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.
Modulo per la sottomissione di una nuova proposta

 

In fase di apertura

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
Monitoraggio dell'Attività dell'Asparaginasi (AAM) in pazienti adulti con Leucemia Linfoblastica Acuta (LAL) ALL2518 ALL

 

Aperto all'arruolamento

Titolo Codice Patologia Fase Clinicaltrials.gov EudraCT
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

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

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
Occupational status and haematological disease: effects and counselling needs - EMATO 0113

EMATO0213 Altri Oss

Italian Registry on the prevalence of IDH1/IDH2 mutations in Patients with Acute Myeloid Leukemia

AML 1516 AML
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
Risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia. A prospective evlaution of quality of life outcomes AML1310 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

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


AIDA 0493 - pazienti anziani APL
GUIDELINES for the treatment of Acute Promyelocytic Leukemia



AIDA 2000 APL

Observational study on number and outcome of pregnancy in childbearing age
female patients treated with chemotherapy for APL (studies AIDA0493, AIDA2000)

APL0511 - Studio osservazionale 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-TRIAL 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
CML 0609 - Studio osservazionale CML

Front-line nilotinib treatment of BCR-ABL+ Chronic Myeloid Leukaemia in chronic phase. An
observational multicentre study of the GIMEMA CML WP

CML 0912 - studio osservazionale CML

Observational study of pregnancy in adult patients with chronic myeloid leukemia (CML)
treated with Imatinib/Nilotinib/Dasatinib. GIMEMA Study CML 1012

CML 1012 - Studio osservazionale CML

Front-line treatment of BCR-ABL+ Chronic Myeloid Leukemia (CML) with dasatinib. An
observational multicentric study.

CML 1113 - studio osservazionale 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.

CML 1315 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.

CML 1415 CML

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

CML 1516 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

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 
CML1516) 

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 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).

GIMEMA Study LLC1114 - EudraCT number 2014-002714-23

LLC 1114 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 LLC 1415 LLC
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
LLC 1518 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 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
Efficacia e sicurezza in pazienti con Leucemia Linfatica Cronica (LLC) trattati con idelalisib e rituximab nella pratica clinica: uno studio GIMEMA-ERIC LLC1718 LLC

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

MDS 0413 MDS
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

Eltrombopag in patients with delayed post transplant thrombocytopenia.

EudraCT number 2011-004608-39 NCT 01791101

Study Phase: II

Objectives: 

The primary objective of this study is to evaluate the effect of eltrombopag in increasing the platelet count in patients with post SCT delayed thrombocytopenia.

Secondary objectives are:

  • Safety profile;
  • Overall survival (OS);
  • Bleeding events;
  • Incidence of bleeding events;
Exploratory objectives
  • Relationship between baseline TPO serum level and response to therapy; 
  • Modifications of T-reg activity during therapy.

Study duration:

48 months (12 months for patients enrolment plus 24 months of treatment and 12 months of follow up).

 

ITP 0511 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

 

Chiuso all'arruolamento

Titolo Codice Patologia Fase Clinicaltrials.gov EudraCT

 

Chiuso

Titolo Codice Patologia Fase Clinicaltrials.gov EudraCT
Terapia "geriatric assessment adapted" per il trattamento della Leucemia Acuta Linfoblastica Ph negativa dell'anziano. LAL 1104 ALL
Terapia della Leucemia Linfoide Acuta (LLA) del Giovane Adulto: intensificazione del trattamento secondo il protocollo pediatrico AIEOP LLA-2000 LAL 1308 ALL https://lal1308.opisprojects.com/
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. LAL 1408 ALL https://lal1408.opisprojects.com/
A multicenter total therapy strategy for Adult de novo Philadelphia Chromosome Positive (Ph+) Acute Lymphoblastic Leukemia (ALL). LAL 1509 ALL
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. LAL 1610 ALL

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.



LAL 1811 ALL

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

LAL 1913 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)
AML 1107 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) AML 1208 AML

Studio prospettico sulle infezioni gravi in pazienti giovani inclusi in uno
studio multicentrico sulla terapia della leucemia mieloide acuta all’esordio
basata sulla determinazione della malattia minima residua

AML 1411 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)
AML 14A 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

"Risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia". GIMEMA Protocol AML1310

AML1310 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. APL 0406 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.
In allegato uno schema riassuntivo per facilitare la scelta sulla base delle caratteristiche dei pazienti.

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
CML 0206 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 CML 0307 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. CML 0408 CML
Long term follow-up of Ph+ CML patients achieving complete
cytogenetic remission with Interferon based therapy
CML 0509 - Studio Osservazionale 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

CML 0811 CML

Ponatinib survey: valutazione retrospettiva dei pazienti italiani inclusi nel programma di uso compassionevole o secondo legge 648/96

CML1214 - Osservazionale CML

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.
LLC 0405 LLC
Studio osservazionale multicentrico descrittivo sulle modalità di impiego della fludarabina orale in pazienti affetti da leucemia linfatica cronica (LLC) LLC 0505 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 LLC 0606 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)
LLC 0709 LLC
A Single-Arm Multi-Center Trial of Bendamustine given with Ofatumumab (BendOfa) in Patients With Refractory or Relapsed Chronic Lymphocytic Leukemia (CLL) LLC 0809 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)
EudraCT number 2011-005329-27 Clinical Trial Number NCT01762202

Fase dello studio: II

Obiettivi:
L’obiettivo primario dello studio è quello di valutare l’efficacia del trattamento di prima scelta FCO2 in termini di percentuale di remissione completa (linee guida IWCLL 2008).

Gli obiettivi secondari sono:

- Risposta globale del trattamento di prima linea con FCO2.
- Sopravvivenza libera da progressione di malattia.
- Tempo ad un nuovo trattamento.
- Sopravvivenza globale.
- Tossicità del trattamento di prima linea con FCO2
- Tossicità in termini di granulocitopenia di grado 3-4;
- L’outcome (percentuale globale di risposte, sopravvivenza libera da progressione di malattia, tempo ad un nuovo trattamento, sopravvivenza globale) secondo le variabili cliniche e biologiche (età, dimensione dei linfonodi, b2-microglobulina, conta dei linfociti, IGVH, p53, NOTCH1, SF3B1, BIRC3, ZAP-70, CD38, CD49d, FLCs, FDG-uptake, istologia dei linfonodi).

Disegno dello studio:

Studio multicentrico di fase II, non comparativo indirizzato alla valutazione dell’efficacia e tossicità della combinazione fludarabina e ciclofosfamide (FC) associata all’anticorpo monoclonale ofatumumab (FCO2) in pazienti giovani non precedentemente trattati affetti da leucemia linfocitica cronica (LLC).

LLC 0911 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

Tipo di studio: osservazionale, retrospettivo

Obiettivi:

Efficacia e sicurezza della combinazione chlorambucil-rituximab somministrata in prima linea nei pazienti anziani e/o unfit con leucemia linfatica cronica B

L’obiettivo primario dello studio è valutare la Risposta globale.

Gli obiettivi secondari sono valutare:

-       La terapia con Chlorambucil associato a Rituximab in termini di sicurezza;
-       Tempo al ritrattamento;
-       Sopravvivenza libera da progressione;
-       Sopravvivenza globale;
-       La relazione tra la risposta e le caratteristiche biologiche e cliniche della malattia al basale: Fitness status, FISH, IgVH, Zap70 e CD38.

 

LLC 1013 - Protocollo Osservazionale LLC
Studio osservazionale per valutare efficacia e sicurezza dell’associazione di bendamustina e rituximab in pazienti affetti da leucemia linfatica cronica LLC 1315 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)
MDS 0205 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. MDS 0306 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

CAD 0111 PTI

Clinical Practice in the prophylaxis and treatment of arterial and venous thromboembolism in patients with hEmatological NEoplasms and LOw PlatElets (PENELOPE Observational Study)

EMATO 0213 - studio Penelope 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 ITP 0207 PTI

Retrospective evaluation of rate and risk factors of throbotic events in patients with primary immune thrombocytopenia.

ITP 0311 - Studio Osservazionale 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

ITP 0614 - studio osservazionale PTI
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 - osservazionale PTI