Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent; the duration of this interval must be discussed with the study chair and the study-assigned research coordinator prior to enrollment
Anti-cancer agents not known to be myelosuppressive (e.g. not associated with reduced platelet or absolute neutrophil count [ANC] counts): >= 7 days after the last dose of agent
Platelet counts >= 100 x 10^9/L
Participants with CD4 counts > 50/microL are eligible for this study if their viral load is < 50 copies/mL by reverse transcription polymerase chain reaction (RT-PCR) since majority of the participants have received aggressive chemotherapy that can potentially decrease the CD4 counts despite the ART therapy; timeline: within 3 weeks prior to start of trial
White blood cell counts > 3000 cells/mcL
Platelet counts > 100 x 10^9/L
Blood counts performed within 28 days prior to randomization must meet the following criteria:
Platelet counts >= 100 x 10^9/L
Patients who have eligible blood counts within 4 weeks from enrollment will not be considered ineligible if subsequent blood counts prior to enrollment fluctuate and become ineligible up until the time of enrollment
Blood counts are not required to be normal prior to enrollment on trial
Adequate organ function and blood cell counts.
Screening blood counts of the following:
Platelet counts > 100,000/mm^3 (without support)
Subjects must be on a prophylactic regimen for Pneumocystis jiroveci pneumonia, or agree to begin such treatment, if CD4+ cell counts are observed to be =< 200/ul in peripheral blood
Adequate blood cell counts (i.e. absolute neutrophil count [ANC] > 1000) at baseline, or willingness to accept supportive measures such as transfusions, filgrastim, and epoetin
DONOR: Fit to receive G-CSF (filgrastim) and give peripheral blood stem cells (normal blood counts, normotensive, and no history of stroke)
Any form of primary or secondary immunodeficiency; must have recovered immune competence after chemotherapy or radiation therapy as evidenced by lymphocyte counts (> 500/mm^3), white blood cell (WBC) (> 3,000/mm^3) or absence of opportunistic infections (Turnstile II)
Blood counts no restrictions
Any form of primary or secondary immunodeficiency; must have recovered immune competence after chemotherapy or radiation therapy as evidenced by lymphocyte counts (> 500/mm^3), white blood cell (WBC) (> 3,000/mm^3) or absence of opportunistic infections (Turnstile II)
Absolute neutrophil counts >= 1,500 cells per uL
Patients who have eligible blood counts within 4 weeks from enrollment will not be considered ineligible if subsequent blood counts prior to enrollment fluctuate and become ineligible up until the time of enrollment
Any form of primary or secondary immunodeficiency; must have recovered immune competence after chemotherapy or radiation therapy as evidenced by lymphocyte counts (> 500/mm^3), white blood cell (WBC) (> 3,000/mm^3) or absence of opportunistic infections (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)
Anticancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil count [ANC] counts): ?7 days after the last dose of agent.
Blood counts performed within 4 weeks prior to study entry must meet the following criteria:
Blood counts performed within 3 weeks prior to starting study therapy must have absolute neutrophil count >= 1,500/mm^3
Blood counts performed within 3 weeks prior to starting study therapy must have platelets >= 100,000/mm^3
Blood counts performed within 3 weeks prior to starting study therapy must have hemoglobin >= 9 g/dL
Within 28 days of study registration: Absolute neutrophil counts >= 1500 cell/mm^3
Subjects must be on a prophylactic regimen for pneumocystis carinii pneumonia, or agree to begin such treatment, if CD4+ cell counts are observed to be =< 200/ul in peripheral blood
Subjects must be on a prophylactic regimen for Pneumocystis carinii pneumonia, or agree to begin such treatment, if the CD4 counts are < 200 cells/uL
Any patient requiring chronic maintenance of white blood cell counts or granulocyte counts through the use of growth factor support (e.g. Neulasta, Neupogen)
Blood counts performed within 28 days prior to randomization must meet the following criteria:
There are no minimum hematological parameter requirements prior to the first two cycles, as patients with AML and myelodysplastic syndrome (MDS) are understood to have low ANC and platelet counts when the disease is active; however, patients with white blood cell (WBC) greater than 50,000 will receive hydroxyurea to reduce the WBC count to below 50,000 at which point they may begin treatment
WBC counts > 2500/µL
Platelet counts ?75 x 10^9/L
Anti-cancer agents not known to be myelosuppressive (eg, not associated with reduced platelet or absolute neutrophil counts): ?7 days after the last dose of agent
Subjects who received systemic anticancer therapy or radiotherapy <14 days prior to their first day of study drug administration. (Hydroxyurea is allowed for up to 28 days after the start of AG-221 for the control of peripheral leukemic blasts in subjects with white blood cell [WBC] counts >30,000/?L as well as prior to enrollment).
Within 8 weeks of randomization: Absolute neutrophil counts >= 1,500 cell/mm^3
WBC counts 2500/mL
The participant has adequate organ and blood cell counts
Marrow involvement less than 25% at transplantation, no limitation on blood counts (low platelet count allowed)
Subject has adequate biological parameters as demonstrated by the following blood counts at screening (obtained ? 14 days prior to starting Cycle 1 Day 1):
Adequate white blood cell counts (with low blast counts), liver function, and renal function
No prior therapy for AML except hydroxyurea to control counts
Platelet count ? 100,000 plts/mm3 (without transfusion); ? 75,000 plts/mm3 for patients with hepatocellular carcinoma only. For hematologic malignancy patients blood counts cited above do not apply
Patients may receive hydroxyurea, low-dose cytarabine and/or glucocorticoids to control peripheral blood leukemic cell counts at study entry
Any patient requiring chronic maintenance of red blood cell, white blood cell or granulocyte counts through the use of blood transfusions or growth factor support (e.g. Neulasta®, Neupogen®)
Adequate neutrophil and platelet counts
Have adequate complete blood counts and liver function tests
Prior treatment with alemtuzumab (Campath) or similar agents or procedures that depress blood T cell counts to below 50% of the lower limit of normal.
Thrombocytopenia with untransfused platelet counts < 20 x 10^9/L in the out-patient or in the in-patient setting and one of the following criteria:
Absolute neutrophil count (ANC) persistently >= 1500/mm^3 (as measured by 3 complete blood counts [CBCs] done over 6 weeks or 2 successive monthly CBCs) despite 6?MP >= 150% of Children’s Oncology Group (COG) dosing
Normal blood counts (lab results must be within 45 days prior enrollment)
Patients must either have grade 4 thrombocytopenia (platelet counts < 25 x 10^9/L) due to chemotherapy unless transfusion within 24-72 hours
Extreme hyperleukocytosis, white blood cell (WBC) counts over 200 x 109/L (200,000/microL) at the time of enrollment
DONOR: Unfit to undergo standard stem cell mobilization and apheresis e.g. abnormal blood counts, history of stroke, uncontrolled hypertension
Any patient requiring chronic maintenance of white blood cell counts or granulocyte counts through the use of growth factor support (e.g. Neulasta, Neupogen)
Has baseline neutrophil counts of > 1500 cells/mm3 within 72 hours prior to registration
Platelet counts ?75,000/mm3 (?75×109/L)
Total white blood cells (WBC) < 2x10^9/L (2000/mm^3)
White blood cells (WBC) >= 3000/mm^3
White blood cells (WBC) >= 3,000/mm^3
White blood cell count (WBC) > 2500 cells/mm^3
White blood cells (WBC) >= 2,500/mm^3
White blood cells (WBC) >= 3000/mm^3
PART I: White blood cell (WBC) >= 2,500 cells/mm^3
PART II: WBC >= 2,500 cells/mm^3
White blood cells (WBC) (> 3000/mm^3)
Normal white blood cells (WBC) (> 3000/mm^3)
White blood cells (WBC) >= 3000/mm^3
Total white blood cell count (WBC) >= 2,000 cells/mm^3 without growth factors within 1 week of the initiation of treatment
White blood cells (WBC) >= 3000/mm^3
White Blood Cell (WBC) ? 2500 cells/mm3
WBC >2500/mm3
White blood cells (WBC) >= 3000/mm^3 within 30 days of enrollment to study
White blood cells (WBC) > 3,000 cells/mm^3
White blood cells (WBC) >= 3000/mm^3
White blood cells >= 3000/mm^3
White blood cells (WBC) > 3000/mm^3
White blood cell (WBC) count at randomization less than or equal to (</=) 50000 cells per cubic millimeter (/mm^3)
Within 6 weeks of day 1: White blood cells (WBC) >= 2000/mm^3
White blood cell (WBC) >= 3500 cells/mm^3 or >= 3.5 bil/L
White blood cells (WBC) > 3000/mm^3
Within 30 days of first vaccination: White blood cells (WBC) >= 3000/mm^3
White blood cells (WBC) >= 3000/mm^3
White blood cells (WBC) >= 3000/mm^3
White blood cells (WBC) >= 3000/mm^3
White blood cells (WBC) >= 3,000/mm^3
White blood cell (WBC) >= 3500 cells/mm^3 or >= 3.5 bil/L
White blood cells (WBC) >= 3000/mm^3
White blood cells (WBC) >= 4,000/mm^3
White blood cells (WBC) >= 4000/mm^3
White blood cells (WBC) >= 4000/mm^3
WBC>3000/mm3
White blood cells (WBC) >= 2,500/mm^3
Peripheral blood leukocyte count (white blood cells [WBC]) < 3000/mm^3.
White blood cell (WBC) ? 3500 cells/mm^3 ? 2 weeks
White blood cells (WBC) >= 3000/mm^3
WBC ? 2,500/mm^3
White blood cell (WBC) > 2,500 cells/mm^3
White blood cells (WBC) >= 4200/mm^3
White blood cells (WBC) >= 3000/mm^3 within 4 weeks of enrollment
White blood cell (WBC) must be > 3500 cells/mm^3
White blood cell (WBC) >= 3500 cells/mm^3 or >= 3.5 bil/L
White blood cell (WBC) >= 3500 cells/mm^3 or >= 3.5 bil/L
STEP 2 ENROLLMENT AND RANDOMIZATION: white blood cells (WBC) >= 3,000/mm^3 within 3 weeks of study entry
WBC at least 3,000/mm3
White blood cells (WBC) >= 3000/mm^3
White blood cells (WBC) < 2,500/mm^3
WBC count <25,000 cells/mm3 (25 x 109/L)
White blood cells (WBC) >= 2000/mm^3
White blood cells (WBC) >= 3000/mm^3
DONOR: white blood cells (WBC) 4.0-10.0 x 10^3/mm^3
White blood cells (WBC) >= 3000/mm^3
White blood cells (WBC) (> 3000/mm^3)
White blood cell (WBC) count >= 3000 cells/mm^3
White blood cell (WBC) count >= 3000 cells/mm^3
White blood cells (WBC) >= 2,000 cells/mm^3
White blood cells (WBC) >= 3000/mm^3
White blood cells (WBC) >= 3000/mm^3
White blood cells (WBC) >= 3000/mm^3
White blood cell (WBC) >= 2000/uL
White blood cells >= 2000/uL, within 4 weeks of randomization
White blood cell (WBC) >= 3,000/ul
White blood cell (WBC) >= 3,000/uL
White blood cell (WBC) greater than or equal to 3,000/ul
Obtained within 14 days prior to course 1 day 1 (C1D1): White blood cells (WBC) >= 2000/uL
While blood cells 2000/ul or more
White blood cells (WBC) >= 2000/uL
White blood cell (WBC) ? 3.00 K/uL
White blood cell count (WBC) > 2500/uL
White blood cell (WBC) >= 2000/uL
White blood cells (WBC) >= 3,000/uL
White blood cell (WBC) > 3500/ul within four weeks of enrollment
White blood cell (WBC) count >= 3,000/uL
White blood cell (WBC) counts > 2500/uL.
Within 14 days of the first dose of study drug: White blood cells (WBCs) >= 2000/uL
WBC < 2,000 uL
White blood cell count (WBC) >= 2000/uL.
Obtained within 14 days prior to randomization/registration: white blood cell (WBC ) >= 2000/uL
While blood cells 2000/ul or more
White blood cell (WBC) count of > 3000/ul
While blood cells 2000/ul or more
White blood cell (WBC) counts > 2500/uL.
White blood cell (WBC) >= 2,500 cells/uL
Obtained within 14 days of the first study treatment: White blood cell (WBC) count > 2500/uL
Leukocytes (white blood cells [WBCs]) >= 3,000/uL.
White blood cell (WBC) >= 2000/uL within 14 days of registration
Obtained within 21 days prior to randomization/registration: White blood cell (WBC) >= 2000/uL.
Obtained within 14 days of the first study treatment: White blood cell (WBC) count > 2500/uL
White blood cell (WBC) counts > 2500/uL
Obtained within 14 days prior to the first study treatment (cycle 1, day 1): white blood cell (WBC) counts > 2500/uL
STUDY TREATMENT: White blood cells (WBC) >= 2000/ul
White blood cell (WBC) count of >= 3000/ul
Leukocytes (white blood cell [WBC]) >= 3,000/uL
White blood cell count (WBC) >= 2000/uL
White blood cells (WBC) >= 3,000/uL
White blood cell (WBC) >= 2000/uL
White blood cell (WBC) >= 2000/uL, within 30 days before study registration
White blood cells (WBC) >= 2000/uL within 14 days prior to first dose
White blood cells (WBC) >= 2000/uL
White blood cells >= 3000/uL obtained < 4 weeks prior to starting treatment
Obtained within 14 days of randomization: White blood cells (WBCs) >= 2000/uL
Within 14 days prior to the first study treatment (cycle 1, day 1): White blood cell (WBC) counts > 2500/uL
White blood cell (WBC) counts > 2500/uL
Performed within 14 days (+ 3 working days) prior to registration: White blood cell (WBC) > 3,000/ul.
White blood cells (WBC)\t>= 2,000/uL
White blood cell count (WBC) >= 3,000/uL
Total white blood cell (WBC) count >= 3000/uL, within 14 days of study registration (within 30 days for pulmonary and cardiac assessments)
White blood cell (WBC) >= 2500 cells/uL (obtained within 28 days prior to first study treatment)
White blood cell (WBC) counts > 2500/uL within 14 days prior to the first study treatment (cycle 1, day 1)
White blood cells (WBC) >= 2000/uL
White blood cell count (WBC) >= 2000/uL should be obtained within 21 days prior to enrollment
Patients with symptoms/signs of hyperleukocytosis or white blood cells (WBC) > 100,000/uL can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg/m^2/dose) prior to enrollment
WBC ?2000/uL
White blood cells (WBC) >= 2000 /uL
White blood cell (WBC) >= 3000/uL
White blood cells (WBC) =< 10,000/uL
The use of hydroxyurea prior to study registration is allowed; patients with symptoms/signs of hyperleukocytosis or white blood cell (WBC) > 100,000/uL can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg/m^2/dose) prior to study day 0 enrollment
White blood count (WBC) >= 2000/uL obtained within 14 days prior to randomization/registration
White blood cell counts (WBC) > 2500/uL
Within 14 days prior to study entry: White blood cell (WBC) >= 2000/uL
White blood cell count (WBC) >= 2000/uL
White blood cells (WBC) >= 3,000/uL
White blood cell (WBC) count > 2500/uL
Must be met within 28 days of course 1 day 1 (C1D1): White blood cell (WBC) >= 2,000/ul
White blood cell (WBC) >= 3,000/uL
INCLUSION CRITERIA FOR ADDITIONAL PTCy-MILs INFUSION AT RELAPSE: White blood cell count (WBC) >= 2,000/uL
White blood cells (WBC) >= 2500/uL
White blood cell (WBC) >= 3,000/uL obtained no more than 28 days prior to the start of neoadjuvant endocrine therapy
White blood cells (WBC) is >= 1500/ul
White blood cells (WBC) >= 2000/uL
White blood cells (WBC) >= 2,000/uL
White blood cell (WBC) >= 2,500 cells/uL
White blood cells (WBC) >= 3,000/ul
White blood cell (WBC) >= 2000/uL
White blood count (WBC) > 2,500/uL
White blood cells (WBC) >= 3,000/ul
White blood cell (WBC) >= 2000/uL
White blood cell (WBC) >= 2,000/ul
White blood cells (WBC) >= 3 x 10^3/ul
White blood cells (WBC) >= 3000/ul performed within 60 days of enrollment
The use of hydroxyurea prior to study registration is allowed; patients with symptoms/signs of hyperleukocytosis or white blood cells (WBC) > 100,000/uL can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg/m^2/dose) prior to enrollment
Within 14 days prior to the first study treatment (cycle 1, day 1): White blood cell (WBC) counts >= 2500/uL.
Receipt of any anti-cancer therapy within 14 days prior to study entry, with the exception of hydroxyurea; if clinically indicated in order to keep white blood cells (WBC) < 30,000/uL, hydroxyurea may be continued through the first cycle
WBC (white blood cell count) is 2000/ul
White blood cell (WBC) >= 3.0 x 10^3/ul
White blood cell (WBC) less than or equal to 2000/uL
White blood cell (WBC) counts > 2500/uL, obtained within 14 days prior to the first study treatment (cycle 1, day 1)
Total absolute phagocyte count (APC = [%neutrophils + %monocytes) x white blood cells [WBC]) is at least 1000/uL
Performed within 14 days prior to study: White blood count (WBC) > 3,000/ul
White blood cells (WBC) >= 2000/uL
White blood cells 2000/ul or more
White blood cell (WBC) >= 2.0 x 10^3/ul
WBC >= 2.0 x 10^3/ul
White blood cell (WBC) >= 3,000/uL
White blood cells (WBC) >= 3500/uL
White blood cell (WBC) counts > 2500/uL
White blood cells (WBC) >= 3000/uL
White blood cell (WBC) >= 2,500 cells/uL
White blood cells (WBC) >= 3000/uL
White blood cell (WBC) > 3500/ul
White blood cell (WBC) >= 2,000 cells/uL
No exclusion for blood counts; however, at the time of treatment initiation, white blood cell (WBC) should be < 30,000/uL (can be controlled with hydroxyurea)
White blood cell count (WBC) >= 3500/ul
White blood cell (WBC) > 2,000/ul
White blood cell (WBC) greater than or equal to 3,000/ul
White blood cell (WBC) >= 3000/UL
White blood cell (WBC) >= 2000/uL
White blood cell (WBC) count >= 2500/ul, obtained within 14 days prior to initiation of study treatment
White blood cells (WBCs) >= 2000/uL
White blood cell (WBC) >= 2000/uL
The use of hydroxyurea prior to study registration is allowed; patients with symptoms/signs of hyperleukocytosis or white blood cell (WBC) > 100,000/uL can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg/m^2/dose) prior to enrollment
White blood cells (WBCs) >= 2000/uL
White blood cell (WBC) count >= 2000/uL
White blood cell (WBC) >= 3000/ul
Prior to cyclophosphamide and T cell infusions: white blood cells (WBC) =< 2000/uL
Within 14 days prior to registration: white blood cells (WBC) >= 2,000/uL
White blood cells (WBC) > 2000/uL
Within 14 days prior to the first study treatment (cycle 1, day 1): White blood cells (WBC) counts > 2500/uL
White blood cells (WBCs) >= 2000/uL
White blood cells (WBC) > 3500/ul
White blood cells (WBC) < 2,000/ul
White blood cell (WBC) count of >= 3000/ul
White blood cell (WBC) > 2,000/ul
White blood cell (WBC) >= 3,000 cells/uL
White blood cells (WBC) >= 2500/uL
White blood cells (WBC) >= 2000/uL
White blood cells (WBC) >= 2000/ul
White blood cell (WBC) >= 3,000/ul
White blood cells (WBC) =< 1000/uL
COHORT A: White blood cells (WBC) >= 2000/uL
COHORT B: WBC >= 2000/uL
Obtained within 14 days prior to the first study treatment (cycle 1, day 1); white blood cell (WBC) counts > 2500/uL
White blood cell (WBC) count of >= 3000/ul
White blood cells (WBC) >= 2000/uL
White blood cell (WBC) >= 3,000/ul
Whole blood cell (WBC) >= 3,000/ul
White blood cells (WBC)\t>= 3000/uL
Obtained within 14 days prior to registration: White blood cells (WBC) >= 3,000/ul
White blood cell (WBC) >= 2000/uL
White blood cells (WBC) >= 2000/uL
White blood cells (WBC): >= 2000/uL (~ 2 x 10^9/L)
White blood cells (WBC) >= 3,000/ul
White blood cells (WBC) > 2.0 K/uL
WBC >= 3,000/ul
White blood cell (WBC) >= 2000/uL
White blood cell (WBC) counts > 2500/uL (obtained within 14 days prior to the first study treatment [course 1, day 1])
Within 14 days prior to enrollment/randomization: White blood cells (WBC) >= 3.0 K/uL
White blood cells (WBC) >= 2.0 x 10^3/uL
White blood cells (WBC) >= 2.0 x 10^3/uL
White blood cell (WBC) > 3000/ul
White blood cell (WBC) > 2000/uL
White blood cell (WBC): >= 2000/uL (~2 x 10^9/L)
White blood count (WBC) of > 2000 ul 3
White blood cell (WBC) >= 3000/uL
White blood cell (WBC) >= 2,000 /uL
White blood cells (WBC) < 50,000/ul at screening
Patients with symptoms/signs of hyperleukocytosis or white blood cell (WBC) > 100,000/uL can be treated with leukapheresis prior to enrollment
WBC >/= 3,000/uL
Patients with symptoms/signs of hyperleukocytosis or white blood cells (WBC) > 100,000/uL can be treated with leukapheresis or may receive up to 2 doses of cytarabine (up to 500 mg/m^2/dose) prior to enrollment
White blood cell (WBC) >= 3.0 K/uL
White blood cell (WBC) > 3.0 K/uL
WBC > 3.0 K/uL
White blood cell count (WBC) >= 2,000/uL
White blood cells (WBC) >= 3,000/ul
Total absolute phagocyte count (APC = %neutrophils + %monocytes) X white blood cell (WBC) is at least 1000/uL
White blood cell (WBC) >= 2000/uL
White blood cells (WBC) >= 2000/uL
White blood cell (WBC) >= 3,000/uL
White blood cells (WBC) >= 3,000/uL
Severe leukocytosis (white blood cell count [WBC] >= 20,000 cells /uL)
White blood cells (WBCs) >= 2000/uL, obtained within 14 days of the first dose of study drug
White blood cells (WBCs) < 3.0 K/UL in the past 30 days
White blood cell (WBC) > 2.0 k/uL
White blood cells (WBCs) < 3.0 K/UL in the past 30 days
Leukocytes (white blood cells [WBC]) >= 3,000/uL (>= 2,500/uL for African-American participants)
White blood cell (WBC) >= 2,500/uL
Leukocytes >= 3,000/uL; Note: if leukopenia is idiopathic and no other significant co-morbidities exist patients will not be excluded on the basis of their white blood cell (WBC)
White blood cell count (WBC) >= 3,000/ul
Within 30 days of eligibility confirmation: Leukocytes (white blood cells [WBC]) >= 3,000/uL
Obtained within 28 days prior to registration: White blood cell (WBC) >= 2500 cells/uL
White blood cells >= 3,000/uL
White blood cells (WBC) > 2.0 X 10^3/uL
White blood cell (WBC) < 3000/uL
White blood cell (WBC) >= 3,000/uL, performed within 28 days prior to registration