Patients already receiving erythropoietin or granulocyte colony stimulating factor (GCSF) for treatment of HIV-related cytopenia are eligibleXx_NEWLINE_xXAbsolute neutrophil count (ANC) >= 1000/mm^3 (after granulocyte colony-stimulating factor [G-CSF] discontinued)Xx_NEWLINE_xXPrior 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)Xx_NEWLINE_xXBiologic 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 treatmentXx_NEWLINE_xXTreatment 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.Xx_NEWLINE_xXUse of granulocyte colony stimulating or granulocyte-macrophage colony stimulating factor in the 2 weeks prior to study drug administration (Cycle 1 Day 1)Xx_NEWLINE_xX4. Receipt of G-CSF, GM-CSF or erythropoietin within 28 days prior to study entry or receiving TAB001;Xx_NEWLINE_xXHas 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.Xx_NEWLINE_xXConcurrent 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.)Xx_NEWLINE_xXUse 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 treatmentXx_NEWLINE_xXReceived marrow stimulating factors:Xx_NEWLINE_xXReceived Pegfilgrastim (GM-CSF or Nulesta) within 3 weeks prior to anticipated first dose of G-CSF.Xx_NEWLINE_xXRecent 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 canakinumabXx_NEWLINE_xXPrior exposure to drugs that are antagonists of colony stimulating factor-1 receptor (CSF1R) like but not limited to emactuzumab (RG7155) (Roche), PLX3397 (Plexicon), and JNJ40346627 (J & J)Xx_NEWLINE_xXScreening 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 weeksXx_NEWLINE_xXHas 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 startXx_NEWLINE_xXTransfusion 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 pembrolizumabXx_NEWLINE_xXSubjects 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)Xx_NEWLINE_xXUse of hematopoietic colony-stimulating growth factors (eg, G-CSF, GM-CSF, M-CSF) ? 2 weeks prior to start of study drugXx_NEWLINE_xXAbsolute 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).Xx_NEWLINE_xXAdequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening and randomization, with the exception of PEGylated granulocyte colony stimulating factor (GCSF) (pegfilgrastim) and darbepoetin which require at least 14 days prior to screening and randomizationXx_NEWLINE_xXConcurrent use of granulocyte macrophage colony-stimulating factor (GM-CSF).Xx_NEWLINE_xXPatients 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 therapyXx_NEWLINE_xXReceived transfusion of blood products or administration of colony stimulating factors within 4 weeks prior to the first dose of treatment.Xx_NEWLINE_xXConcurrent use of human granulocyte-macrophage colony-stimulating factorXx_NEWLINE_xXPatients who are planned to receive the following medications concurrent with radiation: granulocyte stimulating factor (G-CSF), bevacizumab, cyclosporine, antitumor necrosis factor agents, amifostineXx_NEWLINE_xXActive treatment with growth factors such as erythropoietin stimulating agent (ESA), granulocyte colony-stimulating factor (GCSF), or thrombopoietin stimulating factor within 4 weeks of registrationXx_NEWLINE_xXPatients 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.Xx_NEWLINE_xXDONOR: known allergy to granulocyte colony-stimulating factor (G-CSF) or to Escherichia Coli (E. Coli)-derived recombinant protein productsXx_NEWLINE_xX=< 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).Xx_NEWLINE_xXAbsolute neutrophil count >= 1000/uL without growth factor support (e.g. granulocyte colony stimulating factor [GCSF]) in the previous 7 daysXx_NEWLINE_xXInability 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 productsXx_NEWLINE_xXDONOR: Factors which place the donor at increased risk for complications from leukapheresis or granulocyte-colony stimulating factor (G-CSF) therapy could be harvested for bone marrow (BM) if safer for the donor and if approved by PIXx_NEWLINE_xXDONOR: Donor unfit to receive granulocyte colony-stimulating factor (G-CSF) and undergo apheresis.Xx_NEWLINE_xXSignificant allergic reaction to contrast dye or granulocyte-macrophage colony-stimulating (GM-CSF)Xx_NEWLINE_xXPatients must not be receiving growth factors (granulocyte colony-stimulating factor [G-CSF], granulocyte-macrophage colony-stimulating factor [GM-CSF]), except for erythropoietinXx_NEWLINE_xXNeutrophil count ? 1,500/mm3 without granulocyte colony stimulating factor.Xx_NEWLINE_xXCurrently or previously being on erythrocyte stimulating agents (ESA) and granulocyte colony stimulating factors (G-CSF)Xx_NEWLINE_xXPatients must not have received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first BA3011 administration.Xx_NEWLINE_xXHave 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 allowedXx_NEWLINE_xXKnown hypersensitivity reaction to the granulocyte-macrophage colony-stimulating factor (GM-CSF) adjuvant; any known contraindication to GM-CSFXx_NEWLINE_xXKnown allergy or hypersensitivity to KLH, granulocyte macrophage colony stimulating factor (GM-CSF) or yeast derived products, or a history of anaphylactic reactions to shellfish proteinsXx_NEWLINE_xXHas received granulocyte-macrophage colony-stimulating factor (GM-CSF) within 14 days of first dose of pembrolizumabXx_NEWLINE_xXCurrent use of granulocyte colony-stimulating factory (G-CSF) or GM-CSF.Xx_NEWLINE_xXHLA-MATCHED UNRELATED DONOR: Only granulocyte colony-stimulating factor (G-CSF) mobilized PBSC will be permitted as a HSC source on this protocolXx_NEWLINE_xXHas 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 treatmentXx_NEWLINE_xXAbsolute 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)Xx_NEWLINE_xXAbsolute neutrophil count (ANC) >= 1000 x 10^9/L, unsupported by granulocyte colony-stimulating factor (G-CSF) or granulocytes (within 14 days of study registration)Xx_NEWLINE_xXPatients must be able to meet the criteria without transfusion or receipt of colony stimulating factors within 4 weeks before obtaining sampleXx_NEWLINE_xXPatients 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 treatmentXx_NEWLINE_xXAbsolute neutrophil count (ANC) < 1500 cells/uL (granulocyte colony-stimulating factor support should not be used within 2 weeks prior to cycle 1, day 1)Xx_NEWLINE_xXReceived 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.Xx_NEWLINE_xXGranulocyte-macrophage colony stimulating factor (GM-CSF) or granulocyte colony-stimulating factor (G-CSF) use within 2 weeks of study treatment and throughout the studyXx_NEWLINE_xXReceipt 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 treatmentXx_NEWLINE_xXWhite 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 daysXx_NEWLINE_xXAbsolute 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)Xx_NEWLINE_xXFULL 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 treatmentXx_NEWLINE_xXHas 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 activityXx_NEWLINE_xXPatients 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 prohibitedXx_NEWLINE_xXPlatelet and blood transfusions are allowed on protocol; growth factors, including granulocyte colony stimulating factors and erythropoietin are allowedXx_NEWLINE_xXIf currently receiving erythroid stimulating agents (ESA) with plans to continue during study, less than 2 months duration of therapy with ESA prior to screening or dose escalation performed within 2 months of screening or addition of granulocyte colony stimulating factor (GCSF) to ESA within 2 months of screeningXx_NEWLINE_xXNo 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 weeksXx_NEWLINE_xXDONOR: Donor unfit to receive granulocyte-macrophage colony-stimulating (G-CSF) and undergo apheresisXx_NEWLINE_xXContraindication to CE melphalan or any of the required supportive treatments, including hypersensitivity to granulocyte colony stimulating factor (G-CSF) or pegfilgrastimXx_NEWLINE_xXConcomitant therapy with bisphosphonates, RANKL inhibitors or growth-colony-stimulating factors (G-CSF) is allowed as per physician decisionXx_NEWLINE_xXAbsolute 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 startXx_NEWLINE_xXPatients 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 prohibitedXx_NEWLINE_xXPatients 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).Xx_NEWLINE_xXAbsolute neutrophil count >= 1,500/mcL (without granulocyte colony-stimulating factor support within 2 weeks prior to cycle 1, day 1)Xx_NEWLINE_xXAdequate bone marrow function: WBC > 2000/?L; platelet count > 75,000/?L; Neutrophil count > 1000/?L, without use of colony stimulating factors (CSF).Xx_NEWLINE_xXAbsolute neutrophil count (ANC) >= 1500 K/mm^3 (without use of granulocyte colony-stimulating factor [G-CSF] 4 weeks prior to enrollment)Xx_NEWLINE_xXTreatment 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 entryXx_NEWLINE_xXDONOR: Factors which place the donor at increased risk for complications from leukapheresis or granulocyte-colony stimulating factor (G-CSF) therapyXx_NEWLINE_xXSubject 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 1Xx_NEWLINE_xXAbsolute neutrophil count (ANC) >= 1000/mcl (granulocyte-colony stimulating factor [G-CSF] is allowed) (must be within 7 days of MLA)Xx_NEWLINE_xXKnown hypersensitivity to thalidomide, lenalidomide, Keyhole Limpet Hemocyanin (KLH), or granulocyte colony-macrophage stimulating factor (GM-CSF)Xx_NEWLINE_xXTreated 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 continuedXx_NEWLINE_xXPatients 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 continuedXx_NEWLINE_xXPatients with known hypersensitivity to granulocyte-macrophage colony-stimulating factor (GM-CSF), yeast-derived products, or any component of LeukineXx_NEWLINE_xXPrior 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 patientXx_NEWLINE_xXAbsolute 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 daysXx_NEWLINE_xXAbsolute neutrophil count (ANC) >= 1,500/mm^3 (no colony stimulating factor [CSF] support)Xx_NEWLINE_xXPatients 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 prohibitedXx_NEWLINE_xXScreening 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 weeksXx_NEWLINE_xXUse 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 dependentXx_NEWLINE_xXOff all colony forming growth factor(s) >= 2 weeks prior to registration (filgrastim [G-CSF], sargramostim [GM-CSF], erythropoietin)Xx_NEWLINE_xXPeripheral absolute neutrophil count (ANC) >= 750/uL in absence of granulocyte colony stimulating factor (GCSF) for 72 hours (hrs) or pegylated (peg)-GCSF for 14 daysXx_NEWLINE_xXNo PEGylated granulocyte colony stimulating factor (PEG-GCSF) within 14 days of virus administration (day 0)Xx_NEWLINE_xXAbsolute neutrophil count (ANC) ? 1.5 x 10^9/L without granulocyte colony-stimulating factor (G-CSF) support within 7 days preceding the lab assessment.Xx_NEWLINE_xXReceived 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.Xx_NEWLINE_xXHas 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;Xx_NEWLINE_xXConcurrent or prior bone marrow factors (e.g. G-CSF, GM-CSF or erythropoietin) within 3 weeks prior to Day 1 of treatment.Xx_NEWLINE_xXHas received transfusion of blood products (including platelets or red blood cells) or administration of colony stimulating factors within 4 weeks prior to study Day 1.Xx_NEWLINE_xXAbsolute neutrophil count ? 1,500/mm3 (excluding measurements obtained within 7 days after administration of granulocyte colony-stimulating factor [G-CSF]).Xx_NEWLINE_xXPatients 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 allowedXx_NEWLINE_xXAny contraindication to receiving granulocyte-macrophage colony-stimulating factor (GM-CSF) based vaccine productsXx_NEWLINE_xXReceived 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;Xx_NEWLINE_xXBLADDER: Clinical laboratory values at screening: ANC ? 1500/mm^3 without colony stimulating factor supportXx_NEWLINE_xXCancer 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.Xx_NEWLINE_xXHematopoietic 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.Xx_NEWLINE_xXHave received granulocyte colony stimulating factor (G-CSF) or granulocyte/macrophage colony stimulating factor support 3 weeks prior to first IMP administration.Xx_NEWLINE_xXAbsolute neutrophil count (ANC) >= 1000/uL; granulocyte colony-stimulating factor receptor (G-CSF) is not permitted within 14 days of screeningXx_NEWLINE_xXAbsolute neutrophil count (ANC) >= 500/mm^3 (patients should be off granulocyte colony-stimulating factor [G-CSF] for at least 7 days)Xx_NEWLINE_xXAny 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 treatmentXx_NEWLINE_xXBiopsy-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 permittedXx_NEWLINE_xXPatients must have normal organ and marrow function as defined below, independent of growth factor or transfusion support; patients should not receive growth factors or transfusions for at least 7 days prior to first dose of study drug, with the exception of pegylated granulocyte-colony stimulating factor (G-CSF) (pegfilgrastim) and darbepoetin which require at least 14 days prior to screening and randomizationXx_NEWLINE_xXHemoglobin >= 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 enrollmentXx_NEWLINE_xXUse 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 enrollmentXx_NEWLINE_xXAbsolute 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 entryXx_NEWLINE_xXConcurrent 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 treatmentXx_NEWLINE_xXPatients 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 continuedXx_NEWLINE_xXParticipants 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 chemotherapyXx_NEWLINE_xXAbsolute 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 daysXx_NEWLINE_xXUse 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 studyXx_NEWLINE_xXUnable 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 avoidedXx_NEWLINE_xXAny 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.Xx_NEWLINE_xXCancer 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.Xx_NEWLINE_xXAny hematopoietic growth factors (ESAs, Granulocyte colony-stimulating factor (GCSF) and other RBC hematopoietic growth factors (eg, Interleukin-3)Xx_NEWLINE_xXAny 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).Xx_NEWLINE_xXHas 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.Xx_NEWLINE_xXAbsolute neutrophil count >1000/mL (without a colony stimulating factor within the last 2 weeks)Xx_NEWLINE_xXAbsolute neutrophil count (ANC) >= 1.5 x 10^9/L without granulocyte colony-stimulating factor support, obtained within 14 days prior to initiation of study treatmentXx_NEWLINE_xXAbsolute 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.Xx_NEWLINE_xXUse 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.Xx_NEWLINE_xXHave 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.Xx_NEWLINE_xXSubjects who have received any anticancer therapy (including surgery, percutaneous ethanol injection, radio frequency ablation, transarterial [chemo] embolization, hepatic intra-arterial chemotherapy, biological, immunotherapy, hormonal, or radiotherapy) or any blood enhancing treatment (including blood transfusion, blood products, or agents that stimulate blood cell production, eg, granulocyte colony-stimulating factor [G-CSF]) within 28 days prior to randomizationXx_NEWLINE_xXDONOR: 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 studyXx_NEWLINE_xXUse 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 betterXx_NEWLINE_xXUse of hematopoietic colony stimulating growth factors = 1500/mm^3 (without use of granulocyte colony-stimulating factor [G-CSF] 4 weeks prior to enrollment)Xx_NEWLINE_xXSubjects who require the use of granulocyte colony stimulating factors (GCSF) for prophylaxis of neutropenia.Xx_NEWLINE_xXKnown hypersensitivity to granulocyte macrophage colony stimulating factor (GM-CSF) or yeastXx_NEWLINE_xXPatients 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 prohibitedXx_NEWLINE_xXPatients 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 continuedXx_NEWLINE_xXPatients who have received any hemopoietic growth factors (e.g., filgrastim [G-CSF], sargramostim [GM-CSF]) within 2 weeks prior to study startXx_NEWLINE_xXUse 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 screeningXx_NEWLINE_xXAbsolute 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)Xx_NEWLINE_xXParticipants 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 enrollmentXx_NEWLINE_xXSubjects must have completed therapy with granulocyte?colony stimulating factor (G?CSF) or other myeloid growth factors at least 7 days before study treatment initiation, or at least 14 days before study treatment initiation, if pegylated myeloid growth factors were administered.Xx_NEWLINE_xXPatients 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 historyXx_NEWLINE_xXAbsolute neutrophil count (ANC) >= 1.0 x 10^9/L within 7 days of time of consent, without granulocyte- colony stimulating factor (G-CSF)Xx_NEWLINE_xXPatients with any contraindication to receiving rhu granulocyte macrophage colony stimulating factor (rhuGM-CSF) based productsXx_NEWLINE_xXReceipt of colony stimulating factor filgrastim, pegfilgrastim, or sargramostim within 14 days prior to Day 1.Xx_NEWLINE_xXPatients 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 continuedXx_NEWLINE_xXConcurrent 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 allowedXx_NEWLINE_xXHAPLO-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)Xx_NEWLINE_xXAbsolute 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 factorsXx_NEWLINE_xXTreated 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 continuedXx_NEWLINE_xXHemoglobin 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 initiationXx_NEWLINE_xXHas 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 1Xx_NEWLINE_xXAbsolute 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 chemotherapyXx_NEWLINE_xXGranulocyte growth factors (G-CSF), within 3 weeks of study entry.Xx_NEWLINE_xXDONOR: Must consent to granulocyte-colony stimulating factor (G-CSF) (filgrastim) administration and leukapheresis for both PBSC allograft and subsequent donor lymphocyte infusion (DLI)Xx_NEWLINE_xXIt 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)Xx_NEWLINE_xXPatients must have a healthy blood-related donor (parent, child, sibling) willing to undergo apheresis after granulocyte colony-stimulating factor (G-CSF) administrationXx_NEWLINE_xXHematopoietic growth factor receptor agonists (eg, erythropoietin (Epo), granulocyte colony stimulating factor, romiplostim, eltrombopag within 28 days of enrollment.Xx_NEWLINE_xXPatients 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 continuedXx_NEWLINE_xXHave used biologic response modifiers, such as granulocyte-colony stimulating factor, within 3 weeks prior to signing the ICF.Xx_NEWLINE_xXInclusion:\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.Xx_NEWLINE_xXBone marrow function: Absolute neutrophil count (ANC) ? 1500 Cells/?L (with no evidence that this ANC was induced or supported by granulocyte colony stimulating factors)Xx_NEWLINE_xXHave 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.Xx_NEWLINE_xXAbsolute neutrophil count (ANC) >= 1500 cells/uL (without granulocyte colony-stimulating factor support within 2 weeks prior to cycle 1, day 1)Xx_NEWLINE_xXPatients 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 entryXx_NEWLINE_xXReceiving prophylactic use of hematopoietic colony stimulating factorsXx_NEWLINE_xXAllergy 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 optionsXx_NEWLINE_xXRequirement 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 entryXx_NEWLINE_xXScreening 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 weeksXx_NEWLINE_xXAbsolute 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 weeksXx_NEWLINE_xXTreatment 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 continuedXx_NEWLINE_xXScreening 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 weeksXx_NEWLINE_xXAbsolute neutrophil count (ANC) >= 1.5 x 10^9/L for patients in whom < 50% of bone marrow nucleated cells are plasma cells; or an ANC > 1.0 x 10^9/L for patients in whom > 50% of bone marrow nucleated cells are plasma cells; ANC must be independent of granulocyte colony-stimulating factor (G-CSF) for >= 1 week and pegylated G-CSF for >= 2 weeks prior to screeningXx_NEWLINE_xXAdequate organ function, defined as (Note: CBC test should be obtained without transfusion or receipt of colony stimulating factors within 2 weeks before obtaining sample):Xx_NEWLINE_xXCondition (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 eligibleXx_NEWLINE_xXCondition (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 eligibleXx_NEWLINE_xXPatients 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 continuedXx_NEWLINE_xXAbsolute 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 factorsXx_NEWLINE_xXThe use of growth factors other than erythropoiesis stimulating agents or G-CSF (filgrastim) (Neupogen or Neulasta) during the study periodXx_NEWLINE_xXEngraftment of neutrophils (absolute neutrophil count [ANC] >= 1.0 X 10^9/L) for 3 days without granulocyte colony-stimulating factor (g-csf) supportXx_NEWLINE_xXReceived 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.Xx_NEWLINE_xXSubjects 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 daysXx_NEWLINE_xXAnticipated use of filgrastim (G-CSF) or sargramostim (GM-CSF) within 30 days after receiving auranofinXx_NEWLINE_xXCurrent 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 globulinXx_NEWLINE_xXPatients with any contraindication or known hypersensitivity to receiving sargramostatin (recombinant human granulocyte macrophage colony stimulating factor [rhuGM-CSF]) or other yeast based productsXx_NEWLINE_xXDONOR: Willing to receive Triplex vaccination, a minimum of 14 days prior to the start of granulocyte stimulating factor (GSF) mobilizationXx_NEWLINE_xXHemoglobin > 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)Xx_NEWLINE_xXAbsolute neutrophil count (ANC) ? 1,500/?L without colony-stimulating factor supportXx_NEWLINE_xXSubject 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 acceptableXx_NEWLINE_xXTreatment with marrow stimulating agents (e.g. granulocyte colony stimulating factor [GCSF]) within 3 weeks of baseline scanXx_NEWLINE_xXAbsolute neutrophil count (ANC) >= 1500/mm^3 (without granulocyte colony-stimulating factor [G-CSF] support within 2 weeks prior to cycle 1, day 1)Xx_NEWLINE_xXAbsolute neutrophil count >= 1,000/mcL (in the absence of granulocyte colony stimulating factor (GCSF) for >= 14 days)Xx_NEWLINE_xXNo 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 studyXx_NEWLINE_xXAny 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 treatmentXx_NEWLINE_xXTreatment 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 sessionsXx_NEWLINE_xXHave received treatment with agents specifically targeting colony stimulating factor 1 (CSF-1) or CSF-1R, including imatinib, nilotinib, and sunitinib.Xx_NEWLINE_xXThe patient is receiving colony stimulating factors (CSFs) that cannot be held during the monitoring period for dose-limiting toxicities (DLT).Xx_NEWLINE_xXAdequate 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/dLXx_NEWLINE_xX