List of clinical studies

In opening phase

Pathology Title Code Phase Clinicaltrials.gov
Altri Oss Real-world mapping antithrombotic regimens in Multiple Myeloma patients on treatment (the MARMMOT Study of the GIMEMA Working Party on Hemostasis and Thrombosis) ET0123 N/A link
Altri Oss Real-world ruxolitinib experience in Polycythemia Vera: REVIEW Study MPN0224 N/A link
AML A multicentric, prospective Study addressing the kinetics and impact on survival of Measurable Residual Disease in Acute Myeloid Leukemia patients receiving azacitidine and venetoclax AML2723 N/A link
AML Observational GIMEMA study on the outcome of acute myeloid leukemia (AML) patients treated with new drugs in real-life (Box trial) AML2824 N/A link
PTI Observational Study on the outcome of patients with ITP who underwent Splenectomy after 2010 ITP1324 N/A link

Open for enrollment

Pathology Title Code Phase Clinicaltrials.gov
ALL A Phase IIA Study of feasibility and effectiveness of inotuzumab ozogamicin (IO) in adult patients with B-Cell Acute Lymphoblastic Leukemia with positive Minimal Residual Disease before any Hematopoietic Stem Cell Transplantation ALL2418 II link
ALL Newly diagnosed adult Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia (Ph+ ALL). Sequential treatment with ponatinib and the bispecific monoclonal antibody blinatumomab vs chemotherapy and imatinib ALL2820 III link
ALL Combination of ponatinib plus chemotherapy as frontline treatment for patients with BCR/ABL1-Like Acute Lymphoblastic Leukemia (BCR/ABL1-Like ALL) - BALLik ALL2922 II link
ALL Daratumumab in adults with Very High-Risk T-Lineage Acute Lymphoblastic Leukemia (ALL) treated according to the ALL national treatment program (DARATALL-VHR) ALL3024 II link
ALL Ancillary observational Study of post-frontline sequential treatment of Adult Philadelphia Chromosome-Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) patients with dasatinib and the bispecific monoclonal antibody blinatumomab LAL2217 N/A link
Altri Oss Salvage treatment with glofitamab in patients affected by relapsed/refractory non Hodgkin B cell Lymphoma IMM0123 N/A link
Altri Oss Multicenter retrospective observational study analyzing infective complications and the clinical outcome of patients with acute lymphoblastic leukemia treated with inotuzumab ozogamicin (INO-FIRST) INF0123 N/A link
Altri Oss Observational Study Protocol REALFed: Real world evidence of fedratinib effectiveness in Myelofibrosis MPN0123 N/A link
AML Phase III study to assess the impact of gemtuzumab ozogamicin, in combination with standard chemotherapy, on the levels of minimal residual disease, and the role of glasdegib as a post-transplant maintenance, in adult patients, aged 18-60 years, with previously untreated, de novo, favorable-intermediate-risk acute myeloid leukemia AML1819 III link
AML A Phase 3, prospective, randomized multi-center intervention trial of early intensification in AML patients bearing FLT3 mutations based on peripheral blast clearance. A MYNERVA-GIMEMA study. AMELIORATE (AML Early IntensificatiOn based on peRipheral blAsT clearance) AML1919 III link
AML Tagraxofusp in Patients with CD123+ or with Blastic Plasmacytoid Dendritic Cell Neoplasm Immunophenotype-like Acute Myeloid Leukemia AML2020 II link
AML A Prospective Multicentre Observational Study for the evaluation of clinical-hematological characteristics of familial Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDSs) AML2120 N/A link
AML Role of adrenomedullin in leukemic endosteal/vascualr niches AML2220 N/A link
AML A Multicentric Phase 2 Study of venetoclax and azacitidine for the management of molecular relapse/progression in adult NPM1-mutated Acute Myeloid Leukemia AML2521 II link
AML Novel Approaches to Target MECOM/EVI1 in Acute Myeloid Leukemia AML2623 N/A link
AML A Survivorship Project to understAnd and to impRove long-Term outcomes for Acute myeloid leukemia patients (SPARTA): The SPARTA platform. GIMEMA-EORTC 1621-QLG-LG (SPARTA) N/A
AML Risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia. A prospective evlaution of quality of life outcomes QoL AML1310 N/A
APL Treatment newly diagnosed patients with Acute Promyelocytic Leukemia, aged >12 months and <75 years, using All-Trans Retinoic Acid in combination with Idarubicin AIDA0493 N/A
APL GUIDELINES for the treatment of Acute Promyelocytic Leukemia AIDA2000 N/A
APL A Post-Authorisation Long-Term Retrospective Safety Cohort Study of Arsenic Trioxide in First Line Low- to Intermediate-Risk Acute Promyelocytic Leukaemia (APL) Patients APL0618 N/A link
APL Long Term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia (APL) Patients Treated with Arsenic Trioxide (ATO) or Standard Chemotherapy  QoL-APL0816 N/A
APL 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: A Prospective Evaluation of Quality of Life Outcomes QoL-APOLLO Trial N/A
CML Observational study of pregnancy in adult patients with chronic myeloid leukemia (CML) treated with Imatinib/Nilotinib/Dasatinib. GIMEMA Study CML 1012 CML1012 N/A link
CML Front-line treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) with dasatinib. An observational multicentric study. CML1113 N/A link
CML An international field study for the reliability and validity of the Phase IV EORTC Quality of Life module for patients with Chronic Myeloid Leukemia (EORTC QLQ-CML24) GIMEMA/EORTC- QoLCML0916 N/A
CML The protein tyrosine kinase inhibitor nilotinib as first-line treatment of Ph+, BCR-ABL+ chronic myeloid leukemia (CML) in early chronic phase: a phase IIIb, multicenter study to assess the complete molecular response. A Prospective evaluation of Quality of Life Outcomes QoL CML0811 N/A
CML BOSUTINIB EFFICACY SAFETY TOLERABILITY (BEST) STUDY IN ELDERLY CHRONIC MYELOID LEUKEMIA PATIENTS FAILING FRONT-LINE TREATMENT WITH OTHER TYROSINE KINASE INHIBITORS: A Prospective evaluation of Quality of Life Outcomes CML1516)  QoL-BEST N/A
CML Mid to Long-term Quality of Life Effects Of imatiNIb versus DASatinib in Chronic Myeloid Leukemia Patients (LEONIDAS) QoL-CML0713 (LEONIDAS) N/A
CML Front-line treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) with dasatinib. An observational multicentric study. A Prospective evaluation of Quality of Life Outcomes QoL-CML1113 N/A
CML 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: AProspective evaluation of Quality of Life Outocmes QoL-OPUS N/A
GIMEMA / EORTC QLG PROMOTION Project Patient Reported Outcome Measurements Over Time In ONcology (PROMOTION) Project GIMEMA/EORTC QLG PROMOTION Project N/A link
GIMEMA/ASDOM Electronic data collection to improve quality of care in home-care treated patients PROJECT GIMEMA/ASDOM (ROMAIL) N/A
LLC An observational study to evaluate the clinical and biologic features and outcome of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) treated with venetoclax-based regimens outside clinical trials in Italy CLL1920 N/A link
LLC Observational study on the diagnosis and management of chronic lymphocytic leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche dell’Adulto (GIMEMA) CLL2121 N/A link
LLC Front-line venetoclax and obinutuzumab combination followed by venetoclax or venetoclax and zanubrutinib combination in patients with residual disease: a minimal residual disease (MRD) tailored treatment for young patients with high-risk cll. A phase 2 multicenter study (VIS trial) CLL2222 II link
LLC Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia (CLL) or CLL-like monoclonal B-cell lymphocytosis CLL2323 II link
LLC Incidence of severe COVID-19 infection in patients with chronic lymphocytic leukemia or indolent B-cell non-Hodgkin lymphoma who received pre-exposure prophylaxis with Tixagevimab and Cilgavimab in Italy: an observational study by the GIMEMA Working party on chronic lymphoproliferative disorders and by the Fondazione Italiana Linfomi CLL2423 N/A link
LLC Outcomes of unfit patients with Chronic Lymphocytyc Leukemia (CLL) included in the front-line GIMEMA LLC1114 trial who discontinued ibrutinib due to reasons other than disease progression: a multicenter retrospective/prospective observational study CLL2523 N/A link
LLC Biological and clinical efficacy of recombinant zoster vaccine (Shingrix) in patients with Chronic Lymphocytic Leukemia CLL2624 N/A link
MDS Prospective randomized study on the feasibility of allogeneic stem cell transplantation in higher-risk-myelodysplastic syndromes, performed upfront or preceded by azacitidine or conventional chemotherapy, according to the BM-blast proportion (ACROBAT trial) MDS0519 III link
MDS Molecular mechanisms of disease relapse after allogenic stem cell transplantation in patients with myelodysplastic syndrome MDS0620 N/A link
MDS Prognostic significance and longitudinal assessment ofPatient-Reported Outcomes in MYelodysplastic Syndromes (PROMYS):PROMYS International Registry PROMYS N/A
MM CLinical decision-making, prognosis, quAlity of life and satisfaction with caRe in patIents with relapsed/refracTory multiple mYeloma (CLARITY).  MM1016 N/A
PTI Italian Adult Immune Thrombocytopenia (ITP) Registry - Investigation on a dynamic cohort of Italian patients with active ITP ITP0918 N/A link
PTI Immune Thrombocytopenia (ITP) and COVID-19: national retrospective and prospective observational investigation on the incidence and course of COVID-19 in patients with prior, ongoing or de novo ITP. Evaluation of the impact of COVID-19 pandemic on the management of ITP ITP1021 N/A link
PTI Biologic characterization of patients with immune thrombocytopenia (ITP) ITP1222 N/A link

closed

Pathology Title Code Phase Clinicaltrials.gov
ALL Ponatinib for the management of minimal residual disease (MRD) and hematological relapse in adult Ph+ acute lymphoblastic leukemia (Ph+ ALL) patients ALL2620 II link
ALL Advancing chemical and genomic strategies for relapsed/refractory T-ALL and ETP-ALL ALL2720 N/A link
ALL A multicenter total therapy strategy for Adult de novo Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL). LAL1509 II link
ALL 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 II link
AML A Safety Run-In and Phase 2, Open-Label, Multicentre, Study investigating Safety, Tolerability and Effectiveness of venetoclax add in combination at fludarabine, cyratabine and idarubicine in induction therapy of new onset Non-M3 Acute Myeloid Leukemia AML1718 II link
AML Prospective and Retrospective Observational evaluation of Real World Outcome of Unfit Patients with Acute Myeloid Leukemia Treated with the Combination Venetoclax plus Hypomethylating Agents, under the Italian Law No.648/96 AML2320 N/A link
AML A Phase 2, prospective, multi-center intervention trial in patients with acute myeloid leukemia secondary to myeloproliferative neoplasms unfit for intensive chemotherapy investigating a treatment combination including decitabine and venetoclax ENABLE (vENetoclax plus decitAbine treatment in Blastic phase of myeLoproliferative nEoplasms) AML2420 II link
APL 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 III
CML Front-line nilotinib treatment of BCR-ABL+ Chronic Myeloid Leukaemia in chronic phase. An observational multicentre study of the GIMEMA CML WP CML0912 N/A link
CML 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 CML1315 II link
CML 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. CML1415 IV link
LLC Prospective study on the incidence of hepatitis B virus reactivation in untreated patients with diffuse Large B-Cell Lymphoma/Chronic Lymphoid Leukemia HBsAg-positive treated with Rituximab, Chemotherapy and Tenofovir Alafenamide CLL1818 II link
LLC Impact of treatment with targeted therapies on the generation of effective CAR T cells in patients with chronic lymphocytic leukemia CLL2020 N/A link
LLC A phase 2 multicenter study to assess the activity and the safety of front-line Ibrutinib plus Rituximab (IR) in unfit patients with Chronic Lymphocytic Leukemia (CLL) LLC1114 II link
LLC Phase II study of the combination of Ofatumumab and Ibrutinib followed by allogeneic bone marrow transplant or consolidation for pretreated high risk patients with Chronic Lymphocytic Leukemia LLC1215 II link
PTI 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 N/A link
PTI Real world evaluation among Italian centers of the activity and safety of Fostamatinib in consecutive adult patients with immune thrombocytopenia (ITP) ITP1122 N/A link