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Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients

Primary Purpose

Chemotherapy Induced Nausea and Vomiting

Status
Unknown status
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Palonosetron + Aprepitant
Palonosetron
Sponsored by
Associazione Salentina Angela Serra
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy Induced Nausea and Vomiting focused on measuring palonosetron, aprepitant, CINV, AML, multiple-days

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of Acute Myeloid Leukaemia or High-risk MDS according to IPSS
  • Patient eligible for AML-like induction therapy
  • Candidate for multiple-days chemotherapy (minimum 3 days)
  • Age more, equal18 years
  • ECOG 0-2
  • Not pregnant or nursing
  • Must be able to complete the patient's diary
  • Provide written informed consent

Exclusion Criteria:

  • AML or HR-MDS therapy-related
  • Active infection requiring intravenous antibiotics
  • Prior malignancies at other sites except surgically treated non-melanoma skin cancer, prostate cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for more/equal 5 years
  • Unacceptable hepatic function (more of 2 times the upper limit of normal for liver transaminases) and renal function (creatinine more of 1.5 times the upper limit of normal) unless disease-related
  • Myocardial infarction within the past 6 months
  • Psychiatric or CNS disorders interfering with ability to comply with study protocol
  • Known hypersensitivity to 5-HT3 antagonists and their components CSF involvement
  • Pre-existing nausea or vomiting

Sites / Locations

  • Università-Azienda Policlinico di Bari
  • Ospedale PerrinoRecruiting
  • Ospedale Pugliese-Ciacco
  • IRCCS Casa Sollievo della SofferenzaRecruiting
  • Ospedale Vito FazziRecruiting
  • Ospedale "Cardinale Panico"Recruiting
  • A.O. Riuniti Papardo - PiemonteRecruiting
  • Casa di Cura "La Maddalena"Recruiting
  • Ospedale Ascoli Civico PalermoRecruiting
  • Ospedale MoscatiRecruiting
  • ARON " Cardarelli"Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Palonosetron + Aprepitant

Palonosetron

Arm Description

Oral aprepitant will be given on days 1-3 (day 1, 125 mg 1 h before chemohterapy; days 2-3, 80 mg) multiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.

multiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.

Outcomes

Primary Outcome Measures

Complete Response
The primary endpoint is the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase.

Secondary Outcome Measures

Complete Control
No emetic episode, no need for rescue medication, with a maximum grade of mild nausea
Emesis-free
Percentage of patients without emetic episodes
Presence of nausea
Presence of nausea graded according to Likert scale (none, mild, moderate and severe)
Treatment failure
Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)
Patient global satisfaction
Patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS)
Safety and tolerability
Number of patients experienced at least one adverse events related to study drug administration.

Full Information

First Posted
July 17, 2014
Last Updated
July 30, 2014
Sponsor
Associazione Salentina Angela Serra
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1. Study Identification

Unique Protocol Identification Number
NCT02205164
Brief Title
Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients
Official Title
Phase II Randomized Study of Multiple Doses of Palonosetron Plus Aprepitant Versus Multiple Doses of Palonosetron Alone in Preventing CINV in Patients With Newly Diagnosed AML or High-risk MDS Receiving Multiple Days Chemotherapy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Unknown status
Study Start Date
October 2011 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
October 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Associazione Salentina Angela Serra

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of present study is to evaluate if the addition of Aprepitant to multiple doses of palonosetron IV enhances the efficacy of multiple doses of palonosetron IV alone, in preventing CINV in AML or High risk MDS patient, treated with multiple days chemotherapy.
Detailed Description
This is an open-label, randomized, comparative, multicenter phase II study in patients with AML scheduled to receive multiple days chemotherapy. Patients will receive either PALO+APR or the PALO regimen in a 1:1 ratio according to a computer-generated, random allocation schedule. Below are described the details for both antiemetic regimens: PALO+APR regimen: oral aprepitant will be given on days 1-3 (day 1, 125 mg, days 2-3, 80 mg 1 hour before chemotherapy ) and multiple intravenous bolus of Palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment. PALO regimen: multiple intravenous bolus of Palonosetron without dexamethasone, prior to the administration of chemotherapy, starting the first day of treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy Induced Nausea and Vomiting
Keywords
palonosetron, aprepitant, CINV, AML, multiple-days

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
134 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Palonosetron + Aprepitant
Arm Type
Experimental
Arm Description
Oral aprepitant will be given on days 1-3 (day 1, 125 mg 1 h before chemohterapy; days 2-3, 80 mg) multiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.
Arm Title
Palonosetron
Arm Type
Active Comparator
Arm Description
multiple intravenous bolus of palonosetron 0.25 mg, 30 minutes before chemotherapy, every other single days, for a minimum of 2 administration (day 1, 3), in case of a 3 days chemotherapy regimen, and a maximum of 5 doses (day 1,3,5,7, 9) in case of a 10 days chemotherapy.
Intervention Type
Drug
Intervention Name(s)
Palonosetron + Aprepitant
Other Intervention Name(s)
Aloxi + Emend
Intervention Description
Aloxi 0.25mg Emend 125/80/80 mg
Intervention Type
Drug
Intervention Name(s)
Palonosetron
Other Intervention Name(s)
Aloxi
Intervention Description
Aloxi 0.25mg
Primary Outcome Measure Information:
Title
Complete Response
Description
The primary endpoint is the overall rate of patients achieving a complete response (defined as no emetic episode and no use of rescue medication) during the overall phase.
Time Frame
5 days after chemotherapy
Secondary Outcome Measure Information:
Title
Complete Control
Description
No emetic episode, no need for rescue medication, with a maximum grade of mild nausea
Time Frame
5 days after chemotherapy
Title
Emesis-free
Description
Percentage of patients without emetic episodes
Time Frame
5 days after chemotherapy
Title
Presence of nausea
Description
Presence of nausea graded according to Likert scale (none, mild, moderate and severe)
Time Frame
5 days after chemotherapy
Title
Treatment failure
Description
Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)
Time Frame
5 days after chemotherapy
Title
Patient global satisfaction
Description
Patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS)
Time Frame
5 days after chemotherapy
Title
Safety and tolerability
Description
Number of patients experienced at least one adverse events related to study drug administration.
Time Frame
5 days after chemotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of Acute Myeloid Leukaemia or High-risk MDS according to IPSS Patient eligible for AML-like induction therapy Candidate for multiple-days chemotherapy (minimum 3 days) Age more, equal18 years ECOG 0-2 Not pregnant or nursing Must be able to complete the patient's diary Provide written informed consent Exclusion Criteria: AML or HR-MDS therapy-related Active infection requiring intravenous antibiotics Prior malignancies at other sites except surgically treated non-melanoma skin cancer, prostate cancer, superficial cervical cancer, or other cancer from which the patient had been disease-free for more/equal 5 years Unacceptable hepatic function (more of 2 times the upper limit of normal for liver transaminases) and renal function (creatinine more of 1.5 times the upper limit of normal) unless disease-related Myocardial infarction within the past 6 months Psychiatric or CNS disorders interfering with ability to comply with study protocol Known hypersensitivity to 5-HT3 antagonists and their components CSF involvement Pre-existing nausea or vomiting
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola Di Renzo, MD
Email
direnzo.ematolecce@libero.it
First Name & Middle Initial & Last Name or Official Title & Degree
Claudia Quintavalle, BsC
Email
quinta.ematolecce@libero.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola Di Renzo, MD
Organizational Affiliation
Ospedale Vito Fazzi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Università-Azienda Policlinico di Bari
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale Perrino
City
Brindisi
State/Province
BR
ZIP/Postal Code
72010
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Angela Melpignano, MD
Email
brinemat@tin.it
First Name & Middle Initial & Last Name & Degree
Angela Melpignano, MD
Facility Name
Ospedale Pugliese-Ciacco
City
Catanzaro
State/Province
CZ
ZIP/Postal Code
88100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
IRCCS Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
State/Province
FG
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Cascavilla, MD
Email
nicola.cascavilla@tin.it
First Name & Middle Initial & Last Name & Degree
Nicola Cascavilla, MD
Facility Name
Ospedale Vito Fazzi
City
Lecce
State/Province
LE
ZIP/Postal Code
73100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Di Renzo, MD
Email
direnzo.ematolecce@libero.it
First Name & Middle Initial & Last Name & Degree
Nicola Di Renzo, MD
Facility Name
Ospedale "Cardinale Panico"
City
Tricase
State/Province
LE
ZIP/Postal Code
73100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenzo Pavore, MD
Email
salentoematologia@piafondazionepanico.it
First Name & Middle Initial & Last Name & Degree
Vincenzo Pavone, MD
Facility Name
A.O. Riuniti Papardo - Piemonte
City
Messina
State/Province
ME
ZIP/Postal Code
98121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Donato Mannina, MD
Email
donadani@tiscali.it
First Name & Middle Initial & Last Name & Degree
Donato Mannina, MD
Facility Name
Casa di Cura "La Maddalena"
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Musso, MD
Email
mamusso@libero.it
First Name & Middle Initial & Last Name & Degree
Maurizio Musso, MD
Facility Name
Ospedale Ascoli Civico Palermo
City
Palermo
State/Province
PA
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anxur Merenda, MD
Email
anxurmerenda@libero.it
First Name & Middle Initial & Last Name & Degree
Anxur Merenda, MD
Facility Name
Ospedale Moscati
City
Taranto
State/Province
TA
ZIP/Postal Code
74100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizio Mazza, MD
Email
ematologia.taranto@libero.it
First Name & Middle Initial & Last Name & Degree
Patrizio Mazza, MD
Facility Name
ARON " Cardarelli"
City
Napoli
ZIP/Postal Code
80121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felicetto Ferrara, MD
Email
felicettoferrara@katamail.com
First Name & Middle Initial & Last Name & Degree
Felicetto Ferrara, MD

12. IPD Sharing Statement

Citations:
PubMed Identifier
31725196
Citation
Di Renzo N, Melillo L, Porretto F, Dargenio M, Pavone V, Pastore D, Mazza P, Mannina D, Merenda A, Cascavilla N, Greco G, Matera R, Bonizzoni E, Celio L, Musso M. Every-other-day palonosetron plus aprepitant for prevention of emesis following induction chemotherapy for acute myeloid leukemia: A randomized, controlled study from the "Rete Ematologica Pugliese". Cancer Med. 2020 Jan;9(1):170-178. doi: 10.1002/cam4.2628. Epub 2019 Nov 14.
Results Reference
derived

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Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients

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