Study to Evaluate the Effect of Aprepitant in Children and Adolescents Receiving AML Remission Induction Chemotherapy

NCT02979548 | Unknown Phase 3

• 1 other identifier: IECPG-419
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to find out the efficacy of an anti-emetic drug, Aprepitant as an add-on therapy to prevent vomiting in children and adolescents receiving chemotherapy for leukemia (AML). Children and adolescents admitted with confirmed diagnosis of AML will be assessed for eligibility criteria and enrolled in the study. Then they will be divided (randomized) into experimental and control groups. Experimental group will receive Aprepitant capsules 1 h prior to chemotherapy on days 1-3 in addition to ondansetron. Patients will be required to swallow the whole capsule and opening of capsule will not be permitted. All three doses will be administered under supervision. Control group will receive ondansetron (0.15 mg/kg) as an intravenous bolus 30 minutes before chemotherapy followed by every 8 hourly for 8 days. Metoclopramide will be used as a rescue agent. The data will be collected from each patient in a proforma from day 1 to day 13 of chemotherapy. A Diary will be maintained for nausea and vomiting record. Edmonton's symptom assessment criterion will be used in the diary for assessing severity of nausea. The NCI guidelines will be used to assess the severity of vomiting based on the data provided by the patient in the diary. A modified intention-to-treat population (patients who receive chemotherapy, take one or more doses of study drug, and have one or more post treatment measurements) will be used for efficacy analysis. Proportion of patients with complete response will be compared between patients with or without aprepitant.

Conditions

Chemotherapy Induced Vomiting; Acute Myeloid Leukemia

Keywords

Aprepitant

Outcome Measures

Primary Outcomes (1)

• Proportion of patients with complete response during the acute phase of AML remission induction chemotherapy

  Up to day 8 of induction

Secondary Outcomes (4)

• Time to first episode of vomiting

  Up to day 13

• Incidence of delayed vomiting

  From day 9 to day 13

• Severity of vomiting

  Up to day 13

• Incidence of requirement of rescue medication

  Up to day 8

Study Arms (2)

Group A : Aprepitant (Add on therapy)

EXPERIMENTAL

Aprepitant group will receive aprepitant capsules 1 h prior to chemotherapy on days 1-3 in addition to 5HT3 RA (Ondansetron). The dose of aprepitant will be given based on weight groups Weight 15-40 kg : Aprepitant 80 mg on days 1-3 Weight \> 41kg: Aprepitant 125 mg on day 1 followed by 80 mg on days 2-3 Rescue medication, injection metoclopramide 0.5 mg/kg body weight/day.

Drug: Aprepitant; Drug: Ondansetron; Drug: Metoclopramide

Group B : 5HT3 RA (Ondansetron)

ACTIVE COMPARATOR

On the day of chemotherapy, ondansetron will be administered to all patients as per our institutional practice in a dose of 0.15 mg/kg as an intravenous bolus 30 minutes before chemotherapy followed by every 8 hourly for 8 days. Rescue medication, injection metoclopramide 0.5 mg/kg body weight/day.

Drug: Ondansetron; Drug: Metoclopramide

Interventions

Aprepitant DRUG

Aprepitant is a non peptide, selective, Neurokinin type 1 (NK 1) receptor antagonist. Group A will receive Aprepitant as an add-on anti-emetic therapy in addition to ondansetron.

Also known as: Apretero

Group A : Aprepitant (Add on therapy)

Ondansetron DRUG

Ondansetron is 5HT3 Receptor antagonist used to treat and prevent chemotherapy induced nausea and vomiting

Also known as: Zofer, Emset

Group A : Aprepitant (Add on therapy); Group B : 5HT3 RA (Ondansetron)

Metoclopramide DRUG

Dopamine receptor antagonist , acts at CTZ. Rescue medication, injection metoclopramide 0.5 mg/kg body weight/day.

Also known as: Reglan

Group A : Aprepitant (Add on therapy); Group B : 5HT3 RA (Ondansetron)

Eligibility Criteria

• Age: 5 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Newly diagnosed, chemotherapy-naïve de novo AML patients planned for 3+7 remission induction chemotherapy in the age group 5-18 years
• Weight above 15 kg (Those who are able to swallow the medication )
• Children/adolescents and their caregiver who can understand Hindi or English and willing to participate in the study (with written informed consent)

You may not qualify if:

• Vomiting/retching within 24 h prior to treatment
• Significant organ dysfunction (aspartate aminotransferase/alanine aminotransferase \>2.5 times of upper normal limit, serum bilirubin \>1.5 times of upper normal limit, serum creatinine\>1.5 times of upper normal limit)
• Patient on inotropic support at presentation
• Patient with respiratory failure/mechanical ventilation at presentation

Sponsors & Collaborators

• Dr Atul Sharma: lead

Study Sites (1)

Irch, Aiims , New Delhi , India

New Delhi, DEL, 110029, India

RECRUITING

Related Publications (1)

• Sharma A, Ganguly S, C SK, Pillai AS, Dhawan D, Sreenivas V, Bakhshi S. Addition of aprepitant improves acute emesis control in children and adolescents receiving induction chemotherapy for acute myeloid leukaemia: a randomised, open-label trial. BMJ Support Palliat Care. 2023 Oct;13(e1):e156-e162. doi: 10.1136/bmjspcare-2020-002595. Epub 2020 Oct 29.

  PMID: 33122168 DERIVED

MeSH Terms

Conditions

Leukemia, Myeloid, Acute

Interventions

Aprepitant; Ondansetron; Metoclopramide

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Morpholines; Oxazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Imidazoles; Azoles; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds, 3-Ring; Benzamides; Amides; Organic Chemicals; para-Aminobenzoates; Aminobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Chlorobenzoates; Hydroxybenzoate Ethers; Hydroxybenzoates; Hydroxy Acids; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Phenyl Ethers; Phenols

Central Study Contacts

Atul Sharma, M.D

CONTACT

+91-9968859779; dratulsharma@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Senior Resident

Study Record Dates

• First Submitted: November 28, 2016
• First Posted: December 1, 2016
• Study Start: November 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: December 1, 2018
• Last Updated: January 25, 2017

Record last verified: 2017-01

Locations

IN (1)