NON HODGKIN'S LYMPHOMA MedDRA version: 24.0 Level: LLT Classification code 10067070 Term: Follicular B-cell non-Hodgkin's lymphoma System Organ Class: 100000004864
Conditions
Interventions
Trade Name: AKYNZEO
Product Name: AKYNZEO
Product Code: EU/1/15/1001/001
Pharmaceutical Form: Capsule, hard
Sponsors
ASSOCIAZIONE SALENTINA ANGELA SERRA ONLUS
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary endpoint is the percentage of patients achieving a complete response (defined as no vomiting and no use of rescue medication) during the Conditioning Chemotherapy regimen (BEAM/FEAM). The period of assessment of the primary endpoint will be the overall phase, defined from day 1 (first day of chemotherapy) until 48 hours after the last dose of chemotherapy.;Secondary Objective: Secondary endpoints are During the Running Phase MD-CT and During the Study Phase (MD- HD-CT) - Complete Response, defined as no vomiting and no need for rescue medication; Complete Control (defined as Complete Response with no more than mild nausea); Percentage of emesis-free patients (no emetic episodes); Presence of nausea graded according to Likert scale (none, mild, moderate and severe); Patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS); Those endpoints will evaluated during the acute phase (days of MD-CTadministration), during the delayed phase (up to 48 hours after the last dose of MD-CT) and during each single day of each course of multiple day salvage chemotherapy. During the running phase the following endpoints will be also evaluated. Cube score assessment before MD-CT administration (38) Appendix 3 - Efficacy of the mobilization, as number of aphaeresis,number of CD34+ collected, number and type of G-CSF used and use of Pler;Primary end point(s): The primary endpoint is the percentage of patients achieving a complete response (defined as no vomiting and no use of rescue medication) during the Conditioning Chemotherapy regimen (BEAM/FEAM).;Timepoint(s) of evaluation of this end point: The period of assessment of the primary endpoint will be the overall phase, defined from day 1 (first day of chemotherapy) until 48 hours after the last dose of chemotherapy. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): will be evaluated during “Running” phase (MD-CT) and during “Study” phase (BEAM/FEAM), according to the following scheme. Complete response, Complete control, Percentage of emesis-free patients, Percentage of nausea graded according to Likert scale, Patient global satisfaction with antiemetic therapy, as measured by a visual analogue scale (VAS);Timepoint(s) of evaluation of this end point: From the first day of chemotherapy (BEAM/FEAM) until 7 days after the last dose | — |
Countries
Italy
Contacts
Public ContactTRIALS OFFICE
U.O. EMATOLOGIA - P.O. VITO FAZZI
Outcome results
None listed