E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
HODGKIN LIMPHOMA |
LINFOMI DI HODGKIN |
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E.1.1.1 | Medical condition in easily understood language |
HODGKIN LIMPHOMA |
LINFOMI DI HODGKIN |
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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 | SOC |
E.1.2 | Classification code | 10005329 |
E.1.2 | Term | Blood and lymphatic system disorders |
E.1.2 | System Organ Class | 10005329 - Blood and lymphatic system disorders |
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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 |
Feasibility and Activity |
fattibilità e attività |
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E.2.2 | Secondary objectives of the trial |
• Comparison of PET interpretation criteria (IHP, Deauville) in predicting outcome • Efficacy of the scheme • Acute and late hematological and extra-hematological toxicities |
• Confronto dei criteri di interpretazione PET (IHP, Deauville) nel predire l'outcome • Efficacia • tossicità acuta e tardiva ematologica ed extra-ematologica |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
OTHER SUBSTUDIES: pet-0 and pet-2 reviewing
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ALTRI SOTTOSTUDI: revisione delle Pet basale e dopo 2 cicli
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E.3 | Principal inclusion criteria |
• Age 18-70 years • Histologically confirmed HL stage I, II unfavorable according to EORTC criteria, with exclusion of stage II B bulky. • Previously untreated • ECOG performance status 0 - 2 • Staging with FDG-PET • Written informed consent • Adequate liver and renal function (total serum bilirubin < 2.5 x ULN, AST/SGOT and/or ALT/SGPT ≤ 2.5 x upper limit of normal (ULN) or ≤ 5.0 x ULN if the transaminase elevation is due to disease involvement, serum creatinine < 2.5 x ULN) |
• Età compresa tra 18 e 70 anni • Conferma istologica del Linfoma di Hdgkin, stadio I-II sfavorevole in accordo con i criteri EORTC, con l’esclusione dello stadio II B bulky. • Pazienti non precedentemente trattati • ECOG performance status 0 - 2 • Stadiazione con FDG-PET • Consenso informato scritto • Adeguata funzionalità epatica e renale (bilirubina totale < 2.5 x ULN, AST/SGOT e/o ALT/SGPT ≤ 2.5 x (ULN) o ≤ 5.0 x ULN se l'aumento delle transaminasi è dovuto al coinvolgimento della malattia, creatinina < 2.5 x ULN) |
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E.4 | Principal exclusion criteria |
• Concomitant cardiac, pulmonary, neurologic, psychiatric or metabolic severe disease. • Uncontrolled diabetes mellitus (with fasting glucose levels above 200 mg/dl). • Other prior malignancies except for adequately treated basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, carcinoma in situ of the breast or other cancer from which the patient has been disease-free for ≥ 3 years • Patients with a known history of HIV seropositivity • Active HCV infection ( PCR + ; AST> 1.5-2x UN) • Woman who is pregnant or breast feeding. Fertile patients not willing to use effective contraception during the study and 3 months after the end of treatment. Women of childbearing potential (WOCBP) are defined as sexually mature women who have not undergone a hysterectomy or who have not been naturally postmenopausal for at least 12 consecutive months. Negative pregnancy test at baseline is required (serumHCG). • Male patient whose sexual partner(s) are WOCBP who are not willing to use a effective contraception during the study and 3 months after the end of treatment • Nodular lymphocyte prevalence histological subtype |
• Concomitanti malattie cardiache, polmonari, neurologiche, psichiatriche e metaboliche. • diabete mellito non controllato (con livelli di glicemia a digiuno superiore a 200 mg / dl). • Altri precedenti tumori maligni ad eccezione del carcinoma a cellule basali, carcinoma a cellule squamose della pelle, carcinoma in situ della cervice, carcinoma in situ del seno o altro da cui il paziente è libero da malattia da almeno 3 anni. • Pazienti HIV positive. • Infezione attiva da HCV ( PCR + ; AST> 1.5-2x ULN) • Donne in gravidanza o allattamento e pazienti in età fertile non disposte a utilizzare un contraccettivo efficace durante lo studio e 3 mesi dopo la fine del trattamento. Sono definite donne in età fertile (WOCBP) le donne sessualmente mature che non hanno subito un’isterectomia o che non sono in menopausa da almeno 12 mesi consecutivi. Al baseline è richiesto il test di gravidanza che dovrà risultare negativo (serum β HCG). • Pazienti di sesso maschile la cui partner sessuale è una donna in età fertile (WOCBP) non disposta a utilizzare un contraccettivo efficace durante lo studio e 3 mesi dopo la fine del trattamento. • Linfoma di Hodgkin a prevalenza linfocitaria nodulare. |
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E.5 End points |
E.5.1 | Primary end point(s) |
• Proportion of patient with a dose intensity reduction (lower than 85% of planned dose) • Proportion of FDG-PET negativity after two cycle of dd-ABVD |
• percentuale di pazienti con una riduzione della dose (inferiore all’ 85% della dose pianificata) • percentuale di FDG-PET negatività dopo due cicli di dd-ABVD |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Overall accuracy and Predictive Value of each interim PET interpretation criteria after a minimum follow-up of three years • PFS and OS • Proportion of early and late toxicities (G3/4 acute toxicities, secondary malignancies, cardiovascular and pulmonary events, infertility) |
• Precisione generale e valore predittivo di ciascun criterio di interpretazione della interim PET dopo un follow up minimo di 3 anni. • PFS e OS • Percentuale di tossicità precoce e tardiva (G3 / G4 di tossicità acuta, tumori secondari, eventi cardiovascolari e polmonari, sterilità) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | Yes |
E.6.13.1 | Other scope of the trial description |
DOSE DENSITY |
INTENSIFICAZIONE DELLA DOSE |
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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 | No |
E.8.1.1 | Randomised | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
E.8.2.4 | Number of treatment arms in the trial | 1 |
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 | 40 |
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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 4 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |