Clinical trial NCT02205164: 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
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Chemotherapy Induced Nausea and Vomiting
Keywords: palonosetron
aprepitant
CINV
AML
multiple-days
Lead sponsor: Associazione Salentina Angela Serra
Sponsor class: OTHER
First posted: 2014-07-31
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Complete Response
timeFrame: 5 days after chemotherapy
Secondary outcomes:
measure: Complete Control
timeFrame: 5 days after chemotherapy
measure: Emesis-free
timeFrame: 5 days after chemotherapy
measure: Presence of nausea
timeFrame: 5 days after chemotherapy
measure: Treatment failure
timeFrame: 5 days after chemotherapy
measure: Patient global satisfaction
timeFrame: 5 days after chemotherapy
measure: Safety and tolerability
timeFrame: 5 days after chemotherapy
Other outcomes:
Locations:
city: Bari
country: Italy
facility: Università-Azienda Policlinico di Bari
state: BA
city: Brindisi
country: Italy
facility: Ospedale Perrino
state: BR
city: Catanzaro
country: Italy
facility: Ospedale Pugliese-Ciacco
state: CZ
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo della Sofferenza
state: FG
city: Lecce
country: Italy
facility: Ospedale Vito Fazzi
state: LE
city: Tricase
country: Italy
facility: Ospedale "Cardinale Panico"
state: LE
city: Messina
country: Italy
facility: A.O. Riuniti Papardo - Piemonte
state: ME
city: Palermo
country: Italy
facility: Casa di Cura "La Maddalena"
state: PA
city: Palermo
country: Italy
facility: Ospedale Ascoli Civico Palermo
state: PA
city: Taranto
country: Italy
facility: Ospedale Moscati
state: TA
city: Napoli
country: Italy
facility: ARON " Cardarelli"
Study officials:
affiliation: Ospedale Vito Fazzi
name: Nicola Di Renzo, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.