Status:
UNKNOWN
Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients
Lead Sponsor:
Associazione Salentina Angela Serra
Conditions:
Chemotherapy Induced Nausea and Vomiting
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 o...
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 regi...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2014
Estimated Enrollment :
134 Patients enrolled
Trial Details
Trial ID
NCT02205164
Start Date
October 1 2011
End Date
October 1 2014
Last Update
July 31 2014
Active Locations (11)
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1
Università-Azienda Policlinico di Bari
Bari, BA, Italy, 70124
2
Ospedale Perrino
Brindisi, BR, Italy, 72010
3
Ospedale Pugliese-Ciacco
Catanzaro, CZ, Italy, 88100
4
IRCCS Casa Sollievo della Sofferenza
San Giovanni Rotondo, FG, Italy, 71013