NCT04168502 Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML
| NCT ID | NCT04168502 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Gruppo Italiano Malattie EMatologiche dell'Adulto |
| Condition | Acute Myeloid Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 414 participants |
| Start Date | 2020-09-24 |
| Primary Completion | 2025-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 414 participants in total. It began in 2020-09-24 with a primary completion date of 2025-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04168502 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 60 Years, studying Acute Myeloid Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04168502 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 414 participants.
Is NCT04168502 currently recruiting?
Yes, NCT04168502 is actively recruiting participants. Contact the research team at p.fazi@gimema.it for enrollment information.
Where is the NCT04168502 trial being conducted?
This trial is being conducted at Alessandria, Italy, Ancona, Italy, Ascoli Piceno, Italy, Avellino, Italy and 11 additional locations.
Who is sponsoring the NCT04168502 clinical trial?
NCT04168502 is sponsored by Gruppo Italiano Malattie EMatologiche dell'Adulto. The trial plans to enroll 414 participants.
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