Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Interventions
- Registration Number
- NCT02205164
- Lead Sponsor
- Associazione Salentina Angela Serra
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 134
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Palonosetron + Aprepitant 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. Palonosetron 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.
- Primary Outcome Measures
Name Time Method Complete Response 5 days after chemotherapy 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
Name Time Method Emesis-free 5 days after chemotherapy Percentage of patients without emetic episodes
Presence of nausea 5 days after chemotherapy Presence of nausea graded according to Likert scale (none, mild, moderate and severe)
Treatment failure 5 days after chemotherapy Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first)
Safety and tolerability 5 days after chemotherapy Number of patients experienced at least one adverse events related to study drug administration.
Patient global satisfaction 5 days after chemotherapy Patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS)
Complete Control 5 days after chemotherapy No emetic episode, no need for rescue medication, with a maximum grade of mild nausea
Trial Locations
- Locations (11)
Ospedale Perrino
🇮🇹Brindisi, BR, Italy
A.O. Riuniti Papardo - Piemonte
🇮🇹Messina, ME, Italy
Università-Azienda Policlinico di Bari
🇮🇹Bari, BA, Italy
IRCCS Casa Sollievo della Sofferenza
🇮🇹San Giovanni Rotondo, FG, Italy
Ospedale Ascoli Civico Palermo
🇮🇹Palermo, PA, Italy
Ospedale Moscati
🇮🇹Taranto, TA, Italy
Ospedale Pugliese-Ciacco
🇮🇹Catanzaro, CZ, Italy
Ospedale "Cardinale Panico"
🇮🇹Tricase, LE, Italy
ARON " Cardarelli"
🇮🇹Napoli, Italy
Ospedale Vito Fazzi
🇮🇹Lecce, LE, Italy
Casa di Cura "La Maddalena"
🇮🇹Palermo, PA, Italy