--- a +++ b/clusters/9knumclustersv2/clust_1025.txt @@ -0,0 +1,23 @@ +Platelet count >= ,/uL; Note: no transfusions are permitted days prior to laboratory studies to determine eligibility +Platelet count >= x ^/L; subjects may receive red blood cells (RBC) transfusions or platelet transfusions, if clinically indicated in accordance with institutional guidelines; however, screening platelet count should be independent of platelet transfusions for at least weeks +Pts may receive RBC or platelet transfusions, if clinically indicated, in accordance with institutional guidelines +Adequate Bone Marrow Function defined as peripheral absolute neutrophil count (ANC) >=/ microlitre (L), platelet count >= ,/L (transfusion independent, defined as not receiving platelet transfusions within a day period prior to enrollment); and hemoglobin >= . grams (g)/decilitre (dL), may receive red blood cell (RBC) transfusions. Subjects with bone marrow involvement will be eligible for study (provided they meet the criteria) but will not be evaluable for hematologic toxicity. +Hemoglobin ? . g/dL (may receive RBC transfusions) Patients known to have bone marrow involvement with neuroblastoma are eligible provided that minimum ANC and platelet count criteria are met but are not evaluable for hematological toxicity. +Newly diagnosed MCL: Platelet count > ,/mm^; patients who have bone marrow infiltration by MCL are eligible if their platelet level is equal to or > than , /mm^; (platelet transfusions are allowed; these patients should be discussed with either the PI or Co-PI of the study for final approval) +Hemoglobin >= . g/dL with transfusions allowed if stem cells available; patients with stem cells available are excluded if they require two platelet transfusions per week to maintain the minimum required platelet count; a bone marrow examination is not medically indicated for patients diagnosed with metastatic pheochromocytoma +Platelet count should be > ,/ul and hemoglobin should be > gm/dl; patients may receive platelet or red blood cell transfusions to maintain hemoglobin and platelets at clinical appropriate levels +Patients on Part A or Part C of the study:\r\n* For patients with solid tumors or ALCL without bone marrow involvement:\r\n** Peripheral absolute neutrophil count (ANC) >= ,/mm^\r\n** Platelet count >= ,/mm^ (transfusion independent, defined as not receiving platelet transfusions within a day period prior to enrollment)\r\n** Hemoglobin >= . g/dL (may receive red blood cell [RBC] transfusions)\r\n* Patients with known bone marrow metastatic disease: \r\n** Peripheral absolute neutrophil count (ANC) >= /mm^\r\n** Platelet count >= ,/mm^ (may receive platelet transfusions)\r\n** Hemoglobin >= . g/dL (may receive RBC transfusions)\r\n** Not known to be refractory to RBC or platelet transfusions\r\nTransfusions are permitted to meet both the platelet and hemoglobin criteria; Note: patients with known bone marrow metastatic disease are not evaluable for hematological toxicity for the purposes of dose escalation +Patients eligible for Part A, Part A, or Part B of the study must meet the hematologic criteria below for enrollment:\r\n* Peripheral absolute neutrophil count (ANC) >= /mm^\r\n* Platelet count >= ,/mm^ (may receive platelet transfusions)\r\n* Hemoglobin >= . g/dL (may receive RBC transfusions)\r\n* Not known to be refractory to red cell or platelet transfusions\r\nTransfusions are permitted to meet both the platelet and hemoglobin criteria +Platelet count ?,/L (Transfusions to achieve this level are allowed). +One of the following diagnoses:\r\n* MDS with International Prognostic Scoring System (IPSS) score of INT- or higher and one of the following:\r\n** Symptomatic anemia with either hemoglobin < . g/dL or requiring red blood cell (RBC) transfusion\r\n** Thrombocytopenia with a history of two or more platelet counts < ,/uL or a significant hemorrhage requiring platelet transfusions\r\n** Neutropenia with two or more absolute neutrophil count (ANC) < ,/uL\r\n* Non-M AML +Platelet count > x ^/L ( x ^/L if myeloma involvement in the bone marrow aspirate is > %) within days prior to cycle day ; subjects may receive platelet transfusions within institutional guidelines +Patients should not have received any platelet transfusions in the last weeks before screening date +Platelet count >= x ^/L (>= x ^/L if myeloma involvement in the bone marrow is > %) within days prior to initial treatment (subjects may be receiving platelet transfusions in accordance with institutional guidelines) +Platelet count ?,/?L (transfusions to achieve this level are allowed). Subjects with a baseline platelet count of <,/?L due to underlying malignancy are eligible with Medical Monitor approval. +Requirement for platelet transfusions. +Platelet count > x ()/L with no evidence of bleeding and not requiring platelet transfusions; +Platelet count of =< x ^/L less than days before enrollment; platelet transfusions are permitted to reach entry criteria but should be discussed on a case-by-case basis with the study principal investigator (PI) and permission will depend on etiology of the thrombocytopenia, if not felt to be due to MM +Patients may receive RBC or platelet transfusions, if clinically indicated, in accordance with institutional guidelines +Adequate bone marrow function defined as absolute neutrophil count (ANC) >=/microliter, hemoglobin >=. gram per deciliter (g/dL) (may receive red blood cell transfusions), platelets >=,/ microliter (transfusion independent, defined as not receiving platelet transfusions within a day period prior to enrollment). +Must have adequate organ function as defined by the following values: Adequate bone marrow function defined as-absolute neutrophil count (ANC) >=/ microliter (L), hemoglobin >=. grams (g)/ deciliter (dL) (may receive red blood cell transfusions), platelets >=,/L (transfusion independent, defined as not receiving platelet transfusions within a day period prior to enrollment). +Subjects for whom prophylactic platelet transfusions, at platelet counts > /L, are anticipated following PBSC transplant