S.C. Medicina Interna II ed Ematologia - Laboratorio di Medicina Interna e Molecolare - A.O. San Luigi Trials

S.C. Medicina Interna II ed Ematologia - Laboratorio di Medicina Interna e Molecolare - A.O. San Luigi	Welcome, Profile Billing Logout

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Saglio, Giuseppe

NCT03250338 / 2017-001600-29: Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML

Recruiting

322

Europe, Canada, US

Crenolanib, Crenolanib besylate, Cytarabine, Mitoxantrone, Placebo Oral Tablet, Fludarabine, Idarubicin, G-CSF

Arog Pharmaceuticals, Inc.

Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

10/24

FISM_registry, NCT02808858: Italian Network MDS Registry

Recruiting

N/A

10000

Europe

Fondazione Italiana Sindromi Mielodisplastiche-ETS

Myelodysplastic-Myeloproliferative Diseases

06/16

05/32

Messa, Emanuela

Phoenix, NCT05924100 / 2021-001538-20: Efficacy and Safety of Luspatercept for the Treatment of Anemia Due to MDS With del5q, Refractory/Resistant/Intolerant to Prior Treatments, RBC-TD

Recruiting

Europe

Luspatercept Injection [Reblozyl]

Associazione Qol-one, Celgene BMS

Myelodysplastic Syndromes, Del(5Q), Anemia, Transfusion-dependent Anemia

12/24

12/29

Cilloni, Daniela

AMELIORATE, NCT04174612 / 2019-003936-21: AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance

Recruiting

172

Europe

Cytarabine, Daunorubicin, Midostaurin, Cytarabine HD

Gruppo Italiano Malattie EMatologiche dell'Adulto, MYNERVA (MYeloid Neoplasms Research Venture AIRC) programma speciale finanziato dall'AIRC - Associazione Italiana per la, Fondazione GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) Franco Mandelli Onlus

Acute Myeloid Leukemia With FLT3/ITD Mutation

12/22

08/25

NCT04168502 / 2019-003871-20: Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML

Recruiting

414

Europe

Gemtuzumab Ozogamicin

Gruppo Italiano Malattie EMatologiche dell'Adulto, Fondazione GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) Franco Mandelli Onlus, Pfizer S.R.L.

Acute Myeloid Leukemia

04/25

04/27

ACROBAT, NCT04184505 / 2019-003997-25: Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS

Recruiting

274

Europe

Azacitidine, AZA, Standard Chemotherapy, STD CHT, Allogeneic stem cell transplantation, HSCT

Gruppo Italiano Malattie EMatologiche dell'Adulto, AIFA - Italian Medicines Agency, Fondazione GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) Franco Mandelli Onlus

High-risk MDS

03/24

IMPACT-AML, NCT06713837: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.

Recruiting

339

Europe, RoW

High intensity therapies, Low intensity therapies

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS, Hospital Vall d'Hebron, Cyprus Institute of Neurology and Genetics, European Leukemia Net, Fundacion Para La Investigacion Hospital La Fe, Ostdeutsche Studiengruppe Haematologie Und Onkologie e.V., Ospedale Pediatrico Bambin Gesù, Czech Lymphoma Study Group, Charite University, Berlin, Germany, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León, University of Bologna, Hannover Medical School, German Society for Pediatric Oncology and Hematology GPOH gGmbH, Toscana Life Sciences Sviluppo s.r.l., Lithuanian University of Health Sciences, Gruppo Italiano Malattie EMatologiche dell'Adulto, TIMELEX

Acute Myeloid Leukemia, Relapse/Recurrence

01/28

MYLOX-1, NCT04679870 / 2020-003087-45: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral GB2064 in Participants With Myelofibrosis

Active, not recruiting

Europe, US, RoW

GB2064

Galecto Biotech AB, OPIS s.r.l

Myelofibrosis

12/23

06/26

NCT05306301 / 2022-000633-17: Ponatinib Plus Chemotherapy in Acute Lymphoblastic Leukemia Patients

Recruiting

Europe

Ponatinib

Gruppo Italiano Malattie EMatologiche dell'Adulto, Incyte Biosciences International Sàrl, Docteur-Yersin 12, 1110 Morges, Switzerland, FONDAZIONE GIMEMA

Chemotherapy, Leukemia, Acute Lymphoblastic

02/25

07/28

IDIOME-STUDY, NCT03503409: IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome

Active, not recruiting

Europe

AG-120

Groupe Francophone des Myelodysplasies

Myelodysplastic Syndromes, Acute Myeloid Leukemia

04/25

SENTRY-2, NCT05980806: A Study of Selinexor Monotherapy in Subjects with JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

Recruiting

118

Europe, Canada, US, RoW

Selinexor 60 mg, KPT-330, Selinexor 40 mg, Ruxolitinib, JAKAFI, Pacritinib, VONJO, Momelotinib, OJJAARA

Karyopharm Therapeutics Inc

Myelofibrosis, Moderate Thrombocytopenia

04/26

10/28

1621-QLG-LG, NCT03755856: Long-term Outcomes for Acute Myeloid Leukemia Patients

Recruiting

N/A

343

Europe, RoW

Questionnaire

Gruppo Italiano Malattie EMatologiche dell'Adulto, European Organisation for Research and Treatment of Cancer - EORTC

Acute Myeloid Leukemia

06/21

12/22

NCT03789981: Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia

Active, not recruiting

N/A

Europe

Immunogenic profile

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Acute Myeloid Leukemia

12/24

12/25

RUX-MF, NCT06516406: Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera

Recruiting

N/A

1055

Europe

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Myelofibrosis, Primary Myelofibrosis, Secondary Myelofibrosis

05/32

NCT04352556: COVID19-hematological Malignancies: the Italian Hematology Alliance

Recruiting

N/A

250

Europe

Ospedale di Circolo - Fondazione Macchi

SARS-CoV-2 Infection, Hematological Malignancies

10/22

GIMEMA 2320, NCT04589728: Prospective and Retrospective Observational Evaluation of Real World Outcome of Unfit AML Patients Treated With the Combination Venetoclax Plus Hypomethylating Agents, Under the Italian Law No.648/96

Recruiting

N/A

104

Europe

Venetoclax plus HMA

Gruppo Italiano Malattie EMatologiche dell'Adulto

Acute Myeloid Leukemia

12/22

12/23

FISiM-Luspa, NCT05520749: Efficacy and Safety of Luspatercept: a Study by Fondazione Italiana Sindromi Mielodisplastiche

Completed

N/A

215

Europe

Luspatercept

Fondazione Italiana Sindromi Mielodisplastiche-ETS, Istituto Clinico Humanitas

Myeloid Dysplasia

12/22

01/23

NCT04460950: Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms

Recruiting

N/A

237

Europe

Gruppo Italiano Malattie EMatologiche dell'Adulto

Acute Myeloid Leukemia, Familial Acute Myeloid Leukemia, Myelodysplastic Syndromes

03/25

GIMEMA, NCT06657846: HRQoL and Financial Toxicity in Patients with VEXAS Syndrome

Not yet recruiting

N/A

100

Europe

Gruppo Italiano Malattie EMatologiche dell'Adulto

VEXAS

02/25

06/25

NCT05553873: Evaluation of Inflammatory Markers in ph Negative Myeloproliferative Neoplasms: Impact on Outcome and Response to Therapy. Multicenter Retro-prospective Observational Study. The INFLA-ME (INFLAmmation in Myeloproliferative Disease) Study.

Recruiting

N/A

500

Europe

University of Milano Bicocca

Myeloproliferative Disease, Inflammatory Markers

12/26

Trial + Data / Events

Status

Region

Interventions

Sponsor

Conditions

Primary compl

Study compl

Saglio, Giuseppe

NCT03250338 / 2017-001600-29: Study Investigating the Efficacy of Crenolanib With Chemotherapy vs Chemotherapy Alone in R/R FLT3 Mutated AML

Recruiting

322

Europe, Canada, US

Crenolanib, Crenolanib besylate, Cytarabine, Mitoxantrone, Placebo Oral Tablet, Fludarabine, Idarubicin, G-CSF

Arog Pharmaceuticals, Inc.

Relapsed/Refractory Acute Myeloid Leukemia With FLT3 Activating Mutations

10/24

FISM_registry, NCT02808858: Italian Network MDS Registry

Recruiting

N/A

10000

Europe

Fondazione Italiana Sindromi Mielodisplastiche-ETS

Myelodysplastic-Myeloproliferative Diseases

06/16

05/32

Messa, Emanuela

Phoenix, NCT05924100 / 2021-001538-20: Efficacy and Safety of Luspatercept for the Treatment of Anemia Due to MDS With del5q, Refractory/Resistant/Intolerant to Prior Treatments, RBC-TD

Recruiting

Europe

Luspatercept Injection [Reblozyl]

Associazione Qol-one, Celgene BMS

Myelodysplastic Syndromes, Del(5Q), Anemia, Transfusion-dependent Anemia

12/24

12/29

Cilloni, Daniela

AMELIORATE, NCT04174612 / 2019-003936-21: AML Patients Bearing FLT3 Mutations Based on Peripheral Blast Clearance

Recruiting

172

Europe

Cytarabine, Daunorubicin, Midostaurin, Cytarabine HD

Acute Myeloid Leukemia With FLT3/ITD Mutation

12/22

08/25

NCT04168502 / 2019-003871-20: Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML

Recruiting

414

Europe

Gemtuzumab Ozogamicin

Gruppo Italiano Malattie EMatologiche dell'Adulto, Fondazione GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) Franco Mandelli Onlus, Pfizer S.R.L.

Acute Myeloid Leukemia

04/25

04/27

ACROBAT, NCT04184505 / 2019-003997-25: Feasibility of Allogeneic Stem Cell Transplantation in Higher-risk-MDS

Recruiting

274

Europe

Azacitidine, AZA, Standard Chemotherapy, STD CHT, Allogeneic stem cell transplantation, HSCT

Gruppo Italiano Malattie EMatologiche dell'Adulto, AIFA - Italian Medicines Agency, Fondazione GIMEMA (Gruppo Italiano Malattie EMatologiche dell'Adulto) Franco Mandelli Onlus

High-risk MDS

03/24

IMPACT-AML, NCT06713837: A Randomized Pragmatic Clinical Trial for Relapsed or Refractory Acute Myeloid Leukemia.

Recruiting

339

Europe, RoW

High intensity therapies, Low intensity therapies

Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS, Hospital Vall d'Hebron, Cyprus Institute of Neurology and Genetics, European Leukemia Net, Fundacion Para La Investigacion Hospital La Fe, Ostdeutsche Studiengruppe Haematologie Und Onkologie e.V., Ospedale Pediatrico Bambin Gesù, Czech Lymphoma Study Group, Charite University, Berlin, Germany, Fundación Instituto de Estudios de Ciencias de la Salud de Castilla y León, University of Bologna, Hannover Medical School, German Society for Pediatric Oncology and Hematology GPOH gGmbH, Toscana Life Sciences Sviluppo s.r.l., Lithuanian University of Health Sciences, Gruppo Italiano Malattie EMatologiche dell'Adulto, TIMELEX

Acute Myeloid Leukemia, Relapse/Recurrence

01/28

MYLOX-1, NCT04679870 / 2020-003087-45: A Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral GB2064 in Participants With Myelofibrosis

Active, not recruiting

Europe, US, RoW

GB2064

Galecto Biotech AB, OPIS s.r.l

Myelofibrosis

12/23

06/26

NCT05306301 / 2022-000633-17: Ponatinib Plus Chemotherapy in Acute Lymphoblastic Leukemia Patients

Recruiting

Europe

Ponatinib

Gruppo Italiano Malattie EMatologiche dell'Adulto, Incyte Biosciences International Sàrl, Docteur-Yersin 12, 1110 Morges, Switzerland, FONDAZIONE GIMEMA

Chemotherapy, Leukemia, Acute Lymphoblastic

02/25

07/28

IDIOME-STUDY, NCT03503409: IDH1 (AG 120) Inhibitor in Patients With IDH1 Mutated Myelodysplastic Syndrome

Active, not recruiting

Europe

AG-120

Groupe Francophone des Myelodysplasies

Myelodysplastic Syndromes, Acute Myeloid Leukemia

04/25

SENTRY-2, NCT05980806: A Study of Selinexor Monotherapy in Subjects with JAK Inhibitor-naïve Myelofibrosis and Moderate Thrombocytopenia

Recruiting

118

Europe, Canada, US, RoW

Selinexor 60 mg, KPT-330, Selinexor 40 mg, Ruxolitinib, JAKAFI, Pacritinib, VONJO, Momelotinib, OJJAARA

Karyopharm Therapeutics Inc

Myelofibrosis, Moderate Thrombocytopenia

04/26

10/28

1621-QLG-LG, NCT03755856: Long-term Outcomes for Acute Myeloid Leukemia Patients

Recruiting

N/A

343

Europe, RoW

Questionnaire

Gruppo Italiano Malattie EMatologiche dell'Adulto, European Organisation for Research and Treatment of Cancer - EORTC

Acute Myeloid Leukemia

06/21

12/22

NCT03789981: Exploring Disease Immunogenicity and the Immunological Effects of Hypomethylating Agents in Acute Myeloid Leukemia

Active, not recruiting

N/A

Europe

Immunogenic profile

Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori

Acute Myeloid Leukemia

12/24

12/25

RUX-MF, NCT06516406: Ruxolitinib in Primary Myelofibrosis and Secondary to Essential Thrombocythemia or Polycythemia Vera

Recruiting

N/A

1055

Europe

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Myelofibrosis, Primary Myelofibrosis, Secondary Myelofibrosis

05/32

NCT04352556: COVID19-hematological Malignancies: the Italian Hematology Alliance

Recruiting

N/A

250

Europe

Ospedale di Circolo - Fondazione Macchi

SARS-CoV-2 Infection, Hematological Malignancies

10/22

Recruiting

N/A

104

Europe

Venetoclax plus HMA

Gruppo Italiano Malattie EMatologiche dell'Adulto

Acute Myeloid Leukemia

12/22

12/23

FISiM-Luspa, NCT05520749: Efficacy and Safety of Luspatercept: a Study by Fondazione Italiana Sindromi Mielodisplastiche

Completed

N/A

215

Europe

Luspatercept

Fondazione Italiana Sindromi Mielodisplastiche-ETS, Istituto Clinico Humanitas

Myeloid Dysplasia

12/22

01/23

NCT04460950: Observational Study for the Evaluation of Incidence of Familial AML/MDSs in Patients With Myeloid Neoplasms

Recruiting

N/A

237

Europe

Gruppo Italiano Malattie EMatologiche dell'Adulto

Acute Myeloid Leukemia, Familial Acute Myeloid Leukemia, Myelodysplastic Syndromes

03/25

GIMEMA, NCT06657846: HRQoL and Financial Toxicity in Patients with VEXAS Syndrome

Not yet recruiting

N/A

100

Europe

Gruppo Italiano Malattie EMatologiche dell'Adulto

VEXAS

02/25

06/25

Recruiting

N/A

500

Europe

University of Milano Bicocca

Myeloproliferative Disease, Inflammatory Markers

12/26



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