Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML

Last updated: November 7, 2024
Sponsor: Gruppo Italiano Malattie EMatologiche dell'Adulto
Overall Status: Active - Recruiting

Phase

3

Condition

Acute Myeloid Leukemia

Leukemia

Platelet Disorders

Treatment

Gemtuzumab Ozogamicin

Glasdegib

Clinical Study ID

NCT04168502
AML1819
  • Ages 18-60
  • All Genders

Study 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

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 (exceptfor 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, documentedby bone marrow aspiration (or biopsy in case of dry tap) (not supervening afterother myeloproliferative disease or myelodysplastic syndromes of ≥ 6 monthsduration)

  5. Patients with favorable-intermediate AML according to ELN 2017 (except forFLT3-ITD/TKD positive AML)

  6. WHO performance status 0-3

  7. Adequate renal (serum creatinine ≤ 2 x the institutional ULN) and liver (total serumbilirubin ≤ 2 x ULN; serum ALT and AST ≤ 2.5 x ULN) function, unless considered dueto organ leukemic involvement

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

  9. Absence of severe concomitant neurological or psychiatric diseases and congestiveheart failure or active uncontrolled infection

  10. Absence of any psychological, familial, sociological and geographical conditionpotentially hampering compliance with the study protocol and the follow-up schedule.

Exclusion

Exclusion Criteria:

  1. Patients already treated for their AML by other chemotherapeutic agents (except forno 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 normalupper 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 aneffective method of birth control. Women of childbearing potential must have anegative serum pregnancy test within 48 hours prior to administration ofchemotherapy. Post-menopausal women must be amenorrheic for at least 12 months to beconsidered of non-childbearing potential. Male and female patients must agree toemploy an effective barrier method of birth control throughout the study and for atleast 6 months following discontinuation of study drug.

Study Design

Total Participants: 414
Treatment Group(s): 2
Primary Treatment: Gemtuzumab Ozogamicin
Phase: 3
Study Start date:
September 24, 2020
Estimated Completion Date:
April 30, 2027

Study 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.

Connect with a study center

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    Firenze,
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    Palermo,
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  • AOU Policlinico Tor Vergata- UOC Trapianto cellule staminali

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  • Ao Complesso Ospedaliero San Giovanni / Addolorata - Roma - Uoc Ematologia

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  • Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali

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