Interleukins, interferons and cytokines (other than hematopoietic growth factors): >= days after the completion of interleukins, interferon or cytokines (other than hematopoietic growth factors)
Hemoglobin >= . g/dL, independent of transfusion and/or growth factors within days prior to Step registration
Growth factors that support platelet or white cell number or function must not have been administered within the days prior to enrollment ( days if pegfilgrastim)
Haemopoietic growth factors within weeks prior to receiving study drug.
Absolute neutrophil count (ANC) >= ,/ul without the use of hematopoietic growth factors (within days of treatment initiation)
Taken any of the listed below concomitant medications, growth factors or stimulating agents within the designated washout period:
ANC > ,/l (unsupported by growth factors) and
Hematopoietic growth factors: patients must be at least days since the completion of therapy with a growth factor prior to registration
Hematologic growth factors are not allowed at Screening or during the first cycle of treatment.
Hematopoietic growth factors: At least days since the completion of therapy with a growth factor; at least days from the last administration of PEG-ylated GCSF (Neulasta)
Use of hematopoietic growth factors within weeks of treatment
Subject's central laboratory values must fulfill the following requirements during Screening: Blood product transfusions and hematopoietic growth factors may not be used to meet eligibility criteria. Screening samples should not be collected within days after subject receives a blood product transfusion or growth factors.
Acceptable hematologic status (growth factors cannot be used within the previous days), as specified below:
Platelet transfusions are acceptable prior to treatment to achieve the above numbers, however growth factors are not allowed within days of registration
Off all treatments for MDS (including AZA and DAC) for ? weeks before randomization; growth factors (G-CSF, erythropoietin and thrombopoietin) and transfusions are allowed before and during the study as clinically indicated
Treatment with cytarabine at any dose, lenalidomide, or any other therapy targeted to the treatment of MDS (other than growth factors and other supportive care measures) within weeks of planned randomization
Off biologic therapies including hematopoietic growth factors >= week
Absolute neutrophil count ? . /L (without myeloid growth factors within week of study entry)
Hematologic growth factors are not allowed at Screening or during the first cycle of treatment
Hematopoietic growth factors: At least days since the completion of therapy with a growth factor.
Without transfusion and growth factors within days
Hemoglobin >= g/dl (pre transfusion values used for prognostic factor, can be transfused or use recombinant erythropoietin growth factors but must not have active bleeding)
Has received blood transfusions or growth factors within the last weeks prior to randomization
Hematologic growth factors are not allowed at screening or during the first cycle of treatment
Absolute neutrophil count (ANC) ? , cells/mm (. x /L) (Growth factors cannot be used within days ( days for pegfilgrastim) prior to initiation of therapy)
Chemotherapy, targeted therapy, growth factors or radiation therapy within days of CD
Hematopoietic growth factors
Use of hematopoietic growth factors within weeks prior to initiation of therapy
AT SCREENING: Hemoglobin within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility.
AT SCREENING: Platelet count within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility.
AT SCREENING: Absolute neutrophil count within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility.
AT SCREENING: Absolute lymphocyte count within institutional normal limits. Administration of growth factors or blood transfusions will not be allowed to confirm eligibility.
Growth factors that support platelet or white cell number or function must not have been administered within the days prior to enrollment
Hematopoietic growth factors: at least days since the completion of therapy with a growth factor that supports platelet, red or white cell number or function
Platelet and blood transfusions are allowed on protocol; growth factors, including granulocyte colony stimulating factors and erythropoietin are allowed
Participants are required to stop receiving myeloid growth factors at least week (Neupogen) or weeks (Neulasta) before starting treatment on the study
Administration of myeloid growth factors or platelet transfusion =< days prior to registration
Growth factors that support platelet or white cell number or function must not have been administered within the past days and are not permitted while on the study
Hemoglobin >= . g/dL (without the use of growth factors) (within days prior to registration)
Platelet count >= x ^/L (without use of growth factors [ie., interleukin (oprelvekin)]) (within days prior to registration)
Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of epidermal growth factor (EGF), platelet derived growth factor (PDGF), or fibroblast growth factors (FGF) receptors within days preceding study entrance
Patients must not have received any other treatment for their disease, including hematopoietic growth factors, aside from hydroxyurea for count control, within three weeks of beginning the trial, and should have recovered from all toxicities of prior therapy (to grade or )
Subjects must not be receiving growth factors, except for erythropoietin
For hypomethylating failure cohorts, treatment for MDS with any other drug not being an HMA with the following exceptions: prior treatment with growth factors and/or lenalidomide is allowed for any cohort
Neutrophil count >= /mm^ (no growth factors within days)
Must not have received any hematopoietic growth factors within days/
Hematopoietic growth factors: At least days since the completion of therapy with a growth factor.
For frontline cohort: no prior potentially curative therapy for leukemia; prior therapy with hydroxyurea, hematopoietic growth factors, azacytidine, decitabine, tretinoin (ATRA), or a total dose of cytarabine up to g (for emergency use for stabilization) is allowed
Absolute neutrophil count (ANC) >= ,/mcL (subjects may be treated with hematopoietic growth factors to achieve or maintain this level)
Patients must not have received myeloid growth factors within weeks before mobilization attempt on this study
Patients who have received growth factors within days prior to initiation of dosing of CFI- fumarate.
Patients must not be receiving growth factors
The use of the following within days before treatment:\r\n* Immunosuppressive drugs\r\n* Systemic glucocorticoids\r\n* Hematopoietic growth factors\r\n* Experimental therapy
The use of the following within days before treatment:\r\n* Chemotherapy\r\n* Radiation therapy\r\n* Immunosuppressive drugs\r\n* Systemic glucocorticoids\r\n* Hematopoietic growth factors\r\n* Experimental therapy
Growth factors that support platelet or white cell number or function must not have been administered within the past days
Participant has received prior therapy for MDS. (Prior supportive care in form of transfusions or growth factors, etc., is not considered prior therapy.)
Interleukins, interferons, and cytokines (other than hematopoietic growth factors): ? days after the completion of interleukins, interferons, or cytokines (other than hematopoietic growth factors)
Receiving hematopoietic growth factors
Hemoglobin ? . g/dL; platelets ? x /L; absolute neutrophil count ? . x /L without the use of hematopoietic growth factors
Currently being treated with hematopoietic growth factors other than erythropoietin (EPO). Treatment with hematopoietic growth factors may be started during the study with development, or worsening, of cytopenia
Received hematopoietic growth factors within specified limits prior to treatment ( weeks for epoetin alpha (Procrit) & weeks for darbepoetin alpha (Aranesp)).
All cytokines or hematopoietic growth factors must be discontinued a minimum of days prior to the start of vorinostat on this protocol
ANC >= /uL (no hematopoietic growth factors within days of the start date for vorinostat on this protocol)
Absolute neutrophil count >= ,/mcL (patients may be treated with hematopoietic growth factors to achieve or maintain this level)
Previously untreated with HMAs (prior therapy with transfusions, hematopoietic growth factors, or immunosuppressive therapy is allowed).
Within days of study registration: Hemoglobin value >= g/dL at the screening visit (independent of blood transfusion and/or growth factors within months prior to registration)
Concomitant medication restrictions\r\n* Growth factor(s): growth factors that support platelet or white cell number or function must not have been administered within days prior to enrollment ( days if Neulasta)\r\n* Corticosteroids: patients requiring corticosteroids should not be on a chronic dose; patients should be off steroid for at least days prior to immunotherapy (IT) and they should not receive steroids during protocol treatment\r\n* Investigational drugs: patients who are currently receiving another investigational drug are not eligible
Subjects must not be receiving growth factors, except for erythropoietin
Growth factors:\r\n* Patients must not have received growth factors for days prior to CPX-\r\n* Patients must not have received pegfilgrastim for days prior to CPX-
Absolute neutrophil count >= ,/mcL without the use of hematopoietic growth factors
All cytokines or hematopoietic growth factors must be discontinued a minimum of days prior to protocol therapy
Absolute neutrophil count >= ,/mcL (without hematopoietic growth factors)
Receiving growth factors (filgrastim, XM-filgrastim, peg-filgrastim, plerixafor, etc) or undergoing apheresis < days prior to the start of treatment on protocol (day -)
All biologic agents including hematopoietic growth factors must have been stopped at least week prior to treatment on the study
Any hematopoietic growth factors (ESAs, Granulocyte colony-stimulating factor (GCSF) and other RBC hematopoietic growth factors (eg, Interleukin-)
Patients receiving erythropoiesis-stimulating agents or other hematopoietic growth factors.
Hematologic growth factors are not allowed at screening or during the first cycle of phase a or b.
Patients should not receive growth factors or transfusions for at least days prior to first dose of study drug, with the exception of pegylated G-CSF (pegfilgrastim) and darbopoeitin which require at least days prior to screening and randomization
Discretionary use of growth factors allowed
Administration of myeloid growth factors or platelet transfusion within days prior to the first dose of study treatment
Use of hematopoietic colony stimulating growth factors </= weeks prior to first dose Additional exclusion criteria for PDR/LCL
Platelets > ,/mm^ without growth factors or transfusions
Platelets >= ,/mcL without growth factors or transfusions
Administration of myeloid growth factors or platelet transfusion within days prior to the first dose of study treatment
Hematopoietic growth factors: at least days since the completion of therapy with a growth factor that supports platelet, red or white cell number or function
Subjects must have completed therapy with granulocyte?colony stimulating factor (G?CSF) or other myeloid growth factors at least days before study treatment initiation, or at least days before study treatment initiation, if pegylated myeloid growth factors were administered.
Adequate bone marrow function indicated by ANC > . x /L and platelets > x /L without growth factors or transfusions within the weeks prior to starting AMG
Absolute neutrophil count (ANC) >= . K/uL, unless if cytopenias are deemed to be due disease at discretion of clinical investigator; transfusions and growth factors are permissible
Hemoglobin >= g/dL, unless if cytopenias are deemed to be due disease at discretion of clinical investigator; transfusions and growth factors are permissible
Platelet count >= K/uL, unless if cytopenias are deemed to be due disease at discretion of clinical investigator; transfusions and growth factors are permissible
Interleukins, interferons, and cytokines (other than hematopoietic growth factors): ? days after the completion of interleukins, interferons or cytokines (other than hematopoietic growth factors)
Prior use of growth factors =< days prior to registration
Administration of growth factors or blood transfusions will not be allowed within weeks of the hematology labs required to confirm eligibility
Subjects must not be receiving growth factors, except for erythropoietin
Neutrophil count >= /mm^; (no growth factors within days prior to first dose of the study drug)
Growth factors: interval >= week and >= weeks before study enrollment for standard and long-acting growth factors (e.g., pegfilgrastim), respectively
Prior treatment within the past months with sunitinib, sorafenib, bevacizumab or other multikinase inhibitors targeting any of the following: vascular endothelial growth factors (VEGF), FMS-like tyrosine kinase (FLT), stem cell growth factor (c-KIT), platelet-derived growth factors-alpha and -beta (PDGF-alpha,-beta), colony-stimulating factor (CSF), and the RET receptor for glial-derived neurotrophic factors
Absolute neutrophil count (ANC) >= . x ^/L (>= /mm^) may be supported by transfusion and/or hematopoetic growth factors
Platelets (PLT) >= x ^/L (>= ,/mm^) may be supported by transfusion and/or hematopoetic growth factors
Previous treatment with anti-angiogenesis agents including thalidomide, or inhibitors of epidermoid growth factor (EGF), platelet derived growth factor (PDGF), or fibroblast growth factors (FGF) receptors
Use of hematopoietic growth factors within the weeks prior to initiation of therapy
Platelet count >= K/uL, unless if cytopenias are deemed to be due to disease at discretion of clinical investigator; transfusions and growth factors are permissible
Neutrophil count >= . x ^/l anytime within the last seven days before enrollment; patients can be on myeloid or erythroid growth factors, for example filgrastim
No concurrent growth factors unless vital for the patient
Granulocyte growth factors (G-CSF), within weeks of study entry.
Hematopoietic grow factors: It must have been at least days since the completion of therapy with GCSF or other growth factors at the time of enrollment. It must have been at least days since the completion of therapy with pegfilgrastim (Neulasta).
Administration of myeloid growth factors or platelet transfusion within days prior to the first dose of study treatment
Received any hematopoietic growth factors within days prior to screening.
Growth factors that support platelet or white cell number or function must not have been administered within the past days; growth factors include: GCSF (filgrastim), PEG-GCSF (Neulasta), GM-CSF (sargramostim) and erythropoietin
Hematopoietic growth factors: at least days must have elapsed since the completion of therapy with a growth factor; at least days must have elapsed after receiving pegfilgrastim
A minimum of days must have elapsed since the administration of hematopoietic growth factors with short half life (filgrastim, erythropoietin), while for longer acting hematopoietic growth factors, the minimum time elapsed is days
Patients who have received hematopoietic growth factors (filgrastim, pegfilgrastim, or sargramostim) within days of first dose of screening
Absolute neutrophil count ? ,/mm (not supported by growth factors in the preceding days);
Patients who had received prior EPO treatment or other recombinant growth factors regardless of the outcome (Patient who had received prior EPO treatment or other recombinant growth factors for less than weeks and not within months before screening without a documented response are allowed)
endocrine therapy, immunotherapy, transfusion, hematopoietic factors within days prior to planned first dose of study drug (Note: After completion of dose escalation, patients with AML are not required to meet these hematologic criteria, eg. transfusions and hematopoietic growth factors.)
endocrine therapy, immunotherapy, transfusion, or hematopoietic factors within days prior to planned first dose of study drug (Note: Patients with AML are not required to meet these hematologic criteria, eg, transfusions and hematopoietic growth factors.),
Hematopoietic grow factors: It must have been at least days since the completion of therapy with GCSF or other growth factors at the time of enrollment. It must have been at least days since the completion of therapy with pegfilgrastim (Neulasta).
Hematologic growth factors are not allowed at screening or during the first cycle of treatment
At least days since the completion of therapy with hematopoietic growth factors
Concomitant use of biological agents including growth factors. Exception: - to -patient breast cancer cohort enrolled to explore the use of prophylactic growth-factor support of a . mg/m dose of eribulin.
Patients must not have received any other treatment for their disease, including hematopoietic growth factors, within three weeks of beginning the trial, and should have recovered from all toxicities of prior therapy (to grade or )
Absolute neutrophil count of =< . x ^/L less than days before enrollment; use of growth factors is permitted to fulfill this criterion, but should be discussed on a case-by-case basis with the study PI and permission will depend on etiology of the neutropenia, if not felt to be due to MM
No blood modifiers while enrolled in the study (i.e., growth factors such as erythropoiesis-stimulating agent [ESA] or filgrastim [G-CSF]); NOTE: blood transfusions are allowed per institutional guidelines
Growth factors that support platelet or white cell number or function must not have been administered within days of blood draw documenting hematopoietic function (ANC, Platelets) eligibility. .
ANC: /ul (no short acting hematopoietic growth factors within days of blood draw documenting eligibility and no long-acting hematopoietic growth factors within days of blood draw documenting eligibility)
patients who received hematopoietic growth factors within days of starting study drug or Pegfilgrastim (Neulasta) within days of starting study drug
Administration of growth factors or blood transfusions will not be allowed to confirm eligibility
Prophylactic use of hematopoietic growth factors within week prior to starting trial treatment
Administration of myeloid growth factors or platelet transfusion within days prior to the first dose of study treatment
Subject is receiving anticoagulant, pro-coagulant or antithrombotic, antiplatelet agents, and/or PLT specific growth factors within days prior to randomization
Subject is receiving anticoagulant, pro-coagulant or antithrombotic, antiplatelet agents, and/or PLT specific growth factors within days prior to randomization
Platelets >= ,/mcL, independent of transfusions/growth factors within months of treatment start
PREOPERATIVE FACTORS:
INTRAOPERATIVE FACTORS:
Growth factor(s): Must not have received any hematopoetic growth factors within days of study entry.
Platelets > ,/mm^ without growth factors or transfusions
ESAs (Erythropoiesis stimulating agent) and other RBC (Red blood cell) hematopoietic growth factors (eg, interleukin-)
Platelets ? ,/mm (untransfused [> days] without growth factors)
Patient must not have received any growth factors =< days of entry onto this study