Requirements for Initiating KTE Sample Clauses

Requirements for Initiating KTE. X19 Infusion If any of the following criteria are met prior to the initiation of KTE-X19 infusion, then the workup listed in Section 7.12.7 must be performed to determine the potential cause if there is no identified source of infection. • Temperature > 38° Celsius within 72 hours of KTE-X19 infusion • CRP > 100 mg/L anytime between enrollment to start of conditioning chemotherapy • WBC count or WBC differential, which is suggestive of infectious process, and is observed between enrollment and the initiation of KTE-X19 infusion (eg, WBC > 20 000/µL, rapidly increasing WBC, or differential with high percentage of segs/bands) Additionally: • If any screening assessments or procedures are repeated between confirmation of eligibility and the start of KTE-X19 infusion and results are outside the eligibility criteria listed in Section 5, then the condition must resolve prior to proceeding with KTE-X19 infusion (except for peripheral blood cell counts that have been impacted by conditioning chemotherapy). • Complete history and physical exam, including HEENT exam, cardiac, vascular, respiratory, gastrointestinal, integumentary, and neurological systems, must not reveal evidence of infection/inflammation. • The subject must not have received systemic antimicrobials for the treatment of a known or suspected infection within 48 hours before KTE-X19 infusion (prophylactic use of antimicrobials is allowed). • Treatment course of any antimicrobials given for known or suspected antecedent infection should be complete as per infectious disease consult (if applicable) recommendation before stopping or switching to prophylactic antimicrobials. • If a subject is confirmed to have an infectious process for which antimicrobials are not available (eg, viral pneumonia), the infection must be clinically resolved as determined by the investigator in consultation with infectious disease service (if applicable). • Most recently collected blood, urine, or other body fluid cultures must show no growth for at least 48 hours, and any other infectious workup performed (eg, bacterial, viral serologies, PCR, stool studies, imaging studies) must be negative. If clinical suspicion is for an infection for which cultures are unlikely to be positive within 48 hours (eg, fungal infection), adequate time must be allowed for cultures to become positive. After the above criteria are met, then the subject can proceed with administration of KTE-X19. If the KTE-X19 infusion is delayed > 2 weeks, prot...
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