Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients
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
2 other identifiers
interventional
134
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Oct 2011
Typical duration for phase_2
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2011
CompletedFirst Submitted
Initial submission to the registry
July 17, 2014
CompletedFirst Posted
Study publicly available on registry
July 31, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2014
CompletedJuly 31, 2014
July 1, 2014
2.8 years
July 17, 2014
July 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
5 days after chemotherapy
Secondary Outcomes (6)
Complete Control
5 days after chemotherapy
Emesis-free
5 days after chemotherapy
Presence of nausea
5 days after chemotherapy
Treatment failure
5 days after chemotherapy
Patient global satisfaction
5 days after chemotherapy
- +1 more secondary outcomes
Study Arms (2)
Palonosetron + Aprepitant
EXPERIMENTALOral 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.
Palonosetron
ACTIVE COMPARATORmultiple 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.
Interventions
Aloxi 0.25mg Emend 125/80/80 mg
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (11)
Università-Azienda Policlinico di Bari
Bari, BA, 70124, Italy
Ospedale Perrino
Brindisi, BR, 72010, Italy
Ospedale Pugliese-Ciacco
Catanzaro, CZ, 88100, Italy
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG, 71013, Italy
Ospedale Vito Fazzi
Lecce, LE, 73100, Italy
Ospedale "Cardinale Panico"
Tricase, LE, 73100, Italy
A.O. Riuniti Papardo - Piemonte
Messina, ME, 98121, Italy
Casa di Cura "La Maddalena"
Palermo, PA, 90127, Italy
Ospedale Ascoli Civico Palermo
Palermo, PA, 90127, Italy
Ospedale Moscati
Taranto, TA, 74100, Italy
ARON " Cardarelli"
Napoli, 80121, Italy
Related Publications (1)
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.
PMID: 31725196DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicola Di Renzo, MD
Ospedale Vito Fazzi
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 17, 2014
First Posted
July 31, 2014
Study Start
October 1, 2011
Primary Completion
August 1, 2014
Study Completion
October 1, 2014
Last Updated
July 31, 2014
Record last verified: 2014-07