[c09aa8]: / clusters / 9knumclustersv2 / clust_1944.txt

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Diagnostic bone marrow and peripheral blood specimens must be submitted for immunophenotyping and selected molecular testing, and the establishment of BCR/ABL status; testing will be performed by the Eastern Cooperative Oncology Group (ECOG)-American College of Radiation Imaging Network (ACRIN) Leukemia Translational Research Laboratory (LTRL) and reported to the institution\r\n* NOTE: IT IS ESSENTIAL THAT A SAMPLE CONTAINING SUFFICIENT BLAST CELLS BE SUBMITTED TO THE ECOG-ACRIN LTRL AT BASELINE SO THAT SUBSEQUENT BONE MARROW ASSESSMENTS OF MRD CAN BE DONE; IN ADDITION TO ALLOWING THE LTRL TO CONFIRM ELIGIBILITY BASED ON BLAST CELL IMMUNOPHENOTYPE AND BCR/ABL STATUS, IT IS ALSO IMPERATIVE THAT AN ADEQUATE NUMBER OF BLASTS BE BANKED FOR ANALYSIS BY DRS MULLIGHAN/WILLMAN. WITHOUT ADEQUATE BASELINE SAMPLES, PATIENTS WILL NOT BE ABLE TO BE TREATED AND RANDOMIZED ON THIS PROTOCOL; IF A BONE MARROW ASPIRATE IS NOT AVAILABLE FOR LTRL SUBMISSION AT BASELINE, IT IS IMPERATIVE THAT DR PAIETTA FROM THE LTRL IS CALLED TO DISCUSS THE PERIPHERAL BLOOD WBC AND BLAST COUNT BEFORE BLOOD ONLY IS SUBMITTED\r\n* NOTE: Hydroxyurea can be given for up to days prior to initiation of protocol therapy for control of leukocyte count and/or other symptoms or signs; corticosteroids can be given after pre-registration to the protocol and submission of baseline marrow and blood samples for control of leukocyte count and/or other symptoms or signs prior to initiation of protocol therapy if needed; if corticosteroids are given prior to pre-registration, contact the study chair as the patient may still be eligible to participate
Patients with M marrow or better are eligible; patients with M or M marrow (greater than % lymphoblasts) will not be eligible to be randomized\r\n* Rating: M, M; Blast Cells (%): -.\r\n* Rating: M; Blast Cells (%): .-.\r\n* Rating: M; Blast Cells (%): > -\r\n* Rating: M; Blast Cells (%): > .\r\n* The term blast cell includes any cell that cannot be classified as a more mature normal element, and includes leukemic cells, pathologic lymphocytes, and stem cells
Peripheral blast count </= ,/mm at the time of initiation of infusion on Cycle Day
Patients must have a peripheral blast count < ,/uL within days prior to registration; (treatment with hydroxyurea and steroids is permitted to bring the countdown)
Leukemic blast counts of >,/l
Have a peripheral blast count of >,/mm (may use hydroxyurea as in # above)
Patient previously diagnosed with AML (defined as a bone marrow or peripheral blood blast percentage of >%).
Peripheral blast count of <%
Peripheral blood lymphoblasts =< , mcL; hydroxyurea and/or leukapheresis is permitted to reduce the peripheral blast count prior to enrollment and treatment
Bone marrow blast count ? % or peripheral blast count ? %, or IPSS-R score ? ..
Peripheral blood blast count =< , at time of eligibility assessment (within days of start of therapy); blast counts that increase beyond , after a patient is deemed eligible will not disqualify the patient
Leukemic blast cell count > /L before the start of study therapy and despite the use hydroxyurea.
Patients with leukemic/blast phase transformation MPN
Must have an absolute blast count (ABC) of < K/ul in the peripheral blood prior to initiating study treatment, performed within days of treatment initiation; use of hydroxyurea to control blast counts prior to initiating study treatment is acceptable
Patients should have a circulating blast count of less than ,/mm^ (control with hydroxyurea or similar agent is allowed)
Circulating blast count > ,/uL by morphology or flow cytometry (cyto-reductive therapies including leukapheresis or hydroxyurea are allowed)
Subjects with peripheral blood blast count of > % at the screening or baseline hematology assessments
Circulating blast count > ,/uL by morphology or flow cytometry (cyto-reductive therapies including leukapheresis or hydroxyurea are allowed)
MDS patients: \r\n* Cytogenetics consistent with poor or very poor risk group by -risk classification;\r\n* Cytogenetics consistent with monosomal karyotype\r\n* Bone marrow blast count > % but less than % at any time during their disease course before HSCT\r\n* Peripheral blood blast =< % at HSCT
AML patients: \r\n* Cytogenetics and molecular features consistent with adverse risk group;\r\n* Presence of minimal residual disease by multi-color flow cytometry or cytogenetics or molecular studies at the time of HSCT; \r\n* Presence of active disease defined as bone marrow blast count > % but less than =< % at the time of HSCT\r\n* Peripheral blood blast count =< % at HSCT
Bone marrow blast count > % for cohort
Blasts in peripheral blood < , (treatment with hydroxyurea is permitted up to hrs prior to LY administration to achieve blast counts < , prior to enrollment)
Bone marrow blast ? %
In order to prevent tumor lysis syndrome, acute leukemia patients must have a peripheral blast count under x ^/L; this should be achieved with hydroxyurea cytoreduction, prior to starting DT
White blood cell count > , per micro liter (/L); hydroxyurea may be used to control the level of circulating leukemic blast cell counts prior to study entry and, if needed, concomitantly while on TAK- treatment during the first days of the study. Hydroxyurea can be used up to a maximum dose of gram per (g/) day.
Research participants absolute leukemic blast count does not exceed , cells/uL
Circulating blast count >= ,/uL by morphology or flow cytometry (cytoreductive therapies including leukapheresis or hydroxyurea are allowed)
Have a peripheral blast count of >,/mm (may use hydroxyurea as in # above)
Blast count =< ,
Blood blast percentage higher than %
TdT-positive leukemia (ALL, AML, or blastic CML) that has failed at least one standard treatment regimen and for which no standard therapies are expected to result in durable remission. Leukemia is minimally defined as at least % blast cells present in marrow or peripheral blood. TdT must be expressed in at least % of blast cells present and documented either immunologically or biochemically;
Hyperleukocytosis with > , blasts/ul; hydroxyurea for blast count control is permitted before starting treatment and up to maximum of days after starting treatment on the study; the white blood cell (WBC) need not reach ,/ul to start hydroxyurea during protocol; the decision to start hydroxyurea during this time is at the discretion of the treating physician; patients will be withdrawn from the study if > , blasts/ul persists on hydroxyurea or recur >= days after starting treatment on the study
Concurrent chemotherapy (except hydroxyurea) or interleukin- (IL-) therapy or anticipated need during the study treatment for week after the last dose of ALT--hydroxyurea is permitted at any time to control blast count
Subject has circulating blast count > ,/?L (subjects may be enrolled if circulating blast count is controlled by hydroxyurea and/or, if clinically indicated, by leukophoresis)
Patients with acute leukemia must have chemotherapy sensitive disease, as defined by at least a % reduction in circulating absolute blast count due to the most proximal regimen
Peripheral blood blast count of >= % or bone marrow blast count of >=%
Absolute blast count (ABC) ? ,/mm
Bone marrow documenting blast count >= % or >= % in CMML patients who have progressed beyond CMML and received myelosuppressive chemotherapy
For a diagnosis of AML, a bone marrow blast count of % or more is required.
Circulating blast count >= ,/uL by morphology or flow cytometry (cytoreductive therapies including leukapheresis or hydroxyurea are allowed)
Peripheral blood blast count < %
Have a circulating blast count of less than ,/mm (control with hydroxyurea is allowed)
Peripheral blood blast count < ,/uL
Peripheral blood blast count < %
Requires agents other than hydroxyurea to control blast count
Patients should have a circulating blast count of less than ,/mm^ (control with hydroxyurea or similar agent is allowed)
Patients should have a circulating blast count of less than ,/mm^ (control with hydroxyurea or similar agent is allowed)
Absolute leukemic blast count in peripheral blood >,/ microliter;
Circulating blast count >= ,/uL within the week preceding enrollment
Bone marrow involvement with >= % lymphoblasts, peripheral blast count less than , per uL
hyperleukocytosis (blast counts > /mm).
Hydroxyurea to control peripheral blood blast count must be discontinued within hours prior to the initiation of treatment; hydroxyurea can also be given through the first cycle of treatment, but should not be initiated earlier than day
Patients with rapidly increasing peripheral blood blast counts
Peripheral blood blast count must be ? , cells/L.
Peripheral blood blast ? % Be able to start study therapy between to days following allogeneic HSCT Post transplant bone marrow blast count ? % confirmed within days prior to starting study therapy Adequate engraftment within days prior to starting study therapy:
Bone marrow blood blast count < %
Blast count ?%
Blast count ? % (WHO criteria)
Have a circulating blast count of less than /mm (control with hydroxyurea or similar agent is allowed);
AML, ALL\r\n* Normal values for absolute neutrophil count (> /microL) and platelet count (> ,/microL)\r\n* Absence of extramedullary leukemia\r\n* Less than percent blast cells present in the bone marrow
Absolute blast count ?,/mm or symptoms of leukostasis