Patients must have normal organ and marrow function independent of transfusion for at least 7 days prior to screening and independent of growth factor support for at least 14 days prior to screening
Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
Patients may have received prior therapy for the treatment of MDS, including but not limited to: growth factor, transfusion support, immunomodulatory (IMID) therapy, DNA hypomethylating therapy, or cytotoxic chemotherapy prior to enrollment.
REGISTRATION STEP 2-RANDOMIZATION: Patients who are transfusion-dependent and patients receiving growth factor support are eligible; patients must discontinue growth factor support prior to initiation of protocol therapy
Hemoglobin (Hgb) < 9 g/dL without growth factor or transfusion support
Growth factor(s): Must not have received within 1 week of entry onto this study.
Platelets >= 100 x 10^9/L within 28 days of treatment initiation and must be independent of hematopoietic growth factor support
Hemoglobin >= 9 g/dL (transfusion is acceptable to meet this criteria) within 28 days of treatment initiation and must be independent of hematopoietic growth factor support
Hemoglobin < 10.0 g/dL, independent of transfusion or growth factor support
Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening and randomization, with the exception of PEGylated granulocyte colony stimulating factor (GCSF) (pegfilgrastim) and darbepoetin which require at least 14 days prior to screening and randomization
Platelet count >= 75,000/mm^3; in the case that platelets are between 50,000 -75,000, the patient can be enrolled if the plasma cell count in the bone marrow is superior to >= 50%; to meet this hematological eligibility no transfusion support and hematological growth factor are not allowed within 7 days before study enrollment
Acceptable hematologic status (without growth factor support or transfusion dependency):
Therapy with a growth factor within 7 days of starting study drug
Patients who have received neutrophil growth factor support within 14 days of randomization.
(* = without ongoing growth factor or transfusion support)
Patients must not have received growth factor(s) within 1 week of entry onto this study
Hemoglobin > 9 g/dL, without transfusion or hematopoietic growth factor
Patients must have adequate organ and bone marrow function within 14 days prior to registration, as defined by: platelets >= 100,000/mcl, regardless of transfusion or growth factor support
Hemoglobin (HGB) >= 7 g/dl without transfusion or growth factor support for at least 1 week
Platelet >= 30,000/mm^3 without transfusion or growth factor support for at least 1 week
Platelets >= 50,000/mcl; transfusion and/or growth factor are permitted within any timeframe
Hemoglobin > 8.0 g/dL independent of transfusion and growth factor support for at least 7 days prior to screening (except for pegylated G-CSF [pegfilgrastim] and darbepoetin which require at least 14 days prior to screening)
If the bone marrow evaluation shows heavy infiltration with underlying disease, growth factor support may be administered after screening and prior to the first dose of therapy
Platelets >= 100,000/mcl, regardless of transfusion or growth factor support
PHASE I: Platelets >= 100,000/mcL without growth factor support
PHASE II SCLC: Platelets >= 100,000/mcL without growth factor support
UROTHELIAL CARCINOMA EXPANSION COHORT: Platelets >= 100,000/mcL without growth factor support
mCRPC EXPANSION COHORT: Platelets >= 100,000/mcL without growth factor support
Hemoglobin >= 9 g/dL, with or without transfusion support; NOTE: If the patient’s bone marrow biopsy shows greater than or equal to 50% plasma cells, hemoglobin > 8 g/dL (transfusion support or growth factor support is acceptable)
Bone marrow reserve consistent with: absolute neutrophil count (ANC) >= 1.5 x 10^9/L values must be obtained without the need for myeloid growth factor support, platelet or packed red blood cell (PRBC) transfusion support within 14 days
Bone marrow reserve consistent with: platelet count >= 100 x 109/L values must be obtained without the need for myeloid growth factor support, platelet or PRBC transfusion support within 14 days
Bone marrow reserve consistent with: hemoglobin >= 9 g/dL values must be obtained without the need for myeloid growth factor support, platelet or PRBC transfusion support within 14 days
White blood cell >= 2,500 cells/ul without growth factor support
Hematopoietic growth factor (At least 14 days from last dose of hematopoietic growth factor prior to first dose of tazemetostat)
Current or planned growth factor or transfusion support until after initiation of treatment; if growth factor or transfusion support is provided between screening and start of treatment, the participant will no longer be eligible
Platelets >= 50,000/mm^3 or >= 30,000/mm^3 in the setting of marrow involvement by disease or splenomegaly due to disease (independent of growth factor or transfusion support)
Growth factor(s): must not have received within 2 weeks of entry onto this study
Platelets >= 100,000/uL (without transfusion or growth factor support), performed within 28 days prior to registration
Values must be obtained without need for myeloid growth factor or platelet transfusion support within 14 days of registration; however, erythrocyte growth factor is allowed as per published American Society of Clinical Oncology (ASCO) guidelines
Platelets > 50 K without growth factor or transfusion support for a week at least
NOTE: white blood count and platelet count criteria must be met without any transfusion or growth factor support
Adequate hematologic function independent of growth factor support for at least 7 days prior to screening and randomization, with the exception of pegylated G-CSF (pegfilgrastim) and darbepoetin which cannot be administered within 14 days of screening
Hemoglobin >= 9 g/dL (Note: no transfusion within 56 days. Ongoing growth factor support is acceptable if on a stable dose for the past 56 days), within 28 days of day 0.
Platelets >= 100,000/mm^3 (without transfusion or growth factor support)
Patients must have normal organ and marrow function as defined below, independent of growth factor or transfusion support; patients should not receive growth factors or transfusions for at least 7 days prior to first dose of study drug, with the exception of pegylated granulocyte-colony stimulating factor (G-CSF) (pegfilgrastim) and darbepoetin which require at least 14 days prior to screening and randomization
At least 7 days since the completion of therapy with a growth factor
Hematopoietic growth factor (At least 14 days from last dose of hematopoietic growth factor prior to first dose of tazemetostat)
ANC ? 750 cells/?L or ? 500 cells/?L in subjects with documented bone marrow involvement, and independent of growth factor support 7 days before assessment.
ANC ? 750 cells/?L, or ? 500 cells/?L in subjects with documented bone marrow involvement, and independent of growth factor support 7 days before assessment.
Hematopoietic growth factor At least 14 days
Treatment with a long-acting hematopoietic growth factor within 2 weeks prior to initiation of study drug or a short-acting hematopoietic growth factor within 1 week prior to initiation of study drug
Hematopoietic growth factor; at least 14 days from last dose
Laboratory results within 7 days prior to MRZ administration (transfusions and/or growth factor support may not be used to meet this criteria):
Evidence of myeloid engraftment. Use of growth factor supplementation is allowed.
Adequate hematologic function without growth factor or transfusion support
Prior therapy with growth factor support, lenalidomide, 5-azacytidine, decitabine or other investigational agents are allowed; a four week wash out period will be required before receiving study medication
Patients who have received hematopoietic growth factor support within 14 days of day 1 of SGN-35
(* = without ongoing growth factor or transfusion support)
Adequate marrow function independent of growth factor or transfusion support within 2 weeks of screening as per protocol, unless cytopenia is due to marrow involvement of CLL
Hematologic(These values must be independent of growth factor support and stable for at least one week post transfusion)
Serum bilirubin <=1.25 x upper limit of normal (ULN)( These values must be independent of growth factor support and stable for at least one week post transfusion)
Patients must have normal organ and marrow function, independent of transfusion or growth factor support within 14 days before enrollment; patients should not receive growth factors or transfusions for at least 7 days prior to the first dose of study drug, with the exception of pegylated GCSF (pegfilgrastim) and darbepoetin, which require at least 14 days prior to screening and enrollment
Hematopoietic growth factor (granulocyte growth factor, erythropoiesis stimulating agent, thrombopoietin mimetic) within 28 days prior to Randomization
Platelets >= 50 × 10^9/L; if the bone marrow contains >= 50% plasma cells, a platelet count of >= 30 × 10^9/L is allowed (without transfusion support and without hematological growth factor support within 2 weeks of cycle 1 day 1)
Hemoglobin >= 8 g/dL. No transfusion or growth factor support for one week prior to labs.
Platelet count >= 75 x 10^9/L. No transfusion or growth factor support for one week prior to labs.
Patients must have normal organ and marrow function, independent of growth factor or transfusion support; patients should not receive growth factors or transfusions for at least 7 days prior to first dose of study drug, with the exception of pegylated G-CSF (pegfilgrastim) and darbepoeitin which require at least 14 days prior to screening and randomization
Patients must have acceptable organ and marrow function, which should be present independent of growth factor or transfusion support for at least 7 days prior to first dose of study drug, with the exception of pegylated G-CSF (pegfilgrastim) and darbopoeitin which require a 14-day period between dosing and first dose of study drug
Hemoglobin >= 9 g/dL without need for hematopoietic growth factor or transfusion support within 30 days prior to treatment initiation
Growth factor(s): must not have received within 2 weeks of entry onto this study
Subject must have adequate bone marrow independent of growth factor support per local laboratory reference range at Screening.
Hemoglobin >= 8.0 g/dL (without transfusion or growth factor support)
Neutrophils >= 1.0 x 10^9/L (growth factor support is not allowed), within 14 days prior to registration
Adequate bone marrow independent of growth factor support, renal and hepatic function per defined laboratory criteria
Hemoglobin >= 8 g/dL (without platelet transfusion or myeloid growth factor support within two weeks of screening)
Adequate bone marrow function without transfusion or growth factor support, defined as:
Acceptable hematologic status (without growth factor support for neutropenia or transfusion dependency):
Hemoglobin >= 9.0 g/dl (transfusion and/or growth factor support allowed)
Hemoglobin >= 9.0g/dL (without need for transfusion support within 30 days; growth factor allowed)
Adequate hematologic function independent of transfusion and growth factor support for at least 7 days prior to screening (with the exception of pegylated G-CSF (pegfilgrastim) and darbepoetin which require at least 14 days prior to screening), defined as:
ANC > 1500/mm³, platelets > 100,000/mm³, Hgb > 9 g/dL. Values must be obtained without need for myeloid growth factor or platelet transfusion support within 14 days, however, erythrocyte growth factor is allowed as per published ASCO guidelines.
Hemoglobin ? 10 g/dL, independent of transfusion or growth factor support
Hemoglobin > 8 mg/dL without need for hematopoetic growth factor or transfusion support
Platelets >= 20,000/ul without growth factor or transfusional support
Platelets >= 20,000/ul without growth factor or transfusional support
Treatment with amifostine or palifermin (keratinocyte growth factor) during radiotherapy
Hemoglobin ? 10 g/dL without need for hematopoietic growth factor or transfusion support
Subjects with myelodysplastic syndrome who have not been treated previously with 5-azacytidine or decitabine are eligible, regardless of International Prognostic Scoring System risk score; subjects may have received transfusion support, growth factor support, or lenalidomide as previous therapy; however, they shall not have received growth factor support or lenalidomide within 4 weeks of study enrollment
Platelets >= 75,000/uL unless related to bone marrow involvement by HIV-cHL
Platelet count >= 50,000/uL (unless documented bone marrow involvement with lymphoma)
Subjects with a bone marrow biopsy which shows microscopic, low-level involvement of lymphoma are eligible
NOTE: these requirements do not apply to those with marrow involvement of lymphoma (any extent)
Platelet count >= 75,000/?L (unless documented bone marrow involvement with lymphoma)
Patients must have histologically or cytologically confirmed non-Hodgkin’s lymphoma for which standard therapies do not exist or are no longer effective; to be eligible for this study, lymphoma patients must have no marrow involvement as documented by routine marrow aspiration and biopsy performed within 30 days of study entry
Platelets >= 100,000, unless due to direct bone marrow involvement of disease
Platelets >= 75,000/mcL (>= 30,000 if there is bone marrow involvement with lymphoma)
Platelets >= 50,000/mm^3\r\n* Exception: unless documented bone marrow involvement by lymphoma
Platelets >= 75,000/mcL, unless due to marrow involvement by lymphoma in which case a platelet count of >= 30,000/mcL will be used
Absolute neutrophil count >= 1000/mm^3 within 45 days prior to initiation of therapy. (Patients with documented marrow involvement (with lymphoma) or hypersplenism secondary to involvement of the spleen by lymphoma at the time of randomization are not required to meet the parameter).
Platelet count >= 75K /mm^3 within 45 days prior to initiation of therapy. (Patients with documented marrow involvement (with lymphoma) or hypersplenism secondary to involvement of the spleen by lymphoma at the time of randomization are not required to meet the parameter).
Serum creatinine =< 2.0 mg/dL or creatinine clearance of > 40 ml/min within 45 days prior to initiation of therapy. (Patients with documented marrow involvement (with lymphoma) or hypersplenism secondary to involvement of the spleen by lymphoma at the time of randomization are not required to meet the parameter).
Total bilirubin =< 1.5 mg/dL within 45 days prior to initiation of therapy. (Patients with documented marrow involvement (with lymphoma) or hypersplenism secondary to involvement of the spleen by lymphoma at the time of randomization are not required to meet the parameter).
Patients with blood or platelet transfusion within 1 week prior to signing Consent A, or with platelets < 50,000/mm^3, neutrophils < 750/mm^3, or hemoglobin < 8.5 g/dL, unless the cytopenias are considered by the treating physician to be largely due to marrow involvement by lymphoma
Platelets >= 75,000/mcL (unless dysfunction is secondary to lymphoma involvement)
Patients must have measurable malignancy as defined by at least one of the criteria below\r\n* Lymphoma mass that is measurable (minimum 1.5 cm in largest diameter) by computed tomography (CT) scan is required unless bone marrow lymphoma is detectable\r\n* For a lymphoma mass to count as measurable malignancy, it must have abnormally increased metabolic activity when assessed by positron emission tomography (PET) scan\r\n* For lymphoma with only bone marrow involvement, no mass is necessary, but if a mass is not present, bone marrow malignancy must be detectable by flow cytometry
Platelets: >= 75,000/mm^3, unless decreased due to bone marrow involvement with lymphoma
Platelet >= 75,000/mm^3\r\n*Unless related to bone marrow involvement with disease, in which case platelets must be >= 50,000/mm^3
Parenchymal brain involvement with lymphoma
Platelet count >= 75,000/ul (unless documented bone marrow involvement with lymphoma)
Platelets > 100,000/mm^3 unless deemed related to lymphoma involvement in the bone marrow and felt potentially reversible by the treating physician
Platelets >= 100,000/mcL except in cases of marrow infiltration by lymphoma
Platelet count >= 50 x 10^9/L (>= 20 x 10^9/L if lymphoma involvement in the pre-treatment bone marrow is found) within 14 days prior to starting therapy
Platelets > 75,000, unless due to direct bone marrow involvement of disease
To be performed within 14 days prior to day 1 of protocol therapy: platelets >= 30,000/mm^3\r\n* NOTE: Platelet transfusions are not permitted within 7 days of platelet assessment unless cytopenia is secondary to disease involvement\r\n* Exception: Unless documented bone marrow involvement by lymphoma
Platelets > 75,000, unless due to direct bone marrow involvement of disease
Platelets >= 70,000/mcL, OR >= 50,000/mcL if lymphomatous bone marrow involvement; patients with documented marrow involvement may be transfused to this value, performed within 10 days of treatment initiation
Platelets >= 75,000 / mcL if no bone marrow involvement, platelets >= 50,000 / mcL if documented bone marrow involvement
Platelets >= 75,000/mm^3 (unless these parameters are abnormal secondary to lymphomatous involvement of bone marrow); all participants must cease colony-stimulating factor therapy at least 24 hours prior to institution of cycle 1 chemotherapy
Part 1: platelets >= 75,000/mcl; Part 2: platelets >= 50,000/mcl if there is bone marrow involvement by lymphoma; platelets >= 75,000/mcl if there is no bone marrow involvement
Platelets >= 100,000/mm^3 (100 x 10^9/L) (unless due to marrow involvement) obtained within 4 weeks prior to registration
Platelets >= 100,000/mcl unless in the opinion of the treating physician, thrombocytopenia is due to splenomegaly or bone marrow involvement
If bone marrow is involved with lymphoma and normal marrow function prior to onset of lymphoma is documented: ANC of > 750
If bone marrow is involved with lymphoma and normal marrow function prior to onset of lymphoma is documented: any hemoglobin
If bone marrow is involved with lymphoma and normal marrow function prior to onset of lymphoma is documented: platelets of > 50,000/mm^3
Platelets >= 100,000/ul (unless these abnormalities are due to bone marrow involvement)
Platelets >= 75,000 total (>= 50,000 if bone marrow involvement)
Platelets >= 75,000/uL (unless significant bone marrow involvement with MCL)
Patients with documented marrow involvement by lymphoma at the time of registration are not required to meet the above hematologic parameters
Platelets >= 50,000/uL (unless documented bone marrow involvement with lymphoma)
Platelets > 75,000 unless impairment due to organ involvement by lymphoma
Lymphoma participants without bone marrow involvement must have platelet count >= 50,000/mm^3 (without transfusion support); Note: these criteria are waived for participants with leukemia or lymphoma participants with bone marrow involvement
Platelets >= 75,000 unless cytopenias are related to bone marrow involvement with disease
Have evidence of bone marrow involvement of lymphoma at time of transplant staging
Platelets >= 100 x 10^9/L without platelet transfusion dependency, unless due to bone marrow involvement with lymphoma
Platelets >= 75,000/mcL (unless due to lymphoma involvement of the bone marrow)
Platelets >= 75,000/uL, unless due to bone marrow involvement by lymphoma
platelets ?30,000/?L in absence of bone marrow involvement
Platelets ?100,000/µL (unless due to documented leukemic involvement of the bone marrow at the time of study entry).
Screening laboratory values: Neutrophils < 1.5 x 109/L (unless due to NHL involvement of the bone marrow). Platelets < 100 x 109/L (unless due to NHL involvement of the bone marrow). Serum creatinine ?2.0 mg/dL; subjects with serum creatinine ?2.0 mg/dL are eligible if the creatinine clearance (Cockcroft Gault equation [Cockcroft, 1976]) is ?40 mL/min. Total bilirubin > 1.5 times ULN [upper normal limit] (unless due to liver involvement by NHL or Gilbert's disease). Transaminases > 3 times ULN (unless due to NHL involvement).
Neutrophils < 1.5 x 10^9/L (unless due to iNHL involvement of the bone marrow)
Platelets < 50 x 10^9/L (unless due to iNHL involvement of the bone marrow)
Adequate hematologic function (unless abnormalities related to lymphoma infiltration of the bone marrow or hypersplenism due to lymphoma) as follows:
Platelets > 100,000/mm^3 unless deemed likely related to lymphoma involvement in the bone marrow where minimum allowable platelet count will be 50,000/mm^3
Platelets >= 75,000/?L unless due to marrow involvement by lymphoma
Hemoglobin > 7.0 g/dL unless due to marrow involvement by lymphoma
Platelets >= 100 x 10^9/L (or platelet count >= 30 x 10^9 cells/L in patients with lymphoma or CLL if bone marrow disease involvement is documented)
Platelet count >= 75,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\r\n* Hemoglobin >= 8.0 g/dl at baseline (may receive red blood cell [RBC] transfusions)
For patients with solid tumors without known bone marrow involvement: \r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 75,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\r\n* Hemoglobin >= 8.0 g/dl at baseline (may receive packed red blood cell [PRBC] transfusions)
* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
For patients with solid tumors without known bone marrow involvement: platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\r\n* Hemoglobin >= 8 g/dL
Platelet count >= 100,000/uL (transfusion independent)
Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors within 90 days prior to step 1 registration
Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment) for patients with solid tumors without bone marrow involvement
For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)\r\n* Hemoglobin >= 8.0 g/dL at baseline (may receive red blood cell [RBC] transfusions)
For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count >= 75,000/ul (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
Platelet count >= 75,000/uL (transfusion independent for >= 7 days)
Platelet count >= 75,000/uL (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to enrollment) for subjects without bone marrow involvement
Platelet count >= 75 × 10^9/L or >= 50× 10^9/L if there is lymphoma involvement in the bone marrow, independent of platelet transfusion
Screening platelet count should be independent of platelet transfusions for at least 2 weeks.
Platelet count >= 100,000/uL (transfusion independent)
Platelet count ? 75,000/uL (transfusion independent)
Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count >= 75 x 10^9/L (transfusion independent for > 7 days)
Platelet count >= 75,000 and transfusion independent
Platelet count of at least 100,000/L (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment)
Platelet count >= 75,000/uL (transfusion independent)
Platelet count: >= 50,000 (transfusion independent; >= 7 days from last transfusion)
Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment).
Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count ? 100,000/mm3 (transfusion independent defined as no platelet transfusion within 7 days and recovery from nadir)
Platelet count >= 100,000/mm^3 (transfusion independent defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) within 14 days of registration
Platelet count >= 100,000/uL (transfusion independent)
Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization
Platelet count >= 100,000/ mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count of >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
PART 2 GROUP 1 INCLUSION CRITERIA: Platelet count >= 75,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
PART 2 GROUP 3 INCLUSION CRITERIA: Platelet count >= 75,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count >= 100,000/uL (transfusion independent)
Platelet count of >= 100 k/mL independent of transfusion and/or growth factors within 3 months prior to randomization
Platelets >= 100,000/mcL (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
Platelets >= 75,000/mcl (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
Platelets >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within 7 days\r\nprior to laboratory sample)
Platelet count >= 100,000 x 10^9/uL independent of transfusion and/or growth factors within 3 months prior to randomization
Platelet count >= 100,000/uL independent of transfusion and or growth factors within 3 months prior to enrollment
Platelet count (transfusion independent) >= 75,000/mm^3
For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3 within 7 days prior to enrollment \r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count >= 50,000/ul (transfusion independent)
For subjects with solid tumors without known bone marrow involvement: platelet count >= 75,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count > 100,000/mm^3; independent of transfusion
Platelet count 50,000/uL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment. Exception: Patients that are platelet dependent due to previous extensive treatment- e.g. - MIBG therapy).
Screening platelet count should be independent of platelet transfusions for at least 1 week
Platelet count >= 100,000/uL (transfusion independent)
Platelet count ?100 × 10^9/L (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to study drug administration)
Platelet count >= 50,000 mm^3; platelet count should be independent of transfusions for at least 14 days for eligibility
Platelet count >= 100,000/uL (transfusion independent)
Platelet count: >= 50,000/ul, transfusion independent (no platelet transfusions within 1 week)
For subjects with solid tumors without known bone marrow involvement: \r\n*Platelet count ? 75,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Obtained within 28 days prior to registration: Platelets > 100,000 cells/mm^3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
Platelet count > 100,000/mm^3. Patients who have bone marrow infiltration by MCL are eligible if their platelet level is >= 50,000 /mm^3 independent of platelet transfusions.
For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Within 7 days prior to study registration: Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelets >= 100,000/mm^3 (transfusion independent (except for patients with marrow involvement by disease where there is no blood count requirement, except for platelet count which must be >= 25,000 prior to enrollment (can be achieved with transfusion)
Platelet count >= 50,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment); in NB patients with known bone marrow involvement relaxed platelet count eligibility requirement should be used: a platelet count of >= 20,000/mm that can be maintained with =< 1 platelet transfusion per week
Platelet count >= 100,000/uL (transfusion independent)
Platelet count: >= 50,000/mm^3, transfusion independent (no platelet transfusions within 1 week)
Platelet count > 100,000/uL (transfusion independent)
Platelet count >= 75,000/uL (transfusion independent)\r\n* If the ANC and/or platelet count are not adequate, but due to bone marrow metastatic disease, these criteria will be waived
For patients with solid tumors without bone marrow involvement: platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment)
For patients with solid tumors and known bone marrow metastatic disease: platelet count >= 75,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
For patients with solid tumors without bone marrow involvement: platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
For patients with solid tumors without known bone marrow involvement: platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count >= 100,000/uL (transfusion independent)
For patients with solid tumors or ALCL without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count >= 100,000/uL (transfusion independent)
Platelet transfusion independent for at least 4 weeks prior to enrollment
Platelet count >= 75,000/uL (transfusion independent)
Platelet count >= 100,000/mm^3 (transfusion independent)
Platelet count > 30,000 K/uL independent of transfusion support
Platelets >= 100,000 cells/mm^3 (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample)
Within 28 days prior to signing informed consent: Platelet counts >= 100,000/mm^3 or >= 50,000/mm^3 if bone marrow involvement with lymphoma, independent of transfusion support in either situation
Platelets >= 100,000/mcL (transfusion independent, defined as not receiving platelet transfusions within a 7-day period prior to enrollment)
Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment) and
Platelet count >= 100,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count >= 75,000/uL (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment)
Platelet count >= 100,000/uL (transfusion independent)
Platelet count >= 100,00 mm^3 independent of transfusion support
Platelet count < 50,000 cells/mm^3 (50 x 10^9/L) independent of transfusion support
Platelets: >= 100,000/mm^3 (transfusion independent defined as not receiving platelet transfusions within 7 days prior to registration)
Platelet count >= 75,000/uL (transfusion independent)
Platelet count >= 75,000/uL for patients with solid tumors without bone marrow involvement (transfusion independent, defined as not receiving platelet transfusions within a 7 day period prior to enrollment); platelet count >= 25,000/uL for patients with known bone metastatic disease (transfusions are permitted to reach the platelet criteria)
Platelet count >= 75,000/ mm^3 (transfusion independent for > 7 days)
Platelet count >= 75,000/uL (transfusion independent)
Screening platelet count should be independent of platelet transfusions for at least 2 weeks
Screening platelet count >= 50 x 10^9/L independent of platelet transfusions for at least 2 weeks
Platelet count: 100,000/ul and transfusion independent (no platelet transfusions within 7 days of blood draw documenting eligibility)
Platelet count > 100,000/uL (transfusion independent)
Platelet count >= 100,000/mm^3 or >= 50,000/mm^3 if bone marrow involvement independent of transfusion support in either situation
Platelet count >= 100,000/mm3 independent of transfusion support OR >= 50,000/mm3 independent of transfusion\r\nsupport if bone marrow involvement
Transfusion independent
Platelet count >= 25,000 cells/mm^3 (25 x 10^9/L) independent of transfusion within 7 days of screening
GENERAL INCLUSION CRITERIA FOR SUBPROTOCOLS: For patients with solid tumors without known bone marrow involvement:\r\n* Peripheral absolute neutrophil count (ANC) >= 1000/mm^3\r\n* Platelet count >= 100,000/mm^3 (transfusion independent, defined as not receiving platelet transfusions for at least 7 days prior to enrollment
Platelet count >= 100,000/uL (transfusion independent)
Platelet count >= 40,000 cells/mm^3 (40 x 10^9/L) independent of transfusion within 7 days of screening, unless they have significant bone marrow involvement of their malignancy confirmed on biopsy
Platelet count >= 100,000/mm^3 (transfusion independent)
Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors within 90 days prior to Step 1 registration
Phase I only: Patients must have mean hemoglobin concentration < 10.0 g/dL of 2 measurements (not influenced by RBC transfusion within 7 days of measurement) and having received < 4 units of RBCs within 8 weeks prior to start of treatment OR,
Total hemoglobin >= 9 g/dL (may be post-transfusion)
Pre-transfusion hemoglobin of <= 10 g/dL,
Total hemoglobin >= 9 g/dL (which may be post transfusion)
Hemoglobin < 9 g/dL (hemoglobin may be supported by transfusion, erythropoietin, or other approved hematopoietic growth factors)
Hemoglobin >= 9 g/dL (with or without transfusion support)
hemoglobin ? 9 g/dL; subjects requiring transfusion will be eligible to start study
Hemoglobin ? 9.0 g/dL independent of transfusion and/or growth factors within 3 months prior to randomization
Hemoglobin >= 9 g/dL (with or without transfusion support)
Hemoglobin >= 9 g/dL (with or without transfusion support) within 14 days prior to start of protocol therapy.
Hemoglobin >= 10 g/dl (may achieve by transfusion)
Meet the following laboratory parameters, per the reference range, at least once during the screening period: ANC of at least 1000/?L (Subjects may use growth factor support to achieve ANC eligibility criteria), AST and ALT not higher than 3 x ULN, Calculated creatinine clearance of at least 30 mL/min using a modified Cockcroft-Gault calculation, platelet count of at least 30,000 mm³ (independent of transfusion for 2 weeks), hemoglobin of at least 8.0 g/dL (subjects may receive blood transfusion to achieve hemoglobin eligibility criteria), and total bilirubin not higher than 1.5 x ULN (subjects with Gilbert's Syndrome may have bilirubin higher 1.5 x ULN).
Hemoglobin >= 9 g/dL (transfusion to meet eligibility allowed)
Hemoglobin ? 8 g/dL, with or without transfusion support
Within 7 days of enrollment and with 24 h of starting lymphodepleting chemotherapy: Hemoglobin >= 9.0 g/dL (transfusion allowed).
STRATUM A: Hemoglobin >= 8.0 g/dL without support of a blood transfusion within 7 days of the test
STRATUM B: Hemoglobin >= 8.0 g/dL without support of a blood transfusion within 7 days of the test
STRATUM C: Hemoglobin >= 8.0 g/dL without support of a blood transfusion within 7 days of the test
COHORT 1: HORMONE RECEPTOR POSITIVE BREAST CANCER: Hemoglobin >= 9 mg/dL (transfusion to obtain hemoglobin >= 9 mg/dL within 24 hours prior to dosing is allowed)
COHORT 2: TRIPLE NEGATIVE BREAST CANCER: Hemoglobin >= 9 mg/dL (transfusion to obtain hemoglobin >= 9 mg/dL within 24 hours prior to dosing is allowed)
COHORT 3: ENDOMETRIAL CANCER: Hemoglobin >= 9 mg/dL (transfusion to obtain hemoglobin >= 9 mg/dL within 24 hours prior to dosing is allowed)
Hemoglobin >= 9.0 g/dL independent of transfusion.
Hemoglobin >= 9 g/dL but transfusion allowed
Hemoglobin ? 9 g/dL (uncorrected by RBC transfusion)
REP ELIGIBILITY: Hemoglobin greater than or equal to 8.0 g/dL (Note that this threshold is slightly lower than the initial trial screening parameter since most subjects will require blood transfusion at some point during the protocol treatment, and the established threshold for transfusion is 8 gm/dL)
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Hemoglobin greater than or equal to 8.0 g/dL (Note that this threshold is slightly lower than the initial trial screening parameter since most subjects will require blood transfusion at some point during the protocol treatment, and the established threshold for transfusion is 8 gm/dL)
Hemoglobin ? 9.0 g/dL without transfusion support within 14 days prior to study treatment (erythropoietin or darbepoetin permitted)
Hemoglobin >= 9.0 g/dL (transfusion is allowed to correct anemia).
Hemoglobin >= 8 mg/dL (Note: Transfusion may be used for eligibility outside of 7 days)
Hemoglobin >= 9.0 g/dL\r\n* Patients may have a transfusion of red blood cells to meet the hemoglobin requirement
Hemoglobin >= 9 g/dL (transfusion allowed but must demonstrate stability after transfusion)
Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
Hemoglobin >= 10 g/dL (transfusion to obtain hemoglobin >= 10 g/dL within 24 hours prior to dosing is allowed)
Hemoglobin >= 9 g/dL\r\n* May receive transfusion to meet this goal
Hemoglobin >= 9 g/dL\r\n* Note: Patients requiring transfusion to meet the hemoglobin requirement are not eligible for the study
Hemoglobin of >= 10 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
Hemoglobin >= 9.0 g/dL, independent of transfusion and/or growth factors within 3 months prior to randomization
Hemoglobin > 10.0 g/dL (transfusion and/or erythropoiesis stimulating agents [ESA] allowed)
Hemoglobin >= 7.5 g/dL in the presence of bone marrow involvement independent of transfusion and/or growth factors within 3 months prior to enrollment
Hemoglobin ? 9.0 g/dL (in the absence of transfusion within 2 weeks before randomization)
Hemoglobin >= 9.0 g/dL, which must be stable in the opinion of the investigator without a history of transfusion dependence
Hemoglobin >= 9 g/dL without transfusion dependency
Hemoglobin concentration > 8 g/dL (with or without support)
Hemoglobin >= 9.0 g/dL without transfusion support within the past 28 days (erythropoietin or darbepoetin permitted)
Hemoglobin >= 9 g/dL (with or without support)
Hemoglobin 10 gl/dl (transfusion allowed)
Hemoglobin >= 8 g/dL (may be post-transfusion)
Hemoglobin >= 9 g/dL (SI units 90 g/L) (in the absence of transfusion within 24 hours prior to dosing)
Hemoglobin <9 g/dL (may receive transfusion or erythropoietin to maintain)
Hemoglobin >= 8.0 g/dL without transfusion if stem cells are not available
Hemoglobin (Hb) >= 9 g/dL (independent of transfusion and/or growth factors within 3 months prior to cycle 1 day 1)
Hemoglobin > 8 gm/dL without transfusion and off erythropoietin for 14 days or darbepoetin (Aranesp) for 21 days
Hemoglobin ?9 g/dL, without transfusion support within 7 days preceding the lab assessment.
Hemoglobin >9.0 g/dL (may be maintained by transfusion)
Hemoglobin ?8.0 g/dL with or without transfusion support
Hemoglobin >= 8 g/dL (transfusion allowed)
Hemoglobin >= 9 g/dL (transfusion to meet this criterion is allowed)
Hemoglobin ? 9.0 g/dL without transfusion and/or growth factors in the 3 months prior to randomization
Hemoglobin >= 8.0 g/dL; if patients have a hemoglobin level below 8, blood transfusion is allowed to meet the eligibility criteria as long as post transfusion hemoglobin is maintained at >= 8.0 g/dL for 7 days or longer
Hemoglobin > 9 g/dl (blood transfusion is allowed to meet the eligibility criteria as long as post transfusion hemoglobin is maintained at >= 9.0 g/dL for 7 days or longer)
Transfusion dependency defined by transfusion of at least 4 units of RBC (red blood cells) within 8 weeks before Screening; pre-transfusion Hgb (hemoglobin) values must be ? 9 g/dL to be taken into account.
Hemoglobin >= 9 g/dL, without ongoing chronic blood transfusion or colony stimulating factor support to maintain normal levels; principal investigator approval is required; (limited red blood cell [RBC] transfusion is allowed for an acute change in hemoglobin)
Hemoglobin >= 8; transfusion is allowed
Hemoglobin < 8 g/dL within 21 days of initiation of protocol therapy; transfusion may be used to meet hemoglobin eligibility criteria
Must have symptomatic anemia untransfused with hemoglobin < 9.5 g/dL =< 8 weeks prior to randomization or with red blood cells (RBC) transfusion dependence (i.e., >= 2 units/month) confirmed for =< 8 weeks before randomization\r\n* NOTE: For non-transfusion dependent patients (i.e., receiving < 2 units/4 weeks x 8 weeks pre-study) who receive periodic transfusions, the mean 8 week pre-transfusion hemoglobin should be used to determine protocol eligibility and response reference\r\n* For non-transfusion dependent patients, a minimum of 2 pre-transfusion or un-transfused hemoglobin values are required
Hemoglobin >80 g/dL (without transfusion support within 7 days from start of leukapheresis)
Hemoglobin > 9 g/dL (International System [SI] units: 90 g/L) without transfusion support or growth factors within 10 days of starting INC280
Hemoglobin ? 9 g/dL. This criterion must be met without transfusion.
Hemoglobin >= 9 g/dL (after transfusion, if necessary) within 4 weeks of pre-registration
Hemoglobin > 9.0 without transfusion support in the past 28 days
Hemoglobin >= 8 g/dL (may be post-transfusion)
Hemoglobin >=9.0 grams/decilitre(g/dL) (after transfusion if needed)
Hemoglobin >= 9.0 g/dL (90 g/L); previous transfusion is allowed
Hemoglobin =< 10.0 g/dL for males and =< 9.0 g/dL for females (transfusion allowed to achieve or maintain levels)
Hemoglobin ? 8.0 g/dL with or without transfusion support
Hemoglobin >= 10.0 g/dL independent of transfusion
Hemoglobin > 9.0 g/dL (transfusion and/or erythropoiesis stimulating agents [ESA] allowed)
Hemoglobin >= 8 g/dl (transfusion support allowed)
Hemoglobin >= 8.0 g/dl with transfusion support
Has hemoglobin <8.0g/dL. The use of transfusion with pRBC to correct anemia and meet eligibility criteria will not be allowed.
Hemoglobin >= 10 g/dL (after transfusion if necessary)
EXPANSION COHORT ONLY: Hemoglobin >= 9 g/dL; subjects may not have had an RBC transfusion within 7 days of screening assessment
Hemoglobin >= 8 g/dL; if anemia is present to the extent that the hemoglobin is < 8 g/dL, then correction by transfusion is indicated before entry into this study
Hemoglobin ? 9 g/dL (uncorrected by RBC transfusion)
Hemoglobin ? 9 g/dL, (? 8 g/dL for subjects who are transfusion dependent)
Hemoglobin concentration > 8 g/dL (with or without support)
Hemoglobin >= 10 mg/dL (in the absence of transfusion within 24 hours prior to dosing)
Hemoglobin >= 8 g/dL (transfusion support allowed)
Hemoglobin ?9 g/dL, without the need for transfusion in the 2 weeks prior to screening
Hemoglobin ? 9 g/dL, without the need for transfusion in the 2 weeks prior to screening
Hemoglobin >= 10 g/dL (may be post-transfusion)
Hemoglobin at least 10 g/L (transfusion is allowed to achieve hemoglobin of 10 g/L)
Hemoglobin >/= 10.0 g/dL without transfusion support
Hemoglobin >= 9.0 g/dL\r\nNote: patient may receive blood transfusion to achieve a hemoglobin >= 9.1 g/dL; however, hemoglobin must be stable at or above 9 g/dL two weeks prior to dosing
Screening blood counts of the following: Absolute neutrophil count ? 1000/?L, Platelets ? 75,000/?L, Hemoglobin ? 8 g/dL (with transfusion support);
Anemia, defined as hemoglobin <10 gram per deciliter (g/dL) or >2 g/dL below lower limit of normal or both; transfusion support or concurrent treatment with erythropoietin stimulating agents is not permitted
Hemoglobin >= 90 g/L independent of transfusion
Hemoglobin >= 8.5 g/dL without transfusion support > 7 days prior to registration
Hemoglobin ?9 g/dL(without transfusion support)
Hemoglobin <10 g/dL (may be determined following transfusion)
Absolute neutrophils count (ANC) ? 1.5 x 10E9/L, platelets ? 100 x 10E9/L, hemoglobin > 9 g/dL (without transfusion or erythropoiesis stimulating agents dependency).
Within 14 days of treatment initiation: Platelets >= 100,000/mcL
Within 14 days of treatment initiation: Platelets >= 100,000/mcL
Platelets >= 100,000 / mcL (up to 14 days before treatment initiation)
Within 10 days of treatment initiation: Platelets >= 100,000/mcL
Platelets >= 100,000/mcL, performed within 10 days of treatment initiation
Platelets >= 100,000/mcL, performed within 14 days of treatment initiation
Platelets >= 100,000/mcL, performed within 10 days of treatment initiation
Within 2 weeks prior to initiation of study treatment: Platelets >= 100,000/mcL
Platelets >= 100,000 / mcL, performed within 14 days of treatment initiation
Platelets >= 100,000/mcL within 14 days of treatment initiation
Platelets >= 60,000/mcL (>= 75,000/mcL in expansion cohort) (performed within 28 days of treatment initiation)
Platelets >= 100,000 / mcL, performed within 28 days of treatment initiation
Performed within 10 days of treatment initiation: Platelets ? 100,000/mcL
Platelets >= 100,000 / mcL, should be performed within 10 days of treatment initiation
Platelets >= 100,000 / mcL, performed within 10 days of treatment
Platelets ? 100,000 / mcL within 21 days of treatment initiation
Platelets >= 75,000 / mcL within 21 days of treatment initiation
Performed within 10 days of treatment initiation: platelets >= 100,000 / mcL
Should be performed within 30 days of treatment initiation: platelets ? 75,000 / mcL
Platelets >= 100,000 / mcL (performed within 10 days of treatment initiation)
Platelets >= 100,000 / mcL, performed within 14 days of treatment initiation
Platelets >= 100,000/mcL, performed within 28 days of treatment initiation
To be performed within 14 days of treatment initiation: platelets ? 100,000 / mcL
Platelets ? 25,000 /mcL within 14 days of treatment initiation
Platelets >= 75,000/mcL within 14 days of treatment initiation
Within 10 days of treatment initiation: Platelets >= 100000mcL.
Within 14 days of treatment initiation: Platelets >= 100,000/mcL
Performed within 10 days of treatment initiation: Platelets >= 50,000/mcL (in cases with bone marrow [BM] involvement >= 30,000/mcL)
Within 10 days of treatment initiation: Platelets >= 100,000/mcL
Within 10 days of treatment initiation: Platelets ? 100,000/mcL
Platelets >= 100,000 / mcL (performed within 10 days of treatment initiation)
Performed within 10 days of treatment initiation: Platelets >= 100,000/mcL
Platelets >= 50,000 / mcL, performed within 10 days of treatment initiation
Platelets >= 40,000/mcL (performed within 14 days of treatment initiation)
Performed within 7 days of treatment initiation: Platelets >= 100,000/mcL
Performed within 14 days of treatment initiation: Platelets >= 100,000/uL
Platelets >= 75,000/mcL, performed within 14 days of treatment initiation
Platelets >= 100,000/mcL, performed within 10 days of treatment initiation
Performed within 10 days of treatment initiation: Platelets >= 100,000/mcL
Platelets >= 100,000/mcL within 14 days of treatment initiation
Within 10 days of treatment initiation: Platelets >= 100,000/mcL
Within 14 days of treatment initiation: Platelets >= 100,000/mcL
Performed within 10 days of treatment initiation: Platelets >= 100,000/mcL
Platelets >= 20,000 /mcL performed within 10 days of treatment initiation
Platelets >= 100,000 /mcL (within 10-15 days of treatment initiation)
Platelets >= 60,000/uL performed within 7 days of treatment initiation
Platelets >= 100,000/mcL within 14 days of treatment initiation
Platelets >=100,000 /mcL (performed within 10 days of treatment initiation)
Within 10 days of treatment initiation: Platelets >= 100,000/mcL
Completed within 10 days of SBRT treatment initiation: Platelets >= 100,000 / mcL
Platelets >= 100,000/mcL within 14 days of treatment initiation
Platelets >= 50,000 /mcL, performed within 10 days of treatment initiation
Within 10 days of treatment initiation: Platelets >= 100,000/mcL
Platelets >= 75,000 / mcL, performed within 10 days of treatment initiation
Platelets >= 100,000/mcL (within 28 days of treatment initiation)
Performed within 14 days (+3 working days) of treatment initiation: Platelets >= 100,000 / mcL
Performed within 14 days of treatment initiation: Platelets >= 100,000/mcL
Platelets >= 100,000/mcL, performed within 10 days of treatment initiation
Performed within 10 days of treatment initiation; platelets ? 100,000 / mcL
Platelets >= 100,000/mcL, should be performed within 10 days of treatment initiation
Within 14 days of study drug(s) initiation: Platelets >= 100,000/·L.
Platelets ? 150,000 / mcL within 7 days of treatment initiation
Lymphocytes ? 500 / mcL within 7 days of treatment initiation
All screening labs should be performed within 14 days (+3 working days) of treatment initiation: platelets >= 100,000 /mcL;
Platelets >= 100,000 / mcL, performed within 28 days of treatment initiation
Within 10 days of treatment initiation: Platelets >= 100,000/mcL
Platelets >= 100,000/mcL (performed within 10 days of treatment initiation)
Within 30 days prior to treatment initiation: Platelets >= 100,000/mcL
Platelets >= 100,000 /mcL (performed within 10 days of treatment initiation)
Platelets >= 100,000 / mcL, performed within 10 days of treatment initiation
Platelets >= 100,000/mcL (within 14 days of treatment initiation)
Platelets >= 100 K/mcL, should be performed within 28 days of treatment initiation, unless otherwise indicated
Platelets >= 75 x 10^9/L, performed within 28 days of treatment initiation
Within 14 days of treatment initiation: Platelets >= 100,000/mcL
Performed within 28 days of radiation therapy: Platelets >= 100,000/mcL
Platelets >= 100,000/mcL, performed within 28 days of treatment initiation
Platelets >= 100,000/mcL (labs should be performed within 14 days of treatment initiation)
Platelets >= 100,000/mcL within 7 days of treatment initiation
Performed within 10 days of treatment initiation: Platelets >= 100,000/mcL
Platelets >= 100,000/mcL, within 14 days prior to initiation of study drug
Performed within 10 days of treatment initiation: Platelets >= 100000/mcL
Platelets >= 100,000/mcL (performed within 10 days of treatment initiation)
Obtained within 14 days prior to initiation of treatment: Platelets >= 100,000/mcL
Platelets >= 100,000 / mcL, performed within 10 days of treatment initiation
Platelets >= 80,000/mcL, performed within 10 days of treatment initiation
Platelets >= 100,000 / mcL, performed within 10 days of protocol enrollment
Platelets ? 100,000/microliter independent of transfusion and/or growth factors within 3 months prior to randomization
Platelets >= 100,000/microliter
Platelets ? 75,000/microliter
Platelets >= 75,000/microliter
Platelets >= 75,000 per microliter
Platelets >= 100,000/microliter
Platelets >= 100,000 microliter (transfusion independent)
platelets greater than or equal to 100,000 cells/microliter
Platelets >= 100,000/microliter
Platelets ? 100,000/microliter without transfusion and/or growth factors in the 3 months prior to randomization
Platelets > 50,000 per microliter
Platelets ?100,000/uL (microliter)
Platelets >= 75,000/microliter
WBC >3000/microliter
Platelets >= 100 K/microliter should be obtained with 28 days prior to randomization
WBC >3000/microliter.
ANC Granulocytes < 1,500/ microliter
Platelets < 75,000/ microliter
Platelets >= 100,000/microliter
Platelets >= 100,000/microliter
Platelets >= 100,000/microliter
Platelets >= 100,000/microliter
Platelets >= 100,000/microliter
Platelets >= 50,000/microliter
Platelets >= 100,000/microliter
Platelets >= 100,000/microliter
Platelets >= 150,000/microliter
Platelets >= 100,000/microliter
Platelets >= 100,000/microliter
Platelets >= 100,000/microliter
Platelets >= 100,000/microliter
Platelets >= 100,000/microliter
Must have platelet count ? 100 x 10^9/L within 14 days prior to randomization. Must not have required transfusion of platelets within 1 week of baseline platelet assessment.
Evidence of mucosal or internal bleeding or platelet transfusion refractory
Platelet count > 100,000/mm^3 (100 x 10^9/L). Must not have required transfusion of platelets within 1 week of baseline platelet count assessment.
Platelet count ? 50 × 109/L (without transfusion or thrombopoietin or thrombopoietin analogues within 2 weeks of study entry)
Platelet count ? 100 x 10?/L (?100,000/cubic millimeters)
Disease-related platelet transfusion within 8 weeks of registration
Evidence of mucosal or internal bleeding and/or are platelet transfusion refractory (i.e. platelet count fails to increase by > 10,000 cells/mm3 after transfusion of an appropriate dose of platelets)
Platelet count ? 50,000/uL, with or without transfusion support
Platelet count ? 100,000/mm3 without transfusion.
Platelet count >= 100 x 10^9/L (in absence of blood transfusion).
STRATUM A: Platelet count >= 50,000/mm^3 without support of a platelet transfusion within 7 days of the test
STRATUM B: Platelet count >= 50,000/mm^3 without support of a platelet transfusion within 7 days of the test
STRATUM C: Platelet count >= 50,000/mm^3 without support of a platelet transfusion within 7 days of the test
Research participant platelet count must be > 100,000; however, if platelet level is between 75,000-99,000, then CAR T-cell infusion may proceed after platelet transfusion is given and the post transfusion platelet count is > 100,000
Platelet count >= 100,000/uL (no platelet transfusion within 7 days prior to obtaining laboratory result)
Platelet count > 100,000/uL without platelet transfusion within the past 7 days
Within 7 days prior to administration of study treatment: Platelet count >= 100 x 10^9/L (unless due to bone marrow infiltration by tumor, in which case platelet >=50,000/ mm^3 is allowed).
Platelet counts >=100,000/uL (without transfusion support) results within 7 days before study drug administration
Platelet count of greater than 20,000/ul, with no platelet transfusion in prior 2 weeks
FOR ALL PHASES (Ib AND II): Blood or platelet transfusion within 7 days prior to treatment start
Platelet count < 75,000 mm3 without transfusion support within 7 days prior to testing
PHASE I: Subjects must have absolute neutrophil count (ANC) > 1,000 for 3 days and platelet transfusion independence as defined as a platelet count > 20,000 for 7 days
PHASE II: Subjects must have ANC > 1,000 for 3 days and platelet transfusion independence as defined as a platelet count > 20,000 for 7 days
FULL STUDY INCLUSION CRITERIA: Platelet count >= 75,000/mm^3, without platelet transfusion within 3 weeks before the start of study treatment
Performed within 14 days (+ 3 working days) prior to registration: Platelet count of > 100,000/mm^3 (may be reached by transfusion).
Platelet count of >= 100,000/mm^3 (Note: Transfusion or growth factor may be used for eligibility outside of 7 days)
Platelet count < 50 × 10^9/L in the 4 weeks before screening or platelet transfusion(s) within 8 weeks before screening
To be performed within 10 business days prior to day 1: Platelets >= 50,000/mm^3; NOTE: platelet transfusion and packet red blood cell transfusion can be given prior to enrollment to achieve a target platelet (Plt) >= 50,000/uL and hemoglobin of >= 8.5 g/dL
Platelet > 20 x 10^9/L without platelet transfusion within 1 week
Platelet count >= 50,000 (platelet [plt]/mm^3), with or without transfusion support; NOTE: If the patient’s bone marrow biopsy shows greater than or equal to 50% plasma cells, the platelet count should be > 3 0,000 plt/mm^3 (transfusion support or growth factor support is acceptable)
Platelet count of greater than 20,000/mul, with no platelet transfusion in 2 weeks prior to registration; this criteria is waived if the thrombocytopenia is due to bone marrow involvement with the disease
Adequate engraftment within 7 days prior to starting study therapy: ANC ? 1.0 x 109/L without daily use of myeloid growth factor; and platelet ? 25 x 109/L without platelet transfusion within 1 week
Platelet count >= 100,000/mm^3 (no transfusion within 7 days of enrollment)
Platelet count >= 40 x 10^3/mm^3 (may be post-transfusion)
Research participant platelet count must be >= 100,000; however, if platelet level is between 75,000-99,000, then T-cell infusion may proceed after platelet transfusion is given and the post transfusion platelet count is >= 100,000
Platelet count >= 20 x 10^9/L and able to achieve a platelet count of >= 50 x 10^9/L with transfusion support
Platelet count >= 100,000/uL (may be a post transfusion value)
Platelet ?100 x 10^9/L, without transfusion within 7 days preceding the lab assessment
Platelet count (>=) 10*10^9 per liter (L) (prior platelet transfusion is permitted)
Platelet count ? 100,000/mm3 (IU: ? 100 × 109/L) (excluding measurements obtained within 7 days after a transfusion of platelets).
Platelet count ?10,000 ?L with or without transfusion support
Platelet count ? 100 x 109/L (100,000/µL) without transfusion
Platelet count >= 100,000/mm^3 and no transfusion in prior 4 weeks, within 28 days of day 0.
Platelet count >= 50,000/uL; platelet transfusion is not permitted within 7 days of screening
Obtained within 14 days (or as stipulated) prior to study drug (treatment) administration: platelet count ? 50,000/ul (without platelet transfusion in the previous 5 days)
Platelet count >= 100,000/ul (no platelet transfusion for more than 3 days)
Platelet count >= 100 x 10^9/L (no transfusion allowed within 2 weeks)
Patients on Part C with acute lymphoblastic leukemia: platelet count >= 20,000/mm^3 (may receive platelet transfusions); these patients must not be known to be refractory to red cell or platelet transfusion
Platelet count must be >= 50,000/mm^3 (not achieved by transfusion)
Platelet count must be >= 75,000/mm^3 (not achieved by transfusion) unless due to underlying disease in which case there is no grade restriction
Platelet count ? 30,000 cells/?L without transfusion support 7 days before assessment. Subjects with transfusion-dependent thrombocytopenia are excluded.
Within 56 days prior to randomization: Platelet count >= 50,000/mcL (50 x 10^9/L) without platelet transfusion
Patient has evidence of mucosal or internal bleeding and/or is platelet transfusion refractory
Platelet count >= 100 x 10^9/L without transfusion, obtained within 14 days prior to initiation of study treatment
Patients with significant pulmonary dysfunction, large intracranial metastases, or significant thrombocytopenia (platelet count refractory to transfusion)
Subjects with evidence of mucosal or internal bleeding and/or platelet refractory (i.e., unable to maintain a platelet count >= 50,000 cells/mm^3)
Platelet count < 75,000 cells/mm^3 at time of screening evaluation; transfusion may not be used to meet platelet eligibility criteria within 7 days of obtaining screening evaluation
Platelet count >= 100 x 10^9/L without platelet transfusion within 7 days
Platelet count >= 40 x 10^3/mm^3 (may be post-transfusion)
Hematologic function, as follows (no platelet transfusion within 2 weeks and no RBC transfusion within 4 days before the first dose of study drug)
Platelet transfusion within 2 weeks and RBC transfusion within 4 days before the first dose of study drug
At least 4 weeks (28 days) prior to registration: Platelet count >= 100 x 10^9/L (no transfusion allowed within 2 weeks)
Platelet count > 100,000/uL without platelet transfusion within the past 7 days
Platelet count ? 10,000 ?L with or without transfusion support
Platelet count < 75,000 cells/mm^3 at time of screening evaluation; transfusion may not be used to meet platelet eligibility criteria within 7 days of obtaining screening evaluation
Platelet count >= 75,000/m^3 (no transfusion within 7 days of enrollment)
Platelet count >= 20,000/ul without transfusion for 7 days
Platelet count ? 75 × 109/L without previous transfusion within 10 days of first study drug administration
Platelet count >= 50,000/uL (platelet count must be assessed at least 7 days after a prior transfusion, if any)
Received platelet transfusion within 14 days prior to Screening evaluations.
The mean of the two platelet counts taken within 1 month prior to dosing must be =< 50 x 10^9/L; platelets counts must reflect pre-transfusion trough results or be obtained no sooner than 1 week after platelet transfusion to assure stable baseline platelet count; the platelet count obtained should be outside the expected nadir of prior therapies
Platelet count >= 20,000/mm^3 without transfusion support and no abnormal bleeding
Patients >= 35 days post HCT with platelet count =< 20 x 10^9/l sustained for 7 days or patients are platelet transfusion dependent
Platelet count >= 75,000/mm^3 (without platelet transfusion or myeloid growth factor support within two weeks of screening)
Patients must have platelet count >= 10,000/mm^3 within 72 hours of initiating the induction cycle (for patients with platelets < 10,000/mm^3 at baseline, platelet transfusion support is allowed which is institutional standard of care for AML)
Platelet count must be >= 75,000/mm^3 (not achieved by transfusion)
Patients with evidence of mucosal or internal bleeding and/or platelet transfusion refractory (i.e., unable to maintain a platelet count ? 50,000 cells/dL).
Platelet count >= 100,000 cells/mm3 without transfusion or growth factor requirement
Platelet count ? 100,000/mm3 (without platelet transfusion or growth factor support in the preceding 7 days);
Platelet count >= 100,000/uL (without transfusion within 2 weeks prior to cycle 1, day 1)
Platelet >= 50 x 10^9/L (without transfusion)
Platelet count ? 100 x 10^9/L within 14 days prior to randomization. Must not have required transfusion within 1 week of baseline platelet assessment.
Platelet count < 75,000 mm3 without transfusion support within 7 days prior to testing
Platelet count 75 x 109/L without platelet transfusion within one week. Adequate organ function:
Platelet count ? 50,000/µL, with or without transfusion support; platelet count < 50,000/µL but ? 20,000/µL, with or without transfusion support, is permissible if the subject has not had Grade ? 2 bleeding in the prior 6 months (where grading of the bleeding is determined per the National Cancer Institute's Common Terminology Criteria for Adverse Events [CTCAE], version 5.0)
Platelet count >= 20 x 10^9/L (without transfusion support within 2 weeks of registration)
Platelet count >= 20,000/mm^3 (may receive platelet transfusions); these patients must not be known to be refractory to red cell or platelet transfusion
Patient requiring platelet transfusion threshold of > 20 x 10^9/L
Failure to achieve platelet engraftment (defined as platelet count >= 20 x 10^9/L on 3 consecutive measurements without transfusion for 7 days) by day +28 post UCBT
Patients requiring more than one platelet transfusion per day
Anticipated platelet count =< 50 x 10^9/L for >= 5 days within 72 hours of enrollment
Platelet count >= 75,000/uL (> 72 hours since prior platelet transfusion)
Subjects must have a platelet count of >= 30,000 to receive immunizations; patients requiring platelet transfusions are eligible to enroll and must have a platelet count >= 30,000 within 72 hours prior to their immunization, or platelet count >= 75,000 without transfusion documented within 30 days for subjects < 12 months post-transplant and within 90 days for subjects 12-35 months post-transplant
FOR THE 31 SUBJECTS ENROLLED IN YEAR 1: Subjects must have a platelet count of >= 30,000 to receive the immunizations; patients requiring platelet transfusions are eligible to enroll and must have a platelet count >= 30,000 within 72 hours prior to their immunization, or platelet count >= 75,000 without transfusion documented within 30 days for subjects < 12 months post-transplant and within 90 days for subjects 12-35 months post-transplant
Subjects must have a platelet count of >= 30,000 to receive the immunizations; patients requiring platelet transfusions are eligible to enroll and must have a platelet count >= 30,000 within 72 hours prior to their immunization; for subjects < 12 months post-transplant, if a platelet count of >= 75,000 is documented without transfusion support within 14 days of the immunization, then an additional platelet count does not need to be repeated prior to immunization; for subjects 12-23 months post-transplant, if a platelet count of >= 75,000 is documented without transfusion support within 90 days of the immunization, then an additional platelet count does not need to be repeated prior to immunization
Platelet count of < 50,000 that cannot be corrected with transfusion
Platelet count >= 75,000/mm^3 without transfusion support > 7 days prior to registration
Platelet count >= 100,000/mm^3 (without transfusion within 2 weeks prior to cycle 1, day 1)
Evidence of mucosal or internal bleeding and/or is platelet transfusion refractory
Mucosal or internal bleeding, or platelet transfusion refractory
Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 X 109/L)
Platelets (Plts) greater than or equal to 75,000/mm^3 (transfusion independent)
Platelets greater than or equal to 100,000/mm3 (greater than or equal to 100 X 109/L)
Platelets greater than or equal to 75,000/ul
Platelets greater than or equal to 100,000/mcl
Platelets greater than or equal to 100,000/mcl, within 14 days prior to registration
Platelets greater than or equal to 50,000 mcL
Platelets greater than or equal to 75 x 10^9/L
Platelets greater than or equal to 100,000/mm^3
Platelets greater than or equal to 100,000/uL
Platelets more or equal to 50,000/mL
Platelets (Plts) greater than or equal to 75,000/mm^3 (transfusion independent)
Platelets less than or equal to 75,000
Platelets greater than or equal to 100,000/mm^3
Platelets greater than or equal to 75,000/ul
Platelets greater than or equal to 100,000/mm^3 (CTCAE grade 0-1)
Platelets greater than or equal to 100,000/mcl
Platelets greater than or equal to 100,000/mcl
Platelets greater than or equal to 100 K/uL
Platelets greater than or equal to 100,000/mcL (platelets >= 100 x 10^9/L)
Platelets greater than or equal to 75,000/mm3 (greater than or equal to 75 X 10^9/L)
Platelets greater than or equal to 100,000 cells/mcl
Platelets greater than or equal to 100 x 10^9/L
Platelets greater than or equal to 100,000/mcl
Platelets greater than or equal to 100,000/ul, CTCAE grade 0-1
Platelets greater than or equal to 100,000/mcl
Platelets greater than or equal to 100,000/ul
Platelets greater than or equal to 100,000/ul (CTCAE grade 0-1)
Platelets greater than or equal to 100,000/mcl
Platelets >= 100,000/mm^3, or >= 50,000 in cases of ongoing bone marrow involvement (in either case, these must be independent of transfusion support), documented within 14 days of registration
Absolute neutrophil count (ANC) <1,500/mm3, pre-transfusion platelets <100,000/mm3, or pre-transfusion hemoglobin <9.0 mg/dL (the patient is required to have at least 2 weeks free from blood transfusion, G-CSF and erythropoietin use prior to the hematology test)
Platelets ?75,000/mm3 without platelet transfusion ? 3 days prior to C1D1
Platelets >= 100 x 10^9 (without platelet transfusion)
Platelets >= 100,000/mm^3 transfusion independent (no platelet transfusion one week prior to enrollment)
Platelets ? 50,000/mm^3 independent of transfusion support, with no active bleeding
Platelets: >= 100,000/mm^3 or >= 50,000/mm^3 if known or suspected bone marrow involvement, independent of transfusion support in either situation
Within two weeks prior to enrollment: Platelets >= 75,000/mcL and > 7 days since last platelet transfusion
Platelets ? 100,000/?L without transfusion support within 28 days prior to study treatment
Platelets > 100 x 10^9/L without transfusion
Platelets >= 100,000/mcL (with or without transfusion)
Patients who are receiving regularly scheduled blood (RBC) transfusion therapy (also termed chronic, prophylactic, or preventive transfusion) or have received a RBC transfusion for any reason within 60 days of signing the ICF
Platelets >= 100,000 /mcL in the absence of transfusion support within 7 days of determining eligibility
Platelets >= 50,000/mm^3 independent of transfusion support, with no active bleeding
Platelets (no transfusion within prior 7 days) >= 100 K/cu mm
Platelets >= 75,000/mcL (without transfusion support)
Platelets >= 20,000/mcL or recovery to the baseline count (in the absence of transfusion), within 14 days prior to treatment
Platelets >= 50,000/mcL in the absence of transfusion support within 7 days of determining eligibility within 16 days of treatment initiation
Platelets: >= 100,000/mm^3 or >= 50,000/mm^3 if bone marrow involvement independent of transfusion support in either situation
Platelets ? 100 K/mm^3 (transfusion to achieve this level is not permitted within 2 weeks of first study drug administration)
Platelets >= 50 x 10^9/L (without transfusion support)
Platelets >= 50,000/mcL (transfusion independent)
Platelets >= 75,000/mm^3 without platelet transfusion =< 7 days prior to C1D1
Platelets >= 100,000/mcL (without transfusion within 2 weeks prior to cycle 1, day 1)
Platelets >= 75,000/mcl (without transfusion for 7 days).
Platelets >= 100,000/mcL (transfusion not permitted)
Platelets >= 100,000/?L without transfusion support within the past 28 days
Platelets greater than or equal to 75,000/mm^3 (transfusion independent; no transfusion for >= 7 days prior to study enrollment)
Platelets > 50,000/cu mm (transfusion allowed - however patients must not require more than two platelet transfusions per week)
Platelets > 100,000/ul (transfusion independent)
Platelets >= 75,000/mcL (without transfusion support)
Platelets >= 50,000 X 10^9 /L without transfusion if stem cells are not available
Platelets > 100,000/ul (transfusion independent)
Platelets >= 100,000/mm^3 (transfusion independent)
Platelets > 100,000/ul (transfusion independent)
Platelets > 100 x 10^9/L without transfusion and/or a bone marrow cellularity of >= 20%
Platelets > 50 x 10^9/L without transfusion in the prior 7 days
Platelets (no transfusion within prior 7 days) >= 100 K/cu mm
Transfusion dependence, defined as having had transfusion (in the setting of active disease) of 2 or more units of RBC or platelets within 8 weeks prior to randomization.
Within 28 days of study registration: Platelets >= 100,000 cells/mm^3 (independent of blood transfusion and/or growth factors within 3 months prior to registration)
Platelets >= 100,000/ mm^3 (transfusion independent)
Platelets >= 100,000/mcL (without transfusion)
Within 14 days of subject registration: Platelets 100,000/uL (no transfusion allowed within 2 weeks)
Platelets >= 70 x 10^9/L without platelet transfusion 7 days prior to study entry
Platelets > 100 x 10^9/L without transfusion
Patients must not have received a transfusion (platelets or red blood cells) within 4 weeks of the first dose of study treatment.
Platelets >= 100,000/ul (no platelet transfusion allowed within 2 weeks)
Performed within 14 days of patient registration: Platelets >= 100,000/uL (no transfusion allowed within 2 weeks)
MF PATIENTS: Platelets >= 50,000/mm^3; Note: this must be achieved without transfusion
Platelets ?100,000/mm3 (?100 × 109/L) without platelet transfusion for 7 days
Platelets >100,000/mL (without platelet transfusion within the last 2 weeks)
Platelets >= 75 x 10^9/L (no platelet transfusion within past 14 days)
Need for transfusion within 14 days prior to the first dose of trial treatment
Platelets > 100 k without transfusion support in the past 28 days
Platelets: >= 100 x 10^9/L, or >= 50 x 10^9/L if bone marrow involvement and independent of transfusion support for 14 days in either situation
Platelets >= 20,000 without platelet transfusion
Platelets >= 100,000/mcL at all times during the screening period without platelet transfusion within 3 weeks
Platelets >= 100 x 10^9/L and no platelet transfusion within the past 14 days prior to study registration
Platelets >= 100,000 /mm^3; previous transfusion is allowed
Platelets ? 80 × 10^9 cells/L (transfusion independent, defined as not receiving platelet transfusions within 7 days prior to laboratory sample). In the phase 2 portion, for patients with known bone marrow involvement, platelets ? 50 × 10^9 cells/L
Platelets >= 100 x 10^9/L (tested within 14 days prior to registration)\r\n* Subjects may not have had a transfusion within 7 days of screening assessment
Platelets >= 50,000/mcL in the absence of transfusion support within 7 days prior to determination of eligibility
Platelets >= 100,000/ul (no transfusion allowed within 2 weeks)
Platelets >= 100,000/mm^3 (transfusion independent)
Platelets > 50,000 (platelet transfusion allowed)
The patient has an absolute neutrophil count (ANC) ?1000/µL, platelets ?100,000/µL and is not transfusion dependent for platelets and/or red cells
Platelets >= 100 x 10^9/L (without transfusion < 14 days before enrollment)
Platelets >= 100 x 10^9/L (must be independent of platelet transfusion)
Platelets >= 100,000/mcL (transfusion independent) within two weeks prior to enrollment
Platelets ? 75,000/?L (without intervention, e.g., transfusion)
RECURRENT/ PROGRESSIVE DIPG (STRATUM 1): Platelets >= 100,000/mm^3 (unsupported, defined as no platelet transfusion within 7 days, and recovery from post-transfusion nadir)
NON-PROGRESSED DIPG (STRATUM 2): Platelets >= 100,000/ mm^3 (unsupported, defined as no platelet transfusion within 7 days, and recovery from post-transfusion nadir)
Platelets >= 100 x 10^3/mm; may not be reached by transfusion
Platelets >= 100,000 /uL without transfusion within 10 days prior to dose
Platelets >= 100,000/ul; low platelet counts may be corrected with transfusion to achieve eligibility for study
Platelets ? 100 x 109/L (in case of transfusion stable for ?14 days prior to treatment start)
On a chronic transfusion program or planning on exchange transfusion during the study
Has received a transfusion (platelets or red blood cells) within 3 weeks before the first dose of niraparib
Has received a transfusion (platelets or red blood cells) within 3 weeks of the first dose of niraparib
Platelets >= 60,000/mcL without transfusion support within the past 30 days
Platelets ?50,000/mm3 independent of transfusion
Platelets ?50,000/mm3 independent of transfusion
Platelets > 100,000/u (transfusion independent); patients with bone marrow involvement are eligible provided they meet these criteria
Platelets ? 75,000 cells/mm^3 (75 × 10^9/L), without platelet transfusion, within 72 hours of screening evaluation.
Platelets >= 75,000/uL and transfusion independent, defined as not receiving a platelet transfusion for at least 5 days prior to complete blood count (CBC) documenting eligibility
Platelets >= 100,000/mm^3 or >= 50,000/mm^3 if bone marrow involvement independent of transfusion support in either situation
Patients with platelets >= 100,000/uL (without platelets transfusion for at least one week prior to blood test date); the most recent platelets level taken within 60 days prior to study enrollment will be considered
Platelets >= 75 x 10^9/L and no platelet transfusion within the past 21 days prior to study registration
Platelets >= 75,000/mcl (in the absence of platelet transfusion for >= 14 days)
Platelet greater than or equal to 100,000/mcl
Platelet count equal to or greater than 150,000/mcl
Platelet count must be greater than or equal to 100,000/mm3; and
Within 30 days prior to enrollment: Platelet count equal to or greater than 150,000/mcl
Platelet count greater than or equal to 100 x 10 to the ninth/Liter
Platelet count of greater than or equal to 100,000/mcL
REP ELIGIBILITY: Platelet count greater than or equal to 100,000/mcL
CHEMOTHERAPY/CELL INFUSION ELIGIBILITY: Platelet count greater than or equal to 100,000/mcL
Platelet count greater than or equal to 100,000/uL
Platelet count greater than or equal to 55,000/mm^3 without transfusion support
Platelet count greater than or equal to 100,000/mm^3
Platelet count greater than or equal to 45,000/mm^3 without transfusion support
Platelet count greater than or equal to 100 x 10^9/L
platelet count greater than or equal to 75 x 10^9/L.
platelet count must be greater than or equal to 100,000/mm3; and
Platelet count: greater than or equal to 50,000 at least one week since last platelet transfusion
Platelet count greater than or equal to 100,000/mm^3 (Turnstile II)
Platelet count greater than or equal to 100,000/mm^3 (Turnstile II)
Platelet count must be greater than or equal to 75,000/mm3; and
Platelet count greater than or equal to 45,000/mm^3 without transfusion support
Platelet count greater than or equal to 100,000/mcL
platelet count must be greater than or equal to 100,000/mm3; and
Platelet count greater than or equal to 100 x 109/L
Platelet count greater than or equal to 100,000/mm^3
Platelet count greater than or equal to 75 X 10^9/L
Platelet count greater than or equal to 100,000/uL
Platelet count greater than or equal 75 x 10^9/L (greater than or equal 75,000/mm^3)
Platelet count greater than or equal to 75,000/mcL
Platelet count greater than or equal to 50,000/mm^3
Platelet count equal or greater than 50,000 mm^3 independent of platelet transfusion
Platelet count equal to or less than 100,000/mm3
Platelet count greater than or equal to 100,000/mm^3
Platelet count greater than or equal to 100,000/mm3 or greater than or equal to 100 x 10^9/L.
Platelet count greater than or equal to 25,000/uL
Platelet count greater than or equal to 100,000/mm^3
Platelet count less than (<) 50,000/millimeter^3 (mm^3), Life expectancy of less than or equal to (<=) 6 months