor cells to the patients; to minimize this risk, patients who have evidence of circulating tumor cells by light microscopy and flow cytometry will be excluded
Patients will NOT receive a second infusion of GD-2 CAR T cells if >= 5 % of the circulating T cells are GD2-CAR positive by flow cytometry
Bone marrow and peripheral blood studies must be available for confirmation of diagnosis; cytogenetics, flow cytometry, and molecular studies (such as Flt-3 status) will be obtained as per standard practice
CD20+ bone marrow or lymph node by immunohistochemistry or flow cytometry\n obtained within 28 days prior to registration
CD19 expression must be detected on greater than 15% of the malignant cells by immunohistochemistry or greater than 30% by flow cytometry in a Clinical Laboratory Improvement Amendments (CLIA) approved test in the Laboratory of Pathology, Center for Cancer Research (CCR), National Cancer Institute (NCI), National Institutes of Health (NIH) or from the referring institution or reference laboratory; the choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each patient; in general immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood and bone marrow samples
Patients must have measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis
Patients with evidence of myelodysplasia, leukemia by morphology, immunostains flow cytometry or abnormal cytogenetics on a bone- marrow aspirate or biopsy; the diagnosis of myelodysplasia will be made by an independent investigator of the Laboratory of Pathology, National Cancer Institute (NCI) taking into consideration the totality of the clinical, pathological, flow cytometric and cytogenetic and present in a particular individual’s evaluation
Patients will be tested for human leukocyte antigen A0201 (HLA-A0201) as determined by flow cytometry followed by molecular analysis of a peripheral blood specimen; however this result will not be an inclusion criterion
Available autologous transduced EBV-specific cytotoxic T lymphocytes with >= 15% expression of HER2 CAR determined by flow-cytometry and killing of HER2-positive targets >= 20% in cytotoxicity assay
Presence of circulating lymphoma cells by morphology or flow cytometry (> 0.1%) at or near the time of peripheral blood stem cell (PBSC) collection if unpurged/unselected PBSC are to be used (patients with cryopreserved stem cells which are negative [=< 0.1% involved] by flow cytometry will also be considered eligible)
Available autologous transduced peripheral blood T-cells with >= 15% expression of CD19CAR determined by flow-cytometry
Bone marrow aspirate or biopsy must have ? 5% blasts by morphology and/or flow cytometry.
For relapsed patients, CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry within 3 months of study entry
For relapsed patients, documentation of CD19 tumor expression demonstrated in bone marrow or peripheral blood by flow cytometry within 3 months of study entry.
PNH diagnosis confirmed by documented by high-sensitivity flow cytometry
Evidence of myelodysplasia or myeloid leukemia by morphology, immunostains, flow cytometry, or cytogenetics on a bone marrow aspirate or biopsy.
Patients must have a history of relapsed/refractory CD19+ B-ALL involving the marrow to be eligible for infusion of modified T cells; please note >= 5% blasts by morphology, fluorescent in situ hybridization (FISH)/cytogenetics, molecular translocation and/or flow cytometry constitutes a bone marrow relapse on this protocol \r\n* Patients must also fulfill one of the following criteria to be eligible for infusion of modified T cells:\r\n** Second or greater (>= 2) relapse\r\n** Early first marrow relapse (1st CR < 18 months)\r\n** Intermediate/late first marrow relapse (1st CR >= 18 months from 1st CR) with poor initial response (>= 5% blasts by morphology and/or flow cytometry) following re-induction chemotherapy\r\n** Refractory disease\r\n** Ineligible for hematopoietic stem cell transplant (HSCT) as determined by the treating physician in consultation with the bone marrow transplant (BMT) service\r\n** Patient would not benefit from additional cytotoxic chemotherapy as determined by the treating physician
PNH diagnosis confirmed by documented by high-sensitivity flow cytometry.
Neoplastic mast cells must express CD30 by immunohistochemistry or flow cytometry
Bone marrow and peripheral blood studies must be available for confirmation of diagnosis; cytogenetics, flow cytometry, and molecular studies (such as Fms-like tyrosine kinase 3 [FLT-3] status) will be obtained as per standard practice
Available autologous T cells with >= 15% expression of CD30CAR determined by flow-cytometry
Measurable disease defined by: \r\n* Lugano classification for systemic lymphoma or\r\n* Atypical and or malignant lymphocytes quantifiable by flow cytometry or morphology in blood or bone marrow or \r\n* Modified severity-weighted assessment tool (mSWAT) > 0 or Sezary count >= 1000 cells/uL for CTCL
Have documented CD45 expression by leukemic cells via flow cytometry (a \blast gate\ on CD45 vs. side scatter analysis consistent with AML)
Diagnosis of PNH by flow cytometry
Additionally, patients who were previously MRD negative for >= 3 months after induction therapy with/without consolidative HDT/ASCT and have turned MRD positive (by flow cytometry) within the last 3 months and do not have any evidence of progressive disease are eligible.
Untreated, histological confirmed acute myeloid leukemia (AML) based on World Health Organization (WHO) 2008 criteria with Kit expression (CD 117) of myeloblasts >= 20% by flow cytometry from bone marrow aspirate at diagnosis
Patient must have > 10% disease burden measured by cytomorphology, flow cytometry, or cytogenetics
Individuals whose lymphoblasts have surface immunoglobulin by flow cytometry and/or known t(8;14), t(2;8), or t(8;22); absence of surface immunoglobulin by flow cytometry at time of initial diagnosis or relapse is sufficient to rule out mature B-cell leukemia; karyotype or fluorescent in situ hybridization (FISH) results documenting absence of t(8;14), t(2;8), or t(8;22) are not necessary prior to enrollment if absence of surface of immunoglobulin is documented by flow cytometry
At least 1 of the following high-risk features for previously untreated patients:\r\n* Rai stage II disease\r\n* Rai stage 0-I with disease-related fatigue\r\n* Serum beta 2 microglobulin (beta2M) >= 3 mg/L\r\n* Absolute lymphocyte count >= 25,000/uL\r\n* Unmutated immunoglobulin heavy variable cluster (IGHV) gene or IGHV3-21\r\n* Zeta-chain-associated protein kinase 70kDa (ZAP70) positive (>= 20% by flow cytometry or positive by immunohistochemistry)\r\n* CD38 positive (>= 30% by flow cytometry); OR\r\n* Deletion 11q or 17p by fluorescent in situ hybridization (FISH)
Tissue diagnosis of lymphoplasmacytic lymphoma with surface immunoglobulin G (IgG), immunoglobulin A (IgA) or immunoglobulin M (IgM) phenotype with a monoclonal heavy and light chain as determined by flow cytometry; all primary diagnostic lymph node and/or bone marrow biopsies will be reviewed at the University of Texas M.D. Anderson Cancer Center (UTMDACC)
Patients must have a diagnosis of B-ALL by flow cytometry, bone marrow histology, and/or cytogenetics
Patients must have CD19+ acute lymphoblastic leukemia (ALL) as confirmed by flow cytometry and/or immunohistochemistry
Diagnosis of CLL by immunophenotyping and flow cytometry analysis of blood or bone marrow.
Confirmed B-cell CLL/SLL with a characteristic immunophenotype by flow cytometry, and symptomatic disease requiring treatment
Confirmation of diagnosis of B cell malignancy and positivity for CD19 confirmed by the Laboratory of Pathology of the National Cancer Institute (NCI); the choice of whether to use flow cytometry or immunohistochemistry will be determined by what is the most easily available tissue sample in each patient; immunohistochemistry will be used for lymph node biopsies, flow cytometry will be used for peripheral blood, fine needle aspirates and bone marrow samples
With minimal residual disease (MRD) or relapse post-HSCT (for the phase I dose escalation) as evidenced by 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
Available allogeneic CD19CAR transduced tri-virus-specific cytotoxic T lymphocytes with >=15% expression of CD19CAR determined by flow cytometry and greater than 10% killing of one or more viral antigen pulsed targets in a cytotoxicity assay at an effector:target ratio of 20:1
Evidence of bone marrow MRD defined as ? 0.01% by flow cytometry performed in the study central lab
Patients with leukemic form of PTCL who will not have a measurable lesion in two dimensions by CT scan, relapsed or refractory disease must be detected by immunohistochemistry or flow cytometry and molecular clonality studies in bone marrow or peripheral blood
Greater than 20% aberrant intraepithelial lymphocytes (IEL) as assessed by flow cytometry
AML blasts must express CD30 (>= 10% expression as assessed by flow-cytometry or 2+ expression by immunohistochemistry) (whenever possible CD30 expression will be assessed by both methods)
Histological diagnosis of Diffuse Large B Cell Lymphoma (de novo or transformed) expressing CD19 by immunohistochemistry or flow cytometry analysis (>30% positivity), based on recent (less than 6 months) or new biopsy.
Presence of hepatopetal flow
Hematologic malignancy in complete remission with minimal residual disease (MRD) detectable by conventional cytogenetics, fluorescence in situ hybridization (FISH), flow cytometry, or molecular testing
Bone marrow and peripheral blood studies must be available for confirmation of diagnosis; cytogenetics, flow cytometry, and molecular studies (such as JAK-2, myeloproliferative leukemia [MPL] and calreticulin [CALR] mutational status) will be obtained as per standard practice
Available autologous T cells with >= 15% expression of CD30CAR determined by flow-cytometry required prior to treatment with ATLCAR.CD30 cells
The evidence of CD19+ expression on leukemia cells must be confirmed by pathology review of the bone marrow and/or peripheral blood specimens (flow cytometry and/or immunohistochemistry) collected at the time of current relapse and prior to the initiation of therapy