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:

1. Patients aged between 18 and 60 years.

2. Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 14 days HU) or radiotherapy.

3. 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).

4. Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3-ITD/TKD positive AML).

5. WHO performance status 0-3.

6. 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.

7. Left Ventricular Ejection Fraction (LVEF) ≥ 50%, as determined by echocardiogram

8. Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection.

9. 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.

GIMEMA AML2120

A retrospective and prospective multicentre observational study for the evaluation of incidence of familial AML/MDSs in patients with myeloid neoplasms (AML/MDS)

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Sindromi target: 

Principali Criteri Inclusione:

Familiarity for myeloid neoplasm is suspected when the patient affected by AML/MDSs presents:

- a first-or second-degree family member who has a diagnosis of acute leukemia (AML or ALL), or MDSs, or other myeloid neoplasms;

- a first-or second-degree family member who has a diagnosis of other hematologic neoplasms;

- a first-or second-degree family member who has a diagnosis of solid tumor that has arisen in age < 40 years;

- presence of signs, symptoms or laboratory tests compatible with one of the known syndromes with germinal susceptibility to AML/MDSs

GIMEMA MDS0519

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)

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Trattamento: azacitidina vs HSCT upfront, 3+7

Sindromi target: High risk MDS

Principali Criteri Inclusione:

1. Patients with newly diagnosed higher-risk MDS, including IPSS Intermediate-2 and high, and

IPSS-R intermediate to very-high

2. Age 18-70 years

3. Previously untreated for HR-MDS

4. HSCT – eligible

5. Life expectancy ≥3 months;

7. Eastern Cooperative Oncology Group Performance Status Grade of 0-2

Principali Criteri Esclusione:

1. Acute myeloid leukaemia with >20% blasts in BM or peripheral blood (PB);

2. concurrent malignancy diagnosed in the past 12 months (with the exception of skin basalioma);

3. severe renal, cardiac, liver or lung impairment;

8. prior Treatments:

a) prior investigational drugs (within 30 days);

b) radiotherapy, chemotherapy, or cytotoxic therapy for non-MDS conditions within the previous 6 months;

c) growth factors (EPO, G-CSF or GM-CSF) during the previous 21 days;

d) androgenic hormones during the previous 14 days;

e) prior transplantation or cytotoxic therapy, including azacitidine, AZA or chemotherapy,administered to treat MDS

GIMEMA AML2824

Observational GIMEMA study on the outcome of acute myeloid leukemia (AML) patients treated with new drugs in real-life

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Sindromi target: acute myeloid leukemia

Principali Criteri Inclusione:

1. Aged 18 years or older

2. AML diagnosis according to the ELN guidelines, excluding M3

3. Signed Informed consent, if applicable

4. Treatment initiation with novel drugs in monotherapy or combination, in accordance with the AIFA authorizations, from the AIFA registration up to 31.12.2027 with particular attention to:

• patients affected by FLT3-mutated AML treated with gilteritinib.

• patients affected by IDH-mutated AML treated with IDH inhibitors.

• patients affected by AML in maintenance therapy with oral azacytidine.

• patients affected by AML treated with glasdegib.

• patients affected by AML treated with gemtuzumab ozogamicin.

• other novel drugs or combination for the treatment of AML approved during the study period.

Principali Criteri Esclusione:

Patients included in interventional clinical trials.

STML-401-0521

Post-Authorisation Registry of ELZONRIS (Tagraxofusp) in Patients with Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN)

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Sindromi target: BPDCN

Principali Criteri Inclusione:

2. Male or female, and aged ≥ 18 years old at the time of ICF signature.

3. Diagnosed with BPDCN, confirmed by hematopathology and biomarkers (inclusive of CD123, CD4, and CD56).

4. (a) Primary study cohort: previously untreated (i.e., first line) for BPDCN.

(b) Exploratory cohort: relapsed/refractory (R/R) to prior treatment for BPDCN

5. Planning to start treatment with tagraxofusp monotherapy for BPDCN at the time of ICF signature or has started treatment with tagraxofusp monotherapy for BPDCN within 3 months prior to ICF signature.

Principali Criteri Esclusione:

1. Currently (or planning to) participating in another study or registry where BPDCN treatment outcomes are reported.

2. Participating in an interventional clinical trial at the time of ICF signature.