Clinical trial • Phase II • Oncology

INOTUZUMAB OZOGAMICIN for B-cell acute lymphoblastic leukemia | Minimal residual disease-positive B-cell acute lymphoblastic leukemia

Phase II trial of INOTUZUMAB OZOGAMICIN for B-cell acute lymphoblastic leukemia | Minimal residual disease-positive B-cell acute lymphoblastic leukemia.

Overview

Trial Therapeutic Area
Oncology
Trial Disease
B-cell acute lymphoblastic leukemia | Minimal residual disease-positive B-cell acute lymphoblastic leukemia
Trial Stage
Phase II
Drug Modality
ADC|Small molecule
Orphan Drug
Yes

Key dates

Initial CTIS Submission Date
15-10-2024
First CTIS Authorization Date
03-12-2024

Trial design

None/Not specified-controlled Phase II trial across 41 sites in Italy.

Comparator
None/Not specified
Biomarker Stratified
True, biomarker: measurable BCR-ABL1 fusion transcript (cohort 1) and measurable IG/TCR specific rearrangement (cohort 2)
Target Sample Size
76

Eligibility

Recruits 76 The record indicates 'isVulnerablePopulationSelected': true. Consent requirement: 'Signed written informed consent according to ICH/EU/GCP and national local laws.' Subject information and informed consent forms are listed in the documents. Participants are adults (no paediatric enrolment stated); no information on assent or parental consent is provided..

Pregnancy Exclusion
Patients who are pregnant or breast feeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of induction therapy). Post menopausal women must be amenorrhoic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 4 months following discontinuation of study drugs. Fertile patients will be advised to adopt contraceptive methods while on treatment
Vulnerable Population
The record indicates 'isVulnerablePopulationSelected': true. Consent requirement: 'Signed written informed consent according to ICH/EU/GCP and national local laws.' Subject information and informed consent forms are listed in the documents. Participants are adults (no paediatric enrolment stated); no information on assent or parental consent is provided.

Inclusion criteria

  • {"criterion_text":"- To be classified as having ALL according to WHO classification of haematological neoplasms, patients must have >20% blasts in bone marrow at the time of diagnosis\n- For females of childbearing potential, a negative pregnancy test must be documented at Screening\n- Female and male patients who are fertile should use an effective form of contraception with their sexual partners from screening through 4 months after the end of treatment. As a precautionary measure, breast-feeding should be discontinued during treatment with Inotuzumab and should not be restarted after discontinuation of Inotuzumab. Male patients must agree to refrain from sperm donation, from initial treatment administration until 12 months after the last dose of study drug\n- Signed written informed consent according to ICH/EU/GCP and national local laws.\n- Blasts at the diagnosis or in any timepoint had to be CD22+\n- To have a measurable BCR-ABL1 fusion transcript (cohort 1) or a measurable IG/TCR specific rearrangement (cohort 2)\n- To have any measurable MRD positivity after at least: a. 3 months of therapy for Ph+ ALL, or the failure of at least 2nd line TKI (cohort 1) b. 2 courses of therapy for Ph- ALL (cohort 2)\n- and to not have more than 5% of bone marrow blasts. Patients has to be in 1st or 2nd complete remission.\n- Patients = 18 years old with no upper age limit\n- Patients with a life expectancy >12 weeks\n- Adequate hepatic function as defined by the following criteria: a. total serum bilirubin =1.5 x upper limit of normal (ULN), unless due to Gilbert’s syndrome b. alanine aminotransferase (ALT) =2.5 × ULN c. aspartate aminotransferase (AST) =2.5 × ULN\n- Adequate pancreatic function as defined by the following criterion: a. serum lipase and amylase =1.5 × ULN"}

Exclusion criteria

  • {"criterion_text":"- More than 5% of BM blasts\n- Uncontrolled hypertension (diastolic blood pressure >90 mm Hg; systolic >140 mm Hg). Patients with hypertension should be under treatment on study entry to effect blood pressure control\n- Creatinine level > 2.5mg/dl or Glomerular Filtration Rate (GFR) < 20 ml/min or proteinuria > 3.5 g/day\n- Documented inherited protrombotic disorders\n- Patients who have received any investigational drug = 4 weeks\n- Patients who have undergone major surgery = 2 weeks prior to starting study drug or who have not recovered from side effects of such therapy;\n- Patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention or with a life expectancy due to other malignancy <6 months\n- Patients that have received Inotuzumab or Anti CD22 directed therapies before\n- Patients with known hereditary coagulopathy\n- Patient that received during their life diagnosis of VOD or had ongoing VOD\n- Patients with hypersensitivity to the active substance or to any of the excipients (Sucrose, Polysorbate 80, Sodium chloride, tromethamine)\n- WHO performance status = 50% (Karnofsky) or = 3 (ECOG)\n- Patients who are pregnant or breast feeding and adults of reproductive potential not employing an effective method of birth control (women of childbearing potential must have a negative serum pregnancy test within 48 hrs prior to administration of induction therapy). Post menopausal women must be amenorrhoic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for up to 4 months following discontinuation of study drugs. Fertile patients will be advised to adopt contraceptive methods while on treatment\n- Patients unwilling or unable to comply with the protocol\n- Active HBV or HCV hepatitis, or AST/ALT = 2.5 x ULN and bilirubine = 1.5 x ULN\n- Evidence of liver fibrosis, portal hypertension or other clinically relevant liver abnormalities at screening liver ultrasonography\n- History of alcohol abuse\n- Burkitt lymphoma and active CNS leukemia. Patients with previuos neurological toxicitiy as well comorbidity will be carefully evaluated for enrolment\n- Ongoing or active infections\n- Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL)\n- Clinically significant, uncontrolled, or active cardiovascular disease, specifically including, but not restricted to: a. any history of myocardial infarction, stroke, or revascularization b. unstable angina or transient ischemic attack within 6 months prior to enrollment c. congestive heart failure within 6 months prior to enrollment, or left ventricular ejection fraction (LVEF) less than lower limit of normal per local institutional standards within 6 months prior to enrollment d. history of clinically significant (as determined by the treating physician) atrial arrhythmia e. any history of ventricular arrhythmia f. any history of venous thromboembolism including deep venous thrombosis or pulmonary embolism;"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- Primary end point is % of MRD negativity after course 2 (or course 1 if will be performed only course1).","definition_or_measurement_approach":"Percent of participants achieving MRD negativity after course 2 (or after course 1 if only one course performed); measurement method for MRD not detailed in the CTIS record."}

Secondary endpoints

  • {"endpoint_text":"- Molecular Disease Progression: defined as the rise of more than 2 log in MRD from any previous determination","definition_or_measurement_approach":"Defined as the rise of more than 2 log in MRD from any previous determination"}
  • {"endpoint_text":"- Disease Progression: this is also equivalent to Treatment Failure, Lack of Efficacy, or No Response.","definition_or_measurement_approach":"Disease progression equivalent to treatment failure/lack of efficacy/no response (no further measurement method specified)"}
  • {"endpoint_text":"- Overall Survival (OS), defined as the number of days between the first study drug administration and death from any cause or lost to follow up.","definition_or_measurement_approach":"OS measured as number of days between first study drug administration and death from any cause or lost to follow up"}
  • {"endpoint_text":"- Event Free Survival (EFS), defined as the number of days between the first study drug administration and any event including disease progressionor death.","definition_or_measurement_approach":"EFS measured as number of days between first study drug administration and any event including disease progression or death"}
  • {"endpoint_text":"- DFS (Disease Free Survival), defined as the interval between the date of response achievement and the date of death, relapse or last follow-up.","definition_or_measurement_approach":"DFS measured as interval between date of response achievement and date of death, relapse or last follow-up"}
  • {"endpoint_text":"- Incidence time and nature of any adverse event.","definition_or_measurement_approach":"Incidence, timing and nature of adverse events; specific grading/criteria not detailed here"}
  • {"endpoint_text":"- Severe effect related to treatment safety is defined as an adverse event occurring within the first cycle, judged to be related to treatment and meeting any of the following criteria: o Grade 3 non-hematological toxicity lasting more than 7 days. o Grade 4 non-hematological toxicity.","definition_or_measurement_approach":"Severe treatment-related safety event = AE within first cycle, related to treatment, and either Grade 3 non-hematological toxicity lasting >7 days or Grade 4 non-hematological toxicity"}
  • {"endpoint_text":"- Incidence, severity, seriousness and treatment-causality of Treatment Emergent Signs and Symptoms.","definition_or_measurement_approach":"Assessment of incidence, severity, seriousness and causality of treatment-emergent signs and symptoms; specific scales not provided here"}
  • {"endpoint_text":"- Frequency of clinically significant abnormalities in physical examination, safety laboratory tests, vital signs and 12-Lead ECG.","definition_or_measurement_approach":"Frequency of clinically significant abnormalities detected on physical exam, labs, vital signs and 12-lead ECG"}
  • {"endpoint_text":"- VOD occurred during or after protocol or transplant procedures for up to 2 years.","definition_or_measurement_approach":"Recording occurrence of veno-occlusive disease (VOD) during or after protocol or transplant procedures for up to 2 years"}

Recruitment

Planned Sample Size
76
Recruitment Window Months
98
Consent Approach
Signed written informed consent according to ICH/EU/GCP and national local laws. Subject information and informed consent forms are listed in the CTIS documents. Adult participants provide consent; no assent or parental consent procedures are described in the record. Languages of forms not specified in the available metadata.

Geography

Total Number Of Sites
41
Total Number Of Participants
76

Italy

Earliest CTIS Part Ii Submission Date
24-10-2024
Latest Decision Or Authorization Date
23-04-2026
Processing Time Days
546
Number Of Sites
41
Number Of Participants
76

Sites

Site Name
Azienda Ospedaliera Universitaria Citta Della Salute E Della Scienza Di Torino
Department Name
DIPARTIMENTO DI ONCOLOGIA ED EMATOLOGIA
Principal Investigator Name
Ernesta Audisio
Principal Investigator Email
eaudisio@cittadellasalute.to.it
Contact Person Name
Ernesta Audisio
Site Name
Ospedale S. Eugenio, ASL Roma 2
Department Name
DIPARTIMENTO DELLE SPECIALITÀ
Principal Investigator Name
Carla Mazzone
Principal Investigator Email
carla.mazzone@aslroma2.it
Contact Person Name
Carla Mazzone
Contact Person Email
carla.mazzone@aslroma2.it
Site Name
Azienda Ospedaliera Universitaria San Giovanni Di Dio E Ruggi d'Aragona
Department Name
DIPARTIMENTO ONCO EMATOLOGICO
Principal Investigator Name
Carmine Selleri
Principal Investigator Email
cselleri@unisa.it
Contact Person Name
Carmine Selleri
Contact Person Email
cselleri@unisa.it
Site Name
Azienda Sanitaria Locale Di Pescara
Department Name
DIPARTIMENTO ONCOLOGICO-EMATOLOGICO
Principal Investigator Name
Prassede Salutari
Principal Investigator Email
prassede.salutari@ausl.pe.it
Contact Person Name
Prassede Salutari
Contact Person Email
prassede.salutari@ausl.pe.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
DIPARTIMENTO DI MEDICINA TRASLAZIONALE E DI PRECISIONE
Principal Investigator Name
Sabina Chiaretti
Principal Investigator Email
chiaretti@bce.uniroma1.it
Contact Person Name
Sabina Chiaretti
Contact Person Email
chiaretti@bce.uniroma1.it
Site Name
Azienda Ospedaliera Santa Croce E Carle
Department Name
SC EMATOLOGIA
Principal Investigator Name
Daniele Mattei
Principal Investigator Email
mattei.d@ospedale.cuneo.it
Contact Person Name
Daniele Mattei
Contact Person Email
mattei.d@ospedale.cuneo.it
Site Name
Fondazione IRCCS Policlinico San Matteo
Department Name
DIPARTIMENTO ONCOLOGIA
Principal Investigator Name
Patrizia Zappasodi
Principal Investigator Email
p.zappasodi@smatteo.pv.it
Contact Person Name
Patrizia Zappasodi
Contact Person Email
p.zappasodi@smatteo.pv.it
Site Name
Azienda Ospedaliera Universitaria Senese
Department Name
DIPARTIMENTO DI SCIENZE MEDICHE, CHIRURGICHE E NEUROSCIENZE
Principal Investigator Name
Monica Bocchia
Principal Investigator Email
bocchia@unisi.it
Contact Person Name
Monica Bocchia
Contact Person Email
bocchia@unisi.it
Site Name
University Hospital Of Ferrara
Department Name
DIPARTIMENTO ONCOLOGICO MEDICO SPECIALISTICO
Principal Investigator Name
Gian Matteo Rigolin
Principal Investigator Email
rglgmt@unife.it
Contact Person Name
Gian Matteo Rigolin
Contact Person Email
rglgmt@unife.it
Site Name
Azienda Ospedaliera Ordine Mauriziano Di Torino
Department Name
DIPARTIMENTO DI SCIENZE CLINICHE E BIOLOGICHE
Principal Investigator Name
Alessandro Cignetti
Principal Investigator Email
alessandro.cignetti@unito.it
Contact Person Name
Alessandro Cignetti
Contact Person Email
alessandro.cignetti@unito.it
Site Name
Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii
Department Name
DIPARTIMENTO DI ONCOLOGIA ED EMATOLOGIA
Principal Investigator Name
Federico Lussana
Principal Investigator Email
flussana@asst-pg23.it
Contact Person Name
Federico Lussana
Contact Person Email
flussana@asst-pg23.it
Site Name
University of Trieste Maggiore Hospital
Department Name
DAI EMATOLOGIA, ONCOLOGIA E INFETTIVOLOGIA
Principal Investigator Name
Francesco Zaja
Principal Investigator Email
francesco.zaja@asugi.sanita.fvg.it
Contact Person Name
Francesco Zaja
Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
DIPARTIMENTO DI DIAGNOSTICA PER IMMAGINI, RADIOTERAPIA ONCOLOGICA ED EMATOLOGIA
Principal Investigator Name
Federica Sorà
Principal Investigator Email
federica.sora@Unicatt.it
Contact Person Name
Federica Sorà
Contact Person Email
federica.sora@Unicatt.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
DIVISIONE DI ONCOEMATOLOGIA
Principal Investigator Name
Federica Gigli
Principal Investigator Email
federica.gigli@ieo.it
Contact Person Name
Federica Gigli
Contact Person Email
federica.gigli@ieo.it
Site Name
IRCCS Ospedale Policlinico San Martino
Department Name
DIPARTIMENTO TERAPIE ONCOLOGICHE INTEGRATE
Principal Investigator Name
Roberto Massimo Lemoli
Principal Investigator Email
roberto.lemoli@unige.it
Contact Person Name
Roberto Massimo Lemoli
Contact Person Email
roberto.lemoli@unige.it
Site Name
Azienda Ospedaliero-Universitaria Maggiore Della Carita
Department Name
DIMECS E DIPARTIMENTO ONCOLOGICO
Principal Investigator Name
Monia Lunghi
Principal Investigator Email
monia.lunghi@med.unipmn.it
Contact Person Name
Monia Lunghi
Contact Person Email
monia.lunghi@med.unipmn.it
Site Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Department Name
DIPARTIMENTO DI MEDICINA INTERNA
Principal Investigator Name
Nicola Fracchiolla
Principal Investigator Email
nicola.fracchiolla@policlinico.mi.it
Contact Person Name
Nicola Fracchiolla
Site Name
Azienda Ospedaliera Di Rilievo Nazionale Antonio Cardarelli
Department Name
DIPARTIMENTO ONCO-EMATOLOGICO E PNEUMOEMATOLOGICO
Principal Investigator Name
Mario Annunziata
Principal Investigator Email
mario.annunziata@aocardarelli.it
Contact Person Name
Mario Annunziata
Site Name
Casa Sollievo Della Sofferenza
Department Name
DIPARTIMENTO DI ONCO-EMATOLOGIA
Principal Investigator Name
Mariachiara Abbenante
Principal Investigator Email
m.abbenante@operapadrepio.it
Contact Person Name
Mariachiara Abbenante
Contact Person Email
m.abbenante@operapadrepio.it
Site Name
Azienda Unita Locale Socio Sanitaria N 8 Berica
Department Name
DIPARTIMENTO STRUTTURALE ONCOLOGIA CLINICA
Principal Investigator Name
Giorgia Scotton
Principal Investigator Email
giorgia.scotton@aulss8.veneto.it
Contact Person Name
Giorgia Scotton
Site Name
Azienda Ospedaliero-Universitaria Di Bologna IRCCS Istituto Di Ricerca E Di Cura A Carattere Scientifico
Department Name
DIPARTIMENTO DI MEDICINA SPECIALISTICA, DIAGNOSTICA E SPERIMENTALE (DIMES)
Principal Investigator Name
Cristina Papayannidis
Principal Investigator Email
cristina.papayannidis@unibo.it
Contact Person Name
Cristina Papayannidis
Contact Person Email
cristina.papayannidis@unibo.it
Site Name
Central Hospital Of Bolzano
Department Name
SC EMATOLOGIA E CENTRO TRAPIANTO MIDOLLO OSSEO
Principal Investigator Name
Federico Mosna
Principal Investigator Email
federico.mosna@sabes.it
Contact Person Name
Federico Mosna
Contact Person Email
federico.mosna@sabes.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
DIPARTIMENTO DI MEDICINA
Principal Investigator Name
Maria Ilaria Del Principe
Principal Investigator Email
del.principe@med.uniroma2.it
Contact Person Name
Maria Ilaria Del Principe
Contact Person Email
del.principe@med.uniroma2.it
Site Name
Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
Department Name
DIPARTIMENTO DI ONCOLOGIA CLINICA
Principal Investigator Name
Chiara Cattaneo
Principal Investigator Email
chiara.cattaneo@asst-spedalicivili.it
Contact Person Name
Chiara Cattaneo
Site Name
Azienda Ospedaliero-Universitaria Ss.Antonio E Biagio E C.Arrigo Alessandria
Department Name
DIPARTIMENTO INTERNISTICO E DI EMERGENZA-URGENZA E ACCETTAZIONE STRUTTURALE
Principal Investigator Name
Daniela Pietrasanta
Principal Investigator Email
dpietrasanta@ospedale.al.it
Contact Person Name
Daniela Pietrasanta
Contact Person Email
dpietrasanta@ospedale.al.it
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I G M Lancisi G Salesi
Department Name
DIPARTIMENTO DI MEDICINA INTERNA
Principal Investigator Name
Silvia Trappolini
Contact Person Name
Silvia Trappolini
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
DIPARTIMENTO DI EMATOLOGIA ED ONCOLOGIA
Principal Investigator Name
Giovanni Grillo
Principal Investigator Email
giovanni.grillo@ospedaleniguarda.it
Contact Person Name
Giovanni Grillo
Site Name
Azienda Sanitaria Territoriale Di Ascoli Piceno
Department Name
UO EMATOLOGIA
Principal Investigator Name
Piero Galieni
Principal Investigator Email
piero.galieni@sanita.marche.it
Contact Person Name
Piero Galieni
Contact Person Email
piero.galieni@sanita.marche.it
Site Name
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.
Department Name
UNITA' EMATOLOGIA E TRAPIANTO DI CELLULE STAMINALI
Principal Investigator Name
Marianna Norata
Principal Investigator Email
marianna.norata@irst.emr.it
Contact Person Name
Marianna Norata
Contact Person Email
marianna.norata@irst.emr.it
Site Name
ULSS3 SERENISSIMA - Ospedale dell'Angelo di Mestre
Department Name
UO EMATOLOGIA
Principal Investigator Name
Cristina Skert
Principal Investigator Email
cristina.skert@aulss3.veneto.it
Contact Person Name
Cristina Skert
Site Name
ASST Valle Olona
Department Name
DIPARTIMENTO ONCOLOGICO
Principal Investigator Name
Elisabetta Todisco
Principal Investigator Email
elisabetta.todisco@asst-valleolona.it
Contact Person Name
Elisabetta Todisco
Site Name
Grande Ospedale Metropolitano Bianchi Melacrino Morelli
Department Name
DIPARTIMENTO ONCO-EMATOLOGICO E RADIOTERAPICO
Principal Investigator Name
Caterina Alati
Principal Investigator Email
caterina.alati@gmail.com
Contact Person Name
Caterina Alati
Contact Person Email
caterina.alati@gmail.com
Site Name
Ospedale Vito Fazzi Lecce
Department Name
Polo Oncologico - UO EMATOLOGIA
Principal Investigator Name
Nicola Di Renzo
Principal Investigator Email
direnzo.ematolecce@gmail.com
Contact Person Name
Nicola Di Renzo
Contact Person Email
direnzo.ematolecce@gmail.com
Site Name
Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
Department Name
UOC EMATOLOGIA
Principal Investigator Name
Endri Mauro
Principal Investigator Email
endri.mauro@aulss2.veneto.it
Contact Person Name
Endri Mauro
Contact Person Email
endri.mauro@aulss2.veneto.it
Site Name
Ospedale San Raffaele S.r.l.
Department Name
AREA ONCOLOGICA
Principal Investigator Name
Fabio Ciceri
Principal Investigator Email
ciceri.clinicaltrials@hsr.it
Contact Person Name
Fabio Ciceri
Contact Person Email
ciceri.clinicaltrials@hsr.it
Site Name
Azienda Ospedaliera Universitaria Integrata Verona
Department Name
DAI MEDICO GENERALE
Principal Investigator Name
Massimiliano Bonifacio
Principal Investigator Email
massimiliano.bonifacio@univr.it
Contact Person Name
Massimiliano Bonifacio
Site Name
Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello
Department Name
DIPARTIMENTO DI ONCOLOGIA
Principal Investigator Name
Antonino Mulè
Principal Investigator Email
a.mule@villasofia.it
Contact Person Name
Antonino Mulè
Contact Person Email
a.mule@villasofia.it
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
DIPARTIMENTO ONCOEMATOLOGICO
Principal Investigator Name
Anna Maria Mianulli
Principal Investigator Email
amianulli@auslrn.net
Contact Person Name
Anna Maria Mianulli
Contact Person Email
amianulli@auslrn.net
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
DIPARTIMENTO SCIENZE ONCOLOGICHE
Principal Investigator Name
Agostino Tafuri
Principal Investigator Email
agostino.tafuri@ospedalesantandrea.it
Contact Person Name
Agostino Tafuri
Site Name
Azienda Ospedaliero Universitaria Ospedali Riuniti
Department Name
DIPARTIMENTO ONCO-EMATOLOGICO
Principal Investigator Name
Lorella Melillo
Principal Investigator Email
lmelillo@ospedaliriunitifoggia.it
Contact Person Name
Lorella Melillo
Site Name
Azienda Sanitaria Universitaria Friuli Centrale
Department Name
DIPARTIMENTO DI MEDICINA SPECIALISTICA
Principal Investigator Name
Mario Tiribelli
Principal Investigator Email
mario.tiribelli@uniud.it
Contact Person Name
Mario Tiribelli
Contact Person Email
mario.tiribelli@uniud.it

Sponsor

Primary sponsor

Full Name
Fondazione Gimema Franco Mandelli Onlus
Organisation Type
Patient organisation/association
Country Of Registered Address
Italy

Third parties

  • {"country":"Italy","full_name":"Azienda Socio Sanitaria Territoriale Papa Giovanni Xxiii","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Italy","full_name":"Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.r.l.","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Italy","full_name":"Azienda Ospedaliero-Universitaria Policlinico Umberto I","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"Italy","full_name":"Azienda Ospedaliera Ospedali Riuniti Villa Sofia Cervello","duties_or_roles":"4","organisation_type":"Hospital/Clinic/Other health care facility"}

Investigational products

Investigational Product Name
BESPONSA 1 mg powder for concentrate for solution for infusion
Active Substance
INOTUZUMAB OZOGAMICIN
Modality
ADC
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Authorisation Status
Marketing authorisation number EU/1/17/1200/001
Orphan Designation
Yes
Maximum Dose
500 µg/ m2 (maxDailyDoseAmount field = 500, doseUom µg/ m2)
Investigational Product Name
PONATINIB
Active Substance
PONATINIB
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
45 mg (maxDailyDoseAmount field = 45, doseUom mg)
Investigational Product Name
CYCLOPHOSPHAMIDE
Active Substance
CYCLOPHOSPHAMIDE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
100 mg/m2 (maxDailyDoseAmount field = 100, doseUom mg/m2)
Investigational Product Name
VINCRISTINE
Active Substance
VINCRISTINE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
1 mg/m2 (maxDailyDoseAmount field = 1, doseUom mg/m2)
Investigational Product Name
METHOTREXATE
Active Substance
METHOTREXATE
Modality
Small molecule
Routes Of Administration
INTRAVENOUS
Route
INTRAVENOUS
Maximum Dose
15 mg/m2 (maxDailyDoseAmount field = 15, doseUom mg/m2)
Investigational Product Name
PURINETHOL 50 mg compresse
Active Substance
MERCAPTOPURINE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Authorisation Status
Marketing authorisation number 010344012 (authorisationCountryCode: IT)
Maximum Dose
75 mg/m2 (maxDailyDoseAmount field = 75, doseUom mg/m2)
Investigational Product Name
PREDNISONE
Active Substance
PREDNISONE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
40 mg/m2 (maxDailyDoseAmount field = 40, doseUom mg/m2)
Combination Treatment
Yes

Related trials

Other published trials that may interest you.