Elenco studi GIMEMA
Per attivare un nuovo studio, di cui il Promotore sia la Fondazione GIMEMA, è necessario seguire alcune procedure:
- presentazione della proposta al Working Party (WP) specifico per la patologia oggetto dello Studio;
- approvazione da parte del WP;
- invio al Centro Dati del modulo “nuova proposta” con allegata una breve sinossi dello Studio.
In fase di apertura
Titolo | Codice | Patologia | Fase | Clinicaltrials.gov | EudraCT |
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 | LLC | II | https://www.clinicaltrials.gov/ct2/show/NCT05478512 | |
Ibrutinib for the Treatment of Autoimmune Hemolytic Anemia in Patients With Chronic Lymphocytic Leukemia (CLL) or CLL-like monoclonal B-cell lymphocytosis |
CLL2323 | LLC | II | https://www.clinicaltrials.gov/ct2/show/NCT05694312 | |
Real world evaluation among Italian centers of the activity and safety of Fostamatinib in consecutive adult patients with immune thrombocytopenia (ITP) | ITP1122 | PTI | https://www.clinicaltrials.gov/ct2/show/NCT05613296 | ||
Biologic characterization of patients with immune thrombocytopenia (ITP) |
ITP1222 | PTI | https://www.clinicaltrials.gov/ct2/show/NCT05694325 |
Aperto all'arruolamento
Titolo | Codice | Patologia | Fase | Clinicaltrials.gov | EudraCT |
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 | ALL | II | https://www.clinicaltrials.gov/ct2/show/NCT03610438 | |
Ponatinib for the management of minimal residual disease (MRD) and hematological relapse in adult Ph+ acute lymphoblastic leukemia (Ph+ ALL) patients | ALL2620 | ALL | II | https://www.clinicaltrials.gov/ct2/show/NCT04475731 | |
Advancing chemical and genomic strategies for relapsed/refractory T-ALL and ETP-ALL | ALL2720 | ALL | https://www.clinicaltrials.gov/ct2/show/NCT04582487 | ||
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 | ALL | III | https://www.clinicaltrials.gov/ct2/show/NCT04722848 | |
Combination of Ponatinib Plus Chemotherapy As Frontline Treatment For Patients With BCR/ABL1-Like Acute Lymphoblastic Leukemia (BCR/ABL1-Like ALL) - BALLik |
ALL2922 | ALL | II | https://www.clinicaltrials.gov/ct2/show/NCT05306301 | |
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 | ALL | https://www.clinicaltrials.gov/ct2/show/NCT03318770 | ||
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 | AML | III | https://www.clinicaltrials.gov/ct2/show/NCT04168502 | |
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 | AML | III | https://www.clinicaltrials.gov/ct2/show/NCT04174612 | |
Tagraxofusp in Patients with CD123+ or with Blastic Plasmacytoid Dendritic Cell Neoplasm Immunophenotype-like Acute Myeloid Leukemia | AML2020 | AML | II | https://www.clinicaltrials.gov/ct2/show/NCT04342962 | |
A Prospective Multicentre Observational Study for the evaluation of clinical-hematological characteristics of familial Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDSs) |
AML2120 | AML | https://www.clinicaltrials.gov/ct2/show/NCT04460950 | ||
Role of adrenomedullin in leukemic endosteal/vascualr niches | AML2220 | AML | https://www.clinicaltrials.gov/ct2/show/NCT04460963 | ||
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 | AML | https://www.clinicaltrials.gov/ct2/show/NCT04589728 | ||
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 | AML | II | https://www.clinicaltrials.gov/ct2/show/NCT04763928 | |
A Multicentric Phase 2 Study of venetoclax and azacitidine for the management of molecular relapse/progression in adult NPM1-mutated Acute Myeloid Leukemia | AML2521 | AML | II | https://www.clinicaltrials.gov/ct2/show/NCT04867928 | |
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) | 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 | AML | |||
Treatment newly diagnosed patients with Acute Promyelocytic Leukemia, aged >12 months and <75 years, using All-Trans Retinoic Acid in combination with Idarubicin |
AIDA0493 | APL | |||
GUIDELINES for the treatment of Acute Promyelocytic Leukemia |
AIDA2000 | 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 | APL | https://www.clinicaltrials.gov/ct2/show/NCT03751917 | ||
Long Term Quality of Life Symptom Burden in Acute Promyelocytic Leukemia (APL) Patients Treated with Arsenic Trioxide (ATO) or Standard Chemotherapy | QoL-APL0816 | 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 | APL | |||
Observational study of pregnancy in adult patients with chronic myeloid leukemia (CML) treated with Imatinib/Nilotinib/Dasatinib. GIMEMA Study CML 1012
|
CML1012 | CML | https://www.clinicaltrials.gov/ct2/show/NCT01752062 | ||
Front-line treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) with dasatinib. An observational multicentric study. |
CML1113 | CML | https://www.clinicaltrials.gov/ct2/show/NCT01761890 | ||
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 | 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 | 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 |
QoL-BEST | CML | |||
Mid to Long-term Quality of Life Effects Of imatiNIb versus DASatinib in Chronic Myeloid Leukemia Patients (LEONIDAS) | QoL-CML0713 (LEONIDAS) | 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 | 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 | CML | |||
Patient Reported Outcome Measurements Over Time In ONcology (PROMOTION) Project | GIMEMA/EORTC QLG PROMOTION Project | GIMEMA / EORTC QLG PROMOTION Project | http://promotionproject.gimema.it/ | ||
Electronic data collection to improve quality of care in home-care treated patients | PROJECT GIMEMA/ASDOM (ROMAIL) | GIMEMA/ASDOM | |||
A retrospective and prospective study to evaluate the clinical and biologic features and outcome of patients with relapsed or refractory chronic lymphocytic leukemia (CLL) treated with venetoclax outside clinical trials in Italy |
CLL1920 | LLC | https://www.clinicaltrials.gov/ct2/show/NCT04282811 | ||
Impact of treatment with targeted therapies on the generation of effective CAR T cells in patients with chronic lymphocytic leukemia |
CLL2020 | LLC | https://www.clinicaltrials.gov/ct2/show/NCT04640909 | ||
Observational study on the diagnosis and management of chronic lymphocytic leukemia (CLL) in Italy by Gruppo Italiano Malattie EMatologiche dell’Adulto (GIMEMA) |
CLL2121 | LLC | https://www.clinicaltrials.gov/ct2/show/NCT04867915 | ||
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 | MDS | III | https://www.clinicaltrials.gov/ct2/show/NCT04184505 | |
Molecular mechanisms of disease relapse after allogenic stem cell transplantation in patients with myelodysplastic syndrome |
MDS0620 | MDS | https://www.clinicaltrials.gov/ct2/show/NCT04587856 | ||
Prognostic significance and longitudinal assessment ofPatient-Reported Outcomes in MYelodysplastic Syndromes (PROMYS):PROMYS International Registry | PROMYS | MDS | |||
CLinical decision-making, prognosis, quAlity of life and satisfaction with caRe in patIents with relapsed/refracTory multiple mYeloma (CLARITY). | MM1016 | MM | |||
Italian Adult Immune Thrombocytopenia (ITP) Registry - Investigation on a dynamic cohort of Italian patients with active ITP |
ITP0918 | PTI | https://www.clinicaltrials.gov/ct2/show/NCT03465020 | ||
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 | PTI | https://www.clinicaltrials.gov/ct2/show/NCT04735588 |
Chiuso all'arruolamento
Titolo | Codice | Patologia | Fase | Clinicaltrials.gov | EudraCT |
A multicenter total therapy strategy for Adult de novo Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL). | LAL1509 | ALL | II | https://www.clinicaltrials.gov/ct2/show/NCT01361438 | |
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 | II | https://www.clinicaltrials.gov/ct2/show/NCT03367299 | |
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 EORTC | AML | III | ||
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 | AML | II | https://www.clinicaltrials.gov/ct2/show/NCT03455504 | |
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 | III | ||
Front-line nilotinib treatment of BCR-ABL+ Chronic Myeloid Leukaemia in chronic phase. An observational multicentre study of the GIMEMA CML WP |
CML0912 | CML | https://www.clinicaltrials.gov/ct2/show/NCT01699217 | ||
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 | CML | II | https://www.clinicaltrials.gov/ct2/show/NCT02398825 | |
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 | CML | IV | https://www.clinicaltrials.gov/ct2/show/NCT02602314 | |
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 | LLC | II | https://www.clinicaltrials.gov/ct2/show/NCT03804372 | |
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 | LLC | II | https://www.clinicaltrials.gov/ct2/show/NCT02232386 | |
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 | LLC | II | https://www.clinicaltrials.gov/ct2/show/NCT02388048 | |
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 | LLC | II | https://www.clinicaltrials.gov/ct2/show/NCT03455517 | |
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 | PTI | https://www.clinicaltrials.gov/ct2/show/NCT02298075 |
Chiuso
Titolo | Codice | Patologia | Fase | Clinicaltrials.gov | EudraCT |
Asparaginase Activity Monitoring (AAM) in adult patients with Acute Lymphoblastic Leukemia (ALL) |
ALL2518 | ALL | II | https://www.clinicaltrials.gov/ct2/show/NCT03668392 | |
Terapia "geriatric assessment adapted" per il trattamento della Leucemia Acuta Linfoblastica Ph negativa dell'anziano. | LAL1104 | ALL | II | https://www.clinicaltrials.gov/ct2/show/NCT00475280 | |
Terapia della Leucemia Linfoide Acuta (LLA) del Giovane Adulto: intensificazione del trattamento secondo il protocollo pediatrico AIEOP LLA-2000 | LAL1308 | ALL | https://www.clinicaltrials.gov/ct2/show/NCT01156883 | ||
Front-line treatment of Ph positive (Ph+)/Bcr-Abl positive Acute Lymphoblastic Leukemia (ALL) with two tyrosine kinase inhibitors (TKI) (Imatinib and Nilotinib). A phase II exploratory multicentric study in elderly patients and in patients unfit for program of intensive therapy and allogeneic stem cell transplantation. | LAL1408 | ALL | II | https://www.clinicaltrials.gov/ct2/show/NCT01025505 | |
A Phase II study with a sequential clofarabine-cyclophosphamide combination schedule as salvage therapy for refractory and relapsed acute lymphoblastic leukemia (ALL) in adult patients. | LAL1610 | ALL | II | https://www.clinicaltrials.gov/ct2/show/NCT01462253 | |
Front-line treatment of Philadelphia positive (Ph+)/BCR-ABL positive Acute Lymphoblastic Leukemia (ALL) with AP24534 (Ponatinib), a new potent tyrosine kinase inhibitor (TKI). A phase II exploratory multicentric study in patients more than 60 years old or unfit for a program of intensive chemotherapy and stem cell transplantation
|
LAL1811 | ALL | II | ||
National Treatment Program of Philadelphia Chromosome-negative Adult Acute Lymphoblastic Leukemia with Pegylated Asparaginase Added to a Lineage-Targeted Risk- and Minimal Residual Disease-Oriented Strategy |
LAL1913 | ALL | II | https://www.clinicaltrials.gov/ct2/show/NCT02067143 | |
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 | ALL | I | https://www.clinicaltrials.gov/ct2/show/NCT02185781 | |
Front-Line Sequential Treatment of Adult Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL) Patients with Dasatinib and the Bispecific Monoclonal Antibody Blinatumomab |
LAL2116 | ALL | II | https://www.clinicaltrials.gov/ct2/show/NCT02744768 | |
Occupational status and haematological disease: effects and counselling needs | EMATO0113 | Altri Oss | https://www.clinicaltrials.gov/ct2/show/NCT02057185 | ||
Clinical Practice in the prophylaxis and treatment of arterial and venous thromboembolism in patients with hEmatological NEoplasms and LOw PlatElets (PENELOPE Observational Study) |
EMATO0213 | Altri Oss | https://www.clinicaltrials.gov/ct2/show/NCT01855698 | ||
Use of Neutralizing Monoclonal Antibodies for the treatment of COVID-19 in patients with Hematological Malignancies (SIE-GIMEMA Study) |
EMATO0321 | Altri Oss | https://www.clinicaltrials.gov/ct2/show/NCT04932967 | ||
An open label phase II trial of Clofarabine and Temsirolimus in older patients with relapsed or refractory Acute Myeloid Leukemia (AML) | AML1107 | AML | https://www.clinicaltrials.gov/ct2/show/NCT00775593 | ||
The value of high dose vs standard dose Ara-C during induction and of IL-2 after intensive consolidation/autologous stem cell transplantation in patients (age 15 - 60 yrs) with acute myelogenous leukaemia. A randomized phase III trial of the EORTC AND GIMEMA LEUKEMIA GROUPS | AML12 | AML | |||
A phase I study investigating the combination of RAD001 with standard induction and consolidation therapy in older patients with newly diagnosed acute myeloid leukemia (AML) | AML1208 | AML | I | https://www.clinicaltrials.gov/ct2/show/NCT01154439 | |
"Risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia". GIMEMA Protocol AML1310 |
AML1310 | AML | https://www.clinicaltrials.gov/ct2/show/NCT01452646 | ||
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 | https://www.clinicaltrials.gov/ct2/show/NCT01570465 | ||
Clofarabine in combination with a standard remission induction regimen (AraC and idarubicin) in patients 18-60 years old with previously untreated intermediate and bad risk acute myelogenous leukemia (AML) or high risk myelodysplasia (MDS): a phase I-II study of the EORTC-LG and GIMEMA (AML-14A trial) | AML14A | AML | |||
Italian Registry on the prevalence of IDH1/IDH2 mutations in Patients with Acute Myeloid Leukemia |
AML1516 | AML | https://www.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 | https://www.clinicaltrials.gov/ct2/show/NCT03410407 | ||
Gemtuzumab ozogamicin (GO) combined with standard intensive chemotherapy versus standard intensive chemotherapy alone for induction/consolidation in patients 61-75 years old with previously untreated AML: a randomized phase III trial (AML-17) of the EORTC-LG and the GIMEMA-ALWP. | AML17 | AML | |||
Gemtuzumab Ozogamicin (GO) monotherapy versus standard supportive care for previously untreated AML in elderly patients who are not eligible for intensive chemotherapy: a randomized phase II/III trial (AML-19) of the EORTC-LG and GIMEMA-ALWP | AML19 | AML | |||
“A Phase III Randomized, Double-Blind Study of Induction (Daunorubicin/Cytarabine) and Consolidation (High-Dose Cytarabine) Chemotherapy + Midostaurin (PKC412) (IND # 101261) or Placebo in Newly Diagnosed Patients < 60 Years of Age with FLT3 Mutated Acute Myeloid Leukemia (AML)”, NCI Protocol #: CALGB-10603, Novartis code CPKC412A2301, EUDRACT 2006-006852-37 | CPKC412A2301 | AML | |||
A randomised phase III study to compare arsenic trioxide (ATO) combined to ATRA versus standard ATRA and anthracycline-based chemotherapy (AIDA regimen) for newly diagnosed, non high-risk acute promyelocytic leukaemia. | APL0406 | APL | III | https://www.clinicaltrials.gov/ct2/show/NCT00482833 | |
Observational study on number and outcome of pregnancy in childbearing age female patients treated with chemotherapy for APL (studies AIDA0493, AIDA2000) |
APL0511 | APL | https://www.clinicaltrials.gov/ct2/show/NCT01472107 | ||
A randomised phase III study to compare arsenic trioxide (ATO) combined to ATRA versus standard ATRA and anthracycline-based chemotherapy (AIDA regi-men) for newly diagnosed, non high-risk acute promyelocytic leukemia (APL0406): Investigating long-term quality of life outcomes |
QoL APL0406 | APL | |||
Long-term quality of Life and late complications in survivors of Acute Promyelocytic Leukemia (APL) treated with ATRA and standard chemotherapy. Long-term follow-up of patients treated in the GIMEMA AIDA 0493 and AIDA 2000 |
QoL-APL0512 | APL | |||
I protocolli per il trattamento delle LAP di cui la Fondazione GIMEMA è sponsor, sono 3. |
Schema riassuntivo APL | APL | |||
Phase II multicenter study of P210-B3A2 derived peptide vaccine in Chronic Myeloid Leukemia patients in complete cytogenetic response with persistent molecular residual disease during imatinib treatment |
CML0206 | CML | https://www.clinicaltrials.gov/ct2/show/NCT00466726 | ||
The protein tyrosine kinase inhibitor nilotinib as first-line treatment of Ph+ chronic myeloid leucemia (CML) in early chronic phase: a Phase II exploratory, multicenter study | CML0307 | CML | II | https://www.clinicaltrials.gov/ct2/show/NCT00481052 | |
Front-line treatment of Philadelphia positive (Ph pos), BCRABL positive, chronic myeloid leukemia (CML) with two tyrosine kinase inhibitors (TKI) (Nilotinib and Imatinib). A phase II exploratory multicentric study. | CML0408 | CML | II | https://www.clinicaltrials.gov/ct2/show/NCT00769327 | |
Long term follow-up of Ph+ CML patients achieving complete cytogenetic remission with Interferon based therapy | CML0509 | CML | https://www.clinicaltrials.gov/ct2/show/NCT01490853 | ||
Observational study in adult patients with Imatinib-resistant or intolerant chronic myeloid leukemia (CML) treated with Nilotinib. Follow-up of the Italian patients. GIMEMA Study CML0609 | CML0609 | CML | https://www.clinicaltrials.gov/ct2/show/NCT01475110 | ||
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. GIMEMA Protocol CML0811 |
CML0811 | CML | III | https://www.clinicaltrials.gov/ct2/show/NCT01535391 | |
Ponatinib survey: valutazione retrospettiva dei pazienti italiani inclusi nel programma di uso compassionevole o secondo legge 648/96 |
CML1214 | CML | https://www.clinicaltrials.gov/ct2/show/NCT02448095 | ||
Bosutinib Efficacy Safety Tolerability (BEST) study in elderly Chronic Myeloid Laukemia patients failing front-line treatment with other Tyrosine Kinase Inhibitors |
CML1516 | CML | II | https://www.clinicaltrials.gov/ct2/show/NCT02810990 | |
Mid-to Long-Term Outcomes in Chronic Myeloid Leukemia Patients with Complete Cytogenetic Response Treated with Imatinib as First Line Therapy: Health-Related Quality of Life, Symptom Burden and Adherence to Therapy Issues. |
GIMEMA QoL-CML0208 | CML | |||
Patient Reported Outcomes in Chronic Myeloid Leukemia |
GIMEMA/EORTC QoL - CML0310 | CML | |||
Health-related Quality of Life and Fatigue in adult patients with primary Immune Thrombocytopenic Purpura (pITP). | GIMEMA QoL-ITP0411 | ITP | |||
Studio pilota di fase II per la valutazione di una strategia terapeutica diversificata sulla base del profilo biologico in pazienti con Leucemia Linfatica Cronica (LLC) in stadio avanzato e/o progressiva di età < 60 anni | LLC0405 | LLC | https://www.clinicaltrials.gov/ct2/show/NCT00462332 | ||
Studio osservazionale multicentrico descrittivo sulle modalità di impiego della fludarabina orale in pazienti affetti da leucemia linfatica cronica (LLC) | LLC0505 | LLC | |||
A prospective multicenter pilot phase I-II trial to evaluate the efficacy of a treatment with Fludarabine, Cyclophosphamide, Lenalidomide (FCL) for advanced relapsed/refractory chronic lymphocytic leukemia (CLL) patients | LLC0606 | LLC | https://www.clinicaltrials.gov/ct2/show/NCT00727415 | ||
Phase I-II multicenter study to assess the efficacy and safety of the Chlorambucil plus Lenalidomide combination and Lenalidomide maintenance therapy in untreated elderly patients with Chronic Lymphocytic Leukemia (CLL) | LLC0709 | LLC | I/II | https://www.clinicaltrials.gov/ct2/show/NCT01403246 | |
A Single-Arm Multi-Center Trial of Bendamustine given with Ofatumumab (BendOfa) in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia (CLL) | LLC0809 | LLC | II | https://www.clinicaltrials.gov/ct2/show/NCT01244451 | |
Phase 2 multicenter, study to assess the efficacy and the safety of front-line Fludarabine, Cyclophoshamide and Ofatumumab (FCO2) chemoimmunotherapy in young (=65 yrs) patients with Chronic Lymphocytic Leukemia (CLL). GIMEMA Study CLL0911 | LLC0911 | LLC | II | https://www.clinicaltrials.gov/ct2/show/NCT01762202 | |
A retrospective study to assess the efficacy and safety of Chlorambucil plus Rituximab (Chl-R) as front-line therapy in elderly and/or unfit patients affected by B-cell Chronic Lymphocytic Leukemia (B-CLL) |
LLC1013 | LLC | https://www.clinicaltrials.gov/ct2/show/NCT01862445 | ||
An observational study to assess the efficacy and safety of bendamustine plus rituximab in patients affected by chronic lymphocytic leukemia |
LLC1315 | LLC | https://www.clinicaltrials.gov/ct2/show/NCT02491398 | ||
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 | LLC | https://www.clinicaltrials.gov/ct2/show/NCT02582320 | ||
Studio osservazionale retrospettivo multicentrico per valutare l’incidenza della riattivazione dell’Epatite B in pazienti affetti da Leucemia Linfatica Cronica (LLC) trattati con Ibrutinib | LLC1618 | LLC | https://www.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 | LLC | https://www.clinicaltrials.gov/ct2/show/NCT03545035 | ||
A open label, phase II, non randomized, clinical trial of chemotherapy treatment with 5-Azacytidine plus valproic acid and eventually atra for patients diagnosed with Intermediate II and high risk Myelodysplastic syndrome (MDS) | MDS0205 | MDS | II | https://www.clinicaltrials.gov/ct2/show/NCT00439673 | |
Studio multicentrico, in aperto per la valutazione di sicurezza/tollerabilità ed efficacia di Deferasirox (ICL670) in pazienti con Sindrome Mielodisplastica e con emosiderosi cronica trasfusionale. | MDS0306 | MDS | III | https://www.clinicaltrials.gov/ct2/show/NCT00469560 | |
Studio prospettico multicentrico, non interventistico, per la valutazione del rischio infettivo in pazienti affetti da sindrome mielodisplastica: utilità della profilassi antimicrobica e dei fattori di crescita granulocitari |
MDS0413 | MDS | https://www.clinicaltrials.gov/ct2/show/NCT01951430 | ||
Validation of a Myelodysplasia-Specific Measure of Quality of Life |
MDS0613 (QUALMS) | MDS | |||
Short course of Bortezomib in transfusion-dependent patients with refractory cold agglutinin disease |
CAD0111 | PTI | II | https://www.clinicaltrials.gov/ct2/show/NCT01696474 | |
Randomized study for the treatment of primary Immune Thrombocytopenic Purpura (ITP) in newly diagnosed untreated adult patients. Comparison of standard dose prednisone versus high-dose Dexamethasone. GIMEMA Protocol ITP 0207 | ITP0207 | PTI | III | https://www.clinicaltrials.gov/ct2/show/NCT00657410 | |
Retrospective evaluation of rate and risk factors of throbotic events in patients with primary immune thrombocytopenia. |
ITP0311 | PTI | |||
Eltrombopag in patients with delayed post transplant thrombocytopenia |
ITP0511 | PTI | II | https://www.clinicaltrials.gov/ct2/show/NCT01791101 | |
Impiego dei TPO-mimetici come terapia di preparazione alla splenectomia in pazienti adulti affetti da piastrinopenia immune primitiva (primary immune thrombocytopenia, ITP). Studio osservazionale retrospettivo Brooklyn |
ITP0614 | PTI | https://www.clinicaltrials.gov/ct2/show/NCT02063763 | ||
Eltrombopag as Second line Therapy in adult patients with primary Immune Thrombocytopenia (ESTIT study) in an attempt to achieve long-term remission: a single arm multicenter phase II clinical and biological study |
ITP0815 | PTI | II | https://www.clinicaltrials.gov/ct2/show/NCT02402998 |