Gemtuzumab Chemotherapy MRD Levels; Adult Untreated, de Novo, Fav Interm Risk AML
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
1 other identifier
interventional
414
1 country
48
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Sep 2020
Longer than P75 for phase_3
48 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 11, 2019
CompletedFirst Posted
Study publicly available on registry
November 19, 2019
CompletedStudy Start
First participant enrolled
September 24, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
ExpectedNovember 8, 2024
October 1, 2024
4.5 years
November 11, 2019
November 7, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Activity of GO in combination with chemotherapy in terms of MRD negativity achievement
Percentage of MRD negativity after consolidation in patients treated in induction and consolidation with GO
2 months
Study Arms (1)
Experimental arm
EXPERIMENTALInduction: Gemtuzumab 3 mg/m2 day 1,4,7 Daunorubicin 60 mg/m2 day 1-3 Cytosine arabinoside 200 mg/m2 day 1-7 Consolidation: Gemtuzumab 3 mg/m2 day 1 Daunorubicin 50 mg/m2 day 4-6 Cytosine arabinoside 500 mg/m2 twice a day, day 1-6 Allogeneic transplantation or Autologous transplantation according to MRD level clinical observation
Interventions
Patients will receive induction and consolidation with Gemtuzumab ozogamicin, Daunorubicin and Cytarabine
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (48)
A.O. - SS. Antonio e Biagio e Cesare Arrigo - SC Ematologia
Alessandria, Italy
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
Ancona, Italy
Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
Ascoli Piceno, Italy
AO "San Giuseppe Moscati" - UOC Ematologia con unità di trapianto
Avellino, Italy
AOU Consorziale Policlinico "Aldo Moro" - UO Ematologia con trapianto
Bari, Italy
Policlinico S. Orsola - Malpighi - UOC Ematologia
Bologna, Italy
Ao Sant'Anna E San Sebastiano - Caserta - Uoc Onco Ematologia
Caserta, Italy
U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo
Castelfranco Veneto, Italy
Asur Marche Area Vasta 3 - Presidio Ospedaliero Civitanova Marche - Uods Ematologia
Civitanova Marche, Italy
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
Cona, Italy
Asst Di Cremona - Ospedale Di Cremona - Uo Ematologia
Cremona, Italy
Aou Careggi - Firenze - Sod Ematologia
Florence, Italy
Asl Frosinone, Ospedale F. Spaziani - Ematologia
Frosinone, Italy
Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti
Genova, Italy
Presidio Ospedaliero Nord "Santa Maria Goretti" - UOC Ematologia
Latina, Italy
ASL Le/1 P.O. Vito Fazzi - UO Ematologia
Lecce, Italy
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
Mestre, Italy
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
Milan, Italy
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
Milan, Italy
ISTITUTO EUROPEO DI ONCOLOGIA IRCCS - MILANO - DIVISIONE DI ONCOEMATOLOGIA 176 Milano Divisione di Onco-Ematologia Istituto Europeo
Milan, Italy
Aou Di Modena - Sc Ematologia
Modena, Italy
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
Napoli, Italy
Aou Federico Ii - Napoli - Uoc Ematologia
Napoli, Italy
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
Orbassano, Italy
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
Pagani, Italy
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
Palermo, Italy
Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
Palermo, Italy
Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
Pavia, Italy
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
Perugia, Italy
Ao Ospedali Riuniti Marche Nord - Ospedale San Salvatore - Pesaro - Uoc Ematologia E Centro Trapianti
Pesaro, Italy
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
Pescara, Italy
Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
Piacenza, Italy
Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia
Ravenna, Italy
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
Reggio Emilia, Italy
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
Rimini, Italy
Ao Complesso Ospedaliero San Giovanni / Addolorata - Roma - Uoc Ematologia
Roma, Italy
AOU Policlinico Tor Vergata- UOC Trapianto cellule staminali
Roma, Italy
Aou Sant'Andrea - Roma - Uoc Ematologia
Roma, Italy
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
Roma, Italy
Istituti Fisioterapici Ospitalieri - Ifo - Istituto Regina Elena - Roma - Uosd Ematologia
Roma, Italy
Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
Roma, Italy
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
Roma, Italy
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
San Giovanni Rotondo, Italy
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
Sassari, Italy
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
Torino, Italy
Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana
Treviso, Italy
Azienda Sanitaria Universitaria Integrata Di Trieste - Sc Ematologia
Trieste, Italy
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
Udine, Italy
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2019
First Posted
November 19, 2019
Study Start
September 24, 2020
Primary Completion
April 1, 2025
Study Completion (Estimated)
April 1, 2027
Last Updated
November 8, 2024
Record last verified: 2024-10