Studi Clinici
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 | |
Ponatinib for the management of minimal residual disease (MRD) and hematological relapse in adult Ph+ acute lymphoblastic leukemia (Ph+ ALL) patients | ALL2620 | ALL | ||||
Advancing chemical and genomic strategies for relapsed/refractory T-ALL and ETP-ALL | ALL2720 | ALL | ||||
|
AML2020 | AML | II | |||
|
AML2220 | AML | ||||
|
AML2320 | AML | ||||
|
CLL2020 | LLC | ||||
|
MDS0620 | MDS |
Aperto all'arruolamento
Titolo | Codice | Patologia | Fase | Clinicaltrials.gov | EudraCT | |
Studio di fase IIA sulla fattibilità e l’efficacia di Inotuzumab Ozogamicin (IO) in pazienti adulti con Leucemia Linfoblastica Acuta a cellule B con Malattia Minima Residua positiva prima di un trapianto di cellule staminali ematopoietiche
|
ALL2418 | ALL | II | |||
Monitoraggio dell'Attività dell'Asparaginasi (AAM) in pazienti adulti con Leucemia Linfoblastica Acuta (LAL) | ALL2518 | ALL | II | |||
LAL2217 | ALL | |||||
Occupational status and haematological disease: effects and counselling needs - EMATO 0113 |
EMATO0213 | Altri Oss | ||||
Risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia. A prospective evlaution of quality of life outcomes | AML1310 | AML | ||||
Italian Registry on the prevalence of IDH1/IDH2 mutations in Patients with Acute Myeloid Leukemia |
AML1516 | AML | ||||
Coinvolgimento del Sistema Nervoso Centrale (SNC) nella Leucemia Mieloide Acuta (LMA): uno studio osservazionale retrospettivo su pazienti precedentemente registrati negli studi clinici GIMEMA |
AML1617 | AML | ||||
Run-in di Sicurezza e Studio di Fase II in Aperto, Multicentrico, su Sicurezza, Tollerabilità ed Efficacia del Venetoclax in combinazione con Fludarabina, Citarabina e Idarubicina in induzione nella Leucemia Mieloide Acuta non-M3 di nuova diagnosi | AML1718 | AML | ||||
|
AML1819 | AML | III | |||
|
AML1919 | AML | III | |||
|
AML2120 | 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) | 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 | ||||
Observational study on number and outcome of pregnancy in childbearing age |
APL0511 | APL | ||||
|
APL0618 | APL | ||||
Studio randomizzato di fase III che compara triossido di arsenico (ATO) in combinazione con Acido All-trans retinoico (ATRA) e Idarubicina contro la terapia standard con ATRA e chemioterapia basata su antracicline (regime AIDA) in pazienti con nuova diagnosi di leucemia acuta promielocitica ad alto rischio ( APOLLO-TRIAL) |
APOLLO | APL | ||||
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 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 | ||||
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 | CML0811 | CML | ||||
Observational study of pregnancy in adult patients with chronic myeloid leukemia (CML)
|
CML1012 | CML | ||||
Front-line treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) with dasatinib. An |
CML1113 | CML | ||||
Ponatinib survey: valutazione retrospettiva dei pazienti italiani inclusi nel programma di uso compassionevole o secondo legge 648/96 |
CML1214 | 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 | CML | IV | |||
“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 | ||||
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 | ||||
|
CLL1818 | LLC | II | |||
|
CLL1920 | LLC | ||||
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 | ||||
|
MDS0519 | MDS | III | |||
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 | ||||
|
ITP0918 | PTI |
Chiuso all'arruolamento
Titolo | Codice | Patologia | Fase | Clinicaltrials.gov | EudraCT |
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://lal1408.opisprojects.com/ | |
A multicenter total therapy strategy for Adult de novo Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL). | LAL1509 | 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 | ||
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 | ||
D-ALBA Trattamento continuo di prima linea con Dasatinib ed anticorpo monoclonale bispecifico Blinatumomab in pazienti adulti con Leucemia Acuta Linfoblastica (LAL) Philadelphia Positiva (Ph+) |
LAL2116 | ALL | II | ||
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 | ||
Confronto tra terapia con decitabina della durata di 10 giorni rispetto alla chemioterapia convenzionale (“3+7”) seguita da trapianto allogenico in pazienti con AML ≥ 60 anni: studio di fase III randomizzato del Leukemia Group di EORTC, CELG, GIMEMA e del gruppo di studio tedesco sulle SMD. | AML1301 EORTC | AML | III | ||
Front-line nilotinib treatment of BCR-ABL+ Chronic Myeloid Leukaemia in chronic phase. An |
CML0912 | CML | |||
Optimizing Ponatinib USe (OPUS). Studio GIMEMA di fase 2 sull’efficacia e sul profilo di rischio di ponatinib, 30 mg al giorno, in pazienti con Leucemia Mieloide Cronica (LMC) in Fase Cronica, resistenti all’Imatinib. |
CML1315 | CML | II | ||
STUDIO DI EFFICACIA, SICUREZZA E TOLLERABILITÀ DI BOSUTINIB (BEST) IN PAZIENTI ANZIANI AFFETTI DA LEUCEMIA MIELOIDE CRONICA RESISTENTI AL TRATTAMENTO DI PRIMA LINEA CON ALTRI FARMACI INIBITORI DELLA TIROSIN-CHINASI |
CML1516 | CML | II | ||
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 | ||
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 | ||
Attività e sicurezza dell’associazione di Venetoclax e Rituximab (VeRiTAs) in prima linea in pazienti giovani e fit con leucemia linfatica cronica (LLC) non IGHV mutati e/o TP53 mutati. Studio multicentrico di fase II |
LLC1518 | LLC | II | ||
Eltrombopag in patients with delayed post transplant thrombocytopenia. |
ITP0511 | PTI | II | ||
Tasso di risposta e durata della risposta dopo l’interruzione del trattamento con gli agonisti del recettore della trombopoietina (TPO-RA) nei pazienti affetti da trombocitopenia immune primitiva (pITP): studio retrospettivo. | ITP0714 | PTI | |||
Eltrombopag come terapia di seconda linea in pazienti adulti con piastrinopenia immune primitiva (studio ESTIT) al fine di raggiungere la risposta a lungo termine: studio biologico e clinico di fase II multicentrico a singolo braccio |
ITP0815 | PTI | II |
Chiuso
Titolo | Codice | Patologia | Fase | Clinicaltrials.gov | EudraCT |
Terapia "geriatric assessment adapted" per il trattamento della Leucemia Acuta Linfoblastica Ph negativa dell'anziano. | LAL1104 | ALL | |||
Terapia della Leucemia Linfoide Acuta (LLA) del Giovane Adulto: intensificazione del trattamento secondo il protocollo pediatrico AIEOP LLA-2000 | LAL1308 | ALL | https://lal1308.opisprojects.com/ | ||
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 | ||
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 | |||
Occupational status and haematological disease: effects and counselling needs | EMATO0113 | Altri Oss | |||
An open label phase II trial of Clofarabine and Temsirolimus in older patients with relapsed or refractory Acute Myeloid Leukemia (AML) |
AML1107 | AML | |||
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 | |||
"Risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia". GIMEMA Protocol AML1310 |
AML1310 | AML | |||
Studio prospettico sulle infezioni gravi in pazienti giovani inclusi in uno |
AML1411 | AML | |||
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 | |||
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 | |||
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 |
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 | |||
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 | |||
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 | |||
Long term follow-up of Ph+ CML patients achieving complete cytogenetic remission with Interferon based therapy |
CML0509 | 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. GIMEMA Protocol CML0811 - EudraCT number 2011-002787-25 |
CML0811 | CML | III | ||
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 | |||
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 | |||
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 | |||
A Single-Arm Multi-Center Trial of Bendamustine given with Ofatumumab (BendOfa) in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia (CLL) | LLC0809 | LLC | |||
Studio multicentrico di fase II per valutare efficacia e sicurezza della chemioimmunoterapia di prima linea con fludarabina, ciclofosfamide e ofatumumab (FCO2) in pazienti giovani (≤65 anni) con leucemia linfocitica cronica (CLL) |
LLC0911 | LLC | |||
Studio retrospettivo per valutare efficacia e sicurezza della associazione di chlorambucil e rituximab come terapia di prima linea in pazienti anziani e/o unfit con leucemia linfatica cronica B |
LLC1013 | LLC | |||
Studio osservazionale per valutare efficacia e sicurezza dell’associazione di bendamustina e rituximab in pazienti affetti da leucemia linfatica cronica | LLC1315 | LLC | |||
Studio retrospettivo per valutare outcome e caratteristiche clinico-biologiche di pazienti trattati in Italia secondo l’Ibrutinib-Named Patient Program (NPP) con leucemia linfatica cronica (LLC) recidivi o refrattari | LLC1415 | LLC | |||
Efficacia e sicurezza in pazienti con Leucemia Linfatica Cronica (LLC) trattati con idelalisib e rituximab nella pratica clinica: uno studio GIMEMA-ERIC | LLC1718 | LLC | |||
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 | |||
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 | ||
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 | |||
Validation of a Myelodysplasia-Specific Measure of Quality of Life |
MDS0613 (QUALMS) | MDS | |||
Ciclo breve di Bortezomib in pazienti anemici con crioagglutinemia refrattaria. CAD0111. EudraCT number 2011-006329-42 |
CAD0111 | PTI | |||
Clinical Practice in the prophylaxis and treatment of arterial and venous thromboembolism in patients with hEmatological NEoplasms and LOw PlatElets (PENELOPE Observational Study) |
EMATO0213 | PTI | |||
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 | ||
Retrospective evaluation of rate and risk factors of throbotic events in patients with primary immune thrombocytopenia. |
ITP0311 | PTI | |||
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 |