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