E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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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 | 21.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036543 |
E.1.2 | Term | Precursor T-lymphoblastic lymphoma/leukaemia |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.0 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10042987 |
E.1.2 | Term | T-cell type acute leukaemia |
E.1.2 | System Organ Class | 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps) |
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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 |
To evaluate the efficacy of isatuximab |
Valutare l'efficacia di Isatuximab |
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E.2.2 | Secondary objectives of the trial |
-To evaluate the safety profile of isatuximab -To evaluate the duration of response (DOR) -To evaluate progression free survival (PFS) and overall survival (OS) -To evaluate the pharmacokinetics (PK) of isatuximab in patients with T-ALL or T-LBL -To evaluate immunogenicity of isatuximab in patients with T-ALL or T-LBL -To assess minimal residual disease (MRD) and correlate it with clinical outcome |
-Valutare il profilo di sicurezza di Isatuximab -Valutare la durata della risposta (DOR) -Valutare la sopravvivenza libera da progressione (PFS) e la sopravvivenza globale (OS). -Valutare la farmacocinetica (PK) di Isatuximab in pazienti con T-LLA o T-LLB -Valutare l'immunogenicit¿ di Isatuximab in pazienti con T-LLA o T-LLB -Valutare la malattia minima residua (MRD) e la sua correlazione con l' esito clinico |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients must have a known diagnosis of ALL of T cell origin, including T-LBL and T-ALL with extramedullary involvement at relapse confirmed by biopsy -Patients must be previously treated for T-ALL or T-LBL and have relapsed or are refractory to most recent treatment. Patients in first relapse will be eligible regardless of the first remission duration -Patients must have been previously exposed to nelarabine in countries where this drug is available (unless due to a contraindication to its use or administrative issue) -No more than 3 prior salvage therapies. |
-I pazienti devono avere una diagnosi nota di LLA di tipo T, compresi T-LLB e T-LLA con coinvolgimento extramidollare isolato in recidiva, confermato mediante biopsia -I pazienti devono essere stati precedentemente trattati per T-LLA o T-LLB e aver sviluppato una recidiva o essere refrattari al trattamento più recente. I pazienti alla prima recidiva saranno considerati idonei a prescindere dalla durata della prima remissione -I pazienti devono essere stati precedentemente esposti a nelarabina nei Paesi in cui tale farmaco è disponibile (salvo in caso di controindicazioni all’utilizzo o di problemi amministrativi) -Non più di 3 precedenti terapie di salvataggio |
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E.4 | Principal exclusion criteria |
- Prior treatment with immunotherapy/investigational agents within 3 weeks, chemotherapy within 2 weeks of study treatment. Must have recovered from acute toxicity before first study treatment administration - Prior stem cell transplant within 4 months and/or evidence of active systemic Graft versus Host Disease and/or immunosuppressive therapy for Graft versus Host Disease within 1 week before the first study treatment administration - Clinical evidence of active central nervous system (CNS) leukemia - T-ALL with testicular involvement alone. |
-I pazienti devono aver concluso un eventuale trattamento precedente con agenti immunoterapici/sperimentali da >3 settimane e chemioterapia da >2 settimane e devono essersi ripresi da eventuali tossicità acute prima della prima somministrazione del trattamento in studio -Precedente trapianto di cellule staminali entro 4 mesi e/o evidenza di malattia del trapianto contro l’ospite sistemica attiva e/o terapia immunosoppressiva per malattia del trapianto contro l’ospite entro la settimana precedente la prima somministrazione del trattamento in studio -Evidenza clinica di leucemia attiva nel sistema nervoso centrale (SNC) - T-LLA con solo coinvolgimento del testicolo |
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E.5 End points |
E.5.1 | Primary end point(s) |
Overall response rate |
Tasso di risposta globale |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) |
6 mesi dopo la prima somministrazione (giorno 1) all'ultimo paziente, 12 mesi dopo la prima somministrazione (giorno 1) all'ultimo paziente |
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E.5.2 | Secondary end point(s) |
- Duration of response - Time - Progression free survival - Time - Overall survival - Time |
- Durata della risposta - Tempo - Sopravvivenza libera da progressione - Tempo - Sopravvivenza globale - Tempo |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
6 months after last patient 1st administration (Day 1), 12 months after last patient 1st administration (Day 1) |
6 mesi dopo la prima somministrazione (giorno 1) all'ultimo paziente, 12 mesi dopo la prima somministrazione (giorno 1) all'ultimo paziente |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
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 | No |
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 | No |
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 | No |
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 | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Russian Federation |
United States |
Finland |
France |
Hungary |
Italy |
Lithuania |
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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 | 3 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 7 |
E.8.9.2 | In all countries concerned by the trial days | 0 |