For patients with solid tumors, the following criteria apply: a. Hemoglobin ? 9.0 g/dl, b. Absolute lymphocyte count ? 1.0 x 10^9/L, c. Absolute neutrophil count ? 1.5 x 10^9/L, d. Platelets ? 100.0 x 10^9/L
Serum hemoglobin ? 9 g/dL; absolute neutrophil count ? 1.5 x 109/L; platelets ? 100 x 109/L.
Hematology Hemoglobin ? 9 g/dL (SI Units: 90 g/L) Platelet count < 75000/mm3 Absolute neutrophil count (ANC) < 1500/mm3
Has adequate bone marrow function, defined as: Platelet count >= 100 x 109/L Hemoglobin >= 9.0 g/dL Absolute neutrophil count >= 1.5 x 109/L.
At least one cytopenia (ANC < 1800/µL or platelet count < 100,000/µL or hemoglobin [Hgb] < 10 g/dL)
Bone marrow reserve consistent with: absolute neutrophil count ? 1.5 x 109/L, platelet count ? 100 x 109/L, and hemoglobin ? 9 g/dL (without transfusion) within 1 week preceding the administration of the study drugs;
Platelet count ? 100 × 109/L, hemoglobin ? 9.0 g/dL and absolute neutrophil count (ANC) ? 2.0 × 109 /L.
Platelet count ? 100,000, hemoglobin ? 9 g/dL
Platelet count > 100000 /mm3, hemoglobin (Hb) > 8 g/dL, absolute neutrophil count (ANC) 1500/mm3; the patient cannot be transfused in order to meet study entry criteria
Adequate hematologic function as indicated by i. Absolute neutrophil counts (ANC) ? 1,500/mm3 ii. Hemoglobin (Hgb) ? 8.0 g/dL iii. Platelet count ? 100,000/mm3
Hemoglobin ?4.0 g/dL. Absolute neutrophil count ?1.0 x 109/L and platelet count ?75 x 109/L
have adequate hematologic function, defined as having a hemoglobin ?8g/dL, an absolute neutrophil count (ANC) ?1.0 × 109/L, and platelet count ?75.0 x 109/L;
Hematologic: ANC 1.5 x 109/L, Hgb ? 9.0 g/dL and platelet count 100 x 109/L (platelet count > 75 x 109/L if documented evidence of bone marrow involvement).
Bone marrow reserve consistent with absolute neutrophil count (ANC) >= 1500 per micro liter (/mcL); platelet count >= 100,000/mcL; hemoglobin A1c (HbA1c) less than (<) 6.5 percent (%).
Absolute neutrophil count (ANC) ?1.0 x 109/l, hemoglobin ?8 g/dl, platelet count ? 100 x 10^9/l, prothrombin (INR) <1.5.
Subjects with a current or recent history, as determined by the Investigator, of severe, progressive, and/or uncontrolled renal disease (estimated glomerular filtration rate (eGFR) <30ml/min), hepatic (Alanine transaminase (ALT) 2.5 times upper limit of normal (>2.5xULN), bilirubin > 2x ULN), hematological (absolute neutrophil count (ANC) <1.0 x 109/L, platelet count <75x109/L or requires regular platelet transfusions to maintain a platelet count ? 75 x 109/L , hemoglobin <9g/dL), endocrine (glycated Haemoglobin (HbA1c)>7% or random glucose >200mg/dL), pulmonary (Forced Expiratory Volume in 1 second (FEV1) <70% of predicted value), cardiac (New York Heart Association (NYHA)) class III/IV, or neurological disease
Recovery from last induction course of chemotherapy (absolute neutrophil count [ANC] > 500 and platelet > 20,000)
No significant anemia (hemoglobin below 9.0 g/dL) or neutropenia (absolute neutrophil count [ANC] < 1000/mm^3)
Absolute neutrophil count (ANC) of < 1.5×109/L, or platelet count of < 100 ×109/L, or hemoglobin < 9g/dL;
Bone marrow impairment as evidenced by hemoglobin <10.0 g/dL, neutrophil count <1.0 × 109/L, platelets <100 × 109/L
Adequate bone marrow function as defined below: \r\n• Absolute neutrophil count ? 1.5x109 /L (1500 per mm3) \r\n• Platelets ? 100x109 /L (100,000 per mm3) \r\n• Hemoglobin > 9.0 g/dL
Peripheral blood (PB) showing at least two of the following criteria: Absolute neutrophil count (ANC) < 0.5 k/µL Platelet count < 30 k/µL Absolute reticulocyte count < 60,000/µL
Has hemoglobin ? 10 g/dL, ANC ? 1.5 × 109/L, and platelet count ? 100 × 109/L
Absolute neutrophil count < 1,500/?L, platelet count < 100,000/?L, or hemoglobin < 6.2 mmol/L (10 g/dL) at screening
Patients must have a platelet count > 100,000/µL, hemoglobin ? 10.0 gm/dL, white blood cell count (WBC) > 2,000/uL, absolute neutrophil count (ANC) ? 1.5 x 109/L, and a serum creatinine ? 1.5 mg/dL unless the measured creatinine clearance is > 40 mL/min/1.73 m2.
In patients < 18 years of age, moderately severe aplastic anemia is defined as having at least one of the following:\r\n* Platelet count < 40 x 10^9/L\r\n* Absolute neutrophil count (ANC) < 10 x 10^8/L\r\n* Hemoglobin (Hgb) < 9 g/dL
Laboratory test results within these ranges: Absolute neutrophil count ? 1.0 x 109/L, Platelet count ? 50 x 109/L, Serum creatinine ? 1.5 mg/dL, Total bilirubin ? 1.5 mg/dL, AST & ALT ? 2 x ULN
Absolute granulocyte count of ?1,000/?L, platelet count ?50,000/?L, and hemoglobin ?8.0 g/dL, with no transfusion within the preceding 7 days
Adequate organ function as defined by the following criteria: Absolute neutrophil count (ANC) ? 1500/?l, Platelets ? 140,000/?l,Hemoglobin ? 12.0 g/dl, Creatinine < 2.0 mg/dl
Bone Marrow Reserve: absolute neutrophil count ? 1.5 x 10^9/L; platelet count ? 100 x 10^9/L; hemoglobin ? 9.0 g/dL. Must not have required blood transfusion within 1 week of baseline blood count assessment.
Adequate hematologic function: Absolute neutrophil count (ANC) ? 1.0 109/L, platelet count ? 100.0 109/L and hemoglobin ? 8.0 g/dL (patients with bone marrow involvement will not be evaluable for hematologic DLT and can enroll with ANC ? 0.75 109/L, platelet count ? 50.0 109/L and hemoglobin ? 8.0 g/dL)
Absolute neutrophil count (ANC) ?1.0 x 109 /L, hemoglobin ?8 g/dL, and platelet count ? 75 x 109/L.
Adequate bone marrow function, for Portion A: absolute neutrophil count (ANC) ? 1.5 x 109/L, platelet count ?100 x 109/L, hemoglobin >9.0 g/dL. For Portion B: ANC ? 1.0 x 109/L, platelet count ? 75 x 109/L, and hemoglobin ? 8.0 g/dL. In both cases, patients must be transfusion independent at least 14 days prior to screening.
Inadequate bone marrow function per protocol-specified hemoglobin, platelet count, and absolute neutrophil count
Platelet count < 50 x10^9/L or absolute neutrophil count (ANC) < 1 x10^9/L at the Screening visit
Patient must have adequate bone marrow function as evidenced by absolute neutrophil count ?1.5 ×10^9/L; hemoglobin >9 g/dL (Patients are allowed to be transfused to this level); platelets ?75 × 10^9/L
Meets absolute neutrophil count, platelet count, hemoglobin, liver and kidney function laboratory values within 2 weeks prior to first dose of study drug.
Subject has absolute neutrophil count < 1500/?L, platelet count < 100000/?L or hemoglobin < 10 g/dL (6.2 mmol/L).
Blood counts at screening: haemoglobin ? 9.0 g/dl,absolute neutrophil count ? 1500/µl, platelet count ? 100,000/µl.
Absolute neutrophil count < 1000/?L, platelet count < 100,000/?L, or hemoglobin < 10 g/dL (6.2 mmol/L) at screening;
Hematological: Absolute neutrophil count ?1x10^9/L; Platelet count ?75x10^9/L;Hemoglobin ?8g/dL
Adequate bone marrow function as assessed by absolute neutrophil count (ANC) ? 1500/mm3; hemoglobin ? 9.0 g/dL, and platelet count ? 100,000/mm3.
Bone marrow reserve: Absolute neutrophil count (ANC) ? 1.5 x 109/L. Platelets ? 100 x 109/L. Hemoglobin ? 9 g/dL.
Hematological function: hemoglobin >9 g/dL; lymphocyte count >0.50 x 109/L; neutrophil count >1.5 x 109/L; platelet count >100 x 109/L
Patients with severe hematopoietic insufficiency, as defined by an absolute neutrophil count of less than 500/MuL, unless disease-related, and/or a platelet count of less than 30,000/MuL at time of screening for this protocol
There is no specific platelet and absolute neutrophil count that will exclude patients from this study given the natural history of AML
Adequate hematology laboratory results (absolute neutrophil count ? 1.5 x 10^9/L, platelet count ? 75 x 10^9/L, hemoglobin ? 10.0 g/dL).
Has adequate bone marrow function defined as a hemoglobin > 9 g/dL, absolute neutrophil count (ANC) ?1.5 ×10?/L , and platelet count ?100,000/mm³. For subjects who received chemotherapy for melanoma just prior to screening for the study subject needs to have a hemoglobin > 9 g/dL, absolute neutrophil count (ANC) >2 × 10?/L, and platelet count ?100,000/mm³.
Adequate hematologic, hepatic, and renal function (absolute neutrophil count ?1.5x 109/L, Hgb >10 g/dL, platelet count ?100 x 109/L, AST/ALT ?2.5x ULN, creatinine ?1.5x ULN).
Prior to day 1 of brentuximab vedotin, patients must again meet the following criteria:\r\n* Hemoglobin >= 8 g/dL\r\n* Absolute neutrophil count (ANC) >= 1,000 cells/mm^3\r\n* Platelet count >= 75,000/mm^3\r\n* Maximum Child-Pugh score of 5\r\n* Creatinine clearance > 50 mL/min via Cockcroft and Gault
Patients who have had count recovery (absolute neutrophil count [ANC] > 500,000/mm^3; non transfused platelet count over 30,000/mm^3) and are at least 30 days after induction and/or transplantation but no more than 120 days post transplant
Platelet count > 400 × 10^9/L and WBC count < 2.5 × 10^9/L or hemoglobin < 10 g/dL at any dose of hydroxyurea.
Adequate hematological function defined by white blood cell (WBC) count ?3 × 10^9/L; absolute neutrophil count (ANC) ?1.5 × 10^9/L; lymphocyte count ?0.5 × 10^9/L; platelet count ?100 × 10^9/L; and hemoglobin ?9 g/dL (may have been transfused).
Adequate hematological function, defined as WBC ?3 × 10^9/L; ANC ?1.5 × 10^9/L; lymphocyte count ?0.5 × 10^9/L; platelet count ?100 × 10^9/L; and hemoglobin ?9 g/dL (may have been transfused).
Bone Marrow Function: Patients must have adequate bone marrow function defined as a peripheral absolute neutrophil count ? 1000/µl, platelet count ? 100,000/µl (transfusion independent) and hemoglobin ? 8.0 gm/dL
No unexplained absolute eosinophil count > 1.5x10^9/L
Group 4: Patients who meet group 1 inclusion criteria but may have FVC or DLCO-adjusted less than 70% plus have had an adverse event on cyclophosphamide preventing its further use (specifically hemorrhagic cystitis, leukopenia with white blood cell [WBC]< 2000 or absolute neutrophil count [ANC] < 1000 or platelet count < 100,000)
Absolute neutrophil count < 1,500/?L, platelet count < 75,000/?L, or hemoglobin < 5.6 mmol/L (9 g/dL) at screening.
Subjects must have adequate bone marrow function as assessed by the following: hemoglobin >=9.0 g/dL or >=5.6 mmol/L, absolute neutrophil count (ANC) >=1.500/mm^3 or >=1.5 x 10^9/L (CTCAE Grade <=1), platelet count >= 100000/mm^3 or >=100 x 10^9/L
Hematologic function: Absolute neutrophil count (ANC) > 500/?L and platelet count > 25,000/?L without transfusion
Hematological: Absolute neutrophil count (ANC) ? 1.5 x 10^9/L, platelet ? 100 x 10^9/L, hemoglobin ? 9 g/dL
12. Adequate bone marrow function (hemoglobin ? 9.0 g/dL; platelets ? 100 x 109/L; absolute neutrophil count [ANC] ? 1.5 x 109/L) without the use of hematopoietic growth factors.
The following laboratory parameters must be within the ranges specified: Hemoglobin ? 10 g/dL, Neutrophil count ? 1.5 x 109/L, Lymphocyte count ? LLN Platelet count ? 80 x 109/L, Serum creatinine ? 2 mg/dL, Serum bilirubin ? 2 x ULN, AST/ALT ? 2 x ULN.
Platelet count ? 100 x 109/L, absolute neutrophil count (ANC) ? 1.5 x 109/L, Hemoglobin ? 9 g/dL.
Hemoglobin ? 7.5 g/dL, - Absolute neutrophil count ? 1.0 x 109/L (1000/mm3), - Platelets ? 50,000/?L
Subject has absolute neutrophil count < 1000/?L, platelet count < 75,000/?L, and hemoglobin < 8 g/dL (< 5 mmol/L) at Screening
Adequate bone marrow function (subjects other than those with AITL) as evidenced by: absolute neutrophil count ?1.0 ×109/L;hemoglobin >9 g/dL (Subjects may be transfused red blood cells to this level.); platelets ?50 × 109/L
Has adequate bone marrow function, defined as: Platelet count >= 100 X 10*9/L Hemoglobin level >= 9.0 g/dL Absolute neutrophil count >= 1.5 x 10*9/L
Adequate baseline hematological parameters as defined by white blood cell count (WBC) ? 3.5 x 103/µL, lymphocyte count ? 1.0 x 103/µL, platelet count ? 100 x 103/µL, and hemoglobin ? 9 g/dL
Platelet count ? 100,000/cubic millimeters (mm3), hemoglobin (Hb) ? 8.5 g/dl, leukocyte count > 3,000/mm3, absolute neutrophil count (ANC) ? 1,000/mm3
Patients must have adequate bone marrow function, defined as an absolute neutrophil count >= 1.5 x 10^9/L and a platelet count >= 100 x 10^9/L.
Whole Blood Cells (WBC) ?3.0 x 10?/L, Absolute neutrophil count (ANC) ?1.5 x 10?/L and platelet count ?100 x 10?/L
Hemoglobin ? 8.5 mg/dl 14. Absolute neutrophil count ? 1.5 x 10^9/L 15. Platelets ? 75 x 10^9/L 16. Life expectancy ? 3 months
Bone marrow: Absolute Neutrophil Count (ANC) ? 1.5 x 109/L, Hemoglobin (Hgb) ? 9 g/dL, Platelets ? 100 x 109/L
The participant has adequate hematologic function as defined by absolute neutrophil count ? 1500/microliters (?L), hemoglobin ? 9 gram/deciliter (g/dL), and platelet count ?100,000/?L
Bone marrow function: neutrophil count >/=1,000/mm3, platelet count >/= 75,000/mm3 and hemoglobin concentration >/= 8.0 g/dL.
Acceptable laboratory results during screening and prior to first study drug administration of the following parameters: absolute neutrophil count (ANC), platelet count, hemoglobin, total bilirubin, aspartate transaminase (AST/SGOT) and alanine transaminase (ALT/SGPT), renal function based on estimated creatinine clearance
Adequate bone marrow function, defined as an absolute neutrophil count (ANC) of greater than or equal to (>=) 1.5*109 per liter (/L), platelet count >=100*109/L, and hemoglobin >=9 gram per deciliter (g/dL). Receiving transfusions or hematopoietic growth factors to meet enrollment criteria is not allowed within 14 days preceding the first dose of study drug.
Platelet count ? 100 x 109/l, hemoglobin ? 9.0 g/dl and ANC ? 1.0 x 109/l.
Hemoglobin must be >=8 gram per deciliter (g/dL), absolute neutrophil count (ANC) must be >=1500 per microliter (/mcL), and platelet count must be >=75,000/mcL.
Bone marrow reserve consistent with absolute neutrophil count (ANC) ?1.5*10^9/L; platelet count ?100*10^9/L; hemoglobin (Hgb) ?9 g/dL.
For patients with solid tumors without known bone marrow involvement:
For patients with solid tumors without known bone marrow involvement:
For patients with solid tumors without known bone marrow involvement: peripheral absolute neutrophil count (ANC) >= 1000/mm^3
Platelet count >= 50,000/uL for patients with solid tumors and known bone marrow metastatic disease
Absolute neutrophil count >= 1,000/mcL (unless documented bone marrow involvement with lymphoma)
Within 10 days of treatment initiation: Absolute neutrophil count (ANC) >= 1000 cells/mm^3 (or >= 750 in subjects with bone marrow involvement)
Bone marrow involvement with >= 5% lymphoblasts
Absolute neutrophil count (ANC) >= 750/uL for subjects without bone marrow involvement
Absolute neutrophil count (ANC) >= 1500 unless due to direct bone marrow involvement of disease
Absolute neutrophil count (ANC) ? 1,500 cells/mm3 (1.5 x 109/L) unless secondary to extensive bone marrow involvement by lymphoma (ie, ? 50%) as demonstrated by unilateral bone marrow core biopsy performed during Screening or within 3 months prior to signing the ICF. In the case of documented extensive bone marrow involvement an ANC ? 1,000 cells/mm3 (1.0 x 109/L) is required.
Platelet count ? 100,000/mm3 (100 x 109/L) unless secondary to extensive bone marrow involvement by lymphoma (ie, ? 50%) as demonstrated by unilateral bone marrow core biopsy performed during Screening or within 3 months prior to signing the ICF. In the case of documented extensive bone marrow involvement, a platelet count of ? 75,000/ mm3 (75 x 109/L) is required.
Absolute neutrophil count (ANC) >= 750/uL if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); a subject will not be excluded because of pancytopenia >= grade 3 if it is due to disease, based on the results of bone marrow studies
Platelet count >= 50,000/uL if these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); a subject will not be excluded because of pancytopenia >= grade 3 if it is due to disease, based on the results of bone marrow studies
Absolute neutrophil count (ANC) >= 1,000/mm^3 \r\n* Exception: unless documented bone marrow involvement by lymphoma
For patients with solid tumors without known bone marrow involvement:
Absolute neutrophil count (ANC) ? 750/uL\r\n* The above criteria do not have to be met if the patient has bone marrow involvement of tumor
Platelet count ? 75,000/uL\r\n* The above criteria do not have to be met if the patient has bone marrow involvement of tumor
Subjects must have adequate Bone Marrow function defined as: For patients without bone marrow involvement: • Peripheral absolute neutrophil count (ANC) >750/uL
ANC < 0.5 x 10^9/L or platelet count < 50 x 10^9/L unless due to disease involvement in the bone marrow.
Platelet count >= 50,000/mm^3 in the absence of bone marrow involvement; patients with bone marrow involvement only require a platelet count of >= 30,000/mm^3
Absolute neutrophil count >= 1000/mm^3 in the absence of bone marrow involvement; patients with bone marrow involvement are not required to have a minimum absolute neutrophil count
Platelet count >= 50,000/uL unless due to heavily infiltrated bone marrow (> 80% CLL cell infiltrate)
Absolute neutrophil count > 1000 /uL unless due to heavily infiltrated bone marrow (> 80% CLL cell infiltrate)
Absolute neutrophil count ? 1000/mm^3, unless due to disease involvement in the bone marrow
Adequate hematologic function (platelet and absolute neutrophil count [ANC] values in accordance with ongoing ibrutinib studies for patients with CLL), unless cytopenias are due to bone marrow highly infiltrated with CLL cells, e.g. > 80%
Subjects with neutrophils < 1500/uL or platelets < 100,000/uL with splenomegaly or extensive bone marrow involvement as the etiology for their cytopenias are eligible
Absolute neutrophil count (ANC) >= 750/uL\r\n* If these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia >= grade 3 if it is due to disease, based on the results of bone marrow studies
Platelet count >= 50,000/uL\r\n* If these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia >= grade 3 if it is due to disease, based on the results of bone marrow studies
Absolute lymphocyte count >= 150/uL\r\n* If these cytopenias are not judged by the investigator to be due to underlying disease (i.e. potentially reversible with anti-neoplastic therapy); A subject will not be excluded because of pancytopenia >= grade 3 if it is due to disease, based on the results of bone marrow studies
Bone marrow cellularity of > 20% with < 5% involvement with tumor
Diffuse bone marrow involvement confirmed by super-scans
Absolute neutrophil count: >= 1,000/mm^3, unless decreased due to bone marrow involvement with lymphoma
Absolute neutrophil count (ANC) >= 1000/mm^3, unless due to disease involvement in the bone marrow
Absolute neutrophil count (ANC) > 1000/mm^3 unless deemed related to lymphoma involvement in the bone marrow and felt potentially reversible by the treating physician
Bone marrow involvement with >= 5% lymphoblasts
For subjects with solid tumors without known bone marrow involvement: peripheral absolute neutrophil count (ANC) >= 750/mm^3
Platelet count >= 75 × 10^9/L (>= 30 × 10^9/L if myeloma involvement in the bone marrow is > 50%)
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L; ANC < 1.5 x 10^9/L if cytopenia is due to extensive bone marrow involvement of disease as determined by the treating physician
Absolute neutrophil count (ANC) > 1500, unless due to direct bone marrow involvement of disease
Subjects with neutrophils < 1500/uL or platelets < 100,000/uL with splenomegaly or extensive bone marrow involvement as the etiology for their cytopenias are eligible
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L or < 1.0 x 10^9/L but >= 0.75 due to > 30% marrow involvement\r\n* Patients who entered the trial prior to June 4, 2014 were restricted to > 50% marrow involvement
Platelet count >= 75.0 x 10^9/L or =< 75.0 x 10^9/L but >= 50.0 x 10^9/L due to > 30% marrow involvement\r\n* Patients who entered the trial prior to June 4, 2014 were restricted to > 50% marrow involvement
Absolute neutrophil count of less than 1000 cells/ul unless low neutrophil count is thought to be due to malignancy in the bone marrow and malignancy is documented in the bone marrow
Platelet count less than 30,000/uL unless low platelet count is thought to be due to malignancy in the bone marrow and malignancy is documented in the bone marrow
Patients must have evidence of adequate bone marrow reserve as shown by absolute neutrophil count (ANC) of at least 1,000/mm^3; however, if the cytopenias are due to extensive bone marrow involvement by CLL, patients may be included in the study
And patients must have evidence of adequate bone marrow reserve as shown by platelet count of at least 50,000/mm^3; however, if the cytopenias are due to extensive bone marrow involvement by CLL, patients may be included in the study
Bone marrow function: absolute neutrophil count ?1,500/µL, and platelets ? 100,000/ µL;
To be performed within 14 days prior to day 1 of protocol therapy: absolute neutrophil count (ANC) >= 1,000/mm^3\r\n* NOTE: Growth factor is not permitted within 7 days of ANC assessment unless cytopenia is secondary to disease involvement\r\n* Exception: Unless documented bone marrow involvement by lymphoma
Adequate bone marrow function independent of growth factor support at screening unless clearly due to marrow involvement by CLL and/or disease-related immune thrombocytopenia; if cytopenias are due to disease in the bone marrow any degree of cytopenias are allowed; patients with active uncontrolled autoimmune cytopenias are excluded
Absolute neutrophil count (ANC) > 1500, unless due to direct bone marrow involvement of disease
These hematologic function criteria must be met by all patients, regardless of bone marrow involvement with tumor
For subjects with solid tumors without known bone marrow involvement: \r\n*Peripheral absolute neutrophil count (ANC) ? 750/mm^3
Platelets >= 50,000/mm^3 independent of transfusion support, with no active bleeding, and absolute neutrophil count >= 1000/mm^3, unless due to disease involvement in the bone marrow
Absolute neutrophil count (ANC) >= 1,000 /mcL if no bone marrow involvement, ANC >= 800 /mcL if documented bone marrow involvement
Patients with known bone marrow involvement are not eligible
For patients with solid tumors without bone marrow involvement: peripheral absolute neutrophil count (ANC) >= 1000/mm^3
For patients with solid tumors without known bone marrow involvement: peripheral absolute neutrophil count (ANC) >= 1000/mm^3
Phase 1 (Part A): patients with known bone marrow involvement are not eligible
Platelet count ? 50 × 109/L  (? 30 × 109/L if WM involvement in the bone marrow is >\n             50%) within 14 days prior to randomization
Patients with greater than 25% involvement of the bone marrow with HL
Bone marrow cellularity of > 20% with < 10% involvement with tumor
ANC ? 0.5 x 10^9/L or platelet count ? 50 x 10^9/L unless due to disease involvement in the bone marrow.
sphenoid bone or foramen ovale involvement;
Absolute neutrophil count (ANC) >= 1,000/uL unless due to bone marrow involvement
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
Part 1: absolute neutrophil count (ANC) >= 1.5 x 10^9/L; Part 2: ANC >= 1.0 x 10^9/L if there is bone marrow involvement, >= 1.5 x 10^9/L if there is no bone marrow involvement
Platelet count >= 50,000/µL unless due to heavily infiltrated bone marrow (> 80% CLL cell infiltrate); AND
Absolute neutrophil count > 1000/uL unless due to heavily infiltrated bone marrow (> 80% CLL cell infiltrate)
Absolute neutrophil count >= 1,000/mcl unless in the opinion of the treating physician, neutropenia is due to splenomegaly or bone marrow involvement
Absolute neutrophil count (ANC) > 1000 cells/mm^3, unless cytopenias due to non-Hodgkin lymphoma (NHL) (i.e., bone marrow involvement or splenomegaly)
Absolute neutrophil count (ANC) >=1.5 × 10^9 per liter (/L) and platelets >=75 × 10^9/L unless cytopenia is caused by the underlying disease, i.e., no evidence of additional bone marrow dysfunction (e.g., myelodysplastic syndrome, hypoplastic bone marrow)
Absolute neutrophil count (ANC) >= 500 independent of growth factor support; (patients who have cytopenias due to significant bone marrow infiltration do not have to meet hematologic eligibility criteria; significant bone marrow infiltration is defined as > 50% involvement by CLL)
Platelet count >= 30,000 independent of transfusion support; (patients who have cytopenias due to significant bone marrow infiltration do not have to meet hematologic eligibility criteria; significant bone marrow infiltration is defined as > 50% involvement by CLL)
PHASE II: If the patient had significant bone marrow involvement (bone marrow [BM] plasma cells >= 50%), a platelet count >= 30,000 mm^3 and absolute neutrophil count (ANC) >= 1000/mm^3 is required
Absolute neutrophil count (ANC) < 0.75 x 109/L or platelet count < 50 x 109/L unless due to disease involvement in the bone marrow.
ANC < 0.75 x 109/L or platelet count < 50 x 109/L unless there is bone marrow involvement.
Patients with lower values may participate if, in the opinion of the investigator, the cytopenias are the result of bone marrow involvement with active prostate cancer
PART A: FOR PATIENTS WITH KNOWN BONE MARROW INVOLVEMENT (Completed as of Amendment 4)
PART B: FOR PATIENTS WITHOUT KNOWN BONE MARROW INVOLVEMENT
Platelet count >= 100,000/mm^3 (unless due to bone marrow infiltration by tumor in which case >= 50,000/ml are allowed)
Adequate baseline platelet and neutrophil levels must be present, unless there is clear evidence of extensive bone marrow involvement with tumor infiltration; extensive bone marrow involvement is defined as:\r\n* Bone marrow lymphocytes >= 30%
Minimum absolute neutrophil count of 1,000 cells/ul and minimum platelet count (without transfusion) of 20,000/mm^3; values below these levels may be accepted at the discretion of the PI, if thought to be due to bone marrow involvement by malignancy
Lymphoma participants without bone marrow involvement must have absolute neutrophil count (ANC) >= 1,000/mm^3; Note: these criteria are waived for participants with leukemia or lymphoma participants with bone marrow involvement
Absolute neutrophil count (ANC) >= 1.5 unless cytopenias are related to bone marrow involvement with disease
Hemoglobin >= 7 g/dl unless cytopenias are related to bone marrow involvement with disease
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L, unless due to bone marrow involvement with lymphoma
All patients must have bone marrow involvement of their tumor, with documented blast percentage of > 5%.
Lymphoma participants without bone marrow involvement must have: \r\n* Absolute neutrophil count (ANC) >= 1,000/µL, and\r\n* Platelet count > 50,000/mm^3 (without transfusion support)\r\n** Note: these criteria are waived for participants with leukemia or lymphoma participants with bone marrow involvement
Confirmed bone marrow involvement
Absolute neutrophil count >= 1,000/mcL (unless due to lymphoma involvement of the bone marrow)
Absolute neutrophil count (ANC) >= 1000/uL, unless due to bone marrow involvement by lymphoma
absolute neutrophil count >1,000/?L in absence of bone marrow involvement
If patient has extensive bone marrow involvement, minimum ANC and platelet levels are not required.
Absolute neutrophil count ?1,000/µL (unless due to documented leukemic involvement of the bone marrow at the time of study entry)
Platelets >= 100,000; patients with bone marrow involvement are allowed at the investigator’s discretion regardless of cytopenias
Absolute neutrophil count (ANC) >= 1,200; patients with bone marrow involvement are allowed at the investigator’s discretion regardless of cytopenias
Platelet count ? 50 × 10^9/L (? 30 × 10^9/L if myeloma involvement in the bone marrow is > 50%) within 21 days prior to randomization
Absolute neutrophil count (ANC) > 1000/mm^3 unless deemed likely related to lymphoma involvement in the bone marrow where the minimum ANC allowable will be 500/mm^3
Absolute neutrophil count (ANC) >= 1,500/?L unless due to marrow involvement by lymphoma
Bone marrow reserve: absolute neutrophil count (ANC) >=1000/microliter (?L), platelet count >=75,000/?L (>=50,000/?L for participants with bone marrow involvement), and hemoglobin >=8 gram per deciliter (g/dL).
Adequate bone marrow reserve: absolute neutrophil count (ANC) greater than or equal to (>=) 1000 per micro litre (/mcL), platelet count >=75,000/mcL (>=50,000/mcL for participants with bone marrow involvement), and hemoglobin >=8 gram per deciliter (g/dL) (red blood cell [RBC] and platelet transfusion allowed >=14 days before assessment).
Absolute Neutrophil Count (ANC) ? 1.5 x 109/L or ? 1.0 x 109/L (with bone marrow involvement with DLBCL)
Absolute neutrophil count >= 1000 cells/mm^3 (1.0 x 10^9/L), unless they have significant bone marrow involvement of their malignancy confirmed on biopsy, completed within 2 weeks prior to start of protocol therapy; growth factor allowed to achieve
Adequate bone marrow reserve: absolute neutrophil count (ANC) greater than or equal to (>=) 1000 per cubic millimeter (/mm^3), platelet count >=75,000/ mm^3 (>=50,000 per micro liter (/mcL) for participants with bone marrow involvement), and hemoglobin >=8 gram per deciliter (g/dL) (red blood cell [RBC] transfusion allowed >=14 days before assessment).
Absolute neutrophil count >= 500 /uL (absolute neutrophile count [ANC] values in accordance with ongoing ibrutinib studies for patients with CLL), unless cytopenias are due to bone marrow highly infiltrated with CLL cells, e.g. > 80%
Absolute neutrophil count (ANC) < 750/?L
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) > 1,000
Absolute neutrophil count (ANC) >= 1.2 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
Absolute Neutrophil Count (ANC) ? 1,000/?L
Absolute neutrophil count (ANC) ? 1.5 × 10e3/µL
Absolute neutrophil count (ANC) >/= 1.5 × 109/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1,500/mL
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
absolute neutrophil count (ANC) ? 1.5 x 109/L and platelet count ?100 x 109/L
Absolute neutrophil count (ANC) >= 1.0 × 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute Neutrophil Count (ANC) > 1,500/µL
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) > 500
Have an absolute neutrophil count (ANC) ?1.0 × 109/L.
Absolute neutrophil count (ANC) ?1.5 × 10?9/Liter (L);
and absolute neutrophil count (ANC) ? 1.5 × 109/L
Absolute neutrophil count (ANC) > 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1500
Absolute neutrophil count (ANC) >= 1.5 x 10^9
Absolute neutrophil count (ANC) ?1.5×10?/L
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x10^9/L
Platelets ? 50 x 10^9/L; Hb ? 8.0 g/dL; absolute neutrophil count (ANC) ? 1.0 x 10^9/L
Absolute neutrophil count (ANC) ?1.5 x 109/L;
Absolute neutrophil count (ANC) <1.5 x 109/L
Absolute Neutrophil Count (ANC) ? 1.5 x 10?/L.
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) of >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) > 1000
Absolute neutrophil count (ANC) ?1.25 x 109/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1,000/?l
Within 14 days of randomization: Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 × 10^9/L.
Absolute neutrophil count (ANC) >= 1.5 × 10^9/L.
Absolute neutrophil count (ANC) > 1500/l
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L.
Absolute neutrophil count (ANC) ? 1.0 x 10^9/L
Absolute neutrophil count (ANC) ?1,000/µL
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L (in absence of blood transfusion).
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L.
Absolute neutrophil count (ANC) >= 1 x 10^9/L
Absolute neutrophil count (ANC) ?1.0 × 10^9/L (Grade ?2).
Absolute neutrophil count (ANC) ? 1.0 x 109/L
Absolute neutrophil count (ANC) =< 1.0
Absolute neutrophil count (ANC) ? 1.0 x 10^9/L
Absolute neutrophil count (ANC) ? 1,500
Absolute neutrophil count (ANC) ? 1.5 x 10^9/L.
Absolute neutrophil count (ANC) > 750
Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
Absolute neutrophil count (ANC) ? 1.5 × 10^9/L
Absolute neutrophil count (ANC) ? 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9 /L
Absolute neutrophil (ANC) count greater than 1000/ µL
Absolute neutrophil count (ANC) ? 1.5 × 109/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L.
Absolute neutrophil count (ANC) ? 1.5 × 10^9/L
Absolute neutrophil count (ANC) ? 1500/?L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1,000/ L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
absolute neutrophil count (ANC) ? 1.5 x 109/L;
(For both cohorts A and B): Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^ 9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1,000
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
Absolute neutrophil count (ANC) ? 1.5 x 10 9/L
Absolute neutrophil count (ANC) > 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) count >= 1.5 X 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.0 x 10^9 /L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) < 1500/mL
Absolute neutrophil count (ANC) < 500/ml
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1.5 x 109/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9 cell/ml
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1 x 10^9/L
Absolute neutrophil count (ANC) >= 1500
Absolute neutrophil count (ANC) >= 1500/mL
Absolute neutrophil count (ANC) ? 1500/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1.5 x109/L.
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1500/?l
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1,000/mL
Absolute neutrophil count (ANC) >= 1.2 x 10^9/L
Absolute neutrophil count (ANC) ? 1,000/µL
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1500/?L
Absolute neutrophil count (ANC) > 1500/l
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) < 1.5 x 10^9/L
Absolute neutrophil count (ANC) > 1.5 x10^9/L
Absolute Neutrophil Count (ANC) <1.5 x 109/L
The absolute neutrophil count (ANC) count >= 1500
Absolute neutrophil count (ANC) >= 1500
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) > 1,000
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) > 0.75
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1.5 × 109/L
Absolute neutrophil count (ANC) > 0.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) > 1.5 x 10^9/L
b. Absolute neutrophil count (ANC) ? 1,500/µL
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.0 × 10^9/L
Absolute neutrophil count (ANC) is >= 1,000
Absolute neutrophil count (ANC) >= 1.5 × 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) > 500
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1,000/mL
Patients should have an absolute neutrophil count (ANC) of > 500?L
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) < 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1500
Absolute neutrophil count (ANC) > 500
Absolute neutrophil count (ANC) > 1000
Absolute neutrophil count (ANC) > 1000
Absolute neutrophil count (ANC) ? 1.5 x 109/L
Absolute neutrophil count (ANC) <1.5 X 109/L
Absolute neutrophil count (ANC) < 1.5 x 109/L
Absolute neutrophil count (ANC) >= 1500
Absolute neutrophil count (ANC) ? 1.5 x 109/L
Absolute neutrophil count (ANC) >= 1.5 x 100/L
Absolute neutrophil count (ANC) ? 1500 /µL
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
ANC (absolute neutrophil count) is 1,500
Absolute neutrophil count (ANC) >= 1.5 x 10^9/ L
Absolute neutrophil count (ANC) less than or equal to 1000
Absolute neutrophil count (ANC) >= 1500/µL
Absolute Neutrophil Count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.2 x 10^9/L
Absolute neutrophil count (ANC) >= 1500
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.2 x 10^9/L
Absolute Neutrophil Count (ANC) < 1,500/µL
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L within 2 weeks before baseline
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) > 1500
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.2 x 10^9/L, within 2 weeks of the first dose of study treatment
Absolute neutrophil count (ANC) >= 1.2 x 10^9/L
Absolute neutrophil count (ANC) >= 1000
Absolute neutrophil count (ANC) >= 500
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) < 1.5
Absolute neutrophil count (ANC) > 500
Absolute neutrophil count (ANC) >= 1.0 x 10^9/l
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) greater than 500/µL.
Absolute neutrophil count (ANC) ? 1.5 x 109/L,
Absolute neutrophil count (ANC):
Absolute neutrophil count (ANC) < 1,000/?L
Absolute neutrophil count (ANC) ? 1.5 x 10^9/liter (L) and
Absolute neutrophil count (ANC) >= 1500
Absolute neutrophil count (ANC) < 1000
Absolute neutrophil count (ANC) ?1000/?L.
Absolute Neutrophil count (ANC) ?1.0 x10?/L (without G-CSF support)
Absolute neutrophil count (ANC) > 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/l
Absolute neutrophil count (ANC) ?1.5 x 109/L
Absolute Neutrophil Count (ANC) < 1.5x109/L
Absolute neutrophil count (ANC) ?1,500 /mL
Absolute Neutrophil Count (ANC) <1.5 x 109/L (1.5x103/µL)
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) < 1500/ml, and/or
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1000
Absolute neutrophil count (ANC) ?1.5×109/L
Absolute neutrophil count (ANC) ? 1.5 × 10e3/µL
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) must be > 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1 x 10^9/L
Absolute neutrophil count (ANC) ?1500/?L.
Absolute neutrophil count (ANC) > 1500
Absolute neutrophil count (ANC) < 1500/ml
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.0 x 10^9 /L
Absolute neutrophil count (ANC) >= 1,500
Absolute neutrophil count (ANC) >= 1000
Hematologic absolute neutrophil count (ANC) >= 1.5 X 10^9/L
Absolute neutrophil count (ANC) >= 1.0 × 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
and absolute neutrophil count (ANC) ? 1.5 × 10^9/L
Absolute neutrophil count (ANC) (neutrophil and bands) ?1.5 x 10 ^9/L
Absolute neutrophil count (ANC) >= 1500 mL
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1,000/?L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) ?1500/µL
Absolute neutrophil count (ANC) ?1.5 x 109/L.
Absolute neutrophil count (ANC) >= 1,500
Absolute neutrophil count (ANC) =< 500
Absolute neutrophil count (ANC) > 750
Absolute neutrophil count (ANC) >= 1000/mL
Absolute neutrophil count (ANC) >= 1500
Absolute neutrophil count (ANC) <1.5 x 109/L
Absolute neutrophil count (ANC) ?1 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L.
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.2 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1500/?L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1.5 x 10^9/L
Absolute neutrophil count (ANC) =< 1.0
Absolute Neutrophil Count (ANC) ? 1.5 x 109/L
Absolute neutrophil count (ANC) < 1 x 10^9/L
Absolute neutrophil count (ANC) < 1500/mL
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) > 1000
Absolute neutrophil count (ANC) >= 1000
Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
Absolute neutrophil count (ANC) >= 1500/ml
Absolute neutrophil count (ANC) >= 1.0 X 10^9/L
Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
Absolute neutrophil count (ANC) >1000/?L and Platelet count > 25,000/?L
Absolute neutrophil count (ANC) > 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1500/mL
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1000
Absolute neutrophil count (ANC) ?1.5 x 10^9/L
Absolute neutrophil count (ANC) > 1000
Absolute neutrophil count (ANC) ? 1.5 x 109/L
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) ? 1.5 × 109/L
Absolute neutrophil count (ANC) ? 1500/?L (without intervention, e.g., G-CSF)
Absolute neutrophil count (ANC) >= 1500/mL
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) <1,000/?L (1.0 X 109/L)
Absolute neutrophil count (ANC) ?1.0 × 109/L
Subjects with an absolute neutrophil count (ANC) >500/?L at Screening.
Absolute neutrophil count (ANC) of 750
Absolute neutrophil count (ANC) ?1.0 ×109/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1,000/?L
Absolute neutrophil count (ANC) < 1500/ml
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1,000
Absolute neutrophil count (ANC) ? 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1.5 x 10^9/L
Absolute Neutrophil Count (ANC) < 1.5 x 109/L Cardiac function:
Absolute neutrophil count (ANC) > 1.5 x 109/L
Absolute neutrophil count (ANC) ?1500/?L
Absolute neutrophil count (ANC) >= 0.75 X 10^9/L
Absolute neutrophil count (ANC) >= 1500
Absolute neutrophil count (ANC) < 1.0 x 109/L
Absolute neutrophil count (ANC) of >= 500/?L
Absolute neutrophil count (ANC) ? 1500/µL (? 1.5 x 103/µL)
Absolute neutrophil count (ANC) <1,500/?L
Absolute neutrophil count (ANC) >=1.5*10^9/L.
Absolute neutrophil count (ANC) ? 1,000/?l
Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1500/?L and platelet count ? 75,000/?L.
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1,000/?L, platelets ? 100,000/?L.
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >=1.2x10^9/L
Absolute neutrophil count (ANC) ?1.5 x 10?/L
Absolute neutrophil count (ANC) >= 1500
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1.5 x 109/L
Absolute neutrophil count (ANC) ?1.5 x 109/L.
Absolute neutrophil count (ANC) >= 1000/?L
Absolute neutrophil count (ANC) ? 1.0 x 109/L
Absolute Neutrophil Count (ANC) ? 1.5 x 109/L.
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1.5 x 109/L
Absolute neutrophil count (ANC) ?1.0 x 109/L
Absolute neutrophil count (ANC) ? 1.5 x 10^9/L and platelet count ?100 x 10^9/L
Absolute neutrophil count (ANC) ? 1,500/µL
Absolute neutrophil count (ANC) ? 1500/µL
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1.5 x 10^9/L;
Absolute neutrophil count (ANC) ?1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1,500
Absolute neutrophil count (ANC) of ?1.0x109/L.
Absolute neutrophil count (ANC) < 1,000/?L
Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
Absolute neutrophil count (ANC) >= 1,000
Absolute neutrophil count (ANC) >= 1.5 X 10^9/L
absolute neutrophil count (ANC) >=1.5*10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) < 1,000/µL (1.0 x 109/L)
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Participants with an absolute neutrophil count (ANC) < 500
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) > 1500
Absolute neutrophil count (ANC) ?1.5 × 10^9/liter (L);
Absolute neutrophil count (ANC) > 1 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 0.75 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) ? 1,500 x10^9/L
Absolute neutrophil count (ANC) > 0.75 x 10^9/L
Absolute Neutrophil Count (ANC) > 500/?l and platelet count >50,000/?l
Absolute neutrophil count (ANC) >= 1 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) of =< 1000
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/l
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L
Absolute neutrophil count (ANC) >= 1.0 x 10^9/L
Absolute neutrophil count (ANC) >= 1.2 X 10^9/L
Absolute Neutrophil Count (ANC) ? 1.5 x 10E9/L
Absolute neutrophil count (ANC) ?1.5 x 109/L
Absolute neutrophil count (ANC) ? 1.5x10^9/L;
Absolute neutrophil count (ANC) >= 1,500 microliter (mcL)
Absolute neutrophil count ? 1,000/microliter (uL)
Platelet count >= 100,000 x 10^9/microliter
Absolute neutrophil count (ANC) >= 1,500 microliter (mcL)
Absolute neutrophil count >= 1,000/microliter
Platelet count >= 50,000/microliter
Absolute neutrophil count >= 1500 per microliter
Absolute neutrophil count (ANC) >= 1,500/microliter
Absolute neutrophil count >= 1,000 microliter
absolute neutrophil count greater than or equal to 1,500 cells/microliter
Absolute neutrophil count >= 1,500/microliter
Absolute neutrophil count (ANC) ? 1500/microliter
Absolute neutrophil count >= 1,300/microliter
Absolute neutrophil count > 1000/microliter
Platelet count > 100,000/microliter
Absolute neutrophil count >= 1000/microliter (mcL)
Absolute neutrophil count (ANC) >= 1000/microliter
Absolute neutrophil count less than 1500 per microliter.
Absolute neutrophil count of > 1500 per microliter
Platelet count > 100,000 per microliter
Platelet count >= 100,000/microliter
Absolute neutrophil count (ANC) greater than or equal to (?) 1000/microliter
Absolute neutrophil count >= 1,500/microliter
Absolute neutrophil count less than 200/microliter
Platelet count less than 20,000/microliter
Absolute neutrophil count >= 1,500/microliter
Absolute neutrophil count >= 1,500/microliter
Absolute neutrophil count >= 1,500/microliter
Neutrophils (absolute neutrophil count [ANC]) >= 1,500/microliter
Absolute neutrophil count >= 1,500/microliter
Absolute neutrophil count >= 1,500/microliter
Absolute neutrophil count >= 1,500/microliter
Absolute neutrophil count >= 1,500/microliter
Absolute neutrophil count >= 1,500/microliter
Absolute neutrophil count >= 1,500/microliter
Absolute neutrophil count >= 1,000/microliter
Leukocyte count >= 3,000/microliter
Platelet count >= 100,000/microliter
Absolute neutrophil count >= 1,500/microliter
Leukocyte count >= 3,000/microliter obtained =< 45 days prior to randomization
Absolute neutrophil count >= 1,500/microliter obtained =< 45 days prior to randomization
Absolute neutrophil count >= 1,500/microliter
Absolute neutrophil count >= 1,500/microliter
Absolute neutrophil count greater than 1000/mm^3 without support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without support of filgrastim
Absolute neutrophil count > 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without support of filgrastim
Absolute neutrophil count > 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1500/mm^3 without the support of filgrastim
Absolute neutrophil count greater than or equal to 1000/mm^3 without the support of filgrastim or other growth factors
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count (ANC) >= 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than or equal to 1000/mm^3 without the support of filgrastim or other growth factors
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count (ANC) >= 1 K/mcL, with or without filgrastim (GCSF) support
Absolute neutrophil count (ANC) >= 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm3 without the support of filgrastim
Absolute neutrophil count greater than or equal to 1000/mm^3 without the support of filgrastim or other growth factors
Absolute neutrophil count greater than 1500/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count (ANC) >= 1.5 x 10^9/L without filgrastim (GCSF) support within 7 days
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than or equal to 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Absolute neutrophil count greater than 1000/mm^3 without the support of filgrastim
Hematopoietic engraftment as evidenced by recovery of the absolute neutrophil count to greater than 500/mm^3 for > 3 days without filgrastim (G-CSF) support and within 40 days of transplant (i.e. complete blood counts [CBCs] obtained 3 or more days apart while off of G-CSF must demonstrate an absolute neutrophil count > 500/mm^3); if absolute neutropenia is not achieved due to a non-myeloablative transplant, the patient can be enrolled on day +21 to +40
Absolute neutrophil count (ANC) greater than or equal to 1500/mm3 (greater than or equal to 1.5 X 103/uL)
Absolute neutrophil count greater than or equal to 1,500/mcl
Absolute neutrophil count (ANC) greater than or equal to 750/mm^3
ANC must be greater than or equal to 1500/mm3,
Within 30 days prior to enrollment: Absolute neutrophil count greater than or equal to 1,500/mcl
Absolute neutrophil count (ANC) greater than or equal to 1500/mm3 (greater than or equal to 1.5 X 103/ul)
Granulocytes greater than or equal to 1500/ul
Absolute neutrophil count (ANC) greater than or equal to 1500/µL
Third or greater relapse.
Absolute Neutrophil Count (ANC) greater than or equal to 1 x 10 to the ninth/Liter
Subject in whom all visible vessels or suture holes greater than or equal to 2mm in diameter have been ligated;
Serum creatinine equal or greater than 2.5 mg/deciliter
PART I: Greater than or equal to 1 week since standard or investigational treatment for metastatic disease
REP ELIGIBILITY: Absolute neutrophil count greater than or equal to 1000/mcL
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Absolute neutrophil count greater than or equal to 1000/mcL
Absolute neutrophil count greater than or equal to 1.5 x 10^9 cells/L
Absolute neutrophil count greater than or equal to 1500/mm^3
Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L
absolute neutrophil count (ANC) greater than or equal to 1.0 x 10^9/L (for Cohorts 3A and 3B leucocyte count greater than or equal to 2 x 10^9/L; participants with bone marrow involvement should have ANC greater than or equal to 0.8 x 10^9/L and leucocyte count greater than or equal to 1 x 10^9/L).
Absolute neutrophil count (ANC) greater than or equal to 1000/mm^3
absolute neutrophil count (ANC) must be greater than or equal to 1000/mm3;
ANC greater than or equal to 500 (7 days after last dose of growth factor)
Absolute neutrophil count greater than or equal to 1000/mm^3 (Turnstile II)
Serum creatinine less than or equal to 1.5 in males, or 1.4 in female
Absolute neutrophil count greater than or equal to 1000/mm^3 (Turnstile II)
Inclusion Criteria:\n\n        Participants must meet all of the following criteria to be included in the study:\n\n          1. Age greater than or equal to 18 years.\n\n          2. Histopathologic diagnosis of CTCL (mycosis fungoides [MF] or Sezary Syndrome [SS]),\n             confirmed by skin biopsy, or lymph node, or blood assessment, of current disease.\n\n          3. CD25 assay-positive tumor, defined as detectable CD25 on greater than or equal to 20%\n             of total lymphoid infiltrate in biopsied skin lesions by immunohistochemistry.\n\n          4. CTCL disease stage at study entry as follows, according to ISCL/EORTC (Olsen 2011).\n\n               -  Lead-In Phase: Stage IA - IV, except participants with CNS involvement.\n\n               -  Main Study: Stage IA - IVA2 including lymph node disease N2 and N3\n\n          5. History of prior therapies for CTCL as follows: must have had prior therapy, any\n             number of prior therapies allowed.\n\n             Topical treatments (except topical chemotherapy) and steroids are not considered as\n             prior therapies.\n\n          6. A minimum washout period of 4 weeks after previous CTCL therapy is recommended before\n             the first dose of E7777.\n\n             Participants must have recovered from any adverse effects from any previous CTCL\n             therapy to CTCAE Grade <2 before starting study drug. A shorter washout may be allowed\n             if participant is experiencing progressive disease despite ongoing treatment\n\n          7. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2 in the Lead-In\n             Phase and performance status of 0 or 1 in the Main Study.\n\n          8. Life expectancy greater than or equal to 3 months in the Lead-In Phase and greater\n             than or equal to 12 months in the Main Study.\n\n          9. Adequate bone marrow reserves as evidenced by:\n\n               -  platelets greater than or equal to 100,000/mm3 (100 x 10^9/L)\n\n               -  clinically stable hemoglobin greater than or equal to 9 g/dL (90 g/L) and\n                  hematocrit greater than or equal to 27% without transfusion support\n\n         10. Normal hepatic function as evidenced by:\n\n               -  bilirubin and alkaline phosphatase less than or equal to 1 x the upper limit of\n                  normal (ULN).\n\n               -  aspartate aminotransferase (AST) less than or equal to 75 U/L and alanine\n                  aminotransferase (ALT) less than or equal to 100 U/L.\n\n               -  albumin greater than or equal to 3.0 g/dL (30 g/L).\n\n         11. Adequate renal function as evidenced by serum creatinine less than or equal to 1.8\n             mg/dL (158 umol/L) OR calculated creatinine clearance greater than or equal to 50\n             mL/min (per the Cockcroft-Gault formula) with less than 2+ protein OR 24- hour urine\n             creatinine clearance greater than or equal to 50 mL/minute with 24- hour urine protein\n             less than 1g.\n\n         12. Provide written informed consent prior to any study-specific screening procedures.\n\n         13. Females may not be lactating or pregnant at Screening or Baseline\n\n         14. All females will be considered to be of childbearing potential unless they are\n             postmenopausal or have been sterilized surgically\n\n         15. Male participants must have had a successful vasectomy (confirmed azoospermia) or they\n             and their female partner must meet the criteria above\n\n        Exclusion Criteria\n\n        Participants who meet any of the following criteria will be excluded from the study:\n\n          1. Prior denileukin diftitox therapy\n\n          2. Use of topical steroids within 14 days of Day 1 of initial therapy is not allowed\n\n          3. Active malignancy (except for CTCL, definitively treated basal or squamous cell\n             carcinoma of the skin, and carcinoma in-situ of the cervix) within the past 24 months.\n\n          4. Serious intercurrent illness\n\n          5. Significant cardiac disease requiring ongoing treatment, including congestive heart\n             failure (CHF), severe coronary artery disease (CAD), cardiomyopathy, uncontrolled\n             cardiac arrhythmia, unstable angina pectoris, or myocardial infarction (MI)\n\n          6. Significant pulmonary symptoms or disease\n\n          7. History of uncontrolled seizure disorder or active central nervous system disease\n\n          8. Major surgery within 2 weeks of study enrollment\n\n          9. Significant or uncontrolled infections requiring specific anti-infective therapy\n\n         10. Known human immunodeficiency virus (HIV) infection; known active hepatitis B or\n             hepatitis C infection\n\n         11. Females who are pregnant (positive urine test) or breastfeeding\n\n         12. Any history of a medical condition or a concomitant medical condition that, in the\n             opinion of the investigator, would compromise the participant's ability to safely\n             complete the study.
Absolute neutrophil count (ANC) greater than or equal to 750/mm^3
Creatinine less than or equal to 2.0 unless related to the disease
ANC must be greater than or equal to 1500/mm3
Greater than or equal to 6 weeks since the receipt of chemotherapy or radiation therapy
Bilirubin greater than or equal to 2.0 x ULN
Inclusion Criteria\n\n          1. Signed written informed consent must be obtained and documented according to\n             International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the\n             local regulatory requirements, and permission to use private health information in\n             accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior\n             to study-specific screening procedures\n\n          2. For solid tumors or lymphoma, a histologically or cytologically confirmed solid tumor\n             that is metastatic, unresectable, or recurrent and for which standard curative or\n             palliative therapies do not exist or are no longer effective.\n\n          3. ? 18 years of age\n\n          4. For solid tumors, measurable disease as defined by Response Evaluation Criteria in\n             Solid Tumors (RECIST 1.1)\n\n          5. For lymphoma, measurable disease as defined by the International Workshop to\n             Standardize Response Criteria for Non-Hodgkin's Lymphoma\n\n          6. For multiple myeloma, measurable disease as defined by the International Uniform\n             Response Criteria for Multiple Myeloma\n\n          7. Karnofsky performance status greater than or equal to 70%\n\n          8. Male or female patients of child-producing potential must agree to use contraception\n             or avoidance of pregnancy measures during the study and for 30 days after the last\n             BBI608 dose\n\n          9. Females of childbearing potential must have a negative serum pregnancy test\n\n         10. Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 1.5\n             × upper limit of normal(ULN)\n\n         11. Hemoglobin (Hgb) greater than or equal to 10 g/dl\n\n         12. Total bilirubin less than or equal to 1.5 × ULN\n\n         13. Creatinine less than or equal to 1.5 x ULN or creatinine clearance greater than 60\n             mL/min/1.73 m2 for patients with creatinine levels above institutional normal.\n             Creatinine < 2.5 x ULN for multiple myeloma patients.\n\n         14. Absolute neutrophil count greater than or equal to 1.5 x 109/L\n\n         15. Platelets greater than or equal to 100 x 109/L\n\n         16. Life expectancy greater than or equal to 3 months\n\n        Exclusion Criteria\n\n          1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents\n             within four weeks of first dose with the exception for a single dose radiation up to\n             8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days\n             before beginning the administration of BBI608.\n\n          2. Surgery within 4 weeks prior to first dose\n\n          3. Any known untreated brain metastases. Treated subjects must be stable for 4 weeks\n             after completion of that treatment, with image documentation required. Patients must\n             have no clinical symptoms from brain metastases and must be either off steroids or on\n             a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients\n             with known leptomeningeal metastases are excluded, even if treated.\n\n          4. Pregnant or breastfeeding\n\n          5. Significant gastrointestinal disorder(s), in the opinion of the Principal\n             Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small\n             intestine resection)\n\n          6. Unable or unwilling to swallow BBI608 capsules daily\n\n          7. Uncontrolled intercurrent illness including, but not limited to ongoing or active\n             infection, clinically significant non-healing or healing wounds, symptomatic\n             congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant\n             pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled\n             infection or psychiatric illness/social situations that would limit compliance with\n             study requirements
Inclusion Criteria\n\n          1. Signed written informed consent must be obtained and documented according to\n             International Conference on Harmonisation (ICH)- Good Clinical Practice (GCP), the\n             local regulatory requirements, and permission to use private health information in\n             accordance with the Health Insurance Portability and Accountability Act (HIPPA) prior\n             to study-specific screening procedures\n\n          2. For solid tumors or lymphoma, a histologically or cytologically confirmed solid tumor\n             that is metastatic, unresectable, or recurrent and for which standard curative or\n             palliative therapies do not exist or are no longer effective.\n\n          3. ? 18 years of age\n\n          4. For solid tumors, measurable disease as defined by Response Evaluation Criteria in\n             Solid Tumors (RECIST 1.1)\n\n          5. For lymphoma, measurable disease as defined by the International Workshop to\n             Standardize Response Criteria for Non-Hodgkin's Lymphoma\n\n          6. For multiple myeloma, measurable disease as defined by the International Uniform\n             Response Criteria for Multiple Myeloma\n\n          7. Karnofsky performance status greater than or equal to 70%\n\n          8. Male or female patients of child-producing potential must agree to use contraception\n             or avoidance of pregnancy measures during the study and for 30 days after the last\n             BBI608 dose\n\n          9. Females of childbearing potential must have a negative serum pregnancy test\n\n         10. Aspartate transaminase (AST) and alanine transaminase (ALT) less than or equal to 1.5\n             × upper limit of normal(ULN)\n\n         11. Hemoglobin (Hgb) greater than or equal to 10 g/dl\n\n         12. Total bilirubin less than or equal to 1.5 × ULN\n\n         13. Creatinine less than or equal to 1.5 x ULN or creatinine clearance greater than 60\n             mL/min/1.73 m2 for patients with creatinine levels above institutional normal.\n             Creatinine < 2.5 x ULN for multiple myeloma patients.\n\n         14. Absolute neutrophil count greater than or equal to 1.5 x 109/L\n\n         15. Platelets greater than or equal to 100 x 109/L\n\n         16. Life expectancy greater than or equal to 3 months\n\n        Exclusion Criteria\n\n          1. Anti-cancer chemotherapy, radiotherapy, immunotherapy, or investigational agents\n             within four weeks of first dose with the exception for a single dose radiation up to\n             8 Gray (equal to 800 RAD) with palliative intent for pain control up to 14 days\n             before beginning the administration of BBI608.\n\n          2. Surgery within 4 weeks prior to first dose\n\n          3. Any known untreated brain metastases. Treated subjects must be stable for 4 weeks\n             after completion of that treatment, with image documentation required. Patients must\n             have no clinical symptoms from brain metastases and must be either off steroids or on\n             a stable dose of steroids for at least 2 weeks prior to protocol enrollment. Patients\n             with known leptomeningeal metastases are excluded, even if treated.\n\n          4. Pregnant or breastfeeding\n\n          5. Significant gastrointestinal disorder(s), in the opinion of the Principal\n             Investigator, (e.g., Crohn's disease, ulcerative colitis, extensive gastric and small\n             intestine resection)\n\n          6. Unable or unwilling to swallow BBI608 capsules daily\n\n          7. Uncontrolled intercurrent illness including, but not limited to ongoing or active\n             infection, clinically significant non-healing or healing wounds, symptomatic\n             congestive heart failure, unstable angina pectoris, cardiac arrhythmia, significant\n             pulmonary disease (shortness of breath at rest or mild exertion), uncontrolled\n             infection or psychiatric illness/social situations that would limit compliance with\n             study requirements
Absolute neutrophil count greater than or equal to 1000/mcL
Granulocytes greater than or equal to 1500/ul
ANC greater than or equal to 1,500 K/uL
Biochemical recurrence: defined as a cancer antigen (CA)-125 greater than or equal to two times the upper normal limit; patients whose CA125 is less than 100 U/mL must undergo a second confirmatory value within a period of not more than 4 weeks; patients with a level greater than or equal to 100 U/mL may be entered without confirmatory measurement
Absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3;
Absolute neutrophil count (ANC) greater than or equal to 750/mm3 (greater than or equal to 0.75 X 10^9/L)
Absolute neutrophil count greater than or equal to 1.5 x 109/L
Inclusion Criteria:\n\n        1.18 years of age or older 2. Able to provide written informed consent or have their legal\n        representatives provide written informed consent 3. Documented histological or cytological\n        evidence of adenocarcinoma of the prostate. Subjects whose pathology reports are no longer\n        available may be enrolled if, in the opinion of the investigator, the subject has a\n        clinical course consistent with prostatic adenocarcinoma 4. ECOG Performance Status of 0 or\n        1 5. Undergone orchiectomy, or have ongoing LHRH analogue therapy prior to C1D1. Subjects\n        on LHRH analogues should remain on these agents for the duration of the study 6. Castrate\n        levels of testosterone less than or equal to 50 ng/dl (or 1.7 nmol/L) and have progressive\n        disease at Screening defined as PSA rise determined by a minimum of 2 rising PSA values\n        greater than or equal to 1 week between each assessment. The PSA value at the Screening\n        visit must be greater than or equal 2ng/mL with or without: Soft tissue disease progression\n        defined by RECIST 1.1 at Screening or less than or equal to 28 days of C1D1. Measurable\n        disease is not required for entry.\n\n        Lymph nodes greater than or equal to 1.5cm (short axis) are considered measurable disease\n        bone disease progression defined by greater than or equal 2 new lesions on bone scan at\n        Screening, or less than or equal 28 days of C1D1 7. Have received abiraterone and/or\n        enzalutamide. Subject must have received either abiraterone or enzalutamide for greater\n        than or equal to 12 weeks. Other second generation CYP17 inhibitors/androgen receptor\n        antagonists including but not limited to TAK-700 (orteronel), TOK-001 (galeterone) may have\n        been taken in place of abiraterone and ARN-509 (apalutamide) may have been taken in place\n        of enzalutamide.\n\n        8. Adequate hematopoietic function as evidenced by:\n\n          -  WBC greater than or equal to 3,000/?l\n\n          -  ANC greater than or equal to 1,500/?l\n\n          -  Platelet count greater than or equal to 100,000/?l\n\n          -  HGB greater than or equal to 10 g/dl and not transfusion dependent 9. Adequate liver\n             function, including all the following:\n\n          -  Total serum bilirubin less than or equal to 2.0 x ULN unless the subject has\n             documented Gilbert syndrome;\n\n          -  Aspartate and alanine aminotransferase (AST & ALT) less than or equal to 3.0 x ULN or\n             less than or equal to 5.0 x ULN if subject has liver metastasis;\n\n          -  Alkaline phosphatase less than or equal to 3.0 x ULN or less than or equal to 5 x ULN\n             in case of bone metastasis and/or hepatic metastasis 10. Subjects must have adequate\n             renal function as evidenced by a serum creatinine of less than or equal to 2.0 mg/dl\n             11. Potassium (K+) greater than or equal to 3.5 mEq/l 12. Subject and his female\n             partner who is of childbearing potential must use 2 acceptable methods of birth\n             control (one of which must include a condom as a barrier method of contraception)\n             starting at Screening and continuing throughout the study period and for 3 months\n             after final study drug administration.\n\n          -  Two acceptable forms of birth control include:\n\n               1. Condom (barrier method of contraception), and\n\n               2. One of the following:\n\n                    1. Oral, injected or implanted hormonal contraception\n\n                    2. Placement of an intrauterine device (IUD) or intrauterine system (ISU)\n\n                    3. Additional barrier methods of contraception: Occlusive cap (diaphragm or\n                       cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.\n\n                    4. Vasectomy or surgical castration greater than or equal to 6 months prior to\n                       Screening.\n\n             13. Able to swallow study medication 14. Able to comply with study requirements\n\n        Exclusion Criteria\n\n        Each subject eligible to participate in this study must not have any of the following:\n\n          1. Received sipuleucel-T (Provenge ®) treatment within 28 days of C1D1\n\n          2. Received 5-alpha reductase inhibitors such as finasteride (PROSCAR®, PROPECIA®), or\n             dutasteride (AVODART®) within 28 days of C1D1\n\n          3. Received any investigational agent less than or equal to 28 days of C1D1\n\n          4. Received palliative radiotherapy less than or equal to 2 weeks of C1D1\n\n          5. Symptomatic CNS metastases\n\n          6. History of another invasive malignancy less than or equal to 3 years of C1D1\n\n          7. A QTcF interval of greater than 470 msec; if the Screening ECG QTcF interval is\n             greater than 470 msec, it may be repeated, and if repeat less than or equal to 470\n             msec, the subject may be enrolled\n\n          8. Clinically significant cardiac arrhythmias (e.g., ventricular tachycardia, ventricular\n             fibrillation, torsades de pointes, second degree or third degree atrioventricular\n             heart block without a permanent pacemaker in place)\n\n          9. Started a bone modifying agent (e.g. bisphosphonates, denosumab) less than or equal to\n             28 days of C1D1 (note: ongoing bone modifying agents administered less than 28 days\n             are allowed)\n\n         10. Any medical condition that could preclude subject participation in the study, pose an\n             undue medical hazard, or which could interfere with study results\n\n         11. Class III or IV Congestive Heart Failure (CHF) as defined by the New York Heart\n             Association (NYHA) functional classification system within the previous 6 months\n\n         12. A history of loss of consciousness or transient ischemic attack less than or equal to\n             12 months of C1D1\n\n         13. Known active HIV, Hepatitis B, or Hepatitis C infections\n\n         14. Known or suspected hypersensitivity to seviteronel, or any components of the\n             formulation\n\n         15. Any other condition which in the opinion of the investigator would preclude\n             participation in the study
Absolute neutrophil count (ANC) greater than or equal to 1.5 X 10^9/L
Patients must have an interval of greater than or equal to 60 days from the completion of radiation therapy to study entry
Patients must have adequate: i. Bone marrow function: Absolute neutrophil count (ANC) greater than or equal to 1,500/mcl. This ANC cannot have been induced or supported by granulocyte colony stimulating factors. Platelets greater than or equal to 100,000/mcl. ii. Renal function: Creatinine ? 1.5 x institutional upper limit normal (ULN). iii. Hepatic function: Bilirubin ? 1.5 x ULN. SGOT (AST) and SGPT (ALT) ? 3.0 x ULN and alkaline phosphatase ? 2.5 x ULN. iv. Neurologic function: Neuropathy (sensory and motor) less than or equal to Grade 1.
Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L
At the time of randomization, blood counts performed within 4 weeks prior to randomization must meet the following criteria: absolute neutrophil count (ANC) must be greater than or equal to 1500/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 10 g/dL.
DLCO less than or equal to 65% or FEV1 less than or equal to 65%;
Baseline LVEF greater than or equal to (>/=) 55%
At the time of study entry, blood counts performed within 4 weeks prior to study entry must meet the following criteria: absolute neutrophil count (ANC) must be greater than or equal to 1000/mm3; Platelet count must be greater than or equal to 100,000/mm3; Hemoglobin must be greater than or equal to 9 g/dL
CTCAE v4.0 greater than or equal to grade 2 vomiting related to metastatic disease.
Greater than or equal to 10 mm of cervical stromal invasion
Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L (greater than or equal to 1500/mm^3)
Adequate organ function, defined as follows: 8.1. Electrocardiogram (ECG) without significant anomalies, performed in the 7 days preceding entry 8.2. Haemoglobin greater than or equal to 90 g/L 8.3. Total white blood cell count (WBC) greater than or equal to 3.0 x 10^9/L 8.4. Absolute neutrophil count (ANC) greater than or equal to 1.5 x 10^9/L 8.5. Platelet count greater than 100 x 10^9/L 8.6. Total bilirubin less than or equal to 1.5 fold the maximum normal value at the place of evaluation or 2.5 fold the maximum normal value in case of liver metastases 8.7. Glutamic-oxaloacetic transaminase/aspartate aminotransferase (GOT/AST), and glutamic-pyruvic transaminase/alanine aminotransferase (GPT/ALT), less than or equal to 2.5 fold the maximum normal value at the place of evaluation (in case of liver metastasis, less than 5 fold the maximum normal value) 8.8. Creatinine less than or equal to 2 mg/dL (less than or equal to 176 µmol/L)
A discrete hepatic artery feeding the tumor with diameter of the vessels equal to or greater than 1.5 mm.
Evidence of myeloid engraftment defined by absolute neutrophil count greater than or equal to (>=) 0.5*109/liter (L) on 3 consecutive days.
Absolute neutrophil count greater than or equal to 1000/mcl
For Post-allo Part B: Transplant must have been performed with active AML (greater than 5% blasts) using a conventional conditioning regimen and have achieved CR or CRi post-alloSCT (with ANC greater than or equal to 1,000 and platelet greater than or equal to 50,000)
Absolute neutrophil count (ANC) greater than or equal to 1,500/mm^3
Grade greater than equal to (>=) 3 hypertriglyceridemia
Bone marrow blasts greater than or equal to 5% for relapsed patients, or greater than or equal to 20% for untreated patients
A minimum of any one of the following disease-related symptoms must be present: a. Unintentional weight loss greater than or equal to 10% within the previous six months; b. Fevers greater than 100.5°F (38.0°C) for greater than or equal to 2 Weeks without evidence of infection; Or c. Night sweats for more than 1 month without evidence of infection.
History of hemoptysis greater than or equal to (>/=) grade 2 within 3 months of randomization
Absolute neutrophil count (ANC) greater than or equal to 1,500/mm3 or greater than or equal to 1.5 x 10^9/L.
Hematologic: Absolute neutrophil count (ANC) greater than or equal to 1.5 x 109/L, platelets greater than or equal to 100 x 109/L, and hemoglobin greater than or equal to 9 g/dL. Patients may receive erythrocyte transfusions to achieve this hemoglobin level at the discretion of the investigator. Initial treatment must not begin until 5 days after the erythrocyte transfusion.
Serum bicarbonate greater than or equal to 20 mEq/L
Low lean mass defined as either\r\n* Age- and sex- specific relative lean muscle mass standard deviation scores =< -1.0 OR\r\n* Body fat content greater than or equal to 25% in males or greater than or equal to 35% in females
Greater or equal to 6 months from last chemotherapy treatment
Greater than or equal to grade 2 dry mouth prior to chemoradiotherapy or greater than or equal to grade 2 mucositis
Adequate serum folate (greater than or equal to 2 ng/mL) and vitamin B12 (greater than or equal to 200 pg/mL) levels assessed by central laboratory (supplementation and retest acceptable) during screening.
Patient has grade 2 or greater hypo-albuminemia, serum sodium greater than 150 meq/L, serum osmolality greater than 300 mOsm/kg or blood urea nitrate/serum creatinine ratio greater than 25, within 7 days of screening
Mini Mental State Exam score greater than or equal to 19
Requiring greater than or equal to 180 mg of morphine per day
African-American postmenopausal women with waist circumference greater than 35 inches (88 cm), 5-year invasive breast cancer risk is greater than 1.40% using the Contraceptive and Reproductive Experience (CARE) model, and have at least one of the following:\r\n* Elevated fasting glucose is greater than or equal to 100 mg/dL\r\n* Elevated blood pressure is greater than or equal to 130/85 mm/Hg
Have a Khorana thromboembolic risk Score greater than or equal to (>=) 2
Patients with an existing local or systemic infection as defined by evidence of fever (a body temperature greater than or equal to 38.0° Celsius (C) with two readings taken at least 10 minutes apart or one body temperature greater than or equal to 38.3°) and any of the following within 24 hours of enrollment: (a) pulse rate greater than or equal to 100 beats/min; (b) respiratory rate greater than or equal to 20/min; (c) white blood cell (WBC) count greater than or equal to 12,000/mm, less than or equal to 4,000/mm or differential count showing greater than 10% band forms; (d) systolic blood pressure less than or equal to 90 mm Hg
T1 post contrast lesion size greater than or equal to 10 mm
Life expectancy (in the opinion of the investigator) of greater than or equal to (>=) 12 weeks and LDH levels less than or equal to (<=) 2.5 ULN
Absolute neutrophil count (ANC) greater than or equal to (>=) 1500 per cubic millimeter (/mm^3).
The participant has adequate hematologic function as defined by absolute neutrophil count greater than or equal to 1500/microliter (?L), hemoglobin greater than or equal to 9 grams/deciliter (g/dL), and platelet count greater than or equal to 100,000/?L.
The participant has adequate hematologic function as defined by absolute neutrophil count greater than or equal to 1500/microliter (?L), hemoglobin greater than or equal to 9 grams/deciliter (g/dL), and platelet count greater than or equal to 100,000/?L.
T-LGL judged by the investigator to require therapy based upon:  \r\n*Severe neutropenia (absolute neutrophil count < 500/microL)\r\n*Moderate neutropenia (absolute neutrophil count < 1000/microL) with recurrent infections\r\n*Symptomatic or transfusion dependent anemia\r\n*Severe thrombocytopenia (< 50,000/microL)\r\n*Hepatic infiltration resulting in abnormal liver function tests\r\n*Symptomatic splenomegaly
White blood cells (WBCs) >= 2000/microL within 14 days of study registration.
Neutrophils >= 1500/microL within 14 days of study registration.
Platelets >= 100 x 10^3/microL within 14 days of study registration.
Platelet count < 50,000/microL
Peripheral absolute neutrophil count (ANC) greater than or equal to 1000/microL
Platelet count greater than or equal to 100,000/microL (transfusion independent)
Absolute T-cell count (ATC) at screening >= 0.07 K/microL. This is defined as CD3+ T-cell percent (expressed as fraction of 100%) multiplied by the absolute lymphocyte count (ALC, expressed in K/microL).
Absolute neutrophil count greater than or equal to 1,500/microL
Platelets greater than or equal to 100,000/microL
Leukocytes >= 3,000/microL
Absolute neutrophil count >= 1,500/microL
Absolute Neutrophil Count (ANC) ? 1,500/microL
Platelets ? 100,000//microL
Absolute neutrophil count greater than or equal to 1,500/microL
Platelets greater than or equal to 100,000/microL
AML, ALL\r\n* Normal values for absolute neutrophil count (> 1000/microL) and platelet count (> 100,000/microL)\r\n* Absence of extramedullary leukemia\r\n* Less than 5 percent blast cells present in the bone marrow
CLL\r\n* Absence of constitutional symptoms attributable to CLL\r\n* No lymph nodes > 1.5 cm in diameter on computed tomography\r\n* No hepatomegaly or splenomegaly by computed tomography\r\n* Absolute neutrophil count > 1500/microL\r\n* Platelet count > 100,000/microL\r\n* No clonal lymphocytes in the peripheral blood by immunophenotyping \r\n* Bone marrow with no evidence of clonal CLL (by flow cytometry and/or immunohistochemistry)