[c09aa8]: / clusters / 9knumclustersv2 / clust_321.txt

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Patients with whole blood transfusion in the last days prior to entry to the study
Patients who have had a transfusion within days of screening are NOT eligible for participation
Must have transfusion-dependent anemia that meets the following criteria:
For Parts A, B, and C, eligibility of participants who require blood transfusion before and after the start of the study treatment should be discussed by the Sponsor and investigator
Whole blood transfusion in the last days prior to entry to the study
Blood transfusion within weeks prior to screening
Treatment for ? days complicated by either i. Development of a red blood cell transfusion requirement (at least units/month for months) ii. National Cancer Institute (NCI) CTCAE grade ? AEs of thrombocytopenia, anemia, hematoma, and/or hemorrhage while being treated with a dosage of < mg BID
Non-leukocyte leukocyte-depleted whole blood transfusion within days of the date of the genetic sample collection.
Absolute neutrophil count (ANC) <,/mm, pre-transfusion platelets <,/mm, or pre-transfusion hemoglobin <. mg/dL (the patient is required to have at least weeks free from blood transfusion, G-CSF and erythropoietin use prior to the hematology test)
PLT < x/L (,/?L) and/or transfusion dependency (both criteria have to be fulfilled) AND/OR
Advanced primary with impeding occlusion, perforation or bleeding, dependent on transfusion
History of transfusion is acceptable and transfusions may be given to meet eligibility requirements
Patients who require or are likely to require corticosteroid or other immunosuppressive drugs for intercurrent disease (any other significant medical problem related to or independent from the neuroblastoma or its treatment) while tentatively scheduled to receive treatment on this study are ineligible; the only exception is for patients known to require mg/kg or less of hydrocortisone (or an equivalent dose of an alternative corticosteroid) as premedication for blood product transfusion in order to avoid allergic transfusion reactions
Patients should not have transfusion-dependent thrombocytopenia or bleeding disorders
Whole blood transfusion in the last days prior to entry to the study
FOR ALL PHASES (Ib AND II): Blood or platelet transfusion within days prior to treatment start
Subjects who have unknown transfusion history
Non-leukocyte depleted whole blood transfusion within days of the date of patient's start on the study
Blood transfusion within days of consent
No hematologic parameters for inclusion; transfusion-dependent patients are eligible and platelet counts should be maintained greater than ,/mm^ throughout cycles and
Aplastic anemia with absolute neutrophil count (ANC) < , and transfusion dependent after failed immunosuppression therapy
Blood transfusion or administration of growth factors within days prior to a blood draw being used to confirm eligibility
Plts ? , - cannot be transfused (must be ? days from last plt transfusion)
Blood transfusion within days of the blood draw being used to confirm eligibility
History of Grade or higher blood transfusion incident according to US Biovigilance Network which refers to any transfusion followed by a major intervention (vasopressors, intubation, transfer to intensive care) to prevent death.
Patients with transfusion-dependent anemia.
Moderate or severe aplastic anemia defined by one of the following: peripheral blood neutrophils < . x ^/L; platelets < x ^/L or platelet transfusion dependence; reticulocytes < x ^/L in anemic patients or red cell transfusion dependence
Plus any of the following: \r\n- Stroke or central nervous system event lasting more than hours\r\n- Magnetic resonance imaging (MRI) changes indicative of brain parenchymal damage\r\n- Magnetic resonance angiogram (MRA) evidence of cerebrovascular disease\r\n- Acute chest syndrome requiring exchange transfusion or hospitalization\r\n- Recurrent vaso-occlusive pain crisis (more than /year for the last years)\r\n- Stage I or II sickle lung disease\r\n- Sickle retinopathy\r\n- Osteonecrosis\r\n- Red cell alloimmunization (> antibodies) during long-term transfusion\r\n- Constellation of dactylitis in the first year of life and a baseline hemoglobin < g/dL and leukocytosis (> . x ^/mm^) in the absence of infection during the second year of life\r\n- History of invasive pneumococcal disease\r\n- Pitted red blood cell (RBC) count > .% during the first year of life\r\n- Abnormal transcranial Doppler\r\n- Transfusion dependence\r\n- Beta thalassemia major
Transfusion dependent anemia with transfusion dependency of ? months
History of at least one documented blood transfusion within months of enrollment
Transfusion dependent alpha- or beta-thalassemia
No specific hematologic parameters for study entry are required; transfusion-dependent patients are eligible and platelet counts should be maintained greater than ,/mm^
Subject received HMA for at least cycles and was still transfusion dependent (as defined in b below).
TREATMENT: Patients must have >=. g/dL Hb and no blood transfusion in the past days to receive veliparib
Presence of transfusion-dependent thrombocytopenia
Presence of transfusion-dependent thrombocytopenia
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.
Excessive bleeding (above cc) identified prior to anastomosis formation with the need for intra-operative blood transfusion.
Platelet count ? , cells/?L without transfusion support days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded.
Platelet count ? , cells/?L, or ? , cells/?L in subjects with documented bone marrow involvement, and without transfusion support days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded.
Must have symptomatic anemia untransfused with hemoglobin < . g/dL =< weeks prior to randomization or with red blood cells (RBC) transfusion dependence (i.e., >= units/month) confirmed for =< weeks before randomization\r\n* NOTE: For non-transfusion dependent patients (i.e., receiving < units/ weeks x weeks pre-study) who receive periodic transfusions, the mean week pre-transfusion hemoglobin should be used to determine protocol eligibility and response reference\r\n* For non-transfusion dependent patients, a minimum of pre-transfusion or un-transfused hemoglobin values are required
Patients must be off all non-transfusion therapy for MDS for days prior to initiation of study treatment, including all types of growth factors; patients may receive hydrocortisone prophylactically to prevent transfusion reactions
Presence of transfusion-dependent thrombocytopenia
blood transfusion(s) prior to ,
Need for transfusion within days prior to the first dose of trial treatment
Patients who have required a blood transfusion within days prior to study start
Patients with transfusion-dependent thrombocytopenia are not eligible
Patient who is growth factor or transfusion dependent
Non-leukocyte depleted whole blood transfusion within days of the date of the pharmacogenetic sample collection.
Previous major bleed (bleeding requiring transfusion of red blood cells) on LMWH
Subjects may not have had a transfusion within days of screening assessment
Blood transfusion within days of the blood draw being used to confirm eligibility
Blood or albumin transfusion within days of the blood draw being used to confirm eligibility
Presence of transfusion-dependent thrombocytopenia
Patients who are platelet or red blood cell transfusion-dependent are eligible
blood transfusion or hemopoietic factor therapy
Presence of transfusion-dependent thrombocytopenia
On a chronic transfusion program or planning on exchange transfusion during the study
Blood or albumin transfusion within days prior to the blood draw being used to confirm eligibility
Hematologic parameters must be assessed at least days after a prior transfusion, if any
Blood transfusion within days prior to blood draw being used to confirm eligibility
Aplastic anemia with absolute neutrophil count (ANC) < and transfusion dependent after they failed immunosuppression therapy
Documented wish against transfusion for personal or religious beliefs
Subjects who have unknown transfusion history for at least the weeks prior to screening
No specific hematologic parameters for study entry are required; transfusion-dependent patients are eligible and platelet counts should be maintained greater than ,/mm^
History of major bleeding (requiring a blood transfusion ? units) not related to a tumor within the past months
Chronic transfusion-dependent anemia with exposure to at least RBCT
Thalassemia major or sickle cell disease requiring blood transfusion
Previous blood transfusion ( days prior to genetic testing)
Packed cell volume (PCV) >= (with or without transfusion)
For IPSS intermediate- or low-risk MDS, participants must be transfusion dependent for red blood cells or platelets (as determined by instructional practices or local standard of care). Participants who are red blood cell transfusion dependent must also have failed erythropoiesis stimulating agents (primary resistance or relapse after a response) or have serum erythropoietin (EPO) levels > U/L.