RCT of Olanzapine for Control of CIV in Children Receiving HSCT Conditioning
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ClinicalTrials.gov Identifier: NCT03118986 |
Recruitment Status :
Recruiting
First Posted : April 18, 2017
Last Update Posted : February 3, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Vomiting in Infants and/or Children Nausea Hematopoietic System--Cancer | Drug: Olanzapine Drug: Placebo Oral Tablet | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Investigator) |
Primary Purpose: | Supportive Care |
Official Title: | Randomized Controlled Trial of Olanzapine for the Control of Chemotherapy-induced Vomiting in Children Receiving Chemotherapy for Hematopoietic Stem Cell Transplant Conditioning |
Actual Study Start Date : | August 10, 2017 |
Estimated Primary Completion Date : | March 2023 |
Estimated Study Completion Date : | April 2023 |

Arm | Intervention/treatment |
---|---|
Active Comparator: Olanzapine
Standard antiemetics plus olanzapine
|
Drug: Olanzapine
olanzapine 0.1 mg/kg/dose (maximum 10 mg/dose) by mouth as a single daily dose based on actual body weight |
Placebo Comparator: Placebo Oral Tablet
Standard antiemetics plus placebo
|
Drug: Placebo Oral Tablet
Placebo tablets that look like olanzapine and will be dosed as if they are olanzapine |
- Rate of CIV control during the acute phase [ Time Frame: up to 8 days ]Complete CIV control is no vomiting/retching and no use of breakthrough antiemetic agents during phase
- complete CINV control [ Time Frame: up to 1 month ]CINV control - no vomiting/retching and no nausea (Pediatric Nausea Assessment Tool [PeNAT] score=1) during phase of interest
- Safety profile of olanzapine based on toxicities [ Time Frame: up to 1 month ]Based on descriptive statistics on reported toxicities.
- Safety profile of olanzapine based on weight [ Time Frame: up to 1 month ]Based on descriptive statistics on reported body weight
- Safety profile of olanzapine based on Pediatric Adverse Event Rating Scale (PAERs) [ Time Frame: up to 1 month ]Based on descriptive statistics on reported PAERs, will describe the most reported and most bothersome adverse events reported in the PAERs questionnaire.
- Safety profile of olanzapine based on prolactin [ Time Frame: up to 1 month ]Based on descriptive statistics on reported prolactin, will report incidence of abnormal prolactin values comparing the two arms
- Safety profile of olanzapine based on amylase [ Time Frame: up to 1 month ]Based on descriptive statistics on reported amylase, will report incidence of abnormal amylase values comparing the two arms
- Safety profile of olanzapine based on creatine phophotase [ Time Frame: up to 1 month ]Based on descriptive statistics on reported creatine phophotase, will report incidence of abnormal creatine phophotase values comparing the two arms
- Safety profile of olanzapine based on triglycerides [ Time Frame: up to 1 month ]Based on descriptive statistics on reported triglycerides, will report incidence of abnormal triglyceride values comparing the two arms
- Impact of olanzapine on HSCT outcomes on incidence of veno-occlusive disease [ Time Frame: From first HSCT conditioning dose until 100 days post-HSCT ]Looking at incidence of veno-occlusive disease
- Impact of olanzapine on HSCT outcomes on incidence of GVHD [ Time Frame: From first HSCT conditioning dose until 100 days post-HSCT ]Looking at incidence of GVHD between the two arms
- Impact of olanzapine on HSCT outcomes on severity of GVHD [ Time Frame: From first HSCT conditioning dose until 100 days post-HSCT ]Comparing the incidence of the different maximal grades of GVHD between the two arms
- Association between PeNAT and MASCC Antiemesis Tool (MAT) scores [ Time Frame: up to 1 month ]taking maximum daily PeNAT scale score and maximum nausea experience in MAT will estimate the degree of association between PeNAT and MAT

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Ages Eligible for Study: | 30 Months to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Planned autologous or allogeneic HSCT with a conditioning regimen that includes cyclophosphamide ≥ 1 g/m^2/day (≥ 33 mg/kg/day) or highly emetogenic chemotherapy (HEC)
- Body weight of at least 12.5 kg
- 2.5 to 18 years of age. Note that the minimum body weight requirement corresponds to approximately a 2.5 year old.
- A baseline ECG within the month prior to the study drug administration without known clinically significant abnormalities including pathologic prolongation of QTC.
- Samples for all laboratory tests will be obtained within one week prior to administration of the first dose of HSCT conditioning:
- 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
- A plan for scheduled, round-the-clock receipt of ondansetron, granisetron or palonosetron for antiemetic prophylaxis during administration of 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 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.
Exclusion Criteria:
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118986
Contact: Lee Dupuis, RPh, PhD | 416-813-7654 ext 309355 | lee.dupuis@sickkids.ca | |
Contact: Tal Schechter-Finkelstein, MD | 416-813-6906 ext 206906 | tal.schechter-finkelstein@sickkids.ca |
Canada, Ontario | |
Hospital for Sick Children | Recruiting |
Toronto, Ontario, Canada, M5G 1X8 | |
Contact: Lee Dupuis, PhD 416-813-7654 ext 309355 lee.dupuis@sickkids.ca |
Principal Investigator: | Lee Dupuis, RPh, PhD | The Hospital for Sick Children | |
Principal Investigator: | Tal Schechter-Finkelstein, MD | The Hospital for Sick Children |
Responsible Party: | Lee Dupuis, Principal Investigator, The Hospital for Sick Children |
ClinicalTrials.gov Identifier: | NCT03118986 |
Other Study ID Numbers: |
1000053716 |
First Posted: | April 18, 2017 Key Record Dates |
Last Update Posted: | February 3, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
olanzapine vomiting children |
adolescents bone marrow transplant supportive care |
Vomiting Signs and Symptoms, Digestive Olanzapine Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Antipsychotic Agents |
Tranquilizing Agents Central Nervous System Depressants Psychotropic Drugs Serotonin Uptake Inhibitors Neurotransmitter Uptake Inhibitors Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Serotonin Agents |