International normalized ratio (INR) =< 2\r\n* If a patient’s bone marrow function falls below the indicated values and it is not thought to be related to prior treatments a hematology consult will be ordered; if hematology deems the patients safe to proceed with treatment they will be allowed to enroll on study; in such cases, the patient’s absolute neutrophil count must be > 1,000/mcl, hemoglobin must be > 7.5 g/dL and the platelet count must be > 75,000 mcL; each patient will also be seen by a medical oncologist at follow-up visits if possible
Hematology: . Absolute neutrophil count ? 1.5 x 109/L or ? 1,500/µl Platelets ? 100 x 109/L or ? 100,000/µl
Hematologic, renal, and liver function as determined by hematology and clinical chemistry tests will be acceptable if within +/- 2x of “normal” reference range as defined by the local hospital clinical laboratory; final decision on inclusion will be made by physician, concerning suitability of patient for surgery
Evidence of other significant disease including hematologic, renal or liver disease that is not explained by the patient’s current medical condition or concomitant disease, (i.e. levels of absolute neutrophil count [ANC], hemoglobin, platelets, clotting time, serum creatinine, etc); lab values, as determined by hematology and clinical chemistry tests, will be unacceptable if greater than +/- 2x of “normal” reference range as defined by the local hospital clinical laboratory; final decision on inclusion will be made by physician, concerning suitability of patient for surgery
Baseline hematology laboratories will be performed prior to registration, the patient can be enrolled in the trial if laboratory values are deemed clinically acceptable by treating physician
Screening hematology values of the following:
Adequate hematology laboratory values at Cycle 1 Day 1 pre-dosing defined as follows:
Adequate liver and renal function and hematology laboratory values
Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
Use of hydroxyurea within 2 weeks prior to obtaining the screening hematology sample and prior to first dose of IP.
Screening hematology values of the following: absolute neutrophil count ? 1000/?L, platelets ? 100,000/?L, hemoglobin ? 10 g/dL (without transfusion support);
Participants must meet protocol specified hematology and chemistry lab parameters criteria
Have adequate organ function including hematology, renal, and liver.
Hematology and biochemical values within protocol-defined limits
Hematology and biochemical laboratory values within protocol-defined parameters prior to random assignment and at baseline
Hematology and biochemical values within protocol-defined limits
Presence of specific hematology and/or chemistry abnormalities
Lab values (hematology and chemistry) within institution's normal laboratory limits
Chemistry, liver function tests, renal function, total CPK and hematology lab results must be ? Grade 1 at the time of screening;
Adequate hematology, hepatic and renal function laboratory values within 14 days prior to first dose of study drug.
Adequate hematology, liver and renal function laboratory values within 14 days prior to first dose of study treatment.
In the investigator's opinion and in compliance with the Institution Hematology Tumor Board's guidances, the patient should not be eligible for any additional chemotherapy treatment before the ASCI treatment.
Abnormal serum chemistry or hematology laboratory values
Hematology: ANC ? 1.5X109/L; Platelets >100x109/L.
Hematology and biochemistry laboratory results within the limits normally expected for the patient population, without evidence of major organ failure
Consent for sample collection for urine, hematology, histopathology and microbial profiling