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)