Acute Myeloid Leukemia
Conditions
Keywords
De-novo, Favorable risk, Intermediate risk, Gemtuzumab ozogamicin, Acute Myeloid Leukemia
Brief summary
MRD driven study. Addition of gemtuzumab to conventional chemotherapy to reduce MRD of patients with favorable/intermediate-risk AML. Post-consolidation assessment of MRD.
Detailed description
Setting up a multicenter, MRD (Minimal Residual Disease)-driven study that relies on addition of gemtuzumab ozogamicin to conventional chemotherapy to reduce the pre-transplant levels of MRD of patients with favorable/intermediate-risk (according to ELN 2017) AML. Post-consolidation assessment of MRD will be exploited to establish the final risk assignment and to verify whether the delivery of a post remission therapy intensity (AuSCT, Autologous Stem Cell Transplant, vs ASCT, Allogeneic Stem Cell Transplant) of which is MRD-driven will improve the outcome in terms of anti-leukemic efficacy.
Interventions
DRUGGemtuzumab Ozogamicin
Patients will receive induction and consolidation with Gemtuzumab ozogamicin, Daunorubicin and Cytarabine
Sponsors
Gruppo Italiano Malattie EMatologiche dell'Adulto
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
1. Signed written informed consent according to ICH/EU/GCP and national/local laws 2. Patients aged between 18 and 60 years 3. Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy 4. 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) 5. Patients with favorable-intermediate AML according to ELN 2017 (except for FLT3-ITD/TKD positive AML) 6. WHO performance status 0-3 7. 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 8. Left Ventricular Ejection Fraction (LVEF) ≥ 50%, as determined by echocardiogram 9. Absence of severe concomitant neurological or psychiatric diseases and congestive heart failure or active uncontrolled infection 10. Absence of any psychological, familial, sociological and geographical condition potentially hampering compliance with the study protocol and the follow-up schedule.
Exclusion criteria
1. Patients already treated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy 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. 9. Inadequate renal or liver function (metabolic abnormalities \> 2-2.5 times the normal upper limit) 10. Severe heart failure requiring diuretics 11. Ejection fraction \< 50% 12. Uncontrolled infections 13. Severe concomitant neurological or psychiatric diseases 14. Patients who are pregnant or adults of reproductive potential not employing an effective method of birth control. Women of childbearing potential must have a negative serum pregnancy test within 48 hours prior to administration of chemotherapy. Post-menopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential. Male and female patients must agree to employ an effective barrier method of birth control throughout the study and for at least 6 months following discontinuation of study drug.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Activity of GO in combination with chemotherapy in terms of MRD negativity achievement | 2 months | Percentage of MRD negativity after consolidation in patients treated in induction and consolidation with GO |
Countries
Italy
Contacts
Primary ContactPaola Fazi
Backup ContactEnrico Crea
Outcome results
None listed