[c09aa8]: / clusters / 9knumclustersv2 / clust_922.txt

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Systemic steroid pretreatment without presteroid WBC documentation
White Blood Cell Count (WBC) Criteria\r\n* Age -. years: WBC >= /uL \r\n* Age -. years: Any WBC \r\n* Age -. years: Any WBC with:\r\n** Testicular leukemia\r\n** CNS leukemia (CNS)\r\n** Steroid pretreatment
For patients with AML or MDS, patient must have white blood cell count (WBC) ? ,/mL. Hydroxyurea is allowed to achieve this change but must be discontinued a minimum of five () days prior to baseline evaluation
ELIGIBILITY CRITERIA - PHASE I (ARMS A, B, C): Circulating white blood cell (WBC) count must not be above x^/L within days prior to first dose of study agent\r\n* Patients with WBC count above x ^/L may be eligible if they start steroids or hydroxyurea per institutional guidelines, but they must discontinue before day of study drug
ELIGIBILITY CRITERIA - PHASE II (ARM D): Circulating WBC count must not be above x^/L within days prior to first dose of study agent\r\n* Patients with WBC count above x^/L may be eligible if they start steroids or hydroxyurea per institutional guidelines, but they must discontinue before day of study drug
WBC =< x ^/L
WBC ? . x e/L
PART II: WBC >= , cells/mm^
WBC < , uL
Patients receiving other active treatment for their myeloid malignancy including investigational agents with the exception of hydrea for white blood cell (WBC) control
Patients with white blood cell (WBC) > , are not eligible to start therapy; however, it is permissible to use glucocorticoids and/or hydroxyurea to diminish peripheral WBC to less than , provided these agents are stopped at least hours prior to the first dose of MLN (TAK-)
WBC >/mm
Sufficient bone marrow capacity as defined by WBC (white blood cell ) ?./?l, PLT (platelet) count ?./?l, Hb?. g/dl and ANC? mm for the first cycle and WBC?./ ?l,PLT count ?./?l, Hb?. g/dl and ANC? mm for the subsequent cycles
Disease status allows delay of additional anti-leukemia therapy for the duration of the study (hydroxyurea is allowed for control of white blood cell count [WBC] throughout study)
WBC ?/uL
Patients requiring hydroxyurea to bring WBC below ,/uL prior to study enrollment will require a -hour washout prior to starting the study drug
PHASE I STUDY ELIGIBILITY CRITERIA: \r\nWhite blood cell (WBC) >= ,/mcL
a. WBC > ,/L
Any form of primary or secondary immunodeficiency; must have recovered immune competence after chemotherapy or radiation therapy as evidenced by lymphocyte counts (> /mm^), white blood cell (WBC) (> ,/mm^) or absence of opportunistic infections (Turnstile II)
Any form of primary or secondary immunodeficiency; must have recovered immune competence after chemotherapy or radiation therapy as evidenced by lymphocyte counts (> /mm^), white blood cell (WBC) (> ,/mm^) or absence of opportunistic infections (Turnstile II)
MLL rearranged AND age < months AND WBC < x ^/L AND prednisone good response
WBC ? x ^/L AND/OR prednisone poor response
WBC > . x ^/L with an ANC > . x ^/L and off G-CSF for days
Any form of primary or secondary immunodeficiency; must have recovered immune competence after chemotherapy or radiation therapy as evidenced by lymphocyte counts (> /mm^), white blood cell (WBC) (> ,/mm^) or absence of opportunistic infections (Turnstile II - Chemotherapy/Cell Infusion Exclusion Criteria)
Hemoglobin level greater than (>) gram per deciliter (g/dL) (following blood transfusion is acceptable) and normal white blood cell (WBC) and neutrophil counts (elevated WBC/absolute neutrophil count [ANC] attributed to steroid treatment is acceptable)
WBC>/mm
Receipt of any anti-cancer therapy within days prior to study entry, with the exception of hydroxyurea; if clinically indicated in order to keep white blood cells (WBC) < ,/uL, hydroxyurea may be continued through the first cycle
EXCLUSION CRITERIA FOR TREATMENT: WBC less than or equal to /uL
If WBC ?,/?L, cytoreduction with hydroxyurea is permitted prior to enrollment.
Screening urinalysis < white blood cell/high power field (WBC/hpf) (unless alternate urinary diagnosis not consistent with infection)
WBC >= . x ^/ul
WBC ?,/l
Absolute WBC count ? /L. AML Cohort:
Absolute White blood cell (WBC) count ? /L (NOTE: Hydroxyurea is not allowed to attain a WBC count ? x /L).
WBC ? ,/mm^
For CMML participants: WBC count <,/mcL before administration of the first dose of study drug on Cycle Day ; participants must have been off hydroxyurea for at least week prior to WBC count assessment.
WBC ? /?L
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 , will receive hydroxyurea to reduce the WBC count to below , at which point they may begin treatment
Mantle cell lymphoma International Prognostic Index (IPI) (MIPI) score must be calculated and entered in Oncology Patient Enrollment Network (OPEN)\r\n* NOTE: for this calculation white blood cell (WBC) ,/mm^ = ,/uL = . x ^/L should be entered as
WBC counts > /L
COHORT B: WBC >= /uL
Subjects who received systemic anticancer therapy or radiotherapy < days prior to their first day of study drug administration. (Hydroxyurea is allowed for up to days after the start of AG- for the control of peripheral leukemic blasts in subjects with white blood cell [WBC] counts >,/?L as well as prior to enrollment).
Use of investigational agents/any anticancer therapy within weeks before study entry with the exception of hydroxyurea (NOTE: for patients with hyperleukocytosis [white blood cell (WBC) > ,/uL], hydroxyurea [and leukapheresis, if clinically indicated] will be initiated and these patients will receive -azacytidine when the WBC count has decreased to =< ,/uL; hydroxyurea can be overlapped with -azacytidine in selected cases, after consultation with the study chair; hydroxyurea must be discontinued before the initiation of the HiDAC/mitoxantrone chemotherapy)
WBC at least ,/mm
WBC >= ,/ul
Peripheral white blood cell (WBC) count ,/L For cyto-reduction, hydroxyurea is allowed during screening and up to Cycle , Days -, to reduce WBC count to < , L prior to Day . After Cycle , Day , hydroxyurea is prohibited.
WBC > . ^/L at screening.
PRIOR TO POST-TRANSPLANT IMMUNOTHERAPY: WBC >= . X ^/uL
Recipients with agnogenic myeloid metaplasia must have at least of the following features:\r\n* Hemoglobin < g/dl, or > g/dl with transfusion dependence\r\n* WBC < , or > ,/mm^ or requires cytoreductive therapy to maintain\r\n* WBC < ,/mm\r\n* Abnormal cytogenetics including +, p-
WBC counts /mL
WBC count <, cells/mm ( x /L)
WBC ? . X/L
White blood cell count (WBC) should be lower than ,/mm^ prior to initiation of cabozantinib (patients who are otherwise medically eligible for enrollment but have a WBC above ,/mm^ are allowed concurrent treatment with hydroxyurea and/or -mercaptopurine to stabilize the WBC during the first days of therapy; in these situations, hydroxyurea and/or -mercaptopurine will be discontinued once WBC is below ,/mm^, and can be re-started if WBC again rises above ,/mm^ during the first days of therapy of the first cycle)
Prior use of hydroxyurea or isolated doses of cytarabine for palliation (i.e., control of WBC) are allowed but should be discontinued at least hrs prior to enrollment.
WBC count ? . x cells/L
WBC >/= ,/uL
White blood cell count (WBC) at initiation of treatment =< ,/L\r\n* If WBC is > ,/L patients may be started on leukapheresis or an appropriate dose of hydroxyurea (to be determined by the investigators), until WBC < ,/L, at which time the hydroxyurea will be discontinued for hours prior to enrollment
WBC > . K/uL
A total WBC >= . x ^/mcL is allowed for non-Hispanic black males (NHBM) and total WBC >= . x ^/mcL for non-Hispanic black females (NHBF) \r\n* Exception: If the WBC is lower than the above levels, the patient may be enrolled IF the absolute neutrophil count (ANC) is >= . for NHBM, >= . for NHBF, or >= . for all.
Extreme hyperleukocytosis, white blood cell (WBC) counts over x /L (,/microL) at the time of enrollment
?% increase in WBC count (myeloid cell line and monocyte series) within the -week period leading to Cycle , Day
Total bilirubin >., creatinine >, hemoglobin <, platelets <,, WBC <,)
Total bilirubin >., creatinine >, hemoglobin <, platelets <,, WBC <,
Patient has a compromised immune system or autoimmune disease (WBC < or > ,)
WBC < /?L
Patient has compromised immune system or autoimmune disease (WBC < or > ,)
progressive leukocytosis, defined as increasing white blood cell (WBC) count on at least consecutive evaluations, at least weeks apart and doubling from the nadir to ?/?L or absolute increase in WBC by ?/?L above the post-treatment nadir
Total White Blood Cell count (WBC) < x /L prior to first infusion. Prior or concurrent treatment with hydroxyurea to achieve this level is allowed.