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
Absolute neutrophil count (ANC) >= 1000/mm^3 (after granulocyte colony-stimulating factor [G-CSF] discontinued)
The absolute neutrophil count (ANC) >= 1000/mm^3 without colony stimulating factor support
Adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain: Absolute neutrophil count (ANC) ?1500 cells/mm3, Platelet count ?100 x 109/L, Hemoglobin (Hgb) ?10 g/dL
Absolute neutrophil count >= 1000/mm^3 without colony stimulating factor support, within 14 days before the first dose of cabozantinib
The absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support within 7 days before the first dose of cabozantinib
Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, within 14 days prior to registration; this ANC cannot have been induced by granulocyte colony stimulating factors
Absolute neutrophil count >= 1000/uL without growth factor support (e.g. granulocyte colony stimulating factor [GCSF]) in the previous 7 days
Neutrophil count ? 1,500/mm3 without granulocyte colony stimulating factor.
Obtained within 28 days prior to the first dose of cabozantinib: absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support.
Within 14 days prior to registration: Absolute neutrophil count (ANC) >= 1,000/mcl; this ANC cannot have been induced by granulocyte colony stimulating factor
Absolute neutrophil count (ANC) >= 1000 x 10^9/L, unsupported by granulocyte colony-stimulating factor (G-CSF) or granulocytes (within 14 days of study registration)
Within 7 days before the first dose of study treatment: The absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support
Absolute neutrophil count (ANC) < 1500 cells/uL (granulocyte colony-stimulating factor support should not be used within 2 weeks prior to cycle 1, day 1)
Absolute neutrophil count > 750 cells/mm^3 (0.75 x 10^9/L) independent of transfusion and growth factor support for at least 7 days prior to screening (except for pegylated granulocyte-colony stimulating factor [G-CSF] [pegfilgrastim] and darbepoetin which require at least 14 days prior to screening)
FULL STUDY INCLUSION CRITERIA: Absolute neutrophil count (ANC) >= 1000/mm^3, without biologic response modifiers, such as granulocyte colony-stimulating factor (G-CSF), within 6 weeks before the start of study treatment
Adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain: Absolute neutrophil count (ANC) ?1500 cells/mm3, Platelet count ?100 x 109/L, Hemoglobin ?10 g/dL; subjects with thalassemia having a hemoglobin <10 g/dL may be enrolled, per Investigator discretion
Absolute neutrophil count (ANC) >= 1,500/mcl; this ANC cannot have been induced or supported by granulocyte colony stimulating factors
Absolute neutrophil count >= 1,500/mcL (without granulocyte colony-stimulating factor support within 2 weeks prior to cycle 1, day 1)
Adequate bone marrow function: WBC > 2000/?L; platelet count > 75,000/?L; Neutrophil count > 1000/?L, without use of colony stimulating factors (CSF).
Absolute neutrophil count (ANC) >= 1500 K/mm^3 (without use of granulocyte colony-stimulating factor [G-CSF] 4 weeks prior to enrollment)
Absolute neutrophil count (ANC) >= 1000/mcl (granulocyte-colony stimulating factor [G-CSF] is allowed) (must be within 7 days of MLA)
Within 4 days prior to the first dose of cabozantinib: Absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support
Absolute neutrophil count (ANC) >= 1,500/mm^3 (no colony stimulating factor [CSF] support)
Absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support
Peripheral absolute neutrophil count (ANC) >= 750/uL in absence of granulocyte colony stimulating factor (GCSF) for 72 hours (hrs) or pegylated (peg)-GCSF for 14 days
Absolute neutrophil count (ANC) ? 1.5 x 10^9/L without granulocyte colony-stimulating factor (G-CSF) support within 7 days preceding the lab assessment.
Absolute neutrophil count ? 1,500/mm3 (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor [G-CSF]).
RENAL COHORT: Laboratory values as follows within 4 days before the first dose of daratumumab: The absolute neutrophil count (ANC) ? 1500/mm^3 without colony stimulating factor support
BLADDER: Clinical laboratory values at screening: ANC ? 1500/mm^3 without colony stimulating factor support
Within 7 days before the first dose of cabozantinib: The absolute neutrophil count (ANC) >= 1000/mm^3 without colony stimulating factor support
Absolute neutrophil count (ANC) >= 1000/uL; granulocyte colony-stimulating factor receptor (G-CSF) is not permitted within 14 days of screening
Absolute neutrophil count (ANC) >= 500/mm^3 (patients should be off granulocyte colony-stimulating factor [G-CSF] for at least 7 days)
Absolute neutrophil count (ANC) >= 1500/mm^3, without colony stimulating factor support
Absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3, equivalent to CTEP Common Terminology Criteria for Adverse Events (CTCAE) version 4.0, grade 1; this ANC cannot have been induced or supported by granulocyte colony stimulating factors
Absolute neutrophil count >= 1,500/ul without colony stimulating factor support
Absolute neutrophil count >1000/mL (without a colony stimulating factor within the last 2 weeks)
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L without granulocyte colony-stimulating factor support, obtained within 14 days prior to initiation of study treatment
Absolute neutrophil count (ANC) ? 1.0 × 109/L. Screening of ANC should be independent of granulocytecolony stimulating factor (G-CSF) support for at least one week and of pegylated G-CSF for at least two weeks.
Absolute neutrophil count (ANC) >= 1500/mm^3 (without use of granulocyte colony-stimulating factor [G-CSF] 4 weeks prior to enrollment)
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L within 30 days prior to cycle 1 day 1, without granulocyte-colony stimulating factor (G-CSF)
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L within 7 days of time of consent, without granulocyte- colony stimulating factor (G-CSF)
Absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support
Absolute neutrophil count (ANC) greater than or equal to 1,500/ul, equivalent to Common Toxicity Criteria for Adverse Events v4.0 (CTCAE)  grade 1; this ANC cannot have been induced or supported by granulocyte colony stimulating factors
Absolute neutrophil count (ANC) >= 1000/mm^3, with or without granulocyte colony-stimulating factor (G-CSF) support; this requirement may be waived if the patient has hematologic relapse of disease or if patient has not yet recovered counts from chemotherapy
Platelet count >/=100,000 /mm3, hemoglobin >/=9 g/dL, absolute neutrophil count >/= 1500/mm3 without transfusions or granulocyte colony stimulating factor and other hematopoietic growth factors
Absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support
Bone marrow function: Absolute neutrophil count (ANC) ? 1500 Cells/?L (with no evidence that this ANC was induced or supported by granulocyte colony stimulating factors)
Absolute neutrophil count (ANC) >= 1500 cells/uL (without granulocyte colony-stimulating factor support within 2 weeks prior to cycle 1, day 1)
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L within 14 days prior to randomization independent of granulocyte colony-stimulating factor (G-CSF) for >= 1 week and pegylated G-CSF for >= 2 weeks
Absolute neutrophil count (ANC) >= 1500/mm^3 without colony stimulating factor support
Absolute neutrophil count (ANC) greater than or equal to 1500/ul, equivalent to Common Toxicity Criteria for Adverse Events v3.0 (CTCAE) grade 1; this ANC cannot have been induced or supported by granulocyte colony stimulating factors
Engraftment of neutrophils (absolute neutrophil count [ANC] >= 1.0 X 10^9/L) for 3 days without granulocyte colony-stimulating factor (g-csf) support
Absolute neutrophil count (ANC) ? 1,500/?L without colony-stimulating factor support
Absolute neutrophil count (ANC) >= 1500/mm^3 (without granulocyte colony-stimulating factor [G-CSF] support within 2 weeks prior to cycle 1, day 1)
Absolute neutrophil count >= 1,000/mcL (in the absence of granulocyte colony stimulating factor (GCSF) for >= 14 days)
Adequate hematologic status as demonstrated by not requiring transfusion support or granulocyte-colony stimulating factor (G-CSF) to maintain: ANC ?1500 cells/mm3, Platelet count ?100 x 109/L, Hemoglobin ?10 g/dL
Patients already receiving erythropoietin or granulocyte colony stimulating factor (GCSF) for treatment of HIV-related cytopenia are eligible
Prior exposure to CTLA-4 inhibitors (ipilimumab and tremelimumab) is not permitted; prior exposure to the following is allowed: attenuated vaccines, anti-EGFR agents, and granulocyte-macrophage colony-stimulating factor (GM-CSF)
Biologic response modifiers (eg, granulocyte colony-stimulating factor) within 4 weeks before study entry. Chronic erythropoietin therapy is permitted provided that no dose adjustments were made within 2 months before first dose of study treatment
Treatment within 28 days prior to Cycle 1 Day 1 with: i) long acting erythropoiesis stimulating agents, ii) long acting Granulocyte colony-stimulating factor (G-CSF), iii) granulocyte- macrophage colony stimulating factor (GM-CSF), iv) 5-aza, lenalidomide or decitabine, or v) iron chelation and within 14 days prior to Cycle 1 Day 1 with short acting erythropoiesis stimulating agents and short acting G-CSF.
Use of granulocyte colony stimulating or granulocyte-macrophage colony stimulating factor in the 2 weeks prior to study drug administration (Cycle 1 Day 1)
Concurrent MDS therapies, including lenalidomide, erythropoietin, cyclosporine/tacrolimus, granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor, etc. (Prior treatment with these agents is permitted, provided that completion is at least 1 week before the first dose of study treatment.)
Use of hematopoietic colony-stimulating growth factors (e.g. granulocyte colony-stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor [GMCSF], macrophage colony-stimulating factor [M-CSF]) =< 2 weeks prior start of study drug; an erythroid stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment
Screening ANC should be independent of granulocyte-and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks
Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony stimulating factor [G-CSF], granulocyte macrophage colony stimulating factor [GMCSF] or recombinant erythropoietin) within 4 weeks prior to study start
Subjects who have used any of the following within 4 weeks prior to registration: blood or platelet transfusions, erythropoietin, and biologic response modifiers such as granulocyte macrophage colony-stimulating factor (GM-CSF) or granulocyte colony-stimulating factor (G-CSF)
Absolute neutrophil count (ANC) ?1.5 × 10e9/L, hemoglobin (Hb) ?9.0 g/dL, and platelet count ?75.0 × 10e9/L independent of transfusion of red blood cells (RBC) or platelet concentrates and independent of granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF).
Concurrent use of granulocyte macrophage colony-stimulating factor (GM-CSF).
Patients may have had no prior systemic therapy except\r\n* Localized emergency radiation to sites of life threatening or functioning disease\r\n* No more than 1 cycle of chemotherapy according to low or intermediate risk regimens prior to determination of MYCN amplification and histology, as long as the patient DID NOT receive granulocyte colony-stimulating factor (G-CSF) as part of that therapy
Concurrent use of human granulocyte-macrophage colony-stimulating factor
Patients who are planned to receive the following medications concurrent with radiation: granulocyte stimulating factor (G-CSF), bevacizumab, cyclosporine, antitumor necrosis factor agents, amifostine
Active treatment with growth factors such as erythropoietin stimulating agent (ESA), granulocyte colony-stimulating factor (GCSF), or thrombopoietin stimulating factor within 4 weeks of registration
Patients receiving the following medications at study entry or within the preceding 4 weeks are excluded:\r\n* Agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents and topical steroids.\r\n* Allergy desensitization injections.\r\n* Systemic corticosteroids, administered parenterally or orally. Inhaled steroids (e.g. Advair, Flovent, Azmacort) are not permitted. Topical corticosteroids are acceptable, including steroids with very low solubility administered nasally for local effects only (e.g. Nasonex).\r\n* Any growth factors (e.g. granulocyte-macrophage colony-stimulating factor (GM-CSF), granulocyte-colony stimulating factor (G-CSF), erythropoietin).\r\n* Interferon therapy.\r\n* Interleukin-2 or other interleukins.\r\n* For immune modulating agents, it may be necessary for more than 4 weeks to have elapsed since completion of that therapy.
DONOR: known allergy to granulocyte colony-stimulating factor (G-CSF) or to Escherichia Coli (E. Coli)-derived recombinant protein products
=< 7 days before first dose of protocol-indicated treatment:\r\n* Receipt of granulocyte colony?stimulating factor (G-CSF) or granulocyte?macrophage colony stimulating factor (GM-CSF).
Inability to purify >= 2.5 x 10^6 CD34-enriched cells/kg of patient weight from the pooled granulocyte-colony stimulating factor (G-CSF) mobilized leukapheresis products
DONOR: Donor unfit to receive granulocyte colony-stimulating factor (G-CSF) and undergo apheresis.
Significant allergic reaction to contrast dye or granulocyte-macrophage colony-stimulating (GM-CSF)
Patients must not be receiving growth factors (granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF]), except for erythropoietin
Currently or previously being on erythrocyte stimulating agents (ESA) and granulocyte colony stimulating factors (G-CSF)
Patients must not have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first BA3011 administration.
Have had previous treatment for HCL, including purine analogs, rituximab, and other investigational agents; previous treatment with transfusions and other supportive care such as granulocyte colony-stimulating factor (G-CSF) and erythropoietin are allowed
Known hypersensitivity reaction to the granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant; any known contraindication to GM-CSF
Known allergy or hypersensitivity to KLH, granulocyte macrophage colony stimulating factor (GM-CSF) or yeast derived products, or a history of anaphylactic reactions to shellfish proteins
Has received granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days of first dose of pembrolizumab
Current use of granulocyte colony-stimulating factory (G-CSF) or GM-CSF.
HLA-MATCHED UNRELATED DONOR: Only granulocyte colony-stimulating factor (G-CSF) mobilized PBSC will be permitted as a HSC source on this protocol
Absolute neutrophil count >= 1,000/mcL; red blood cell (RBC) transfusions and use of granulocyte colony-stimulating factor (G-CSF) will be allowed in order to meet eligibility parameters (unless dysfunction is secondary to lymphoma involvement)
Patients must not require “support” to maintain adequate blood counts, as defined by:\r\n* Patients must not have received a transfusion (platelets or red blood cells) =< 4 weeks prior to initiating protocol therapy\r\n* Patient must not have received colony stimulating factors (eg, granulocyte colony-stimulating factor, granulocyte macrophage colony stimulating factor, or recombinant erythropoietin) within 4 weeks prior initiating protocol therapy\r\n* Participant has had any known grade 3 or 4 anemia, neutropenia or thrombocytopenia due to prior chemotherapy that persisted > 4 weeks and was related to the most recent treatment
Granulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte colony-stimulating factor (G-CSF) use within 2 weeks of study treatment and throughout the study
Receipt of transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF], or recombinant erythropoietin) within 4 weeks prior to study treatment
White blood cell (WBC) > 2.5 x 10^9/L with an absolute neutrophil count (ANC) > 1.5 x 10^9/L off granulocyte colony-stimulating factor (G-CSF) or granulocyte macrophage colony-stimulating factor (GM-CSF) for 10 days or Neulasta for 21 days
Has received the following at study entry or within 4 weeks prior to study day 1 or has not recovered (i.e., =< grade 1 or at baseline) from adverse events due to agents administered more than 4 weeks earlier:\r\n* Prior anti-cancer monoclonal antibody (mAb), including anti-PD-1, anti-PD-L1 and anti-PD-L2 blockade\r\n* Any growth factors (e.g. granulocyte-macrophage colony-stimulating factor [GM-CSF], granulocyte-colony stimulating factor [G-CSF], erythropoietin)\r\n* Interferon or interleukin therapy\r\n* Other agents with putative immunomodulating activity
Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF), erythropoietin, within 14 days of study drug administration; use of such agents while on study is also prohibited
No transfusion of blood or blood products within 2 weeks and no granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony stimulating factor (GM-CSF) within 2 weeks
DONOR: Donor unfit to receive granulocyte-macrophage colony-stimulating (G-CSF) and undergo apheresis
Contraindication to CE melphalan or any of the required supportive treatments, including hypersensitivity to granulocyte colony stimulating factor (G-CSF) or pegfilgrastim
Concomitant therapy with bisphosphonates, RANKL inhibitors or growth-colony-stimulating factors (G-CSF) is allowed as per physician decision
Absolute neutrophil count < 1000 cells/mm^3; no granulocyte colony stimulating factors (G-CSF or GM-CSF) allowed within 1 week of enrollment; no pegylated granulocyte colony stimulating factors are allowed within 3 weeks of treatment start
Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), GM-CSF, erythropoietin, within 14 days of study drug administration; use of such agents while on study is also prohibited
Treatment with hematopoietic growth factors (granulocyte-colony stimulating factor [G-CSF]):\r\n* Long-acting (e.g., Neulasta) within 14 days prior to study entry\r\n* Short-acting (e.g., Neupogen) within 7 days prior to study entry
DONOR: Factors which place the donor at increased risk for complications from leukapheresis or granulocyte-colony stimulating factor (G-CSF) therapy
Subject has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 4 weeks prior to study day 1
Known hypersensitivity to thalidomide, lenalidomide, Keyhole Limpet Hemocyanin (KLH), or granulocyte colony-macrophage stimulating factor (GM-CSF)
Treated with any hematopoietic colony-stimulating growth factors (e.g., granulocyte-colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF]) =< 2 weeks prior to study registration; NOTE: erythropoietin or darbepoetin therapy, if initiated at least 2 weeks prior to study registration, may be continued
Patients who have been treated with any hematopoietic colony-stimulating growth factors (e.g., filgrastim [G-CSF], granulocyte-macrophage colony-stimulating factor [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 with known hypersensitivity to granulocyte-macrophage colony-stimulating factor (GM-CSF), yeast-derived products, or any component of Leukine
Prior hydroxyurea for control of leukocytosis or use of hematopoietic growth factors (e.g., granulocyte-colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [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
Absolute neutrophil count (ANC) >= 1000 x 10^9/L unsupported by granulocyte-stimulating growth factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) for 3 days
Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 28 days of study drug administration; use of such agents while on study is also prohibited
Screening ANC should be independent of granulocyte and granulocyte/macrophage colony stimulating factor (filgrastim [G CSF] and sargramostim [GM CSF]) support for at least 1 week and of pegylated G CSF for at least 2 weeks
Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GMCSF, M-CSF) ? 2 weeks prior start or study drug. Patients must have completed therapy at least 2 weeks before the screening period begins with any hematopoietic colony-stimulating growth factors. An erythroid stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment and the patient is not red blood cell transfusion dependent
No PEGylated granulocyte colony stimulating factor (PEG-GCSF) within 14 days of virus administration (day 0)
Received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor, and recombinant erythropoietin) within 2 weeks before the first dose of study treatment.
Has received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], GM-CSF or recombinant erythropoietin) within 4 weeks prior to study Day 1;
Any contraindication to receiving granulocyte-macrophage colony-stimulating factor (GM-CSF) based vaccine products
Received immunotherapy (eg, IFNs, tumor necrosis factor, interleukins, or biological response modifiers [granulocyte-macrophage colony-stimulating factor, granulocyte colony-stimulating factor, macrophage colony-stimulating factor]) within 30 days prior to administration of the first study vaccination;
Cancer therapies, including chemotherapy, radiation, biologic, or kinase inhibitors, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) within 4 weeks prior.
Hematopoietic growth factors: erythropoietin, granulocyte colony stimulating factor (G-CSF), granulocyte macrophage colony stimulating factor (GM-CSF), or thrombopoietin receptor agonists at least 7 days (14 days for Aranesp), prior to study enrollment.
Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first IMP administration.
Any hematopoietic growth factors (e.g., filgrastim [granulocyte colony-stimulating factor; G-CSF], sargramostim [granulocyte-macrophage colony-stimulating factor; GM-CSF]) within 14 days prior to receiving study treatment
Biopsy-proven unresectable, metastatic melanoma refractory to standard immunotherapy drugs or regimens, including prior treatment with aldesleukin (IL-2), granulocyte-macrophage colony-stimulating factor (GM-CSF), ipilimumab, nivolumab, pembrolizumab, and/or Imlygic (talimogene laherparepvec [T-VEC]); prior clinical trial participation or treatment with molecularly targeted agents (i.e. vemurafenib/cobimetinib, dabrafenib/trametinib) or chemotherapy (i.e. temozolomide, dacarbazine, platinum, or taxanes) is permitted
Hemoglobin >= 9 g/dL\r\n* Note: blood transfusion will be allowed for patients with hemoglobin < 9 g/dl and granulocyte colony-stimulating factor (G-CSF) is allowed for neutropenic patients at time of enrollment
Concurrent use of any other agent for MDS, CMML, or AML; growth factor use with epoetin, darbepoetin, or granulocyte colony-stimulating factor must be terminated at least 2 weeks before initiation of study treatment
Participants already receiving erythropoietin or colony-stimulating factor therapy are eligible for participation, although the latter must be discontinued at least 24 hours prior to receiving chemotherapy
Absolute neutrophil count (ANC) > 1.5 x 10^9/L off granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) for 10 days or Neulasta for 21 days
Use of biologic response modifiers, such as granulocyte colony-stimulating factor (G-CSF), will not be permitted within 3 weeks prior to study entry; G-CSF and other hematopoietic growth factors may be used in the management of acute toxicity, such as febrile neutropenia, when clinically indicated or at the discretion of the investigator; however, they may not be administered to prevent a dose reduction; patients taking chronic erythropoietin are permitted, provided no dose adjustment is undertaken within 1 month prior to randomization or during the study
Unable or unwilling to discontinue use of prohibited medications within 14 days prior to randomization and while on treatment:\r\n* No chronic treatment with systemic steroids or another immunosuppressive agent; topical or inhaled corticosteroids are allowed\r\n* Growth factors (e.g. granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [G-GM-CSF], erythropoietin, platelets growth factors etc.) are not to be administered prophylactically but may be prescribed by the treating physician for rescue from severe hematologic events\r\n* Live vaccines must not be administered to patient \r\n* Drugs known to be strong inhibitors or inducers of the isoenzyme cytochrome P450 family 3 subfamily A member 4 (CYP3A4) must not be administered as systemic therapy; drugs or substances known to be moderate inhibitors or inducers of CYP3A should be avoided if possible or used subject to caution; co-administration with strong or moderate inhibitors of P-glycoprotein (PgP) should be avoided if possible, or used subject to caution; concomitant use of Seville orange, star fruit, grapefruit and their juices should be avoided
Any hematopoietic growth factors (eg, filgrastim [granulocyte colony-stimulating factor; G-CSF], sargramostin [granulocyte-macrophage colony-stimulating factor; GM-CSF]) within 7 days of the first dose of study drug or pegylated G-CSF (pegfilgrastim) or darbepoetin within 14 days of the first dose of study drug.
Any previous cytotoxic, cytostatic, hormonal, biological or immunological treatment for MDS (Erythropoietin-stimulating agent (ESA) with or without granulocyte colony stimulating factor (G-CSF) are allowed under certain conditions, see exclusion criterion # 5).
Use of any herbal remedy (eg, St. John's wort [Hypericum perforatum]) Note: Granulocyte colony-stimulating factor (G-CSF) and other hematopoietic growth factors may be used in the management of acute toxicity, such as febrile neutropenia, when clinically indicated or at the investigator's discretion. However, they may not be substituted for a required dose reduction. Subjects are permitted to take chronic erythropoietin.
Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support within one week or pegylated G-CSF within two weeks before the Screening Visit.
DONOR: Donors must consent and be eligible to undergo granulocyte colony-stimulating factor (GCSF) mobilization and PBSC harvest; marrow is not allowed as a source of stem cells on this study
Use of any other standard anti-neoplastic drug or growth factor (e.g., anagrelide, granulocyte colony-stimulating factor [G-CSF], Revlimid, clofarabine) except hydroxyurea or experimental drugs, with the exception of ruxolitinib, less than 14 days or 5-half lives prior to starting study therapy and/or lack of recovery from all toxicity from previous therapy to grade 1 or better
Use of hematopoietic colony-stimulating growth factors (eg, G-CSF, GMCSF, M-CSF) ? 2 weeks prior to start of study drug. Patients must have completed therapy at least 2 weeks before the screening period begins with any hematopoietic colony-stimulating growth factors. An erythroid stimulating agent is allowed as long as it was initiated at least 2 weeks prior to the first dose of study treatment and the patient is not red blood cell transfusion dependent
Any hematopoietic growth factors (e.g., filgrastim [granulocyte colony-stimulating factor; GCSF], sargramostim [granulocyte-macrophage colony-stimulating factor; GM-CSF]) within 14 days prior to receiving study treatment
Subjects who have received systemic cancer therapy, radiotherapy, investigational drug treatment outside of this study within 4 weeks before the start of study treatment, granulocyte colony stimulating factors, (G-CSF) or granulocyte macrophage-stimulating factors (GM-CSF), erythropoietin-stimulating agents within 3 weeks before the start of general screening, drugs with known renal toxicity and strong cytochrome P450 3A4 (CYP3A4) inhibitors or strong CYP3A4 inducers within 2 weeks before the treatment.
Colony stimulating factors within 2 weeks of study
Subjects who require the use of granulocyte colony stimulating factors (GCSF) for prophylaxis of neutropenia.
Known hypersensitivity to granulocyte macrophage colony stimulating factor (GM-CSF) or yeast
Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage colony-stimulating factor (GM-CSF), erythropoietin, within 14 days of study drug administration; use of such agents while on study is also prohibited
Use of biologic response modifiers, such as granulocyte macrophage colony-stimulating factor (GM-CSF) or granulocyte colony-stimulating factor (G-CSF) within 4 weeks prior to screening
Participants must have received their last dose of short acting colony stimulating factor, such as filgrastim or sargramostim at least 72 hours prior to enrollment and their last dose of long-acting colony stimulating factors, such as PEG-filgrastim at least 7 days prior to enrollment
Patients receiving growth factors including, but not limited to, granulocyte-colony stimulating factor (G-CSF), granulocyte macrophage-colony stimulating factor (GM-CSF), erythropoietin, etc. within 2 weeks of study drug administration; use of such agents while on study is also prohibited; prior use of growth factors should be documented in the patient’s medical history
Patients with any contraindication to receiving rhu granulocyte macrophage colony stimulating factor (rhuGM-CSF) based products
Receipt of colony stimulating factor filgrastim, pegfilgrastim, or sargramostim within 14 days prior to Day 1.
HAPLO-IDENTICAL DONOR: Factors which place the donor at increased risk for complications from leukapheresis or granulocyte colony-stimulating factor (G-CSF) therapy (e.g., active autoimmune disease, sickle cell trait, symptomatic coronary artery disease requiring therapy)
Hemoglobin count greater than or equal to 9 g/dL or greater than or equal to 5.6 mmol/L\r\n* Note: ANC, platelets, hemoglobin requirement cannot be met by the use of recent transfusions, or growth factor support (granulocyte colony-stimulating factor [G-CSF], erythropoietin, etc.) within 2 weeks prior to treatment initiation
It must have been at least 7 days since the completion of therapy with granulocyte colony stimulating factor (GCSF) or other growth factors at the time of enrollment; it must have been at least 14 days since the completion of therapy with pegfilgrastim (Neulasta)
Patients must have a healthy blood-related donor (parent, child, sibling) willing to undergo apheresis after granulocyte colony-stimulating factor (G-CSF) administration
Hematopoietic growth factor receptor agonists (eg, erythropoietin (Epo), granulocyte colony stimulating factor, romiplostim, eltrombopag within 28 days of enrollment.
Patients who have been treated with any hematopoietic colony-stimulating growth factors (eg, granulocyte-colony stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [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
Have used biologic response modifiers, such as granulocyte-colony stimulating factor, within 3 weeks prior to signing the ICF.
Inclusion:\n\n          1. Male or female infants, children and adolescents aged 1 month to <16 years.\n\n          2. Patients with solid tumors without bone marrow involvement, who are scheduled to\n             receive myelosuppressive CTX.\n\n          3. Body weight ?5 kg.\n\n          4. Patients must have an initial diagnosis and histologic proof of their malignancy. All\n             enrolled subjects should have signed consent for a CTX regimen that is known to be\n             myelotoxic, with counts expected to drop below the absolute neutrophil count (ANC) of\n             0.5 × 109/L for at least 3 days. These regimens would include at least one of the\n             following:\n\n               -  Etoposide\n\n               -  doxorubicin\n\n               -  ifosfamide\n\n               -  cyclophosphamide\n\n          5. ANC and platelet count: Patients must have an ANC >1 × 109/L and a platelet count >100\n             × 109/L to be eligible for therapy at the start of CTX.\n\n          6. Normal cardiac, renal, and hepatic function.\n\n          7. All subjects must have a life expectancy of 12 weeks or more.\n\n          8. Performance Status: Lansky performance score >60 (age 1 to <16 years).\n\n               -  More criteria may apply, please contact the investigator for more information.\n\n        Exclusion:\n\n          1. Bone marrow involvement.\n\n          2. Active myelogenous leukemia or history of myelogenous leukemia.\n\n          3. Previous treatment with colony-stimulating factors (granulocyte colony-stimulating\n             factor [G-CSF], granulocyte-macrophage colony-stimulating factor, interleukin 11\n             [IL-11]) less than 6 weeks prior to study entry.\n\n          4. History of congenital neutropenia or cyclic neutropenia.\n\n          5. Pregnant or nursing female patients.\n\n          6. Fertile patients who do not agree to use highly reliable contraceptive measures Prior\n             bone marrow or stem cell transplant, or prior radiation to ?25% of bone marrow within\n             the 4 weeks prior to the first tbo-filgrastim dose.\n\n          7. Ongoing active infection or history of infectious disease within 2 weeks prior to the\n             screening visit.\n\n          8. Treatment with lithium at screening or planned during the study\n\n               -  More criteria may apply, please contact the investigator for more information.
Have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support within one week or pegylated G-CSF within two weeks before the Screening Visit.
Receiving prophylactic use of hematopoietic colony stimulating factors
Allergy to both penicillin & sulfa or suspected hypersensitivity to granulocyte-macrophage colony stimulating factor (GM-CSF), dimethyl sulfoxide, fetal bovine serum, trypsin, yeast, glycerol or other component of the therapy options
Requirement for routine use of hematopoietic growth factors (including granulocyte colony stimulating factor, granulocyte macrophage colony stimulating factor, or interleukin-11) or platelet transfusions to maintain absolute neutrophil counts or platelets counts above the required thresholds for study entry
Screening ANC should be independent of granulocyte-and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks
Screening ANC should be independent of granulocyte-and granulocyte/macrophage colony stimulating factor (G-CSF and GM-CSF) support for at least 1 week and of pegylated G-CSF for at least 2 weeks
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, granulocyte colony-stimulating factor [G-CSF], granulocyte macrophage colony-stimulating factor [GM-CSF] or recombinant erythropoietin) within 2 weeks prior to the first dose of study treatment are not eligible
Received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors (including granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor, recombinant erythropoietin) within 14 days prior to the first dose of GSK3359609.
Subjects must have fully recovered from the toxic effects of any prior therapy; at least 3 weeks should have elapsed since the last dose of chemotherapy (6 weeks in the case of nitrosourea containing therapy); subjects must have recovered from previous colony-stimulating factor therapy and have been off colony-stimulating factors (G-CSF, granulocyte macrophage colony-stimulating factor [GM-CSF], interleukin [IL]-11) for more than 10 days and off erythropoietin for 30 days
Current systemic treatment for AML, with the exception of granulocyte colony-stimulating factor (G-CSF) must have been discontinued at least 7 days prior to entry into the study; in addition:\r\n* At least 4 weeks before day 1 for interleukin (IL)-11 (oprelvekin)\r\n* At least 8 weeks before day 1 for antithymocyte/antilymphocyte globulin
Patients with any contraindication or known hypersensitivity to receiving sargramostatin (recombinant human granulocyte macrophage colony stimulating factor [rhuGM-CSF]) or other yeast based products
DONOR: Willing to receive Triplex vaccination, a minimum of 14 days prior to the start of granulocyte stimulating factor (GSF) mobilization
Hemoglobin > 8.0 g/dL without transfusion or growth factor support for at least 7 days prior to screening (with the exception of pegylated granulocyte-colony stimulating factor [G-CSF] and darbopoietin, which require at least 14 days of abstinence prior to screening)
Subject is receiving concurrent chemotherapy or biologic or hormonal therapy for cancer treatment; subject is receiving bone marrow stimulatory factors (e.g., granulocyte-macrophage colony-stimulating factor [GM-CSF]); Note: Concurrent use of hormones for noncancer-related conditions (e.g., insulin for diabetes) is acceptable
Treatment with marrow stimulating agents (e.g. granulocyte colony stimulating factor [GCSF]) within 3 weeks of baseline scan
No concurrent use of erythroid stimulating agents, granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) is allowed during study except in cases of febrile neutropenia where G-CSF can be used for short term; growth factors must be stopped 14 days prior to study
Any hematopoietic growth factors (e.g., filgrastim [granulocyte colony-stimulating factor; G-CSF], sargramostim [granulocyte-macrophage colony-stimulating factor; GM-CSF]) within 14 days prior to receiving study treatment
Treatment with granulocyte–macrophage colony stimulating factor (GM-CSF) or granulocyte (G-CSF) within 4 weeks prior to first PET scan; patients should avoid treatment with these agents between the baseline and 6-12 treatment week imaging sessions
Have received treatment with agents specifically targeting colony stimulating factor 1 (CSF-1) or CSF-1R, including imatinib, nilotinib, and sunitinib.