Patients must not be known to be refractory to red blood cell or platelet transfusions
Hemoglobin ? 10 g/dL with no blood transfusions (packed red blood cells and platelet transfusions) in the past 28 days, within 28 days prior to administration of study treatment
Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable
Whole blood transfusions in the last 120 days prior to entry to the study which may interfere with gBRCA testing (packed red blood cells and platelet transfusions are acceptable)
Platelet count >= 100,000/uL; Note: no transfusions are permitted 7 days prior to laboratory studies to determine eligibility
No platelet transfusions within 7 days of registration to meet eligibility criteria; Note: red blood cell transfusions are allowed at any time
Transfusions are permitted to meet both the platelet and hemoglobin criteria; patients must not be known to be refractory to red blood cell or platelet transfusions
Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable)
Platelet count >= 75 x 10^9/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 2 weeks
Pts may receive RBC or platelet transfusions, if clinically indicated, in accordance with institutional guidelines
Use of red blood cell or platelet transfusions within 4 weeks of treatment
Platelets ?100×109/L (w/o transfusions w/in 21 days)
Platelets >= 100,000/mcL (not requiring platelet transfusions)
Platelets >= 50,000/mm^3 for MCL cohort and platelets >= 75,000/mm^3 for DLBCL cohort, performed within 14 days prior to day 1 of protocol therapy\r\n* NOTE: platelet transfusions and packed red blood cell transfusion can be given prior to enrollment to achieve a target platelet (Plt) >= 50,000/uL for MCL and >= 75,000/uL for DLBCL and hemoglobin of >= 8.5 g/dL
Whole blood transfusions in the last 120 days prior to entry to the study
Hematologic function, as follows (no red blood cell or platelet transfusions are allowed within 14 days of the first dose of enfortumab vedotin):
Within two weeks prior to enrollment: Not refractory to red cell or platelet transfusions
Patients should not be known to be refractory to red blood cell or platelet transfusions
Patients must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to screening)
Subjects must be transfusion independent (i.e., no blood product transfusions for a period of at least 14 days prior to screening).
Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable)
Platelets >= 75,000/mm^3 (transfusions not permitted within 7 days of screening)
Patients known to be refractory to platelet or packed red cell transfusions per Institutional Guidelines, or a patient who refuses blood product support.
Within 14 days prior to planned start of treatment: Platelets >= 100,000/mm^3\r\n* Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
Platelets >= 100,000/mcL (not requiring platelet transfusions)
Whole blood transfusions in the last 120 days
Transfusion independent (no red blood cell or platelet transfusions in the preceding 2 weeks of screening)
PHASE I: No blood transfusions 28 days prior to study entry
PHASE II: No blood transfusions 28 days prior to study entry
Patients refractory to red blood cell or platelet transfusions
Patients who refuse to receive blood transfusions
ANC >= 500 X 10^9 /L with transfusions allowed if stem cells available
Platelets >= 20,000 X 10^9 /L with transfusions allowed if stem cells available
Hemoglobin >= 8.0 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 > 50,000/ul and hemoglobin should be > 8 gm/dl; patients may receive platelet or red blood cell transfusions to maintain hemoglobin and platelets at clinical appropriate levels
Willing to undergo blood transfusions as deemed clinically necessary.
Patients who have received no less than 20 transfusions of RBCs;
Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable).
Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable)
Within 14 days prior to day 1 of protocol therapy unless otherwise stated: Platelets >= 75,000/mm^3\r\n* NOTE: Platelet transfusions are not permitted within 14 days of platelet assessment unless cytopenia is secondary to disease involvement
To be performed within 28 days prior to day 1 of protocol therapy: Platelets >= 75,000/mm^3 without transfusions
Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable)
Patients on Part A1 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) >= 1,000/mm^3\r\n** Platelet count >= 75,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)\r\n** Hemoglobin >= 8.0 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) >= 750/mm^3\r\n** Platelet count >= 25,000/mm^3 (may receive platelet transfusions)\r\n** Hemoglobin >= 8.0 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 A2, Part A3, or Part B of the study must meet the hematologic criteria below for enrollment:\r\n* Peripheral absolute neutrophil count (ANC) >= 750/mm^3\r\n* Platelet count >= 25,000/mm^3 (may receive platelet transfusions)\r\n* Hemoglobin >= 8.0 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 ?20,000/µL (Transfusions to achieve this level are allowed).
Anemia that requires red blood cell transfusions
Patients in CRi must have evidence of hematologic recovery after prior therapy independent of red blood cell transfusions
blood transfusions prior to 1990,
Platelet count > 100 x 10^9/L (30 x 10^9/L if myeloma involvement in the bone marrow aspirate is > 50%) within 30 days prior to cycle 1 day 1; subjects may receive platelet transfusions within institutional guidelines
Patients should not have received any platelet transfusions in the last 4 weeks before screening date
Platelet count >= 50 x 10^9/L (>= 30 x 10^9/L if myeloma involvement in the bone marrow is > 50%) within 14 days prior to initial treatment (subjects may be receiving platelet transfusions in accordance with institutional guidelines)
Whole blood transfusions in the last 120 days prior to entry to the study (packed red blood cells and platelet transfusions are acceptable.
Requirement for platelet transfusions.
History of 15 to 75 PRBC transfusions
More than 6 months of cumulative iron-chelation therapy (such as daily deferasirox (Exjade) or deferiprone or 5x/week deferosamine). intermittent deferoxamine doses in association with blood transfusions are not exclusionary regardless of duration of such treatment. -- More than 3 years since patient began receiving regular transfusions (2 units per 8 weeks or 4 units received in a 3 month period).
Active immune thrombocytopenic purpura or history of being refractory to platelet transfusions (within 1 year of first dose)
Patients refractory to red blood cell or platelet transfusions
Subject has received blood transfusions or hematopoietic factor therapy within 14 days prior to the first dose of study drug.
Blood transfusions or hemopoietic factor therapy
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Patients are known to be refractory to red blood cell or platelet transfusions
NON-PROGRESSED DIPG (STRATUM 2): Patients are known to be refractory to red blood cell or platelet transfusions
Patients with leukemia must not be known to be refractory to red blood cell or platelet transfusions.
Platelets >= 50,000/mm^3 or 30,000 (if marrow infiltrated with myeloma; no platelet transfusions are allowed in the 7 days prior to screening)
Adequate renal, hepatic, and bone marrow function without frequent blood product or hematopoietic growth factor support (eg use of erythropoietin or transfusions > 2 units packed red blood cells every 3 months)
Platelets ? 75 x 109/L without transfusions within 21 days before 1st treatment.
Platelet count of =< 50 x 10^9/L less than 7 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
No platelet or blood transfusions within two weeks of obtaining baseline laboratory values
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) >=1000/microliter, hemoglobin >=8.0 gram per deciliter (g/dL) (may receive red blood cell transfusions), platelets >=75,000/ microliter (transfusion independent, defined as not receiving platelet transfusions within a 7 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) >=1000/ microliter (µL), hemoglobin >=8.0 grams (g)/ deciliter (dL) (may receive red blood cell transfusions), platelets >=75,000/µL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment).
Blood transfusions or hemopoietic factor therapy
Subjects for whom prophylactic platelet transfusions, at platelet counts >10× 109/L, are anticipated following PBSC transplant
Platelet count >= 100 X 10^9/L w/o blood transfusions for 7 days preceding lab assessment, obtained within 14 days prior to PET scan