Critètes d'exclusion |
- CNS malignancy, either primary CNS tumor or CNS metastases. A history of CNS leukemia, in remission at study entry, is allowed.
- Pre-existing seizure disorder; known cardiac arrhythmias; known clinically significant ECG abnormalities at baseline including QTc prolongation; uncontrolled diabetes mellitus; history of neuroleptic malignant syndrome; known hypersensitivity or allergy to olanzapine.
- Treatment within 14 days prior to the first day of study drug administration with olanzapine or other anti-psychotic agents (e.g. risperidone, quetiapine, aripiprazole, clozapine, butyrophenone) including those used to control CINV (e.g. chlorpromazine, prochlorperazine, promethazine)
- Scheduled administration (i.e. not PRN) of antiemetics other than dexamethasone and ondansetron, granisetron or palonosetron is not permitted.
Scopolamine patches, aprepitant, fosaprepitant, phenothiazines (e.g. chlorpromazine, prochlorperazine), acupressure or acupuncture are not permitted during the acute and delayed phases. Methylprednisolone and hydrocortisone are permitted during the acute and delayed phases for prevention or treatment of reaction (e.g. thymoglobulin, alemtuzumab, blood products) and during delayed phase for GVHD prophylaxis. Administration of olanzapine other than ordered as per study procedures is not permitted. However, other antiemetics may be administered as needed (PRN) for treatment of breakthrough CINV. For patients receiving busulfan, scheduled administration of benzodiazepines such as lorazepam for seizure prophylaxis is permitted on the days that busulfan is given and for 24 hours after.
- Receipt of cranial boost radiation within 14 days of the first day of HSCT conditioning.
- Planned co-administration of citalopram, amifostine, medications known to alter the metabolism of olanzapine (e.g. ciprofloxacin, valproic acid)
- Previous participation in this study.
- Participants in the optional assessment of nausea severity must be free of cognitive, hearing or visual impairment that preclude completion of the PeNAT.
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