Clinical Trials sponsored by GIMEMA
Interventional Studies
Study Title
GIMEMA Code
Patology
Recruitment status
Study Phase
Randomized
Link to Clinicaltrials.gov
EudraCT
National Treatment Program with Sequential Chemotherapy and Blinatumomab to Improve Minimal Residual Disease Response and Survival in Philadelphia Chromosome-negative B-Cell Precursor Adult Acute Lymphoblastic Leukemia
LAL2317
ALL
Recuiting
Phase II
No
https://clinicaltrials.gov/ct2/show/NCT03367299
2017-004251-23
Phase I protocol of adoptive immunotherapy with enriched and expanded autologous natural killer (NK) cells for patients with Ph+ acute lymphoblastic leukemia (ALL) in complete hematologic remission (CHR) but with persistent/recurrent minimal residual disease (MRD) =60 years or not eligible for other post-CHR treatment modalities. LAL2013 EudraCT number 2013-002547-29
LAL2013
ALL
Recuiting
Phase I
No
https://clinicaltrials.gov/ct2/show/NCT02185781
2013-002547-29
A Safety Run-In and Phase 2B/2A, Open-Label, Multicentre, Study Investigating Safety, Tolerability and Effectiveness of Venetoclax add in combination at Fludarabine, Cytarabine and Idarubicine in Induction Therapy of new onset Non-M3 Acute Myeloid Leukemia
AML1718
AML
Recuiting
Phase II
No
https://clinicaltrials.gov/ct2/show/NCT03455504
2018-000392-33
10-day decitabine versus conventional chemotherapy (“3+7”) followed by allografting in AML patients = 60 years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study Group
AML1301
AML
Recuiting
Phase III
Yes
https://clinicaltrials.gov/ct2/show/NCT02172872
2014-001486-27
A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycLines-based chemotherapy (AIDA regimen) for patient with newLy diagnosed, high-risk acute prOmyelocytic leukemia
APOLLO
APL
Recuiting
Phase III
Yes
NA
2015-001151-68
LAP AIDA 0493 versione emendata pazienti > 60 anni
AIDA0493
APL
Recuiting
NA
No
https://clinicaltrials.gov/ct2/show/NCT01064557
GUIDELINES for the treatment of Acute Promyelocytic Leukemia
AIDA2000
APL
Recuiting
Phase III
No
https://clinicaltrials.gov/ct2/show/NCT01064570
Activity and safety of front-line venetoclax and rituximab association (VeRiTAs) in young and fit patients with chronic lymphocytic leukemia (CLL)
and unmutated IGHV and/or disrupted TP53. A phase 2 multicenter study
LLC1518
CLL
Recuiting
Phase II
No
https://clinicaltrials.gov/ct2/show/NCT03455517
2018-000877-61
Bosutinib Efficacy Safety Tolerability (BEST) study in elderly Chronic Myeloid Laukemia patients failing front-line treatment with other Tyrosine Kinase Inhibitors
BEST
CML
Recuiting
Phase II
No
https://clinicaltrials.gov/ct2/show/NCT02810990
2016-002216-40
SUSTRENIM Study – Sustained treatment-free remission in BCR-ABL+ chronic myeloid leukemia: a prospective study comparing Nilotinib versus Imatinib with switch to Nilotinib in absence of optimal response
SUSTRENIM
CML
Recuiting
Yes
https://clinicaltrials.gov/ct2/show/NTC02602314
2015-005248-33
Optimizing Ponatinib USe (OPUS). A GIMEMA phase 2 study of the activity and risk profile of ponatinib, 30 mg once daily, in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) patients resistant to imatinib.
OPUS
CML
Recuiting
Phase II
No
https://clinicaltrials.gov/ct2/show/NCT02398825
2015-001102-34
Observational Studies
Study Title
GIMEMA Code
Patology
Recruitment status
Link to Clinicaltrials.gov
PNH Registry
PNH Registry
PNH
Recruiting
NA
A Survivorship Project to understAnd and to impRove long-Term outcomes for Acute myeloid leukemia patients (SPARTA): The SPARTA Platform
SPARTA
AML
Recruiting
https://clinicaltrials.gov/ct2/show/NCT03755856
Italian Registry on the prevalence of IDH1/IDH2 mutations in Patients with Acute Myeloid Leukemia
AML1516
AML
Recruiting
https://clinicaltrials.gov/ct2/show/NCT02986620
Central Nervous System (CNS) involvement in Acute Myeloid Leukemia (AML): an observational retrospective multicentre study on patients previously registered in GIMEMA clinical trials
AML1617
AML
Recruiting
https://clinicaltrials.gov/ct2/show/NCT03410407
Prospective survey of severe infections during a multicenter study of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia
AML1411
AML
Recruiting
https://clinicaltrials.gov/ct2/show/NCT01570465
Long Term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia (APL) Patients Treated with Arsenic Trioxide (ATO) or Standard Chemotherapy
QoL_APL0816
APL
Recruiting
https://clinicaltrials.gov/ct2/show/NCT03096496
Observational study on number and outcome of pregnancy in childbearing age female patients treated with chemotherapy for APL (studies AIDA0493, AIDA2000) GIMEMA Study APL0511
APL0511
APL
Recruiting
https://clinicaltrials.gov/ct2/show/NCT01472107
Observational retrospective multicenter Study aimed at evaluating the incidence of Hepatitis B reactivation in patients affected by Chronic Lymphocytic Leukemia treated with Ibrutinib
LLC1618
CLL
Recruiting
https://clinicaltrials.gov/ct2/show/NCT03528941
Efficacy and safety in patients with chronic lymphocytic leukemia (CLL) treated with idelalisib and rituximab in the clinical practice in Italy: a GIMEMA ERIC study
LLC1718
CLL
Recruiting
https://clinicaltrials.gov/ct2/show/NCT03545035
A retrospective study to evaluate the clinical-biologic characteristics and outcome of patients treated in Italy according to the Ibrutinib-Named Patient Program (NPP) for patients with relapsed or refractory chronic lymphocytic leukemia (CLL)
LLC1415
CLL
Recruiting
https://clinicaltrials.gov/ct2/show/NCT02582320
Observational Study of Iclusig® (Ponatinib) Treatment in patients with Chronic Myeloid Leukaemia (CML) in Italy
CML OITI
CML
Recruiting
NA
Ponatinib survey: valutazione retrospettiva dei pazienti italiani inclusi nel programma di uso compassionevole o secondo legge 648/96
CML1214
CML
Recruiting
https://clinicaltrials.gov/ct2/show/NCT02448095
Front-line treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) with dasatinib. An observational multicentric study
CML1113
CML
Recruiting
https://clinicaltrials.gov/ct2/show/NCT01761890
Observational study of conception/pregnancy in adult patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors
CML1012
CML
Recruiting
https://clinicaltrials.gov/ct2/show/NCT01752062
Observational study in adult patients with Imatinib-resistant or intolerant chronic myeloid leukemia (CML) treated with Nilotinib: Follow-up of the Italian patients.
CML0609
CML
Recruiting
https://clinicaltrials.gov/ct2/show/NCT01475110
Italian Adult Immune Thrombocytopenia (ITP) Registry –
Investigation on a dynamic cohort of Italian patients with active ITP
ITP0918
ITP
Recruiting
https://clinicaltrials.gov/ct2/show/NCT03465020
Response rate and response duration after discontinuation of treatment with Thrombopoietin Receptor Agonists (TPO-RAs) in patients affected by primary immune thrombocytopenia (pITP): retrospective study
ITP0714
ITP
Recruiting
https://clinicaltrials.gov/ct2/show/NCT02298075
Impiego dei TPO-mimetici come terapia di preparazione alla splenectomia in pazienti adulti affetti da piastrinopenia immune primitiva (PTI). Studio osservazionale retrospettivo Brooklyn
ITP0614
ITP
Recruiting
https://clinicaltrials.gov/ct2/show/NCT02063763
Studio prospettico multicentrico, non interventistico, per la valutazione del rischio infettivo in pazienti affetti da sindrome mielodisplastica: utilità della profilassi antibiotica/antifungina e dei fattori di crescita granulocitari
MDS0413
MDS
Recruiting
https://clinicaltrials.gov/ct2/show/NCT01951430
Type and DIREction of Clinical and patient-reported outcomes in cancer Trials RepositORY Project -DIRECTORY Project
EORTC QLG DIrectory Project (QOL)
Recruiting
Interventional Studies
Study Title | GIMEMA Code | Patology | Recruitment status | Study Phase | Randomized | Link to Clinicaltrials.gov | EudraCT |
National Treatment Program with Sequential Chemotherapy and Blinatumomab to Improve Minimal Residual Disease Response and Survival in Philadelphia Chromosome-negative B-Cell Precursor Adult Acute Lymphoblastic Leukemia | LAL2317 | ALL | Recuiting | Phase II | No | https://clinicaltrials.gov/ct2/show/NCT03367299 | 2017-004251-23 |
Phase I protocol of adoptive immunotherapy with enriched and expanded autologous natural killer (NK) cells for patients with Ph+ acute lymphoblastic leukemia (ALL) in complete hematologic remission (CHR) but with persistent/recurrent minimal residual disease (MRD) =60 years or not eligible for other post-CHR treatment modalities. LAL2013 EudraCT number 2013-002547-29 | LAL2013 | ALL | Recuiting | Phase I | No | https://clinicaltrials.gov/ct2/show/NCT02185781 | 2013-002547-29 |
A Safety Run-In and Phase 2B/2A, Open-Label, Multicentre, Study Investigating Safety, Tolerability and Effectiveness of Venetoclax add in combination at Fludarabine, Cytarabine and Idarubicine in Induction Therapy of new onset Non-M3 Acute Myeloid Leukemia | AML1718 | AML | Recuiting | Phase II | No | https://clinicaltrials.gov/ct2/show/NCT03455504 | 2018-000392-33 |
10-day decitabine versus conventional chemotherapy (“3+7”) followed by allografting in AML patients = 60 years: a randomized phase III study of the EORTC Leukemia Group, CELG, GIMEMA and German MDS Study Group | AML1301 | AML | Recuiting | Phase III | Yes | https://clinicaltrials.gov/ct2/show/NCT02172872 | 2014-001486-27 |
A randomized Phase III study to compare arsenic trioxide (ATO) combined to ATRA and idarubicin versus standard ATRA and anthracycLines-based chemotherapy (AIDA regimen) for patient with newLy diagnosed, high-risk acute prOmyelocytic leukemia | APOLLO | APL | Recuiting | Phase III | Yes | NA | 2015-001151-68 |
LAP AIDA 0493 versione emendata pazienti > 60 anni | AIDA0493 | APL | Recuiting | NA | No | https://clinicaltrials.gov/ct2/show/NCT01064557 | |
GUIDELINES for the treatment of Acute Promyelocytic Leukemia | AIDA2000 | APL | Recuiting | Phase III | No | https://clinicaltrials.gov/ct2/show/NCT01064570 | |
Activity and safety of front-line venetoclax and rituximab association (VeRiTAs) in young and fit patients with chronic lymphocytic leukemia (CLL) and unmutated IGHV and/or disrupted TP53. A phase 2 multicenter study |
LLC1518 | CLL | Recuiting | Phase II | No | https://clinicaltrials.gov/ct2/show/NCT03455517 | 2018-000877-61 |
Bosutinib Efficacy Safety Tolerability (BEST) study in elderly Chronic Myeloid Laukemia patients failing front-line treatment with other Tyrosine Kinase Inhibitors | BEST | CML | Recuiting | Phase II | No | https://clinicaltrials.gov/ct2/show/NCT02810990 | 2016-002216-40 |
SUSTRENIM Study – Sustained treatment-free remission in BCR-ABL+ chronic myeloid leukemia: a prospective study comparing Nilotinib versus Imatinib with switch to Nilotinib in absence of optimal response | SUSTRENIM | CML | Recuiting | Yes | https://clinicaltrials.gov/ct2/show/NTC02602314 | 2015-005248-33 | |
Optimizing Ponatinib USe (OPUS). A GIMEMA phase 2 study of the activity and risk profile of ponatinib, 30 mg once daily, in Chronic Myeloid Leukemia (CML) Chronic Phase (CP) patients resistant to imatinib. | OPUS | CML | Recuiting | Phase II | No | https://clinicaltrials.gov/ct2/show/NCT02398825 | 2015-001102-34 |
Observational Studies
Study Title | GIMEMA Code | Patology | Recruitment status | Link to Clinicaltrials.gov |
PNH Registry | PNH Registry | PNH | Recruiting | NA |
A Survivorship Project to understAnd and to impRove long-Term outcomes for Acute myeloid leukemia patients (SPARTA): The SPARTA Platform | SPARTA | AML | Recruiting | https://clinicaltrials.gov/ct2/show/NCT03755856 |
Italian Registry on the prevalence of IDH1/IDH2 mutations in Patients with Acute Myeloid Leukemia | AML1516 | AML | Recruiting | https://clinicaltrials.gov/ct2/show/NCT02986620 |
Central Nervous System (CNS) involvement in Acute Myeloid Leukemia (AML): an observational retrospective multicentre study on patients previously registered in GIMEMA clinical trials | AML1617 | AML | Recruiting | https://clinicaltrials.gov/ct2/show/NCT03410407 |
Prospective survey of severe infections during a multicenter study of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia | AML1411 | AML | Recruiting | https://clinicaltrials.gov/ct2/show/NCT01570465 |
Long Term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia (APL) Patients Treated with Arsenic Trioxide (ATO) or Standard Chemotherapy | QoL_APL0816 | APL | Recruiting | https://clinicaltrials.gov/ct2/show/NCT03096496 |
Observational study on number and outcome of pregnancy in childbearing age female patients treated with chemotherapy for APL (studies AIDA0493, AIDA2000) GIMEMA Study APL0511 | APL0511 | APL | Recruiting | https://clinicaltrials.gov/ct2/show/NCT01472107 |
Observational retrospective multicenter Study aimed at evaluating the incidence of Hepatitis B reactivation in patients affected by Chronic Lymphocytic Leukemia treated with Ibrutinib | LLC1618 | CLL | Recruiting | https://clinicaltrials.gov/ct2/show/NCT03528941 |
Efficacy and safety in patients with chronic lymphocytic leukemia (CLL) treated with idelalisib and rituximab in the clinical practice in Italy: a GIMEMA ERIC study | LLC1718 | CLL | Recruiting | https://clinicaltrials.gov/ct2/show/NCT03545035 |
A retrospective study to evaluate the clinical-biologic characteristics and outcome of patients treated in Italy according to the Ibrutinib-Named Patient Program (NPP) for patients with relapsed or refractory chronic lymphocytic leukemia (CLL) | LLC1415 | CLL | Recruiting | https://clinicaltrials.gov/ct2/show/NCT02582320 |
Observational Study of Iclusig® (Ponatinib) Treatment in patients with Chronic Myeloid Leukaemia (CML) in Italy | CML OITI | CML | Recruiting | NA |
Ponatinib survey: valutazione retrospettiva dei pazienti italiani inclusi nel programma di uso compassionevole o secondo legge 648/96 | CML1214 | CML | Recruiting | https://clinicaltrials.gov/ct2/show/NCT02448095 |
Front-line treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) with dasatinib. An observational multicentric study | CML1113 | CML | Recruiting | https://clinicaltrials.gov/ct2/show/NCT01761890 |
Observational study of conception/pregnancy in adult patients with chronic myeloid leukemia (CML) treated with tyrosine kinase inhibitors | CML1012 | CML | Recruiting | https://clinicaltrials.gov/ct2/show/NCT01752062 |
Observational study in adult patients with Imatinib-resistant or intolerant chronic myeloid leukemia (CML) treated with Nilotinib: Follow-up of the Italian patients. | CML0609 | CML | Recruiting | https://clinicaltrials.gov/ct2/show/NCT01475110 |
Italian Adult Immune Thrombocytopenia (ITP) Registry – Investigation on a dynamic cohort of Italian patients with active ITP |
ITP0918 | ITP | Recruiting | https://clinicaltrials.gov/ct2/show/NCT03465020 |
Response rate and response duration after discontinuation of treatment with Thrombopoietin Receptor Agonists (TPO-RAs) in patients affected by primary immune thrombocytopenia (pITP): retrospective study | ITP0714 | ITP | Recruiting | https://clinicaltrials.gov/ct2/show/NCT02298075 |
Impiego dei TPO-mimetici come terapia di preparazione alla splenectomia in pazienti adulti affetti da piastrinopenia immune primitiva (PTI). Studio osservazionale retrospettivo Brooklyn | ITP0614 | ITP | Recruiting | https://clinicaltrials.gov/ct2/show/NCT02063763 |
Studio prospettico multicentrico, non interventistico, per la valutazione del rischio infettivo in pazienti affetti da sindrome mielodisplastica: utilità della profilassi antibiotica/antifungina e dei fattori di crescita granulocitari | MDS0413 | MDS | Recruiting | https://clinicaltrials.gov/ct2/show/NCT01951430 |
Type and DIREction of Clinical and patient-reported outcomes in cancer Trials RepositORY Project -DIRECTORY Project | EORTC QLG DIrectory Project (QOL) | Recruiting |