Overview

Palonosetron Plus Aprepitant Versus Palonosetron in Preventing Nausea and Vomiting in Leukemic Patients

Status:
Unknown status
Trial end date:
2014-10-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Associazione Salentina Angela Serra
Treatments:
Aprepitant
Fosaprepitant
Palonosetron
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