Phase II, open-label, not comparative, multicenter study of multiple doses of NEPA (Netupitant+Palonosetron) in preventing chemotherapy induced nausea and vomiting(CINV) in patient with Non Hodgkin’s Lymphomareceiving salvage chemotherapy followed by high dose chemotherapy and autologous hematopoietic stem cells support. - AS/NEPA/001

ASSOCIAZIONE SALENTINA ANGELA SERRA ONLUS0 个研究点目标入组 81 人开始时间: 2021年9月9日最近更新: 2021年10月8日

研究概览

暂无简介。

•Patients 18 years of age or older deemed eligible to undergo autologous peripheral stem cell transplant;
•Diagnosis of non-Hodgkin lymphoma
•Preparative regimen consisting of BEAM or FEAM (see section 3.3)
•Multiple-day salvage chemotherapy regimen lasting at least 3 days and no more than 6 days.
•Written informed consent
•Patient must be able to complete the patient’s diary.
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 60
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 21

•Prior treatment with investigational medications in 30 days before selection
•Nausea and vomiting at baseline
•Chronic use of other antiemetic agent(s)
•Patients who are unable to take oral medication (e.g. due to tumor obstruction)
•Gastrointestinal obstruction or active peptic ulcer
•Radiation therapy to pelvis or abdomen within 1 week before or after study day 1
•Allogeneic stem cell transplant
•Inadequate organ function defined as: Aspartate transaminase (AST) > 3 x upper limit of normal (ULN); Alanine transaminase (ALT) > 3x ULN; Bilirubin > 3x ULN; Alkaline phosphatase > 3x ULN; Creatinine > 2 mg/dL
•Documented or known hypersensitivity to 5HT3-RA, NK1-RA, or to any component of NEPA
•Pregnant or lactating women
•Uncontrolled Diabetes Mellitus or other uncontrolled concomitant diseases
•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 = 5 years
•Myocardial infarction within the past 6 months
•Psychiatric or CNS disorders interfering with ability to comply with study protocol.

发起方

ASSOCIAZIONE SALENTINA ANGELA SERRA ONLUS