Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Gemtuzumab Ozogamicin.
- Who it may be relevant to
- Registry conditions: Acute Myeloid Leukemia. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Phase 3 Study to Assess Gemtuzumab, in Combination With Standard Chemotherapy, on MRD Levels, in Adult, 18-60 Years, With Previously Untreated de Novo Fav-interm Risk AML
Overview
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
- Drug Gemtuzumab Ozogamicin
Patients will receive induction and consolidation with Gemtuzumab ozogamicin, Daunorubicin and Cytarabine
Primary outcome measures
- Activity of GO in combination with chemotherapy in terms of MRD negativity achievement [Time frame: 2 months]
Eligibility criteria
Inclusion criteria
- Signed written informed consent according to ICH/EU/GCP and national/local laws
- Patients aged between 18 and 60 years
- Patients previously untreated for their AML by other chemotherapeutic agents (except for no more than 7 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.
Exclusion criteria
- Patients already treated for their AML by other chemotherapeutic agents (except for no more than 7 days HU) or radiotherapy
- Acute promyelocytic leukemia
- Blast crisis of chronic myeloid leukemia
- FLT3-ITD/TKD positive AML
- AML supervening after other myeloproliferative disease
- AML supervening after antecedent myelodysplastic syndromes ≥ 6 months duration
- Therapy-related AML
- Other active or progressive malignant diseases.
- Inadequate renal or liver function (metabolic abnormalities > 2-2.5 times the normal upper limit)
- Severe heart failure requiring diuretics
- Ejection fraction < 50%
- Uncontrolled infections
- Severe concomitant neurological or psychiatric diseases
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Italy · 48 centers
- A.O. - SS. Antonio e Biagio e Cesare Arrigo - SC Ematologia — Alessandria
- Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematolog — Ancona
- Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen — Ascoli Piceno
- AO "San Giuseppe Moscati" - UOC Ematologia con unità di trapianto — Avellino
- AOU Consorziale Policlinico "Aldo Moro" - UO Ematologia con trapianto — Bari
- Policlinico S. Orsola - Malpighi - UOC Ematologia — Bologna
- Ao Sant'Anna E San Sebastiano - Caserta - Uoc Onco Ematologia — Caserta
- U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo — Castelfranco Veneto
- … and 40 more centers
Identifiers
NCT: NCT04168502 · AML1819