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%