Overview
Sponsor-declared trial summary
Phase
Therapeutic confirmatory (Phase III)
Status
Ongoing, recruitment ended
Participants planned
236
Countries
1
Sites
78
Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.
To explore the efficacy of a front-line chemo-free strategy based on the administration of Ponatinib plus steroids as induction treatment, followed by the infusion of Blinatumomab as consolidation in adult Ph+ ALL (=18 years, no upper age limit), and to compare it with a chemotherapy scheme combined with Imatinib (cont…
Key facts
- Sponsor
- Fondazione Gimema Franco Mandelli Onlus
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Hemic and Lymphatic Diseases [C15]
- Trial duration
- 8 Sep 2021 → ongoing
- Decision date (initial)
- 2024-10-01
- Transition trial
- Yes
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- Yes
- Funding sources
- Fondazione GIMEMA Franco Mandelli ONLUS · Incyte Biosciences International s.r.l. · Amgen s.r.l
External identifiers
- EU CT number
- 2023-508968-30-00
- EudraCT number
- 2020-006048-15
- ClinicalTrials.gov
- NCT04722848
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy, Safety
To explore the efficacy of a front-line chemo-free strategy based on the administration of Ponatinib plus steroids as induction treatment, followed by the infusion of Blinatumomab as consolidation in adult Ph+ ALL (=18 years, no upper age limit), and to compare it with a chemotherapy scheme combined with Imatinib (control arm), in terms of event-free survival (EFS), a composite endpoint, with events defined as: non achievement of MRD negativity (CMR or PNQ), deaths for any reason, toxicity and resistance (due or not to an ABL1 mutation development) in adult Ph+ ALL (=18 years, no upper age limit).
Secondary objectives 9
- The key secondary objective is represented by the feasibility of patients’ stratification to allo-SCT allocation on the basis of a refined MRD evaluation and on the presence/absence of additional genetic lesions (namely IKZF1 plus CDKN2A/B and/or PAX5).
- Capability of Blinatumomab to further reduce the MRD levels after Ponatinib induction.
- CMR or positive not-quantifiable (PNQ) duration.
- DFS at 1 and 3 years.
- OS at 1 and 3 years.
- Cumulative incidence of relapse (CIR).
- Safety profile.
- Comparison of patients’ quality of life (QoL) profiles over time by randomization arms.
- CMR (or PNQ) achievement, duration of CMR, OS and DFS according to the clinical, biological and molecular characteristics at baseline, including type of fusion protein (p190 vs p210) and presence of additional genomic lesions. 10 & 11 please see the Protocol.
Conditions and MedDRA coding
Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia.
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 11
- Signed written informed consent according to ICH/EU/GCP and national local laws.
- Newly diagnosed adult B-precursor Ph+ ALL patients.
- WHO performance status less or equal to 2.
- Age greater or equal to18 years, with no upper age limit.
- Renal and hepatic function as defined below: - AST (GOT), ALT (GPT), and AP <2 x upper limit of normal (ULN). - Total bilirubin <1.5 x ULN. - Creatinine clearance equal or greater than 50 mL/min.
- Pancreatic function as defined below: - Serum amylase less or equal to 1.5 x ULN and serum lipase less or equal to1.5 x ULN.
- Normal cardiac function.
- No evidence of CNS leukemia at blinatumomab start.
- Negative HIV test, negative hepatitis B (HBsAg) and hepatitis C virus (anti-HCV) test.
- Negative pregnancy test in women of childbearing potential.
- Bone marrow specimen from primary diagnosis available.
Exclusion criteria 12
- History of or current relevant CNS pathology (ongoing grade =2 epilepsy, seizure, paresis, aphasia, clinically relevant apoplexia, severe brain injuries, dementia, Parkinson’s disease, organic brain syndrome, psychosis).
- Impaired cardiac function, including any one of the following: - LVEF <45% as determined by MUGA scan or echocardiogram. - Complete left bundle branch block. - Use of a cardiac pacemaker. - ST depression of >1mm in 2 or more leads and/or T wave inversions in 2 or more contiguous leads. - Congenital long QT syndrome. - History of or presence of significant ventricular or atrial arrhythmia. - Clinically significant resting bradycardia (<50 beats per minute). - QTc >450 msec on screening ECG (using the QTcF formula). - Right bundle branch block plus left anterior hemiblock, bifascicular block. - Myocardial infarction within 3 months prior to starting Ponatinib. - Angina pectoris.
- Other clinically significant vascular and heart disease (e.g., congestive heart failure, uncontrolled hypertension, history of labile hypertension, or history of poor compliance with an antihypertensive regimen).
- Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of Ponatinib (e.g., ulcerative diseases, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection).
- Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL).
- Taking medications that are known to be associated with Torsades de Pointes and medications or herbal supplements that are known to be strong inhibitors of CYP3A4 within at least 14 days before the first dose of ponatinib.
- History of or current autoimmune disease.
- Systemic cancer chemotherapy within 2 weeks prior to study.
- Known hypersensitivity to immunoglobulins or to any other component of the study drug formulation.
- Active malignancy other than ALL with the exception of basal cell or squamous cell carcinoma of the skin, or carcinoma "in situ" of the cervix.
- Active infection, any other concurrent disease or medical condition that are deemed to interfere with the conduct of the study as judged by the investigator.
- Nursing women or women of childbearing potential not willing to use an effective form of contraception during participation in the study and at least 3 months thereafter or male patients not willing to ensure effective contraception during participation in the study and at least three months thereafter.
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The primary endpoint of this study is to evaluate the efficacy of a sequential approach based on the administration of Ponatinib plus and Blinatumomab vs chemotherapy combined with Imatinib, in terms of (EFS), a composite endpoint, with events defined as: non achievement of MRD negativity (CMR or PNQ), deaths for any reason, toxicity and resistance (due or not to an ABL1 mutation development) in adult Ph+ ALL (=18 years, no upper age limit).
Secondary endpoints 8
- The feasibility of patients’ stratification to allo-SCT allocation on the basis of a refined MRD evaluation and on the presence/absence of IKZF1-plus).
- Capability of Blinatumomab to further reduce the MRD levels after Ponatinib induction.
- CMR or PNQ duration.
- DFS at 1 and 3 years.
- OS at 1 and 3 years.
- CIR.
- Safety profile. Safety profile in terms of incidence of grade =3 CTC-NCI side effects and toxicities.
- Comparison of patients’ quality of life (QoL) profiles over time by randomization arms.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 12
PRD3960999 · Product
- Active substance
- Imatinib
- Pharmaceutical form
- CAPSULE, HARD
- Route of administration
- ORAL
- Max daily dose
- 800 mg milligram(s)
- Max total dose
- 360.4 g/m3 gram(s)/cubic meter
- Max treatment duration
- 30 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01EA01 — -
- Marketing authorisation
- EU/1/01/198/005
- MA holder
- NOVARTIS EUROPHARM LIMITED
- MA country
- Iceland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
BLINCYTO 38.5 micrograms powder for concentrate and solution for solution for infusion
PRD3418637 · Product
- Active substance
- Blinatumomab
- Substance synonyms
- MT-103, MEDI-538, MT103, RECOMBINANT ANTIBODY DERIVATIVE AGAINST HUMAN CD19 AND CD3
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INFUSION
- Max daily dose
- 28 µg microgram(s)
- Max total dose
- 3920 µg microgram(s)
- Max treatment duration
- 20 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01XC19 — -
- Marketing authorisation
- EU/1/15/1047/001
- MA holder
- AMGEN EUROPE B.V.
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Iclusig 15 mg film-coated tablets
PRD4563018 · Product
- Active substance
- Ponatinib
- Substance synonyms
- AP-24534, 3-(2-(IMIDAZO(1,2-B)PYRIDAZIN-3-YL)ETHYNYL)-4-METHYL-N-(4-((4-METHYLPIPERAZIN-1- YL)METHYL)-3-(TRIFLUOROMETHYL)PHENYL)BENZAMIDE, Benzamide, 3-(2-imidazo[1,2-b]pyridazin-3-ylethynyl)-4-methyl-N-[4-[(4-methyl-1-piperazinyl)methyl]-3-(trifluoromethyl)phenyl]-
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 45 mg milligram(s)
- Max total dose
- 12.6 g gram(s)
- Max treatment duration
- 40 Week(s)
- Authorisation status
- Authorised
- ATC code
- L01EA05 — -
- Marketing authorisation
- EU/1/13/839/001
- MA holder
- INCYTE BIOSCIENCES DISTRIBUTION B.V.
- MA country
- Norway
- Paediatric formulation
- No
- Orphan designation
- Yes
- Orphan designation number
- EU/3/09/715
- Modified vs. Marketing Authorisation
- No
SUB06859MIG · Substance
- Active substance
- Cyclophosphamide
- Pharmaceutical form
- POWDER FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 750 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 3 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Melphalan 50 mg powder and solvent for solution for injection/infusion
PRD10971210 · Product
- Active substance
- Melphalan Hydrochloride
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION/INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 100 mg/m2 milligram(s)/sq. meter
- Max total dose
- 100 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01AA03 — MELPHALAN
- Marketing authorisation
- PL 15413/0110
- MA holder
- HIKMA FARMACÊUTICA (PORTUGAL), S.A.
- MA country
- United Kingdom
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Vincristine Sulfate 1 mg/ml solution for injection
PRD993268 · Product
- Active substance
- Vincristine Sulfate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2 mg/m2 milligram(s)/sq. meter
- Max total dose
- 28 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01CA02 — VINCRISTINE
- Marketing authorisation
- PL 04515/0008
- MA holder
- HOSPIRA UK LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Keppra 250 mg film-coated tablets
PRD336937 · Product
- Active substance
- Levetiracetam
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 145 g gram(s)
- Max treatment duration
- 145 Day(s)
- Authorisation status
- Authorised
- ATC code
- N03AX14 — LEVETIRACETAM
- Marketing authorisation
- EU/1/00/146/001
- MA holder
- UCB PHARMA S.A. (ANDERL BE)
- MA country
- EU
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Idarubicina Sandoz 1 mg/ml concentrato per soluzione per infusione
PRD1584999 · Product
- Active substance
- Idarubicin Hydrochloride
- Pharmaceutical form
- SOLUTION FOR INFUSION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 10 mg/m2 milligram(s)/sq. meter
- Max total dose
- 40 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 4 Day(s)
- Authorisation status
- Authorised
- ATC code
- L01DB06 — IDARUBICIN
- Marketing authorisation
- 040308076
- MA holder
- SANDOZ S.P.A.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB07627MIG · Substance
- Active substance
- Filgrastim
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- SUBCUTANEOUS
- Max daily dose
- 5 µg/Kg microgram(s)/kilogram
- Max total dose
- 645 µg/Kg microgram(s)/kilogram
- Max treatment duration
- 6 Month(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD981205 · Product
- Active substance
- Mercaptopurine
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 75 mg/m2 milligram(s)/sq. meter
- Max total dose
- 23310 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 27 Month(s)
- Authorisation status
- Authorised
- ATC code
- L01BB02 — MERCAPTOPURINE
- Marketing authorisation
- 010344012
- MA holder
- ASPEN PHARMA TRADING LIMITED
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
LEDERFOLIN 25 mg Polvere per soluzione iniettabile per uso endovenoso
PRD412215 · Product
- Active substance
- Calcium Levofolinate
- Substance synonyms
- Levoleucovorin calcium, CALCIUM (2R)-2-[[4-[[(6S)-2-AMINO-5-FORMYL-4-OXO-1,6,7,8-TETRAHYDROPTERIDIN-6-YL]METHYLAMINO]BENZOYL]AMINO]PENTANEDIOATE
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 37.5 mg/m2 milligram(s)/square meter
- Max total dose
- 450 mg/m2 milligram(s)/square meter
- Max treatment duration
- 6 Day(s)
- Authorisation status
- Authorised
- ATC code
- V03AF04 — CALCIUM LEVOFOLINATE
- Marketing authorisation
- 024659120
- MA holder
- PFIZER ITALIA S.R.L.
- MA country
- Italy
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Dexamethasone Phosphate 4 mg/ml Solution for Injection
PRD1172938 · Product
- Active substance
- Dexamethasone Sodium Phosphate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 10 mg/m2 milligram(s)/sq. meter
- Max total dose
- 250 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 25 Day(s)
- Authorisation status
- Authorised
- ATC code
- H02AB02 — DEXAMETHASONE
- Marketing authorisation
- PA 0822/201/001
- MA holder
- PFIZER HEALTHCARE IRELAND
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Auxiliary 10
Methylprednisolone Sodium Succinate
SUB14562MIG · Substance
- Active substance
- Methylprednisolone Sodium Succinate
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 200 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Methylprednisolone Sodium Succinate
SUB14562MIG · Substance
- Active substance
- Methylprednisolone Sodium Succinate
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 20 mg milligram(s)
- Max total dose
- 300 mg milligram(s)
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06880MIG · Substance
- Active substance
- Cytarabine
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 750 mg milligram(s)
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06880MIG · Substance
- Active substance
- Cytarabine
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 50 mg milligram(s)
- Max total dose
- 500 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB06880MIG · Substance
- Active substance
- Cytarabine
- Pharmaceutical form
- POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 2000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 2900 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 14 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12.5 mg milligram(s)
- Max total dose
- 125 mg milligram(s)
- Max treatment duration
- 10 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 12.5 mg milligram(s)
- Max total dose
- 187.5 mg milligram(s)
- Max treatment duration
- 15 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB08856MIG · Substance
- Active substance
- Methotrexate
- Pharmaceutical form
- SOLUTION FOR INJECTION
- Route of administration
- INTRAVENOUS
- Max daily dose
- 1000 mg/m2 milligram(s)/sq. meter
- Max total dose
- 3035 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 23 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg/m2 milligram(s)/sq. meter
- Max total dose
- 1915 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 38 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB10020MIG · Substance
- Active substance
- Prednisone
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 60 mg/m2 milligram(s)/sq. meter
- Max total dose
- 330 mg/m2 milligram(s)/sq. meter
- Max treatment duration
- 7 Day(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Fondazione Gimema Franco Mandelli Onlus
- Sponsor organisation
- Fondazione Gimema Franco Mandelli Onlus
- Address
- Via Casilina 5
- City
- Rome
- Postcode
- 00182
- Country
- Italy
Scientific contact point
- Organisation
- Fondazione Gimema Franco Mandelli Onlus
- Contact name
- GIMEMA Centro Dati
Public contact point
- Organisation
- Fondazione Gimema Franco Mandelli Onlus
- Contact name
- GIMEMA Centro Dati
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Laboratorio di Ematologia, Policlinico Umberto I, Dip. Medicina Traslazionale e di Precisione ORL-000004351
|
Rome, Italy | Laboratory analysis |
Locations
1 EU/EEA country · 78 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Italy | Ongoing, recruitment ended | 236 | 78 |
| Rest of world | — | 0 | — |
Investigational sites
Azienda Ospedaliero Universitaria Di Modena
DIPARTIMENTO DI SCIENZE MEDICHE E CHIRURGICHE, MATERNO-INFANTILI DELL'ADULTO, Largo Del Pozzo 71, 41124, Modena
Azienda Sanitaria Locale Di Salerno
EMATOLOGIA, Via Nizza 146, 84124, Salerno
Azienda Ospedaliero Universitaria Parma
DIPARTIMENTO MEDICINA GENERALE E SPECIALISTICO, Viale Antonio Gramsci 14, 43126, Parma
I.F.O. Istituti Fisioterapici Ospitalieri
AREA MEDICINA ONCOLOGICA, Via Elio Chianesi N 53, 00144, Rome
Azienda Ospedaliera Universitaria Integrata Verona
DAI MEDICO GENERALE, Piazzale Ludovico Antonio Scuro 10, 37134, Verona
ASSL Nuoro - Ospedale San Francesco
UO EMATOLOGIA E CENTRO TRAPIANTI MIDOLLO OSSEO, via Salvatore Mannironi snc, 08100, Nuoro
ARNAS G. Brotzu
SC EMATOLOGIA E CTMO, Piazzale Alessandro Ricchi 1, 09121, Cagliari
Azienda Ospedaliero-Universitaria Consorziale Policlinico di Bari
DIPARTIMENTO DELL'EMERGENZA E DEI TRAPIANTI DI ORGANI (D.E.T.O.), Piazza Giulio Cesare 11, Italy, Bari
Hospital Santa Maria Della Misericordia
EMATOLOGIA E TRAPIANTO MIDOLLO OSSEO, Piazzale Giorgio Menghini 1, 06129, Perugia
Azienda Ospedaliera Universitaria Gaetano Martino Messina
MEDICINE SPECIALISTICHE E ONCOLOGIA MEDICA, Via Consolare Valeria N 1, 98124, Messina
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone
DIPARTIMENTO BIOMEDICO DI MEDICINA INTERNA E SPECIALISTICA, Via Del Vespro 129, 90127, Palermo
Istituto Clinico Humanitas
CANCER CENTER, Via Alessandro Manzoni 56, 20089, Rozzano
ULSS3 SERENISSIMA - Ospedale dell'Angelo di Mestre
UO EMATOLOGIA, via Paccagnella 11, Italy
Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata Fon
UOC EMATOLOGIA E TRAPIANTO DI CELLULE STAMINALI, Via Alvaro Del Portillo N 200, 00128, Rome
ASST Grande Ospedale Metropolitano Niguarda
DIPARTIMENTO DI EMATOLOGIA ED ONCOLOGIA, Piazza Dell'ospedale Maggiore 3, 20162, Milan
Asl Della Provincia Di Barletta, Andria, Trani, Ospedale "Mons. Dimiccoli" - Barletta
UO EMATOLOGIA, VIA FORNACI 201, 70031, Barletta
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
DIPARTIMENTO DI MEDICINA INTERNA, Via Filippo Corridoni 11, 60123, Ancona
AORN San Giuseppe Moscati Avellino
DIPARTIMENTO ONCO-EMATOLOGICO, Contrada Amoretta, 83100, Avellino
Azienda Socio Sanitaria Territoriale Dei Sette Laghi
DIPARTIMENTO DI MEDICINA SPECIALISTICA, Viale Luigi Borri N 57, 21100, Varese
Azienda Sanitaria Locale Br
UO EMATOLOGIA, Senza Numero Civico, Strada Statale 7 Mesagne 1, Brindisi
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
DIPARTIMENTO DI CHIRURGIA GENERALE E SPECIALITA' MEDICO CHIRURGICHE, Via Santa Sofia 78, 95123, Catania
Azienda Ospedaliera Santa Croce E Carle
SC EMATOLOGIA, Via Michele Coppino 26, 12100, Cuneo
ASST Valle Olona
DIPARTIMENTO ONCOLOGICO, via Arnaldo da Brescia 1, Italy
Ospedale S. Eugenio, ASL Roma 2
DIPARTIMENTO DELLE SPECIALITÀ, P.le dell'Umanesimo, 10, Roma
Fondazione IRCCS San Gerardo Dei Tintori
UO EMATOLOGIA E CTA, Via Giovanni Battista Pergolesi 33, 20900, Monza
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
DIPARTIMENTO DI ONCOLOGIA, Corso Bramante 88, 10126, Turin
Azienda Ospedaliera Ospedali Riuniti Marche Nord
DIVISIONE DI EMATOLOGIA, Piazzale Carlo Cinelli 4, 61121, Pesaro
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
DIPARTIMENTO DI MEDICINA INTERNA, Via Francesco Sforza 28, 20122, Milan
Azienda Sanitaria Locale Di Pescara
DIPARTIMENTO ONCOLOGICO-EMATOLOGICO, Via Renato Paolini 47, 65124, Pescara
Azienda Ospedaliera Ordine Mauriziano Di Torino
DIPARTIMENTO DI SCIENZE CLINICHE E BIOLOGICHE, Via Ferdinando Magellano 1, 10128, Turin
Azienda Ospedaliero-Universitaria Maggiore Della Carita
DIMECS E DIPARTIMENTO ONCOLOGICO, Corso Giuseppe Mazzini 18, 28100, Novara
Fondazione IRCCS Policlinico San Matteo
DIPARTIMENTO ONCOLOGIA, Viale Camillo Golgi 19, 27100, Pavia
Careggi University Hospital
DIPARTIMENTO DI MEDICINA SPERIMENTALE E CLINICA, Largo Giovanni Alessandro Brambilla 3, 50134, Florence
Azienda Sanitaria Territoriale Di Ascoli Piceno
UOC EMATOLOGIA, Via Degli Iris 1, 63100, Ascoli Piceno
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
DIPARTIMENTO DI ONCOLOGIA, Via Trabucco 180, 90146, Palermo
Ospedale San Raffaele S.r.l.
AREA ONCOLOGICA, Via Olgettina 60, 20132, Milan
Azienda Unita Locale Socio Sanitaria N 8 Berica
DIPARTIMENTO STRUTTURALE ONCOLOGIA CLINICA, Viale Ferdinando Rodolfi 37, 36100, Vicenza
Casa Sollievo Della Sofferenza
DIPARTIMENTO DI ONCO-EMATOLOGIA, Viale Convento Cappuccini 1, 71013, San Giovanni Rotondo
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
DIPARTIMENTO DI MEDICINA SPECIALISTICA, DIAGNOSTICA E SPERIMENTALE (DIMES), Via Pietro Albertoni 15, 40138, Bologna
Ospedale Santa Maria Goretti Latina
UOC EMATOLOGIA, Viale Michelangelo Buonarroti, 04100, Latina
Azienda Ospedaliera Papardo
SC EMATOLOGIA, Viale Ferdinando Stagno D'Alcontres Contrada Papardo, 98158, Messina
La Maddalena S.p.A.
DIPARTIMENTO ONCOLOGICO, Via San Lorenzo 312 D, 90146, Palermo
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
ONCOLOGIA MEDICA, Via Piero Maroncelli 40, 47014, Meldola
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
DIPARTIMENTO DI ONCOLOGIA CLINICA, Piazzale Spedali Civili 1, 25123, Brescia
University of Trieste Maggiore Hospital
DAI EMATOLOGIA, ONCOLOGIA E INFETTIVOLOGIA, Piazza dell Ospitale 1, Italy, Trieste
Azienda Ospedaliera Universitaria Federico II Di Napoli
DIPARTIMENTO DI MEDICINA CLINICA E CHIRURGIA, Via Sergio Pansini 5, 80131, Naples
Istituto Tumori Bari Giovanni Paolo II
UO EMATOLOGIA, Viale Orazio Flacco 65, 70124, Bari
ASL Caserta - Moscati Hospital
UO ONCOEMATOLOGIA, Via Antonio Gramsci, 1, Aversa (CE)
IRCCS Ospedale Policlinico San Martino
DIPARTIMENTO TERAPIE ONCOLOGICHE INTEGRATE, Largo Rosanna Benzi 10, 16132, Genoa
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
DIPARTIMENTO ONCO-EMATOLOGICO E RADIOTERAPICO, Viale Europa, 89133, Reggio Calabria
Ospedale Vito Fazzi Lecce
Polo Oncologico - UO EMATOLOGIA, Piazza Filippo Muratore 1, 73100, Lecce
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
DIPARTIMENTO AREA MEDICA ED ONCOLOGIA, Regione Gonzole 10, 10043, Orbassano
Ospedale S G Moscati
UOC EMATOLOGIA, Via Per Martina Franca, 74010, Statte
Azienda Unita Sanitaria Locale Di Piacenza
DIPARTIMENTO ONCOLOGIA - EMATOLOGIA, Via Giuseppe Taverna 49, 29121, Piacenza
Ospedale Fabrizio Spaziani
EMATOLOGIA, Via Armando Fabi Snc, 03100, Frosinone
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
DIPARTIMENTO DI ONCOLOGIA ED EMATOLOGIA 2, Corso Bramante 88, 10126, Turin
Ospedale Valduce
DIPARTIMENTO MEDICO, via Dante Alighieri 11, Italy
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
DIPARTIMENTO ONCO EMATOLOGICO, Largo Citta' D'ippocrate 1, 84131, Salerno
Central Hospital Of Bolzano
SC EMATOLOGIA E CENTRO TRAPIANTO MIDOLLO OSSEO, Via Lorenz Boehler 5, 39100, Bolzano
Azienda Ospedaliera S Giovanni Addolorata
DIPARTIMENTO SPECIALITÀ, Via Dell' Amba Aradam 9, 00184, Rome
Azienda Sanitaria Universitaria Friuli Centrale
DIPARTIMENTO DI MEDICINA SPECIALISTICA, Piazzale Santa Maria Della Misericordia 15, 33100, Udine
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
DIPARTIMENTO ONCO-EMATOLOGICO E PNEUMOEMATOLOGICO, Via Antonio Cardarelli 9, 80131, Naples
Azienda Socio Sanitaria Territoriale Di Cremona
DIPARTIMENTO ONCOLOGICO, Viale Concordia 1, 26100, Cremona
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
DIPARTIMENTO DI ONCOLOGIA ED EMATOLOGIA, Piazza Oms 1, 24127, Bergamo
Azienda Ospedaliera Universitaria Senese
DIPARTIMENTO DI SCIENZE MEDICHE, CHIRURGICHE E NEUROSCIENZE, Strada Delle Scotte 14, 53100, Siena
Azienda Ospedaliera di Padova
DIPARTIMENTO DI EMATOLOGIA ED IMMUNOLOGIA CLINICA, Via Nicolo' Giustiniani 2, 35128, Padova
Azienda Ospedaliera Policlinico Universitario Tor Vergata
DIPARTIMENTO DI MEDICINA, Viale Oxford 81, 00133, Rome
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
DIPARTIMENTO INTERNISTICO E DI EMERGENZA-URGENZA E ACCETTAZIONE STRUTTURALE, Via Venezia 16, 15121, Alexandria
San Camillo Forlanini Hospital
DIPARTIMENTO ONCOLOGIA E MEDICINE SPECIALISTICHE, Circonvallazione Gianicolense 87, 00152, Rome
Azienda Unita Sanitaria Locale Della Romagna
DIPARTIMENTO ONCOEMATOLOGICO, Viale Luigi Settembrini 2, 47923, Rimini
Azienda Ospedaliero Universitaria Renato Dulbecco
EMATOLOGIA, ONCOLOGIA E MEDICINA TRASFUSIONALE, Viale Pio X 95, 88100, Catanzaro
Azienda Ospedaliero Universitaria Pisana
DIPARTIMENTO DI MEDICINA CLINICA E SPERIMENTALE - DIVISIONE DI EMATOLOGIA, Via Roma 67, 56126, Pisa
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
DIPARTIMENTO DI DIAGNOSTICA PER IMMAGINI, RADIOTERAPIA ONCOLOGICA ED EMATOLOGIA, Largo Francesco Vito 1, 00168, Rome
Istituto Oncologico Veneto
ONCOLOGIA, Via Dei Carpani 16/z, 31033, Castelfranco Veneto
Azienda Ospedaliero-Universitaria Policlinico Umberto I
DIPARTIMENTO DI MEDICINA TRASLAZIONALE E DI PRECISIONE, Viale Del Policlinico 155, 00161, Rome
Azienda Ospedaliero-Universitaria Sant Andre
DIPARTIMENTO SCIENZE ONCOLOGICHE, Via Di Grottarossa 1035-1039, 00189, Rome
Azienda Ospedaliero Universitaria Ospedali Riuniti
DIPARTIMENTO ONCO-EMATOLOGICO, Viale Luigi Pinto 1, 71122, Foggia
Azienda Unita Sanitaria Locale Della Romagna
DIPARTIMENTO ONCOEMATOLOGICO, Viale Vincenzo Randi 5, 48121, Ravenna
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Italy | 2021-09-08 | 2021-09-10 | 2025-01-20 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 17 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_Protocol 2023-508968-30-00_redacted | 1 |
| Recruitment arrangements (for publication) | K1_Recruitment arrangement_Blank document | 1 |
| Subject information and informed consent form (for publication) | L1_SIS and ICF study_redacted | 1 |
| Subject information and informed consent form (for publication) | L2_SIS and ICF translational study redacted | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC blinatumomab | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC IT Filgrastim | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC IT Idarubicin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC IT Lederfolin | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC IT Levetiracetam | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC IT Melfalan | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC IT Mercaptopurina | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC IT Vincristine | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC IT_Desametasone | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC IT_Imatinib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC Ponatinib | 1 |
| Summary of Product Characteristics (SmPC) (for publication) | E2_SmPC_Ciclofosfamide | 1 |
| Synopsis of the protocol (for publication) | D1_Protocol synopsis IT 2023-508968-30-00_redacted | 1 |
Application history
2 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-09-05 | Italy | Acceptable 2024-09-20
|
2024-10-01 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2026-01-13 | Italy | Acceptable | 2026-04-01 |