Table 5. T cells for lymphoma.
| NCT # (ACRONYM) | Disease Target | Cell Type | Age | Inclusion Criteria | Exclusion Criteria | Phase | Sponsor |
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| NCT00002663 | Lymphoma, leukemia, other adult and pediatric solid tumors | Allogeneic EBV-specific CTLs | Child Adult Snr | EBV+ LPD, lymphoma, or other EBV-associated malignancy OR Severely immunocompromised pts at high risk for EBV LPD(> 500 copies/ml EBV DNA in PB) following allo BMT; or allo organ transplant; or HIV-induced immunodeficiency; or congenital immune deficit; or anti-neoplastic or immune suppression tx; or non-immune-suppressed pts with EBV+ lymphoma, EBV+ HD, EBV+ NHL, EBV+ nasopharyngeal carcinoma, EBV+ hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma; Pregnant women | Moribund pts with heart, kidney, liver, lung, or neurologic dysfunction not related to lymphoma, who are unlikely to survive the 6-8 weeks required for in vitro generation and expansion of EBV-specific T cells to be infused and the subsequent 3 weeks required assess effects of infusions | I/II | Memorial Sloan Kettering Cancer Centre and NCI |
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| NCT01948180 (CITADEL) | EBV+ extranodal NK/T cell Lymphoma | Autologous EBV-specific CTLs (CMD-003) | ≥ 18y Adult Snr | SCREENING PHASE 1. extranodal NK/T lymphoma, EBV+ by EBER or LMP1 immunostaining 2. Active dz: relapse/progression,1st/2nd relapse following at least one cycle ABC OR initial dz or 1st/2nd relapse and unable to tolerate one full cycle ABC OR High-risk dz (stage III/IV, KPI grps 3-4 or IPI intermediate-high) prior to second CR regardless of previous chemotx. Weigh ≥ 35 kg; ECOG performance score 0-2, inclusively; Negative β-hCG women of childbearing potential; TREATMENT PHASE Relapse/progression following at least one prior cycle of ABC; Active dz: based on any one of the following at baseline or within 2 wks prior to baseline: Imaging; clinical sign(s): lymphomatous skin lesions, organ dysfunction or organomegaly not attributable to other causes; or other clinical sign(s); PB/plasma ENV DNA; Chemotx completed ≥ 2 wks prior to 1st study dose; Recovery from acute hematological, hepatic and renal chemotherapy-related toxicities as defined by ≤ Grade 1 according to NCI CTCAE v4.0; Life expectancy ≥ 8 weeks. | SCREENING PHASE CNS lymphoma; NK cell leukemia; Hemophagocytic lymphohistiocytosis; HIV+, hep B+, hep C+, syphilis+, HTLV+; Systemic corticosteroids >0.5 mg/kg/day within 10 d prior to obtaining 200 mL PB starting material; Pregnant or lactating; Active second malignancy; Prior alloHSCT or solid organ transplant; ARD:Progression during initial ABC & up to 3 mth after end of initial ABC; OR failure to achieve at least PR with initial ABC. ALC <400/μL; Any previous autologous EBV-specific T cell treatment; Any uncontrolled systemic infection; Third or greater relapse; TREATMENT PHASE Use of any investigational agents within prior 4 wks; Radiotherapy within prior 3 wks; Major surgery within prior 2 wks; Systemic corticosteroids within 24 h prior to study drug administration; Hepatic dysfunction: serum bilirubin >3 × ULN or ALT >5 times ULN or AST >5 times ULN | II | Cell Medica Ltd |
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| NCT00779337 | Lymphoma | Autologous AdE1-Latent Membrane Protein-specific CTLs | ≥ 18y Adult Snr | EBV+ lymphoma by in situ hybridization or equivalent (excluding Burkitts Lymphoma). ECOG performance status 1, 2 or 3 Life expectancy ≥ 6 mths; Measurable disease: relapsing/PR/refractory/PD dz by clinical examination or radiography (incl CT scans/functional imaging), or plasma EBV viral load; No chemotx/radiotx &/or antibody tx ≥ 2 wks prior to anticipated first infusion. | EBV negative tumour; Malignant cells in PB by flow cytometry or morphology; infection, positive serology for HIV I&II, H TLV1 or syphilis; Negative serology for EBV; Psychiatric, addictive or any condition which may compromise trial participation Serious infection within 28 days that has not adequately responded to tx; Pregnancy/not using contraception; Serology (within 3 mths of CTL release date) indicating active HBV or HCV | I | Queensland Institute of Medical Research, The Atlantic Philanthropies, Australian Department of Industry, Tourism and Resources, British Society Health and Medical Research Council, Australia for Haematology, National |
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| NCT00005606 | Lymphoma, Leukemia, Multiple Myeloma Plasma Cell Neoplasm | Allogeneic EBV-specific CTLs | Child Adult Snr (≤ 65 yrs) | Pts who have received or will receive a solid organ transplant or T cell depleted BMT EBV DNA+and seroneg OR EBV sero+ Matched or 1 HLA mismatched sib donor HIV neg Hep B surface antigen neg Hep C antibody neg No prior 1° malignancy within past 5 yrs in donor except previously resected skin cancer | None specified | II | Northwestern University, NCI |
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| NCT01636388 | HL | Allogeneic LMP-specific CTLs | Child Adult (≤ 45 yrs) | Off other investigational tx for 1 mth prior to entry in this study Adequate renal function: Serum creatinine <2.0 × ULN, or Creatinine clearance or radioisotope GFR > 40 ml/min/m2 or >60 ml/min/1.73 m2 or equivalent GFR; Adequate liver function: bilirubin <2.0 × ULN; and SGOT (AST) or SGPT (ALT) <5.0 × ULN; Adequate cardiac function: Shortening fraction of >27% by ECG; HL with: 1° induction failure (failure to achieve initial CR) and/or 1°refractory dz. 1st relapse. Early relapse (within 12 mth off tx) (excl those who received no tx or radiation tx only for initial tx); Late relapse (> 12 mths off tx). Only pts with recurrent Stage III or IV dz &/or B symptoms at relapse (all other late relapses excluded); 2nd relapse; 3rd relapse. History of prior ablative auto HSCT or ineligible for ablative auto HSCT or ≥25% RD after at least two reinduction chemo cycles. EBV sero+ IgG HLA matched family/MUD HLA matched family donor (6/6 or 5/6) MUD (7/8 or 8/8). Ideally have tissue from original dx specimen &/or relapse reviewed centrally for confirmation of HL. If no specimen avail, pathology documenting EBV+ status. Immunophenotyping to confirm dx will be performed. In situ hybridization for EBV (LMP1, and/or EBER) will be performed. All central morphologic, IHC/insitu hybridization performed in Sherrie Perkins & Rodney Miles lab at U of Utah. | HD with ≥ 4th CR, PR, and/or SD; Rapid PD unresponsive to reinduction chemo, radio, or immunotx; EBV neg HL; Patients with no eligible donor; Pregnancy | II | New York Medical College, Children's Research Institute Baylor College of Medicine M.D. Anderson Cancer Center City of Hope Medical Center Johns Hopkins University Ohio State University University of Utah University of Michigan |
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| NCT01956084 | HL, NHL, SCAEBV Lymphoepithelioma, Leiomyosarcoma | Allogeneic LMP1/2-specific CTLs | Child Adult Snr | EBV+ HL/NHL or EBV-associated-T/NK-LPD or lymphoepithelioma/leiomyosarcoma or severe Chronic EBV and in remission (group A) or with detectable dz (group B) after allo SCT Life expectancy > 6 weeks Tumor tissue EBV+; KPS/LPS > 50; Donor HIV neg; ≥ 50% donor chimerism in either PB or BM; Bilirubin <2× ULN, AST <5× ULN, and Hgb >8.0; Creatinine <2× ULN; Off other investigational tx 1 mth prior to entry in this study; | HIV+ GVHD > Grade II Pregnancy | I | Children's Research Institute |
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| NCT02057445 | HL, NHL, Lymphoproliferative disorder, | Allogeneic LMP-specific CTLs | Child Adult Snr (≥ 1yr) | Off other investigational tx 1 mth prior to entry in this study; Adequate renal function: Serum creatinine <2.0 × Must meet criteria as per 21 CFR 1271; ULN, or Creatinine clearance or radioisotope GFR > 40 ml/min/m2 or >60 ml/min/1.73 m2 or equivalent GFR; Adequate liver function: Total bilirubin <2.0 × ULN; and SGOT (AST) or SGPT (ALT) <5.0 × ULN; Adequate pulmonary function: Pulse oximetry >94%. LPS (< 16yr) or KPS (> 16 yrs) ≥ 50%; Life expenctancy ≥ 6 weeks; Negative urine pregnancy test; Clinical status at enrollment allows tapering steroids to < 0.5mg/kg/day prednisone at time of tx. HL/NHL LPD, SCAEBV: > 4000 genomes per μg PBMC DNA, &/or biopsy tissue EBV+ At dx unable to receive conventional chemotx or in 1st relapse AND not a candidate for HSCT PR after conventional tx. Refractory to conventional tx. In 2nd or subsequent relapse. RD after auto, syngeneic or allo HSCT; Ideally have tissue from original dx specimen &/or relapse reviewed centrally for confirmation of HL. If no specimen avail, pathology documenting EBV+ status. Immunophenotyping to confirm dx will be performed. In situ hybridization for EBV (LMP1, and/or EBER) will be performed. All central morphologic, IHC/insitu hybridization performed in Sherrie Perkins & Rodney Miles lab at U of Utah. DONOR ELIGIBILITY for LMP-CTL 3rd Party Banking: Adequate hematopoietic function: ANC > 1000/mm3, hemoglobin > 10 g/dl, platelet count >50,000/mm3 and EBV IgG sero+; ≥ 12 kg or 24 pounds; <18 years: max 3cc/kg blood in 8 wk period; min 60 cc PB × 2; For stem cell collection, PB for LMP specific CTLs collected prior to stem cell collection, no specific day specification; Must meet criteria as per 21 CFR 1271; |
Currently receiving any investigational agents or have received any tumor vaccines within previous 4 wks; Active acute grade III-IV GVHD; Severe refractory intercurrent infection other than EBV; Received alemtuzumab or other anti-Tcell antibody within 28 days. HIV sero+; Pregnancy or lactation; PTLD post solid organ transplantation eligible for the COG PTLD LMP/CTL protocol | I | New York Medical College, Children's Research Institute, Baylor College of Medicine, M.D. Anderson Cancer Center, University of Michigan, University of Utah, City of Hope Medical Center, Ohio University, Johns Hopkins University |
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| NCT01498484 | NHL, EBV infection | Allogeneic EBV-specific CTLs | Child Adult Snr | EBV+ LPD, lymphoma or other EBV-assocd malignancy; OR Current or prior PB EBV DNA > 500 copies/ml by qRT PCR; OR EBV DNA > 500 copies/ml in pts treated for EBV-LPD with chemotx &/or rituximab with no clinically or radiologically evaluable dz but high risk of recurrence; Availability of EBV-specific T cells for adoptive immune cell therapy from donor; 3rd party EBV-CTLs will be: 1) matched for ≥ 2 HLA antigens & 2) restricted by an allele shared with the EBV+ malignancy (if known), or with the donor in HSCT recipients, or patient in organ transplant or immunodeficient patients; KPS/LPS ≥ 20; Life expectancy ≥ 6 weeks; Adequate BM, heart, lung, liver & kidney function at tx initiation with EBV-specificT cells, including: ANC ≥ 1,000/μL +/- GCSF support; Platelets ≥ 20,000/μL; Creatinine ≤ 2.0mg/dl; ALT, AST < 3.0× ULN; Bilirubin < 2.5× ULN; Stable BP & circulation not requiring pressor support; Adequate cardiac function (EKG &/or ECG within 30 days prior to treatment); Abnormalities of specific organs not grounds for exclusion if arising from EBV+ malignancy or its tx (e.g. renal allograft recipient with EBV LPD on dialysis due allograft rejection after immune suppression stopped); EBV+ lymphoma or LPD following allo HSCT; or allo organ transplant, or due to HIV-induced profound acquired immunodeficiency; or other EBV-assocd malignancy due congenital immune deficit or sequela of antineoplastic or immunosuppressive tx; EBV-assocd malignancies without pre-existing immune deficiency, including: EBV+ HD & NHL, EBV+ nasopharyngeal carcinoma, EBV+ hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma. | Active (grade 2-4) aGVHD, cGVHD or overt autoimmune disease (e.g. hemolytic anemia) requiring glucocorticosteroid (>0.5 mg/kg/day prednisone or equiv); Pregnancy; Severe comorbidities, unrelated to EBV-associated malignancy, that would be expected to preclude their survival for the 6 wks required to assess response of T cell therapy Patients eligible for MSK protocol #16-803 (EBV-CTL-201) | II | Atara Biotherapeutics, Memorial Sloan Kettering Cancer Centre |
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| NCT01447056 | HL, NHL, Lymphoproliferative disease, Nasopharyngeal Carcinoma, Leiomyosarcoma, SCAEBV | Allogeneic LMP-specific CTLs | Child Adult Snr |
SCREENING EBV+ HL, NHL, LPD, Nasopharyngeal carcinoma, Leiomyosarcoma, SCAEBV, EBV load in plasma or PBMC > 4000 genomes per ug PBMC DNA &/or biopsy tissue EBV+; KPS/LPS ≥ 50%; TREATMENT EBV+ HL, NHL, LPD, Nasopharyngeal carcinoma, Leiomyosarcoma, SCAEBV, EBV load in plasma/PBMC > 4000 genomes per ug PBMC DNA &/or biopsy tissue EBV+; At dx or in 1st relapse AND unable to receive chemotx OR in 2nd or subsequent relapse OR with RD after auto, syngeneic or allo HSCT; Life expectancy ≥ 6 wks; Tumor tissue EBV+; KPS/LPS score ≥ 50%; Bilirubin < 3 × ULN; AST < 5 × ULN; Hgb > 8.0 g/dL; Serum creatinine < 3 less × ULN; Pulse oximetry > 90%; If post allo HSCT, patient ≥50% donor chimerism in either PB or BM; Clinical status at enrollment allows tapering steroids to < 0.5 mg/kg/day prednisone at tx; Willing to utilize birth control during study and 3 mths after study conclusion. |
SCREENING HIV+; TREATMENT Currently receiving any investigational agents or have received any tumor vaccines within previous 4 wks; Active acute grade III-IV GVHD; Severe intercurrent infection; Alemtuzumab or other anti-T-cell antibody within 28 days; HIV seropositivity; Pregnancy or lactation; Tumor in location where enlargement could cause airway obstruction |
I | Baylor College of Medicine |
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| NCT01555892 (GRALE) | HL, NHL, T/NK lymphoproliferative Disease Lymphoma | Autologous or syngeneic donor LMP1/2, EBNA-1 and BARF-specific CTLs | Child Adult Snr | EBV+ HL/NHL or EBV-assocd T/NK-LPD or SCAEBV ≥ 12 kg In 2nd or subsequent relapse (or 1st relapse or with active dz if immunosuppressive chemotx contraindicated; or multiply relapsed patients in remission who have a high risk of relapse); OR any patient with 1° dz or in 1st remission if immunosuppressive chemotx contraindicated, e.g. HD after solid organ transplant or if Lymphoma is a 2nd malignancy e.g. Richter's transformation of CLL. (Group A) OR In remission or MRD after auto or syngeneic SCT (Group B); Life expectancy ≥ 6 wks; Bilirubin ≤ 3× ULN; AST ≤ 5× ULN; Hgb > 8.0; creatinine ≤2× ULN; Pulse oximetry > 90%; Off other investigational therapy 4 wks prior to entry in this study. KPS/LPS ≥ 50; Willing to utilize birth control during study and 3 mths after study conclusion. | Active infection with HIV, HTLV, HBV, HCV; Pregnant or lactating; Severe intercurrent infection; Current systemic corticosteroids > 0.5 mg/kg/day | I | Baylor College of Medicine, NCI |
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| NCT00062868 | HL, NHL, Lymphoepithelioma, Leiomyosarcoma | Autologous or allogeneic LMP1/2-specific CTLs | Child Adult Snr | In 2nd or subsequent relapse (or 1st relapse or with active dz if immunosuppressive chemotx contraindicated; or multiply relapsed patients in remission who have a high risk of relapse); OR any patient with 1° dz or in 1st remission if immunosuppressive chemotx contraindicated, e.g. HD after solid organ transplant or if Lymphoma is a 2nd malignancy e.g. Richter's transformation of CLL. (Group A) OR In remission or MRD after autol or syngeneic SCT. (Group B); OR detectable dz after alloSCT (Group C); Life expectancy ≥ 6 wks; KPS/LPS ≥ 50; ≥ 50% donor chimerism in either PB or BM if post alloSCT; Bilirubin ≤ 3× ULN; AST ≤ 5× ULN; Hgb > 8.0; creatinine ≤2× ULN; Off other investigational tx 1 mth prior to entry into study | Severe intercurrent infection; HIV+ donors or HIV+ pts if autologous product to be used > Grade II GVHD Pregnancy | I | Baylor College of Medicine |
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| NCT02287311 (MABEL) | HL, NHL, SCAEBV, T/NK-lymphoproliferative Disease | LMP, BARF-1 and EBNA1- specific | Child Adult Snr | EBV+ HL; EBV+ NHL; EBV-assocd T/NK-LPD, or SCAEBV (>4000 EBV genomes per ug PBMC DNA) &/or biopsy tissue EBV+ AND in 1st or subsequent relapse (Group A); with active dz persisting despite tx (Group B); with active dz if immsupp chemotx contraindicated e.g. pts who develop HD after solid organ transplant or if lymphoma = 2nd malignancy e.g.Richter's transformation of CLL (Group C); ≥ 12kg; | Pregnant or lactating; Severe intercurrent infection; Current systemic corticosteroids > 0.5 mg/kg/day; Receiving ATG, Campath, or other immunosuppressive T cell monoclonal antibodies within 30 days. | I | Baylor College of Medicine |
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| NCT00002663 | Lymphoma, Leukemia, Unspecified Adult Solid Tumor, Protocol Specific Unspecified Childhood Solid Tumor, Protocol Specific | Allogeneic EBV-specific CTLs | Child Adult Snr | EBV+ LPD, lymphoma, or other EBV-assocd malignancy OR Severely immunocompromised pts with PB levels EBV DNA > 500 copies/ml at high risk for EBV LPD; Incl pts with/at risk for EBV lymphomas or LPDpost allo BMT or allo organ transplant; AIDS pts w/EBV lymphomas/LPD due HIV-induced acquired immunodeficiency; EBV lymphomas/LPD due congenital imunodeficiencies or acquired as asequela of anti-neoplastic or immsupp tx; EBV+ HD & NHD, EBV+ nasopharyngeal carcinoma, EBV+ hemophagocytic lymphohistiocytosis, or EBV+ leiomyosarcoma in immune compentent pts; Pregnancy not contraindicated for infusions of EBV-specific T cells | Moribund patients who due heart, kidney, liver, lung, or neurologic dysfunction unrelated to lymphoma, are unlikely to survive the 6-8 wks required for in vitro generation and expansion of EBV-specific T cells to be used for tx & the subsequent 3 wks required to assess effects of infusions of EBV-specific T cells. | I/II | Atara Biotherapeutics, Memorial Sloan Kettering Cancer Centre, NCI |
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| NCT02973113 (PREVALE) | HL, NHL, Lymphoproliferative Disorders, EBV-related Lymphoma, EBV-Related PTLD, EBV-Related NHL EBV-Related HL | Autologous EBV-specific CTLs+nivolumab (anti-PD-1 mAB) | Child Adult Snr | PROCUREMENT EBV+ HL or NHL or EBV-assoc T/NK/B cell LPD. 1st 3 pts will be adults. Pts <18 years of age eligible if 1st 3 pts don't experience DLT considered to be primarily related to EB-VST or Nivolumab; Relapsed or refractory lymphoma who failed or are ineligible for autoHSCT; ≥12kg; Life expectancy ≥ 6 weeks. TREATMENT As above AND HL in 2nd relapse or 1st relapse & refractory to at least 2 lines salvage chemotx incl Brentuximab Vedotin or 1° refractory dz after at least 2 lines tx OR NHL in 1st relapse and/or refractory to at least one salvage chemotx or with 1° refractory disease after at least 2 lines of tx or in 2nd or subsequent relapse OR T/NK- or B LPD in 1st relapse &/or refractory to at least one salvage chemotx or with 1° refractory dz after at least 2 lines of tx or in 2nd or subsequent relapse; Life expectancy > 6 weeks; Bilirubin ≤ 3× ULN; AST ≤ 5× ULN; Hgb > 8.0; creatinine ≤2× ULN; pulse oximetry > 90%; Off other investigational therapy 4 wks prior to entry in this study; KPS/LPS > 60; Recovered from acute toxic effects of chemotx at ≥ 1 week before entering study; Willing to utilize birth control during study and 6 mths after study conclusion. | PROCUREMENT Active HIV, HTLV, HBV, HCV infection; Hx of solid organ transplant; TREATMENT Pregnant or lactating; Severe active intercurrent infection; Current systemic corticosteroids >0.5 mg/kg/day; Current investigational agents or radiotx within 4 wks prior to entering study; CNS involvement; Hx of allergic rx n attributed to nivolumab or other checkpoint inhibitors; Uncontrolled autoimmune dz needing systemic steroids or steroid sparing agents except for hypothyroidism or type I diabetes. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhy thmia, or psychiatric illness/social situations that would limit compliance with study requirements. Lipase > 70U/ml | I | Baylor College of Medicine |
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| NCT01333046 (TACTAL) | HL, NHL | 5-azacytadine+ autologous NY-ESO-1, MAGEA4, PRAME, Survivin and SSX-specific CTLs | Adult Snr ≥ 18y | PROCUREMENT HL or NHL Life expectancy ≥ 6 weeks; Hgb > 8.0 TREATMENT: Group A: ≥ 18 years old with active dz: in 2nd or subsequent relapse; in 1st relapse for indolent lymphoma after first-line tx for relapse; or 1st relapse if immsupp chemotx contraindicated; 1° refractory dz or persistent dz after 1st-line tx of relapse; multiply relapsed patients in remission at high risk of relapse; lymphoma is a 2nd malignancy e.g. Richters transformation of CLL after failing front line tx. Group B: ≥ 18 years old after auto or syngeneic SCT (as adjuvant tx) Group C: 5-azacytidine plus multiTAA-T cells. ≥18 years old with active dz in: 2nd or subsequent relapse; 1st relapse for indolent lymphoma after 1st line tx for relapse; 1st relapse if immsupp chemotx contraindicated; with 1° refractory dz or PD after 1st line tx of relapse; or lymphoma as 2nd malignancy e.g. Richters transformation of CLL after failing front line therapy GROUP D: ≤18 yrs old with active disease in: 2nd or subsequent relapse; 1st relapse for indolent lymphoma after 1st line tx for relapse; 1st relapse if immsupp chemotx contraindicated; with 1°refractory dz or persistent dz after 1st line tx of relapse; lymphoma as 2nd malignancy e.g. Richters transformation of CLL after failing front line tx; Life expectancy ≥ 6 weeks; Pulse oximetry ≥95 percent having previously received radiation tx; KPS/LPS > 50; Bilirubin ≤ 2× ULN; AST ≤ 3× ULN; Hgb > 8.0; platelets > 25,000 (Group C only); Creatinine ≤ 2× ULN; Off other investigational tx for 1 mth prior to entry in this study; Off conventional tx ≥ 1 wk prior to entry in this study, including rituximab; Females of child-bearing potential: at least 2 forms contraception unless hx of hysterectomy or tubal ligation; | PROCUREMENT: Severe intercurrent infection; Active HIV infection; Systemic corticosteroids. TREATMENT: Severe intercurrent infection; Systemic corticosteroids; Pregnant or breastfeeding; Abnormal coagulation parameters (PT > 15 s, PTT > 40 s &/or INR > 1.5) Significant active cardiac dz within previous 6 mths incl: NYHA class 4 CHF; Unstable angina; MI; Active HIV or hepatitis B or C infection defined PB reactive for Hep B, C and/or HIV confirmed with qPCR; Known or suspected hypersensitivity to azacitidine or mannitol; Advanced malignant hepatic tumors | I | Baylor College of Medicine, NCI |
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| NCT02203903 (RESOLVE) | Relapsed/Refractor y Hematopoietic Malignancies | Autologous or allogeneic WT1, NE, PR3, PRAME, MAGE-A3, MAGE-A4, NY-ESO, and survivin-specific CTLs | Child Adult 6mo-65y | PROCUREMENT Allo-HSCT with high risk for relapse or residual/recurrent dz OR relapsed/refractory dz (> 2 regimens with > M1 marrow or persistent HD) with anticipated allo-HSCT pre- and/or post-HSCT; ALL, AML, Ambiguous lineage leukemia or lymphoma, CML, MDS: Evidence of active leukemia or lymphoma by flow cytometry/morphology/cytogenetic evaluation in BM or extramedullary sites; HD by morphology, PET/CT uptake in site of previous dz in absence of other etiologies; KPS/LPS > 50; ANC > 500/μL +/- GCSF; Bilirubin < 2.5 mg/dL, AST/ALT <5× ULN, Serum creatinine < 1.0 or 2× ULN (whichever is higher); Pulse oximetry > 90%; LVEF > 50% or LVSF > 27% if hx of TBI; Agree to contraception during study protocol participation (age appropriate) TREATMENT Steroids < 0.5 mg/kg/day prednisone or equivalent KPS/LPS > 50 Pulse oximetry > 90% | PROCUREMENT Uncontrolled infections; HIV infection; Current GVHD > grade 2 or bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis; Pregnancy or lactating TREATMENT Receiving ATG, or Campath or other immsupp T cell mABs within 28 days of screening for enrollment. Uncontrolled infections Acute GVHD > grade 2 or cGVHD manifestations: bronchiolitis obliterans syndrome, sclerotic GVHD, or serositis. | I | Children's Research Institute, Johns Hopkins University |
HD: Hodgkin Disease; HL: Hodgkin lymphoma; NHL: Non-Hodgkins Lymphoma; SCAEBV: severe Chronic Active EBV Infection Syndrome; CTL: cytotoxic T lymphocyte; NCI: National Cancer Institute; DZ: disease; HTLV: human T Cell leukemia virus; ARD: Asparaginase refractory disease; ABC: asparaginase-based chemotherapy; ALC: Absolute lymphocyte count; EBV: Epstein Barr virus; EBER: EBV encoded RNA; ECOG: Eastern Cooperative Oncology Group; NCI CTCAE v4.0: National Cancer Institute Common Terminology Criteria for Adverse Events; PR: partially responsive/partial response; PD: progressive disease; incl: including/includes; sib: sibling; ECG: echocardiogram; neg: negative; 1°: primary; 2°: secondary; RD: residual dz; MUD: or matched unrelated adult donor; SCAEBV: Severe chronic active EBV infection syndrome;qRT-PCR: quantitative real time PCR; Immsupp: immunosuppressive; DLT: dose limiting toxicity; Hx: history; rxn: reaction; MI: Myocardial infarction; TBI: total body irradiation; LVEF: left ventricular ejection fraction; LVSF: left ventricular shortening fraction; mAB: monoclonal antibodies;