Bone Marrow Evaluation Sample Clauses

Bone Marrow Evaluation. Bone marrow aspirates and biopsies will be collected throughout the studyCCI  Screening bone marrow evaluation:  If available, archival formalin-fixed paraffin embedded (FFPE) bone marrow block and/or slides used for the original diagnosis of ALL will be submitted to the central laboratory along with the pathology report.  A bone marrow aspirate and biopsy is required at screening and will be performed after the last dose of systemic chemotherapy and within approximately 14 days before enrollment to establish baseline disease. ■ If there is a delay between when the screening bone marrow is performed and the apheresis, contact the Kite Medical Monitor for guidance on whether or not bone marrow evaluation needs to be repeated. If a fresh bone marrow aspirate and biopsy was recently collected and properly stored prior to consent, then contact the Kite Medical Monitor to confirm if this sample is adequate for screening.  In subjects who receive bridging chemotherapy, an additional bone marrow sample is required between the end of bridging chemotherapy and Day -4. If bridging chemotherapy is not administered, then the additional bone marrow sample is not required, however, an assessment of peripheral circulating blasts is required (see Section 7.11.6.3 regarding requirement for peripheral blast count).  On study bone marrow evaluations:  A bone marrow aspirate will be required at all time points CCI to assess treatment response. ■ For subjects who undergo a SCT, bone marrow evaluations are not required during the first 100 days post-SCT. After 100 days, bone marrow evaluations should be performed at the next per protocol time point per the SOA. If a subject has a bone marrow evaluation earlier than the next per protocol time point, then the bone marrow samples should be processed and submitted to the central laboratory per the central laboratory manual.  In addition to the bone marrow aspirate, a bone marrow biopsy is required at Day -4 and Day 28. A bone marrow biopsy at all other time points is recommended and should be performed if standard of care. Note: Anytime the bone marrow aspirate is a dry tap, then a bone marrow biopsy is required. In the case of a dry tap, the bone marrow biopsy will be used to determine disease burden by immunohistochemical (IHC) analyses. The following markers will be analyzed by IHC: XX00, XX00, XX00, XX00, Xxx0 and TdT.  For subjects who sign the optional portion of the consent form, a Day 7 bone marrow biopsy and aspira...
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