Protocolli di ricerca attivi

AOU Alessandria - Leucemia Acuta Mieloide

GIMEMA AML1819

Phase III study to assess the impact of gemtuzumab ozogamicin, in combination with standard chemotherapy, on the levels of minimal residual disease, in adult patients, aged 18-60 years, with previously untreated, de novo, favorable-intermediate-risk acute myeloid leukemia

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Trattamento: gemtuzumab ozogamicin,

Sindromi target: acute myeloid leukemia

Principali Criteri Inclusione:

Patients aged between 18 and 60 years.
Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 14 days HU) or radiotherapy.
Unequivocal diagnosis of de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), other than acute promyelocytic leukemia, documented by bone marrow aspiration (or biopsy in case of dry tap) (not supervening after other myeloproliferative disease or myelodysplastic syndromes of ≥ 6 months duration).
Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3-ITD/TKD positive AML).
WHO performance status 0-3.
Adequate renal (serum creatinine ≤ 2 x the institutional ULN) and liver (total serum bilirubin ≤ 2 x ULN; serum ALT and AST ≤ 2.5 x ULN) function, unless considered due to organ leukemic involvement.
Left Ventricular Ejection Fraction (LVEF) ≥ 50%, as determined by echocardiogram
Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection.
Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule.

Principali Criteri Esclusione:

2. Acute promyelocytic leukemia

3. Blast crisis of chronic myeloid leukemia

4. FLT3-ITD/TKD positive AML

5. AML supervening after other myeloproliferative disease

6. AML supervening after antecedent myelodysplastic syndromes ≥ 6 months duration

7. Therapy-related AML

8. Other active or progressive malignant diseases.

GIMEMA AML1919

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)

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Trattamento: 3+7+midostaurina

Sindromi target: Acute myeloid leukemia

Principali Criteri Inclusione:

1. Patients with de novo AML, untreated, newly diagnosed, according to WHO 2016 criteria

2. Presence of a mutation of FLT3 gene, either ITD and/or TKD

3. Adequate availability of diagnostic biologic material for full cytological, cytogenetic, genetic and immunophenotypic disease characterization according to ELN criteria.

4. Presence of morphologically identifiable blasts on peripheral blood at diagnosis

5. Presence of a Leukemia-associated aberrant immune-phenotype (LAIP) as assessed by MFC

(multiparametric flow cytometry) at diagnosis

6. Age between 18 and 65 years, included

7. ECOG performance status 0-2 or disease-related reversible ECOG 3 score following adequate supportive care.

Principali Criteri Esclusione:

1. Diagnosis of acute promyelocytic leukemia

2. Diagnosis of AML with t(8;21)(q22:q22)/RUNX1-RUNX1T1 and t(16;16)(p13:q22) or inversion of chromosome 16 (16)(p13q22)/CBFB-MYH11; in case of suspicion of CBF-related AML due to morphological and/or immunophenotypic features, specific FISH or molecular testing is strongly recommended

3. Left ventricular ejection fraction < 45% (by echocardiogram or MUGA)

7. QTc >470 msec on screening ECG (Fridericia’s formula)

8. A history of cancer that is not in remission phase following surgery and/or chemotherapy and/or radiotherapy with life expectancy < 1 year.

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AOU Alessandria - Leucemia Acuta Linfoblastica

GIMEMA ALL 2418

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

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Trattamento: Inotuzumab

Sindromi target: acute lymphoblastic leukemia

Criteri Inclusione:

1. To be classified as having ALL according to WHO classification of haematological neoplasms, patients must have >20% blasts in bone marrow at the time of diagnosis.

2. Blasts at the diagnosis or in any timepoint had to be CD22+.

3. To have a measurable BCR-ABL1 fusion transcript (cohort 1) or a measurable IG/TCR specific rearrangement (cohort 2)

4. To have any measurable MRD positivity after at least

a. 3 months of therapy for Ph+ ALL, or the failure of at least 2nd line TKI (cohort 1)

b. 2 courses of therapy for Ph- ALL (cohort 2)

5. and to not have more than 5% of bone marrow blasts. Patients has to be in 1st or 2nd complete remission.

6. Patients ≥ 18 years old with no upper age limit.

7. Patients with a life expectancy >12 weeks

Criteri esclusione:

1. More than 5% of BM blasts

2. WHO performance status ≤ 50% (Karnofsky) or ≥ 3 (ECOG).

3. Active HBV or HCV hepatitis, or AST/ALT ≥ 2.5 x ULN and bilirubine ≥ 1.5 x ULN.

4. Evidence of liver fibrosis, portal hypertension or other clinically relevant liver abnormalities at screening liver ultrasonography

5. History of alcohol abuse.

6. Burkitt lymphoma and active CNS leukemia.

8. Uncontrolled hypertriglyceridemia (triglycerides >450 mg/dL).

9. Clinically significant, uncontrolled, or active cardiovascular disease

IRCCS Candiolo - Sindromi mielodisplastiche

QOL-ONE Phoenix

MDS del5q low-intermediate IPSS R

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Linea terapeutica: Refractory or intollerant to lenalidomide

Coorti: Single ARM Phase 2

Terapia: Luspatercept

Inclusion:

Documented diagnosis of MDS with del5q according to 2018 WHO classification
IPSS-R classification (Greenberg, 2012) of very low, low, or intermediate risk disease, and: < 5% blasts in bone marrow and Peripheral blood WBC count <13,000/μL
Refractory or intolerant to, or ineligible for, prior ESA treatment
Refractory or intolerant to, or ineligible for, prior lenalidomide treatment

Exclusion:

Previously treated with either luspatercept (ACE-536) or sotatercept (ACE-011)
Secondary MDS, ie, MDS that is known to have arisen as the result of chemical injury or treatment with chemotherapy and/or radiation for other diseases.
Known clinically significant anemia due to iron, vitamin B12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding
Prior allogeneic or autologous stem cell transplant

REMARK

MDS low-intermediate IPSS R with anemia TD or non TD

Linea terapeutica: or not candidate to prior ESA treatment /luspatercept/lenalidomide

Coorti: Single ARM Phase 2

Terapia: RVU120

Inclusion:

Very low, low or intermediate risk disease MDS with up to 3.5 points according to International
Prognostic Scoring System Score Revised (IPSS-R) classification (to be confirmed during screening assessment).
Patients with del(5q) and max. one further abnormality (excluding monosomy 7, del(7q), TP53mut) are eligible.
No available option of an approved MDS therapy according to decision of the treating physician and based on the following:
Patients must be ESA exposed (and refractory or intolerant) or ESA naïve and serum erythropoietin level >200 U/L
AND/OR
Luspatercept exposed (and refractory or intolerant) or luspatercept naïve and not eligible for treatment (e.g. not approved)
AND/OR
Lenalidomide exposed (and refractory or intolerant) or lenalidomide naïve and not eligible for treatment (e.g. due to non-presence of del(5q))

Exclusion:

Patient does not accept bone marrow sampling during screening and after the treatment.
Prior treatment with azacitidine (injectable or oral) or decitabine.
Iron chelation therapy

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