E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
DIFFUSE LARGE B CELL NON HODGKIN LYMPHOMA (DLBCL) |
Linfoma non Hodgkin diffuso a grandi cellule B |
|
E.1.1.1 | Medical condition in easily understood language |
adult patients who have relapsed / refractory with Non-Hodgkin's lymphoma, large B-cell variety |
pazienti adulti affetti da Linfoma non-Hodgkin, varieta' a grandi cellule B, in recidiva/refrattari |
|
E.1.1.2 | Therapeutic area | Diseases [C] - Cancer [C04] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10012821 |
E.1.2 | Term | Diffuse large B-cell lymphoma recurrent |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
|
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
examine the efficacy and safety of Plerixafor in combination with G - CSF and chemotherapy, in order to collect an optimal number of peripheral blood HSC in patients with DLBC non Hodgkin lymphoma in order to perform a tandem ASCT. |
Esaminare l'efficacia e la sicurezza del Plerixafor in associazione al G-CSF e chemioterapia, come terapia mobilizzante per doppio trapianto autologo in pazienti affetti da Linfoma Non Hodgkin diffuso a grandi cellule B recidivato o refrattario |
|
E.2.2 | Secondary objectives of the trial |
Number of apheresis to reach the target of 6 x 106/kg CD34 Toxicity of the mobilization procedure Toxicity of double autologous Engrafment early and late overall Survival Disease free survival at six twelve months Progression-free survival at six twelve months |
Numero di aferesi per raggiungere il target di 6 x 106/kg cellule CD34+ Tossicita' delle procedure di mobilizzazione Tossicita' del doppio trapianto autologo Engrafment precoce e tardivo Sopravvivenza globale Sopravvivenza libera da malattia ai mesi 6 e 12 Sopravvivenza libera da progressione ai mesi 6 e 12 |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
DLBC non Hodgkin lymphoma not in CR after first line therapy, or in early relapse after first or second line chemotherapy or primary refractory to first line treatment . PET positivity at study entry and after the 2nd R-DHAP before the first ASCT Age: 18-65 y No Bone Marrow involvement DLCO, FEV1, FVC > 50% predicted LVEF greater than 45% HIV negative Non active HBV/HCV infection |
Paziente con diagnosi di linfoma Non Hodgkin diffuso a grandi cellule (DLBCL) che non abbia raggiunto una RC di malattia dopo la prima linea terapeutica od in recidiva di malattia dopo la prima o seconda linea terapeutica oppure refrattario dopo la prima linea terapeutica. PET positivita' all’ingresso nello studio e dopo il secondo R-DHAP prima del primo trapianto autologo Eta' 18-65 anni Non coinvolgimento midollare Adeguata funzione d’organo definita come: LVEF 45% DLCO, FEV1,FVC > 50% Marker virale HIV negativo |
|
E.4 | Principal exclusion criteria |
Previous ASCT High risk comorbidities for acute treatment complications Primary CNS DLBC non Hodgkin lymphoma Bone Marrow involvement Any active,uncontrolled infections Hypercalcemia Recent Cytokine administration ( peg-filgastrim in 21 d.), other cytokines in 7 d. before study entry Pregnant woman or not willing to use contraception |
Precedente trapianto autologo di cellule staminali Alto rischio di comorbidita' per complicanze da trattamento acuto Diagnosi di Linfoma non Hodgkin a grandi cellule primitivo del SNC Interessamento midollare Ipercalcemia Recente somministrazione di citochine( peg-filgastrim in 21 d.), altre citochine in 7 d. prima dell’ingresso nello studio Gravidanza |
|
E.5 End points |
E.5.1 | Primary end point(s) |
Assess the percentage of patients who reach the target value of CD34 positive> = 6 x 106/kg |
Valutare la percentuale di pazienti che raggiungeranno il valore target di cellule CD34 positive >= 6 x 106/kg |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 months.After treatment of the last patient enrolled |
24 mesi.Al termine del trattamento dell'ultimo paziente arruolato. |
|
E.5.2 | Secondary end point(s) |
Number of apheresis to reach the target of 6 x 106/kg CD34 + cells |
Numero di aferesi per raggiungere il target di 6 x 106/kg cellule CD34+ |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
24 months.After treatment of the last patient enrolled |
24 mesi. Al termine del trattamento dell'ultimo paziente arruolato. |
|
E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
PET positivita' dopo 2 cicli di terapia |
PET positivity post two therapy cycles |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 24 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
|
|
E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 48 |
E.8.9.1 | In the Member State concerned days | 0 |