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