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.
Modulo per la sottomissione di una nuova proposta

 

In fase di apertura

Titolo Codice Patologia Fase Clinicaltrials.gov EudraCT
Real-world mapping antithrombotic regimens in Multiple Myeloma patients on treatment (the MARMMOT Study of the GIMEMA Working Party on Hemostasis and Thrombosis) ET0123 Altri Oss https://clinicaltrials.gov/study/NCT06028087
Real-world ruxolitinib experience in Polycythemia Vera: REVIEW Study MPN0224 Altri Oss https://clinicaltrials.gov/study/NCT06251102

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 AML https://clinicaltrials.gov/study/NCT06090786
Observational GIMEMA study on the outcome of acute myeloid leukemia (AML) patients treated with new drugs in real-life (Box trial) AML2824 AML https://clinicaltrials.gov/study/NCT06513273

Observational Study on the outcome of patients with ITP who underwent Splenectomy after 2010

 ITP1324 PTI https://clinicaltrials.gov/study/NCT06466824

 

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
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
Daratumumab in adults with Very High-Risk T-Lineage Acute Lymphoblastic Leukemia (ALL) treated according to the ALL national treatment program (DARATALL-VHR) ALL3024 ALL II https://clinicaltrials.gov/study/NCT06253637
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
Salvage treatment with glofitamab in patients affected by relapsed/refractory non Hodgkin B cell Lymphoma IMM0123 Altri Oss https://www.clinicaltrials.gov/study/NCT05927558
Multicenter retrospective observational study analyzing infective complications and the clinical outcome of patients with acute lymphoblastic leukemia treated with inotuzumab ozogamicin (INO-FIRST) INF0123 Altri Oss https://www.clinicaltrials.gov/study/NCT06025682

Observational Study Protocol REALFed: Real world evidence of fedratinib effectiveness in Myelofibrosis

 MPN0123 Altri Oss https://www.clinicaltrials.gov/study/NCT05883904
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
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
Novel Approaches to Target MECOM/EVI1 in Acute Myeloid Leukemia AML2623 AML https://www.clinicaltrials.gov/ct2/show/NCT05839392

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 
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
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 LLC https://www.clinicaltrials.gov/ct2/show/NCT04282811

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
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
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 LLC https://www.clinicaltrials.gov/ct2/show/NCT05803395
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 LLC https://clinicaltrials.gov/study/NCT06084923
Biological and clinical efficacy of recombinant zoster vaccine (Shingrix) in patients with Chronic Lymphocytic Leukemia CLL2624 LLC https://clinicaltrials.gov/study/NCT06364033
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
Biologic characterization of patients with immune thrombocytopenia (ITP)
 ITP1222 PTI https://www.clinicaltrials.gov/ct2/show/NCT05694325

 

Chiuso all'arruolamento

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 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
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

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
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 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
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
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
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
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

 

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
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

"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.
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

 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
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
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