Patients with evidence of metastatic disease will be excluded; any evidence of non-contiguous spread beyond the primary site as determined by pre or post-operative magnetic resonance (MR) imaging of brain, pre or post-operative MR imaging of the spine, and post-operative cerebrospinal fluid (CSF) cytology obtained from the lumbar CSF space (the requirement for lumbar CSF examination may be waived if deemed to be medically contraindicated); CSF cytology from a ventriculostomy or permanent ventriculoperitoneal (VP) shunt that reveals the presence of tumor cells is indicative of metastatic disease
No G-CSF (filgrastim) or GM-CSF (sargramostim) within 7 days of registration or pegfilgrastim within 14 days of registration to meet eligibility criteria
Patient must have negative lumbar cerebrospinal fluid (CSF) cytology; CSF cytology for staging should be performed preferably no sooner than 14 days post operatively to avoid false positive CSF; ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study\r\n* Note: patients with positive CSF cytology obtained prior to 14 days after surgery may have cytology repeated to determine eligibility and final CSF status
Patients with metastatic disease by either MRI evaluation (brain and spine) or lumbar CSF cytology are not eligible; patients who are unable to undergo a lumbar puncture for assessment of CSF cytology are ineligible
Lumbar CSF must be assayed for cytology, alpha fetoprotein (AFP) and beta human chorionic gonadotrophin (HCGbeta); a quantitative serum determination of AFP and HCGbeta should be performed at the time of the lumbar CSF assay
For histologically unconfirmed MMGCT, serum and/or CSF tumor markers of HCGbeta > 100 mIU/ml or any elevation of above AFP > 10 IU/L (ng/ml) and/or above institutional norm in the serum and CSF AFP >= 2 IU/L (ng/ml) and/or institutional norm
Patients with no elevations of serum and/or CSF HCGbeta and AFP must have histological diagnosis of malignant GCT or germinoma
Patient must have lumbar CSF for cytology, protein, AFP and HCGbeta within 7 days prior to registration
4. Receipt of G-CSF, GM-CSF or erythropoietin within 28 days prior to study entry or receiving TAB001;
Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 4 weeks prior to study Day 1.
G-CSF: 14 days
GM-CSF or Neulasta®: 21 days
Received 3-bis(2-chloroethyl)-1nitrosourea (BCNU or Carmustine) within 6 weeks prior to anticipated first dose of G-CSF.
Received G-CSF within 14 days prior to anticipated first dose of G-CSF.
Received Pegfilgrastim (GM-CSF or Nulesta) within 3 weeks prior to anticipated first dose of G-CSF.
Received erythrocyte of platelet stimulating agents within 30 days prior to anticipated first dose of G-CSF
Recent use of hematopoietic colony-stimulating growth factors (e.g. G-CSF, GMCSF, M-CSF) Additional exclusion criteria for Combination arm PDR001+canakinumab and single-agent canakinumab
Transfusion of blood products (including platelets or red blood cells[RBCs]) or administration of colony stimulating factors (including G-CSF, GM-CSF or recombinant erythropoietin) within 1 week of the NGS blood sample during screening, and 4 weeks of the first dose of mRNA-4157 or pembrolizumab
Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM-CSF, M-CSF) ? 2 weeks prior to start of study drug
Patients who have received G-CSF since the time of diagnosis of the current disease
DONOR: Known allergy to filgrastim (G-CSF)
Phase I/II: CSF sampling required to document LM if not documented by MRI; NOTE: patients are still eligible if CSF is negative but LM disease is documented on MRI
Concurrent external beam radiation is not allowed with the exception of palliative radiotherapy to a localized region for pain control (i.e. vertebral disease, pelvis, etc) which IS allowed while on the study protocol \r\n* NOTE: patients may need a CSF flow study at the discretion of the treating principal investigator; if a spinal block is seen by CSF flow study or MRI, it will need local RT prior to treatment
Treating physician or considers the potential HLA haploidentical donor to be ineligible to receive G-CSF, and/or concern on the part of the treating physician for risk of harm to the potential donor with administration of G-CSF, and/or refusal by the potential donor (or donor’s guardian) to receive G-CSF
History of clinical hypersensitivity to the designated combination immunotherapy, GM-CSF, Interferon-alpha-2b (Merck), yeast, beef, or to any components used in the preparation of the experimental vaccine.
Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF, or recombinant erythropoietin) within 4 weeks prior to the first dose of study treatment
Received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or recombinant erythropoetin) within 4 weeks prior to the first dose of study treatment.
History of clinical hypersensitivity to GM-CSF, Interferon-alpha-2b (Merck), yeast, beef, or to any components used in the preparation of the experimental vaccine.
Patient has a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX vaccine
Known allergy or hypersensitivity to Keyhole Limpet Hemocyanin (KLH), sargramostim (GM-CSF) or yeast derived products, or a history of anaphylactic reactions to shellfish proteins
Evidence of cerebrospinal fluid (CSF) dissemination (positive CSF cytology for malignancy or MRI findings with CSF dissemination)
Patients may not have any known allergy to CYP and/or GM-CSF.
Patients with contraindications to CYP and/or GM-CSF.
Patient has a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX pancreas vaccine or CRS-207 (e.g., glycerol)
Patients treated with growth factors targeting the myeloid lineage (e.g. G-CSF, GM-CSF and M-CSF) within 2 weeks of starting study treatment. (applicable to combination part only).
Hematopoietic growth factors- At least 7 days must have elapsed since the last dose of G-CSF or GM-CSF. At least 14 days must have elapsed since last dose of pegfilgrastim (Neulasta®).
Patients with a history of allergic reactions to filgrastim (GM-CSF) or the tetanus vaccine
Patient has a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX pancreas vaccine
ADDITIONAL CRITERIA FOR STUDY CONTINUATION: Patient has a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX pancreas vaccine
Known hypersensitivity to any of the products used in the trial – G-CSF (Neupogen, filgrastim), plerixafor (Mozobil), or any components of the chemotherapeutic agents or O6BG/BCNU in vivo selection regimens
Patients with a known or suspected hypersensitivity to GM-CSF (sargramostim), Cytoxan, pentastarch or hetastarch, corn, or dimethyl sulfoxide (DMSO)
Cytokine therapy (e.g. filgrastim [G-CSF], sargramostim [GM-CSF], interleukin [IL]-6, IL-2): must be discontinued a minimum of 24 hours prior to MIBG therapy
Known allergy to sargramostim (GM-CSF)
History of allergy to GM-CSF
Known hypersensitivity to 5AC or GM-CSF
Patients for who clinical suspicion is present of metastatic disease in the cerebrospinal fluid (CSF) or spine must have magnetic resonance imaging (MRI) of spine and CSF obtained (lumbar puncture or through Ommaya, external ventricular drain [EVD] or shunt) with negative cytology; patients with CSF that is positive for tumor cells or metastatic disease found on MRI are ineligible
Off all colony forming growth factor(s) >= 2 weeks prior to registration (filgrastim [G-CSF], sargramostim [GM-CSF], erythropoietin)
Lumbar cerebrospinal fluid (CSF) must be assayed for cytology, alpha fetoprotein (AFP) and beta human chorionic gonadotrophin (HCGB); a quantitative serum determination of AFP and HCGB should be performed at the time of the lumbar CSF assay
For histologically unconfirmed MMGCT, serum and/or CSF tumor markers of HCG? > 100 mIU/ml or any elevation of AFP > 10 IU/L (ng/ml) and/or institutional norm in the serum and CSF AFP > 2 IU/L (ng/ml) and/or institutional norm
Patient must have lumbar CSF for cytology, protein, AFP and HCGB within 7 days prior to registration
Received the last irradiated GM-CSF transfected allogeneic pancreatic cell lines Panc 10.05 and Panc 6.03 at least six months prior (+/- 1 month) (not applicable to the vaccine-naïve cohort patients)
Previous vaccination with the allogeneic GM-CSF-secreting breast tumor vaccine
DONOR: No contraindication to the administration of filgrastim (G-CSF)
White blood cell (WBC) > 2.5 x 10^9/L with an absolute neutrophil count (ANC) > 1.5 x 10^9/L and off G-CSF or sargramostim (GM-CSF_ for 10 days or pegfilgrastim (Neulasta) for 21 days
WBC > 2.5 x 10^9/L with an ANC > 1.5 x 10^9/L and off G-CSF for 3 days
Patients with MRI evidence of LMD, with or without evidence of malignant cells in CSF (“positive cytology”), or; patients with evidence of malignant cells in the CSF (positive cytology), with or without MRI evidence of LMD, or; patients with surgically-proven LMD (leptomeningeal involvement on pathology review) +/- MRI or CSF evidence by MRI or CSF cytology (Cohort D)
Concurrent or prior bone marrow factors (e.g. G-CSF, GM-CSF or erythropoietin) within 3 weeks prior to Day 1 of treatment.
Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug.
Patients may not have any known allergy to CYP and/or GM-CSF.
Patients with contraindications to CYP and/or GM-CSF.
Patients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF]) =< 2 weeks prior to starting study drug; erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued; packed red blood cell (PRBC) transfusion at least four weeks prior to start of therapy is allowed
Lumbar CSF cytology is not required, but may be performed if clinically indicated prior to study enrollment. If lumbar CSF cytology is positive, the patient is considered to have M+ disease and is ineligible \r\n* Note: False positive cytology can occur within 10 days of surgery
Previous treatment with CSF-1R kinase inhibitor or CSF-1R blocking antibody.
Have received cancer therapies including chemotherapy, radiation, biologic, or kinase inhibitors, G-CSF, or GM-CSF within 3 weeks prior ot the first scheduled dose of CMB305
Evidence of cerebrospinal fluid (CSF) dissemination (positive CSF cytology for malignancy or MRI findings consistent with CSF dissemination).
Known hypersensitivity reaction to GM-CSF
Patient must not have received filgrastim (G-CSF, Neupogen) within 7 days of enrollment
Patients must be newly diagnosed with localized primary CNS NGGCT (Stratum 1) or localized primary CNS germinoma (Stratum 2); germ cell tumors located in the suprasellar, pineal, bifocal (pineal + suprasellar) and ventricles are eligible; tumors present in the above mentioned locations and with unifocal parenchymal extension are eligible\r\n* Stratum 1(NGGCT): Patients must have one of the following criteria:\r\n** Patients with serum and/or CSF hCGbeta > 100 mIU/mL or any elevation of serum and/or CSF alpha-fetoprotein (AFP) > 10 ng/mL or greater than the institutional normal are eligible, irrespective of biopsy results\r\n** Patients with any of the following elements on biopsy/resection are eligible, irrespective of serum and/or CSF hCGbeta and AFP levels: endodermal sinus tumor (yolk sac), embryonal carcinoma, choriocarcinoma, malignant/immature teratoma, and mixed GCT with malignant GCT elements\r\n* Stratum 2 (Germinoma): Patients must have both serum and CSF markers obtained (unless obtaining CSF is medically contraindicated) and must have one of the following criteria to be eligible:\r\n** Patients with institutional normal AFP (or =< 10 ng/mL if no institutional normal exists) in both serum and CSF (unless medically contraindicated) AND hCGbeta 5 to =< 50 mIU/mL in serum and/or CSF (unless medically contraindicated) (only 1 is required to be elevated) are eligible; no histologic confirmation required\r\n** Patients with bifocal (pineal + suprasellar) involvement or pineal lesion with diabetes insipidus (D1) AND hCGbeta =< 100 mIU/mL in serum and/or CSF AND institutional normal AFP (or =< 10 ng/mL if no institutional normal exists) in both serum and CSF (unless medically contraindicated) are eligible; no histologic confirmation required\r\n** Patients with histologically confirmed germinoma or germinoma mixed with mature teratoma and hCGbeta =< 100 mIU/mL in serum and/or CSF and institutional normal AFP (or =< 10 ng/mL if no institutional normal exists) in both serum and CSF (unless medically contraindicated) are eligible
Lumbar CSF must be obtained prior to study enrollment unless medically contraindicated; if a patient undergoes surgery and lumbar CSF cannot be obtained at this time, then it should be performed at least 10 days following surgery before study enrollment; false positive cytology can occur within 10 days of surgery; Note: patients with positive CSF cytology obtained prior to 10 days after surgery may have cytology repeated to determine eligibility
Patients must have CSF tumor markers obtained prior to enrollment unless medically contraindicated; ventricular CSF obtained at the time of CSF diversion procedure (if performed) is acceptable for tumor markers but lumbar CSF is preferred; in case CSF diversion and biopsy/surgery are combined, CSF tumor markers should be collected first
Patients with metastatic disease by cranial or spinal MRI evaluation or CSF cytology (unless medically contraindicated) are not eligible
Relapsed/refractory primary vitreoretinal diffuse large B cell lymphoma (DLBCL) with a CNS lesion, with CSF relapse with positive CSF cytology, or with ocular relapse with positive ocular tissue biopsy; NOTE: tissue biopsy requirement of the CNS lesion is as outlined in bullet above
Patients must not have received chemotherapy within 4 weeks, pegfilgrastim (PEG-G-CSF) (Neulasta) within 4 weeks or filgrastim (G-CSF) (Neupogen) within 2 weeks prior to enrollment
Lumbar cerebrospinal fluid (CSF) cytology examination must be obtained pre-operatively or within 31 days following surgery; the optimal time for obtaining CSF is prior to surgery or 1-3 weeks following surgery; ventricular CSF (either pre- or post-op) may be used only if a post-operative spinal tap is contraindicated; if a spinal tap is contraindicated and there is no ventricular CSF available, then CSF cytology can be waived for patients with supratentorial tumors or if there is documentation of spinal subarachnoid metastases (M3); patients who are categorized as M1 must have either an intra-operative positive CSF (via lumbar puncture at the end of the procedure) or a positive lumbar CSF obtained > 7 days post-operatively
Blood transfusion will be allowed for patients with hemoglobin less than 9 g/dl and filgrastim (G-CSF) is allowed for neutropenic patients at time of enrollment; chemotherapy treatment can only be administered 48 hours post G-CSF therapy
Evaluation of lumbar CSF cytology (cytospin preparation for microscopic evaluation) must be performed either pre-operatively or at least 10 days after definitive surgery unless contraindicated
Patients with a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide (DMSO), fetal bovine serum, or trypsin (porcine origin)
Subjects must complete the filgrastim (G-CSF)/plerixafor mobilization of peripheral blood progenitor cells
Use of hematopoietic colony-stimulating growth factors (e.g. filgrastim [G-CSF], sargramostim [GMCSF], lanimostim [M-CSF]) =< 2 weeks prior to starting study drug; erythropoietin, darbepoetin and erythropoietin-biosimilars are allowed for as long as they have been initiated at least 2 weeks prior to study enrollment
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L without use of pegfilgrastim in the preceding 21 days and without non-pegylated filgrastim (G-CSF) or sargramostim (GM-CSF) within 7 days prior to study entry
Patient must have negative lumbar cerebrospinal fluid (CSF) cytology (lumbar CSF must be obtained unless medically contraindicated); CSF cytology for staging should be performed preferably no sooner than 14 days post operatively to avoid false positive CSF, ideally, CSF should be obtained between day 14 and day 21 to allow for final staging status before enrollment onto the study; Note: patients with positive CSF cytology obtained prior to 14 days after surgery may have cytology repeated to determine eligibility and final CSF status
Patients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF]) =< 2 weeks prior to starting study drug; erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued
Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, G-CSF or GM-CSF within 3 weeks prior to the first scheduled CMB305 dosing
No prior G-CSF, GM-CSF or plerixafor within 14 days of study drug dosing
Cancer therapies, including chemotherapy, radiation, biologics or kinase inhibitors, G-CSF or GM-CSF within 3 weeks prior to the first scheduled LV305 dosing. For patients enrolled in Part 2, Site-specific Amendment, erythropoietin, G-CSF, and GM-CSF will be allowed and anti-PD-1 therapy may be given within 3 weeks if it follows their prior treatment schedule.
Known hypersensitivity reaction to the GM-CSF adjuvant; Any known contra-indication to GM-CSF or Cyclophosphamide treatment;
Cancer therapies, including chemotherapy, radiation (non-study regimen related), biologics or kinase inhibitors, G-CSF or GM-CSF within 4 weeks prior to the first scheduled G100 dose
Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF or recombinant erythropoetin) within four weeks prior to study Day 1.
Absolute neutrophils count inferior to 1000 per ?L (1 x 10E9/L). The use of G-CSF is not allowed to reach this level.
Previous exposure to filgrastim, pegfilgrastim, or other G-CSF products in clinical development within 12 months prior to the administration of study drug
Patients must not have known allergic reactions to GM-CSF or the tetanus vaccine
DONOR: Unable to participate in a leukopheresis procedure or receive G-CSF (filgrastim)
Known hypersensitivity to GM-CSF
For patients with LM: Confirmed diagnosis of LM by positive CSF cytology.
For patient with LM, inability to undergo collection of CSF
Known hypersensitivity reaction to the GM-CSF adjuvant
Previous use of pexidartinib or any biologic treatment targeting CSF-1 or the CSF-1R; previous use of oral tyrosine kinase inhibitors, eg, imatinib or nilotinib, are allowed.
Patients with parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head computed tomography [CT]) 21 days prior to study registration; for patients with leptomeningeal disease only, CSF cytology must document lymphoma cells and/or imaging findings consistent with CSF disease 21 days prior to study registration
Patient has a known or suspected hypersensitivity to GM-CSF, hetastarch, corn, dimethyl sulfoxide, fetal bovine serum, trypsin (porcine origin), yeast or any other component of GVAX pancreas vaccine or CRS-207 (e.g., glycerol)
Patients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF]) =< 2 weeks prior to starting study drug; erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued
Patients who have received any hemopoietic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF]) within 2 weeks prior to study start
Current treatment with lenalidomide, thalidomide, imiquimod, interferon, cytokines (filgrastim [G-CSF], sargramostim [GM-CSF], interleukin 1 receptor alpha [IL-1Ra]), tumor necrosis factor alpha [TNFa] antagonists, or lithium
Patients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF]) =< 2 weeks prior to starting study drug; erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued
Concurrent use of sargramostim (GM-CSF); filgrastim (G-CSF) could be used for the short-term management of neutropenic infection; stable doses of erythropoietin stimulating agents that were started > 8 weeks from first ruxolitinib dose or corticosteroids that were being administered prior to screening are allowed
Patients must have recovered from the acute toxicity of all prior chemotherapy; patients may not have received cytotoxic chemotherapy within 2 weeks of first dose of G-CSF (filgrastim) therapy, with exception of hydroxyurea, which is allowed for up to 24 hours prior to first dose of G-CSF, and intrathecal chemotherapy, which is allowed prior to, or in the 1st 72 hours after start of G-CSF therapy
No prior treatment with cytarabine or clofarabine; prior hydroxyurea for control of leukocytosis or use of hematopoietic growth factors (eg, filgrastim [G-CSF], sargramostim [GM-CSF], Procrit, Aranesp, thrombopoietins) is allowed at any time prior to or during study if considered to be in the best interest of the patient
Patients must not have known allergic reactions to GM-CSF
Treated with any hematopoietic colony-stimulating growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF]) =< 2 weeks prior to starting study drug; erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued
Concurrent use of filgrastim (G-CSF) except for the short-term management of neutropenic infection; stable doses of erythropoietin stimulating agents or corticosteroids that were being administered prior to screening are allowed
Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including G-CSF, GM-CSF, or recombinant erythropoietin) within 4 weeks prior to Study Day 1
Known hypersensitivity to GM-CSF, yeast-derived products or any component of the GM-CSF drug product (e.g., mannitol) or poly-ICLC (e.g., carboxymethylcellulose).
Cytology and tumor markers: serum and lumbar CSF must be obtained to evaluate for alpha fetoprotein (AFP) and beta human chorionic gonadotropin (HCG); any patient with elevated AFP (serum > 10 IU/L and CSF > than institutional norm) or elevated B-HCG (serum or CSF > 100 IU/dL) will be considered to have a nongerminomatous germ cell tumors (NGGCT) regardless of histology; lumbar CSF will also be evaluated for dissemination of tumor cells; if elevated, serum and CSF should be repeated after chemotherapy until these values are within normal range; all patients with elevation of AFP or HCG at any time prior to RT will have serum HCG and AFP repeated within 14 days before radiation therapy (RT) or within 14 days of initiation of RT
No evidence of CNS metastasis as indicated by MR images of the brain and spine and by cytologic examination of lumbar CSF 7 to 28 days after surgery; if lumbar puncture is medically contraindicated, ventricular CSF from a shunt or Ommaya reservoir may be used to rule out M1 disease; if CSF sampling is not possible and the patient has no other evidence of metastasis, the patient should be assigned to the intermediate risk arm
No evidence of CNS metastasis as indicated by MR images of the brain and spine and by cytologic examination of lumbar CSF 7 to 28 days after surgery; if lumbar puncture is medically contraindicated, ventricular CSF from a shunt or Ommaya reservoir may be used to rule out M1 disease; if CSF sampling is not possible and the patient has no other evidence of metastasis, the patient will be assigned to the low risk arm
DONOR: Known allergy to filgrastim (G-CSF)
Donor is not allergic to G-CSF
CNS 1 (< 5/?L WBCs in CSF and cytospin negative for blasts)
CSF cytology positive for malignant cells or symptomatic leptomeningeal carcinomatosis in the Phase 1b portion. In Group 3, subjects are required to have CSF cytology positive for malignant cells
Immunotherapy, such as interferon, interleukin-2, GM-CSF, ipilimumab, anti-PD1 or other experimental agent.
Absolute neutrophil count (ANC) >= 1000 x 10^9/L unsupported by G-CSF or GM-CSF for 10 days or Neulasta for 21 days; the hematologic requirements are waived for patients with inadequate counts due to known bone marrow involvement by disease who are otherwise eligible
Patients treated with hematopoietic colony-stimulating growth factors e.g., G-CSF, GM-CSF, M-CSF) ? 2 weeks prior to start. Erythropoietin or darbepoetin is allowed if it was initiated at least 2 weeks prior to entry
For the 7-10% of patients without splenomegaly, the diagnostic entry criteria must include all other features described above and at least 2 of the following criteria: \r\n* Circulating myeloid precursors \r\n* White blood cell (WBC) > 10,000/uL\r\n* Increased fetal hemoglobin (HgbF) for age\r\n* Sargramostim (GM-CSF) hypersensitivity\r\nOR, patients must have been previously diagnosed with JMML
Treatment with any hematopoietic colony-stimulating growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF]) =< 2 weeks prior to starting study drug; erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued
Condition (such as transfusion dependent anemia or thrombocytopenia), therapy, or laboratory abnormality that might confound the study results, or interfere with the patient's participation for the full duration of the study treatment. Patients who received colony stimulating factors (eg, G-CSF, GM-CSF or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment are not eligible
Patients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF]) =< 2 weeks prior to starting study drug; erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to enrollment, may be continued
Known allergy or hypersensitivity to KLH, GM-CSF or yeast derived products, or a history of anaphylactic reactions to shellfish proteins.
Receiving a G-CSF after the institution practice change
Must have achieved neutrophil engraftment (defined as an absolute neutrophil count [ANC] > 500 for three consecutive days) and be off daily filgrastim (G-CSF) prior to starting romiplostim; intermittent G-CSF is allowed
Patients with parenchymal lesions must have unequivocal evidence of disease progression on imaging (MRI of the brain or head computed tomography [CT]) 21 days prior to study registration; for patients with leptomeningeal disease only, CSF cytology must document lymphoma cells and/or imaging findings consistent with CSF disease 21 days prior to study registration (at the discretion of the investigator)
Anticipated use of filgrastim (G-CSF) or sargramostim (GM-CSF) within 30 days after receiving auranofin
Anemia (hemoglobin [Hgb] < 8.0 gm/dl) or leukopenia (absolute neutrophil count [ANC] < 1,000/mcL); use of red cell transfusions, erythropoietin, or filgrastim (G-CSF), as ordered by the managing oncology service, is acceptable and does not preclude participation
Patients with a known hypersensitivity to GM-CSF, yeast-derived products, or any component of the GM-CSF product (e.g., mannitol)
DONOR: related donors and unrelated adult donors, who are harvested at Columbia University Medical Center (CUMC), will receive filgrastim (G-CSF) 5-10 ug/kg/d subcutaneously x 4 days (or, if unable to tolerate G-CSF, sargramostim [GM-CSF] 250-500 mcg/m^2/day subcutaneously x 4 days) and then undergo leukapheresis; if necessary, plerixafor may be included for mobilization
For medulloblastoma patients only, positive CSF cytology