[c09aa8]: / clusters / 9knumclustersv2 / clust_2059.txt

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Mature B ALL (Burkitts-like leukemia) is excluded from enrollment in this trial; pre-study bone marrow biopsy and aspirate must be completed =< week prior to registration
Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging bone marrow (BM) aspirate and biopsy
CRITERIA FOR MAINTENANCE THERAPY-STEP : Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging BM aspirate and biopsy
For patients pre-registering after the completion of radiation therapy, documentation of a bone marrow aspirate and biopsy containing < % clonal plasma cells prior to start of radiation therapy
For patients pre-registering before the start of radiation therapy documentation of bone marrow aspirate and biopsy containing < % clonal plasma cells; radiation therapy should preferably begin within days after bone marrow biopsy
Bone marrow aspirate and biopsy containing < % clonal plasma cells performed after completion of RT and within days prior to registration
Bone marrow aspirate samples have been collected.
Willing and able to undergo a pre-treatment bone marrow aspirate and biopsy and subsequent bone marrow aspirates and biopsies during treatment Specifically for participants in Arm A:
Patient consent to collection of fresh bone marrow biopsy and aspirate for exploratory research obtained from a procedure performed no more than days prior to initiating treatment on cycle , day
Evidence of myelodysplasia or myeloid leukemia by morphology, immunostains, flow cytometry, or cytogenetics on a bone marrow aspirate or biopsy.
Have histologically or cytologically confirmed recurrent AML as defined by >= % myeloblasts by manual aspirate differential of bone marrow biopsy
Measurable or evaluable disease, including at least one of the following: measureable tumor by CT or MRI; a positive MIBG, or PET scan; positive bone marrow biopsy/aspirate.
Myelodysplastic syndromes: diagnosis of very low or low risk MDS (biologically defined as low-risk MDS) by Revised-International Prognostic Score (R-IPSS), pathologically confirmed by a bone marrow aspirate and biopsy prior to registration; blast count must be < %\r\n* Bone marrow aspirate can be obtained from the subject at any time after the subject has given consent; the subject must be registered to the study within days of obtaining the aspirate; (Note: if diagnostic bone marrow is obtained within days prior to registration, a portion of the bone marrow aspirate collected may be used for research baseline sample to alleviate a second biopsy)
< % bone marrow involvement of cellular marrow with lymphoma as determined by bilateral bone marrow aspirate and biopsy; NOTE: the percent involvement should be estimated by the hematopathologist using all of the biopsy material
Documentation of CT, MAGE-A, or WT expression in the bone marrow and/or bone marrow aspirate
Evidence of relapsed/recurrent/residual disease as assessed by bone marrow aspirate and biopsy performed within days prior to study entry
Myeloblasts account for less than % of leukocytes on peripheral blood and bone marrow aspirate
Myeloblast count ? % in peripheral blood or bone marrow aspirate
Hemoglobin ?. g/dL (Grade ?) maintained for ? week from any prior transfusion. Note: Grade ? neutropenia, thrombocytopenia, or anemia is permitted if the abnormality is related to bone marrow involvement with hematological malignancy (as documented by bone marrow biopsy/aspirate obtained since the last prior therapy).
Platelets >= ,/uL, if plasma cell percentage on bone marrow biopsy aspirate or core is > %, platelet eligibility requirement will be adjusted to ,/ul
Patients with newly diagnosed AML based on the World Health Organization classification who have persistent leukemia after a course or more of treatment with induction chemotherapy (the diagnosis of persistent disease, which is defined as > % blasts by evaluation of bone marrow biopsy or bone marrow aspirate)
Confirmed histologic diagnosis on bone marrow biopsy and aspirate within days of trial entry prior to starting cycle .
Greater than % lymphoblasts on screening bone marrow aspirate or biopsy
All patients must be willing to undergo a mandatory serial bone marrow aspirate and/or biopsy at screening and subsequently following treatment for the assessment of biomarker/pharmacodynamics and disease status. Exceptions may be considered after documented discussion with Novartis.
Bone marrow aspirate after completion of therapy demonstrates detectable DTCs (via IHC)
Cohort B will enroll patients with a diagnosis of follicular lymphoma, grade - and A; grade B is excluded; diagnoses made by a fine needle aspirate or bone marrow biopsy alone are not permitted
Presence of >= % blast by morphologic examination of bone marrow aspirate or biopsy
Unwilling or unable to undergo serial bone marrow aspirate/biopsy
Subjects must have bone marrow with >= % blasts (M or M marrow) definitively identified either on a bone marrow aspirate or biopsy sample, as assessed by morphology, immunohistochemical studies, flow cytometry, karyotype, cytogenetic testing such as fluorescent in situ hybridization (FISH) or other molecular studies
Myelodysplastic syndrome. If clinically significant anemia or pancytopenia exists, documentation of a bone marrow aspirate within months prior to the first dose of PRTX- showing no evidence of myelodysplasia is required.
To be eligible for this protocol the patient must have AML not in remission defined as greater than >= % myeloblasts by aspirate morphology as determined by a bone marrow aspirate and biopsy obtained within weeks of study registration\r\n* In the event induction treatment results in a hypoplastic bone marrow status (< % cellularity), precluding accurate enumeration of blast percentages, the patient is still eligible if the preceding bone marrow aspirate contained >= % myeloblasts; to meet this condition, prior induction therapy must have been completed a minimum of days prior to this result
Measurable or evaluable disease, including at least one of the following: Measureable tumor by CT or MRI; or A positive MIBG or PET scan; or Positive bone marrow biopsy/aspirate.
No morphologic evidence of leukemia or active MDS as determined by JHH hematopathologist independent review of a bone marrow aspirate and biopsy done following the completion of therapy
Willingness to undergo a pretreatment bone marrow biopsy and/or aspirate, or archival sample obtained since completion of most recent therapy (as appropriate to subjects with existing bone marrow disease or for whom bone marrow examination is a component of disease status assessment)
Willing to provide research bone marrow aspirate specimen
. Sufficient and viable bone marrow aspirate or peripheral blood collection to use for the ex vivo sensitivity assay.
Diagnosis should be made by bone marrow aspirate or biopsy demonstrating >= % involvement by lymphoblasts, with flow cytometry or immunohistochemistry confirming B-precursor or T-ALL phenotype\r\n* For patients with circulating blasts in the peripheral blood, flow cytometry confirmation of B-ALL or T-ALL phenotype is sufficient for registration onto the study; bone marrow aspirate and/or biopsy should be performed as soon as feasible, preferably prior to the initiation of any therapy\r\n* While myeloid co-expression on blasts determined to be primarily lymphoid is allowed, patients meeting World Health Organization (WHO) diagnostic criteria of mixed phenotype acute leukemia (MPAL) or leukemia of ambiguous lineage are not eligible; patients with mature B-cell phenotype are also not eligible
Willing and able to undergo a pre-treatment bone marrow aspirate and biopsy and subsequent bone marrow aspirates and biopsies during treatment
Newly-diagnosed AML patients according to World Health Organization (WHO) classification who are considered candidates for intensive chemotherapy based upon examination of peripheral blood or bone marrow aspirate specimens or touch preparations of the bone marrow biopsy obtained within two weeks prior to randomization; a bone marrow aspirate is required for enrollment; however, on occasion there is discordance between percentage of myeloblasts on the differential of the peripheral blood or aspirate; the peripheral blood criteria are sufficient for diagnosis; confirmatory immunophenotyping will be performed centrally
Consolidation cycle must commence within sixty days of the bone marrow aspirate and biopsy that confirmed the presence of a CR or CRi
Patients must have maintained peripheral blood evidence of a remission and must have a CR or CRi, confirmed on restaging bone marrow (BM) aspirate and biopsy and cytogenetic analysis
Leukemic blasts must demonstrate surface expression of CD at the time of relapse by local/institutional flow cytometry of a bone marrow aspirate sample; (assessment of CD using a bright fluorophore such as phycoerythrin [PE] is strongly recommended) \r\n* In the case of an inadequate aspirate sample (dry tap) or if bone marrow aspirate is unable to be performed due to patient clinical status, flow cytometry of peripheral blood specimen may be substituted if the patient has at least /uL circulating blasts; alternatively, CD expression may be documented by immunohistochemistry of a bone marrow biopsy specimen
For patients with circulating blasts in the peripheral blood, flow cytometry confirmation of B-precursor or T-ALL phenotype is sufficient for registration onto the study; bone marrow aspirate and/or biopsy should be performed as soon as feasible, preferably prior to the initiation of any therapy
For lymphoblastic lymphoma: diagnosis may be made by i) biopsy of involved site (e.g., node, mediastinal mass), or ii) by cytology from pleural fluid or other fluid collection or iii) by marrow aspirate/biopsy demonstrating < % involvement by lymphoblasts (confirmed by flow cytometry, immunohistochemistry, cytogenetics and/or FISH studies) in a patient with evidence of lymphomatous masses by radiographic studies; note: marrow aspirate and/or biopsy must be performed in patients with lymphoblastic lymphoma prior to study entry to confirm that patient does not meet definition of ALL; in rare circumstances, lymphoblastic lymphoma patients may be registered prior to marrow aspirate/biopsy if it is felt that the procedure cannot be safely performed; permission in advance by principal investigator or designee is required
Bone marrow aspirate or biopsy must have ? % blasts by morphology and/or flow cytometry.
Must be willing to consent to two or more bone marrow aspirate procedures to be completed during study.
Willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines).
Evidence of myelodysplasia or myeloid leukemia by morphology, immunostains, flow cytometry, or cytogenetics on a bone marrow aspirate or biopsy.
Myelodysplastic Syndrome (MDS) according to World Health Organization (WHO) criteria confirmed by bone marrow aspirate and biopsy within weeks prior to first dose. A local laboratory report from this diagnostic bone marrow aspirate and biopsy must be approved by the sponsor
Platelets >= ,/uL, if plasma cell percentage on bone marrow biopsy aspirate or core is > %, platelet eligibility requirement will be adjusted to ,/uL
For purposes of this study, bone marrow aspirate and biopsy are not considered surgical procedures and therefore are permitted within days prior to start of protocol therapy
For subjects in the Phase portion of the trial, central testing of IDH mutation of bone marrow aspirate and peripheral blood, is required during screening to confirm eligibility
The diagnosis and evaluation of AML or MDS will be made by bone marrow aspiration and/or biopsy. If an aspirate is unobtainable (i.e., a \dry tap\), the diagnosis may be made from the core biopsy.
Screening bone marrow aspirate and peripheral blood samples are required of all subjects. A bone marrow biopsy must be collected if adequate aspirate is not attainable unless:
A bone marrow aspirate and biopsy was performed as part of the standard of care within days prior to the start of the study treatment; and
Slides of bone marrow aspirate, biopsy and stained peripheral blood smear are available for both local and central pathology reviewers; and
A bone marrow aspirate sample acquired within days prior to the start of study treatment has been sent for cytogenetic analysis.
Subjects must be able to provide adequate bone marrow (BM) aspirate and biopsy specimens for histopathological analysis and standard cytogenetic analysis during the screening procedure
ALL in first bone marrow relapse occurring > months (> days) from initial diagnosis; marrow must have >= % blasts (M marrow), either on an aspirate or biopsy sample, as assessed by morphology, flow cytometry, and/or immunohistochemistry; individuals with CNS, testicular or other extramedullary involvement are eligible as long as they also meet marrow involvement criteria
Has already had a bone marrow biopsy and aspirate to assess remission status after induction therapy
Bone marrow aspirate/biopsy results showing >% blasts
Requiring salvage chemotherapy for persistent/refractory or relapsed disease after at least one course of conventional chemotherapy, e.g. with +, as defined by persistence of >= % myeloid blasts on bone marrow aspirate or peripheral blood smear; a bone marrow biopsy is not routinely required, but should be obtained if the aspirate is dilute, hypocellular, or inaspirable; outside bone marrow examinations performed within the stipulated time period are acceptable for screening as long as the slides are reviewed at the study institution; flow cytometric analysis of the bone marrow aspirate should be performed according to institutional practice guidelines
All patients must be willing to undergo a mandatory bone marrow aspirate and/or biopsy at baseline for the assessment of biomarker/pharmacodynamics and disease status
Patient must be able/willing to undergo bone marrow aspirate and biopsy
Willing to undergo pre-dose core needle tumor biopsies or bone marrow aspirate for subjects with multiple myeloma.
At pre-ASCT evaluation patients must meet the International Neuroblastoma Response Criteria (INRC) for CR, VGPR, or PR for primary site, soft tissue metastases and bone metastases; patients who meet those criteria must also meet the protocol specified criteria for bone marrow response as outlined below:\r\n* =< % tumor (of total nucleated cellular content) seen on any specimen from a bilateral bone marrow aspirate/biopsy\r\n* Patient who have no tumor seen on the prior bone marrow, and then have =< % tumor on any of the bilateral marrow aspirate/biopsy specimens done at pre-ASCT and/or pre-enrollment evaluation will also be eligible (note that per INRC this would have been defined as overall response of progressive disease [PD])
Patients must have histologically confirmed diagnosis of Philadelphia-negative ALL by bone marrow biopsy or aspirate
Subjects must have presence of < % bone marrow blasts per bone marrow biopsy/aspirate at screening.
Patients undergoing additional procedures during the same anesthetic such as bone marrow aspirate or biopsy will be excluded
Must consent to bone marrow aspirate or biopsy.
Subject must be willing and able to undergo bone marrow aspirate per protocol (with or without bone marrow biopsy per institutional guidelines).