RCT of Olanzapine for Control of CIV in Children Receiving Highly Emetogenic Chemotherapy

Criteria the registry did not label

• Planned receipt of HEC or cyclophosphamide ≥ 1 g/m2/day (≥ 33 mg/kg/day) for cancer treatment or autologous or allogeneic HSCT conditioning.81,82 Examples of HEC are: busulfan IV (myeloablative dosing), carboplatin ≥175mg/m²/dose, cisplatin ≥12mg/m²/dose, cytarabine ≥3g/m²/day, melphalan \>140mg/m², methotrexate ≥12g/m²/dose and thiotepa ≥300mg/m²/dose.
• Plan for inpatient admission from administration of first study drug dose until 24 hours following administration of last study drug dose.
• Body weight of at least 12.5 kg
• 2.5 to \< 18 years of age. Note that the minimum age requirement corresponds to an approximate body weight of 12.5 kg.
• Samples for all laboratory tests will be obtained within one week prior to administration of the first chemotherapy dose of the study chemotherapy block or the first HSCT conditioning dose:
• Plasma creatinine within 1.5 times the upper limit of normal for age.
• Amylase within age-appropriate limits
• Plasma conjugated bilirubin within ≤ 3x upper limit of normal for age unless attributable to Gilbert's Syndrome
• ALT ≤ 5x upper limit of normal for age
  • Baseline ECG within the month prior to study drug administration without known clinically significant abnormalities including pathologic prolongation of QTc
  • A plan for scheduled, round-the-clock receipt of ondansetron, granisetron or palonosetron for antiemetic prophylaxis during administration of chemotherapy or HSCT conditioning.
  • Negative pregnancy test if female of childbearing potential
  • Patients of childbearing potential must consent to use adequate contraception (males and females) or agree to practice abstinence
  • Parent or child able to speak a language in which the (modified Pediatric Adverse Event Rating Scale (PAERS) is available.
  • Optional: Child participants in the optional assessment of nausea severity must be 4 to 18 years of age. Child and a parent/guardian must be English, Spanish or French-speaking. The Pediatric Nausea Assessment Tool58 (PeNAT) is validated in English-speaking children 4 to 18 years old with an English-speaking parent/guardian and has been translated into Spanish and French. The MAT is available in English, Spanish and French.