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

NCT ID: NCT02205164

Last Updated: 2014-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

134 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-10-31

Brief Summary

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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

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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.

Conditions

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Chemotherapy Induced Nausea and Vomiting

Keywords

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palonosetron aprepitant CINV AML multiple-days

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Palonosetron + Aprepitant

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.

Group Type EXPERIMENTAL

Palonosetron + Aprepitant

Intervention Type DRUG

Aloxi 0.25mg Emend 125/80/80 mg

Palonosetron

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.

Group Type ACTIVE_COMPARATOR

Palonosetron

Intervention Type DRUG

Aloxi 0.25mg

Interventions

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Palonosetron + Aprepitant

Aloxi 0.25mg Emend 125/80/80 mg

Intervention Type DRUG

Palonosetron

Aloxi 0.25mg

Intervention Type DRUG

Other Intervention Names

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Aloxi + Emend Aloxi

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Associazione Salentina Angela Serra

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nicola Di Renzo, MD

Role: PRINCIPAL_INVESTIGATOR

Ospedale Vito Fazzi

Locations

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Università-Azienda Policlinico di Bari

Bari, BA, Italy

Site Status ACTIVE_NOT_RECRUITING

Ospedale Perrino

Brindisi, BR, Italy

Site Status RECRUITING

Ospedale Pugliese-Ciacco

Catanzaro, CZ, Italy

Site Status ACTIVE_NOT_RECRUITING

IRCCS Casa Sollievo della Sofferenza

San Giovanni Rotondo, FG, Italy

Site Status RECRUITING

Ospedale Vito Fazzi

Lecce, LE, Italy

Site Status RECRUITING

Ospedale "Cardinale Panico"

Tricase, LE, Italy

Site Status RECRUITING

A.O. Riuniti Papardo - Piemonte

Messina, ME, Italy

Site Status RECRUITING

Casa di Cura "La Maddalena"

Palermo, PA, Italy

Site Status RECRUITING

Ospedale Ascoli Civico Palermo

Palermo, PA, Italy

Site Status RECRUITING

Ospedale Moscati

Taranto, TA, Italy

Site Status RECRUITING

ARON " Cardarelli"

Napoli, , Italy

Site Status RECRUITING

Countries

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Italy

Central Contacts

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Nicola Di Renzo, MD

Role: CONTACT

Email: [email protected]

Claudia Quintavalle, BsC

Role: CONTACT

Email: [email protected]

Facility Contacts

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Angela Melpignano, MD

Role: primary

Nicola Cascavilla, MD

Role: primary

Nicola Di Renzo, MD

Role: primary

Vincenzo Pavore, MD

Role: primary

Donato Mannina, MD

Role: primary

Maurizio Musso, MD

Role: primary

Anxur Merenda, MD

Role: primary

Patrizio Mazza, MD

Role: primary

Felicetto Ferrara, MD

Role: primary

References

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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.

Reference Type DERIVED
PMID: 31725196 (View on PubMed)

Other Identifiers

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2011-003823-36

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

AS/PALO/002

Identifier Type: -

Identifier Source: org_study_id