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.

Phase 1

• Conditions: ON HODGKIN'S LYMPHOMA; MedDRA version: 24.0Level: LLTClassification code 10067070Term: Follicular B-cell non-Hodgkin's lymphomaSystem Organ Class: 100000004864; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-003318-26-IT
• Lead Sponsor: ASSOCIAZIONE SALENTINA ANGELA SERRA ONLUS

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-09
• Last Update Posted: 8 October 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 81

Inclusion Criteria

•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.
•ECOG 0-2
•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

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified