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| ID | Type | Description | Link |
|---|---|---|---|
| 2011-003823-36 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Palonosetron + Aprepitant | Experimental | 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 | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Palonosetron + Aprepitant | Drug | Aloxi 0.25mg Emend 125/80/80 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete Control | No emetic episode, no need for rescue medication, with a maximum grade of mild nausea | 5 days after chemotherapy |
| Emesis-free | Percentage of patients without emetic episodes |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nicola Di Renzo, MD | Contact | direnzo.ematolecce@libero.it | ||
| Claudia Quintavalle, BsC | Contact | quinta.ematolecce@libero.it |
| Name | Affiliation | Role |
|---|---|---|
| Nicola Di Renzo, MD | Ospedale Vito Fazzi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Università -Azienda Policlinico di Bari | Active, not recruiting | Bari | BA | 70124 | Italy | |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31725196 | Derived | 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. |
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| Palonosetron | Drug | Aloxi 0.25mg |
|
|
| 5 days after chemotherapy |
| Presence of nausea | Presence of nausea graded according to Likert scale (none, mild, moderate and severe) | 5 days after chemotherapy |
| Treatment failure | Time (days) to treatment failure (first emetic episode or first need of rescue medication, whichever occurs first) | 5 days after chemotherapy |
| Patient global satisfaction | Patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS) | 5 days after chemotherapy |
| Safety and tolerability | Number of patients experienced at least one adverse events related to study drug administration. | 5 days after chemotherapy |
| Ospedale Perrino |
| Recruiting |
| Brindisi |
| BR |
| 72010 |
| Italy |
|
| Ospedale Pugliese-Ciacco | Active, not recruiting | Catanzaro | CZ | 88100 | Italy |
| IRCCS Casa Sollievo della Sofferenza | Recruiting | San Giovanni Rotondo | FG | 71013 | Italy |
|
| Ospedale Vito Fazzi | Recruiting | Lecce | LE | 73100 | Italy |
|
| Ospedale "Cardinale Panico" | Recruiting | Tricase | LE | 73100 | Italy |
|
| A.O. Riuniti Papardo - Piemonte | Recruiting | Messina | ME | 98121 | Italy |
|
| Casa di Cura "La Maddalena" | Recruiting | Palermo | PA | 90127 | Italy |
|
| Ospedale Ascoli Civico Palermo | Recruiting | Palermo | PA | 90127 | Italy |
|
| Ospedale Moscati | Recruiting | Taranto | TA | 74100 | Italy |
|
| ARON " Cardarelli" | Recruiting | Naples | 80121 | Italy |
|
| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077924 | Palonosetron |
| D000077608 | Aprepitant |
| ID | Term |
|---|---|
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D006571 | Heterocyclic Compounds |
| D007546 | Isoquinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D009025 | Morpholines |
| D010078 | Oxazines |
| D006573 | Heterocyclic Compounds, 1-Ring |
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