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.