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Gemtuzumab Chemotherapy MRD Levels; Glasdegib Post-transplant, Adult Untreated, de Novo, Fav Interm Risk AML

Primary Purpose

Acute Myeloid Leukemia

Status
Recruiting
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Glasdegib
Gemtuzumab Ozogamicin
Sponsored by
Gruppo Italiano Malattie EMatologiche dell'Adulto
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia focused on measuring De-novo, Favorable risk, Intermediate risk, Gemtuzumab ozogamicin, Glasdegib, Acute Myeloid Leukemia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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 months duration
  6. AML supervening after antecedent myelodysplastic syndromes
  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.

Sites / Locations

  • A.O. - SS. Antonio e Biagio e Cesare Arrigo - SC EmatologiaRecruiting
  • Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica EmatologicaRecruiting
  • Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc EmatologiaRecruiting
  • AO "San Giuseppe Moscati" - UOC Ematologia con unità di trapiantoRecruiting
  • AOU Consorziale Policlinico "Aldo Moro" - UO Ematologia con trapiantoRecruiting
  • Policlinico S. Orsola - Malpighi - UOC EmatologiaRecruiting
  • Ao Sant'Anna E San Sebastiano - Caserta - Uoc Onco EmatologiaRecruiting
  • U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo ApostoloRecruiting
  • Asur Marche Area Vasta 3 - Presidio Ospedaliero Civitanova Marche - Uods EmatologiaRecruiting
  • Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della CoagulazioneRecruiting
  • Asst Di Cremona - Ospedale Di Cremona - Uo EmatologiaRecruiting
  • Aou Careggi - Firenze - Sod EmatologiaRecruiting
  • Asl Frosinone, Ospedale F. Spaziani - EmatologiaRecruiting
  • Irccs Aou San Martino - Genova - Uo Ematologia E TrapiantiRecruiting
  • Presidio Ospedaliero Nord "Santa Maria Goretti" - UOC EmatologiaRecruiting
  • ASL Le/1 P.O. Vito Fazzi - UO EmatologiaRecruiting
  • Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo EmatologiaRecruiting
  • Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc EmatologiaRecruiting
  • Irccs Ospedale S. Raffaele - Milano - Uo OncoematologiaRecruiting
  • ISTITUTO EUROPEO DI ONCOLOGIA IRCCS - MILANO - DIVISIONE DI ONCOEMATOLOGIA 176 Milano Divisione di Onco-Ematologia Istituto EuropeoRecruiting
  • Aou Di Modena - Sc EmatologiaRecruiting
  • Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di MidolloRecruiting
  • Aou Federico Ii - Napoli - Uoc EmatologiaRecruiting
  • Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E OncoematologiaRecruiting
  • Asl Salerno, Presidio Ospedaliero Tortora Pagani - EmatologiaRecruiting
  • Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con UtmoRecruiting
  • Aou Policlinico P. Giaccone - Palermo - Uo EmatologiaRecruiting
  • Fondazione Ircss Policlinico San Matteo - Pavia - Uo EmatologiaRecruiting
  • Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo OsseoRecruiting
  • Ao Ospedali Riuniti Marche Nord - Ospedale San Salvatore - Pesaro - Uoc Ematologia E Centro TrapiantiRecruiting
  • Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia ClinicaRecruiting
  • Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro TrapiantiRecruiting
  • Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - EmatologiaRecruiting
  • Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc EmatologiaRecruiting
  • Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo EmatologiaRecruiting
  • Ao Complesso Ospedaliero San Giovanni / Addolorata - Roma - Uoc EmatologiaRecruiting
  • AOU Policlinico Tor Vergata- UOC Trapianto cellule staminaliRecruiting
  • Aou Sant'Andrea - Roma - Uoc EmatologiaRecruiting
  • Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area EmatologicaRecruiting
  • Istituti Fisioterapici Ospitalieri - Ifo - Istituto Regina Elena - Roma - Uosd EmatologiaRecruiting
  • Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule StaminaliRecruiting
  • Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. EmatologiaRecruiting
  • Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - EmatologiaRecruiting
  • Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc EmatologiaRecruiting
  • Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2Recruiting
  • Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca TrevigianaRecruiting
  • Azienda Sanitaria Universitaria Integrata Di Trieste - Sc EmatologiaRecruiting
  • Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica EmatologicaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Experimental arm

Standard arm

Arm Description

Induction: 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 Maintenance with glasdegib 100 mg daily for one year or until toxicity/relapse

Induction: 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

Outcomes

Primary Outcome Measures

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
Efficacy of Glasdegib maintenance vs clinical observation
Disease Free Survival (DFS) in patients randomized to glasdegib maintenance or clinical observation

Secondary Outcome Measures

Full Information

First Posted
November 11, 2019
Last Updated
July 19, 2022
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT04168502
Brief Title
Gemtuzumab Chemotherapy MRD Levels; Glasdegib Post-transplant, Adult Untreated, de Novo, Fav Interm Risk AML
Official Title
Phase 3 Study to Assess Gemtuzumab, in Combination With Standard Chemotherapy, on MRD Levels, and the Role of Glasdegib as a Post-transplant Maintenance, in Adult, 18-60 Years, With Previously Untreated de Novo Fav-interm Risk AML
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 24, 2020 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
April 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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. Role of a post-SCT maintenance with glasdegib.
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. Finally, the role of a post-SCT maintenance with glasdegib will be explored.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
De-novo, Favorable risk, Intermediate risk, Gemtuzumab ozogamicin, Glasdegib, Acute Myeloid Leukemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
414 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Induction: 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 Maintenance with glasdegib 100 mg daily for one year or until toxicity/relapse
Arm Title
Standard arm
Arm Type
Active Comparator
Arm Description
Induction: 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
Intervention Type
Drug
Intervention Name(s)
Glasdegib
Intervention Description
After randomization patients in both arms will be randomized to maintenance with glasdegib vs clinical observation
Intervention Type
Drug
Intervention Name(s)
Gemtuzumab Ozogamicin
Intervention Description
Both arms, before randomization, will receive induction and consolidation with Gemtuzumab ozogamicin, Daunorubicin and Cytarabine
Primary Outcome Measure Information:
Title
Activity of GO in combination with chemotherapy in terms of MRD negativity achievement
Description
Percentage of MRD negativity after consolidation in patients treated in induction and consolidation with GO
Time Frame
2 months
Title
Efficacy of Glasdegib maintenance vs clinical observation
Description
Disease Free Survival (DFS) in patients randomized to glasdegib maintenance or clinical observation
Time Frame
2,5 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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 ≥ 6 months duration AML supervening after antecedent myelodysplastic syndromes 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paola Fazi
Phone
0670390528
Email
p.fazi@gimema.it
First Name & Middle Initial & Last Name or Official Title & Degree
Enrico Crea
Phone
0670390514
Email
e.crea@gimema.it
Facility Information:
Facility Name
A.O. - SS. Antonio e Biagio e Cesare Arrigo - SC Ematologia
City
Alessandria
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Zallio
Facility Name
Aou Ospedali Riuniti "Umberto I - G.M. Lancisi - G. Salesi"- Ancona - Sod Clinica Ematologica
City
Ancona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Attilio Olivieri
Email
a.olivieri@univpm.it
Facility Name
Area Vasta N. 5 Ascoli Piceno - S. Benedetto Del Tronto, Presidio Ospedaliero Av5 Osp. Gen. Prov.Le "C.G.Mazzoni" - Uoc Ematologia
City
Ascoli Piceno
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Piero Galieni
Phone
3388149974
Email
piero.galieni@sanita.marche.it
Facility Name
AO "San Giuseppe Moscati" - UOC Ematologia con unità di trapianto
City
Avellino
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Storti
Facility Name
AOU Consorziale Policlinico "Aldo Moro" - UO Ematologia con trapianto
City
Bari
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carluccio
Facility Name
Policlinico S. Orsola - Malpighi - UOC Ematologia
City
Bologna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Curti
Facility Name
Ao Sant'Anna E San Sebastiano - Caserta - Uoc Onco Ematologia
City
Caserta
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Camera
Phone
330344420
Email
ancamera@unina.it
Facility Name
U.O.C. Oncoematologia - Istituto Oncologico Veneto Irccs, Presidio Ospedaliero S. Giacomo Apostolo
City
Castelfranco Veneto
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Gottardi
Phone
3476260749
Email
michele.gottardi@aulss2.veneto.it
Facility Name
Asur Marche Area Vasta 3 - Presidio Ospedaliero Civitanova Marche - Uods Ematologia
City
Civitanova Marche
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Milena Mirabile
Email
milena.mirabile@hotmail.it
Facility Name
Aou Arcispedale Sant'Anna - Cona (Fe) - Uoc Ematologia E Fisiopatologia Della Coagulazione
City
Cona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Ciccone
Email
m.ciccone@ospfe.it
Facility Name
Asst Di Cremona - Ospedale Di Cremona - Uo Ematologia
City
Cremona
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alfredo Molteni
Phone
338/3169286
Email
alfredo.molteni@asst-cremona.it
Facility Name
Aou Careggi - Firenze - Sod Ematologia
City
Firenze
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Scappini
Email
scappinib@aou-careggi.toscana.it
Facility Name
Asl Frosinone, Ospedale F. Spaziani - Ematologia
City
Frosinone
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vincenza Martini
Email
vincenzamartini@inwind.it
Facility Name
Irccs Aou San Martino - Genova - Uo Ematologia E Trapianti
City
Genova
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Germana Beltrami
Email
germana.beltrami@hsanmartino.it
Facility Name
Presidio Ospedaliero Nord "Santa Maria Goretti" - UOC Ematologia
City
Latina
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cimino
Facility Name
ASL Le/1 P.O. Vito Fazzi - UO Ematologia
City
Lecce
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Di Renzo
Facility Name
Aulss 3 Serenissima, Ospedale Dell'Angelo - Mestre - Uo Ematologia
City
Mestre
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Renato Bassan
Email
Renato.Bassan@aulss3.veneto.it
Facility Name
Asst Grande Ospedale Metropolitano Niguarda - Milano - Sc Ematologia
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Roberto Cairoli
Email
roberto.cairoli@ospedaleniguarda.it
Facility Name
Irccs Ospedale S. Raffaele - Milano - Uo Oncoematologia
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabio Ciceri
Email
ciceri.clinicaltrials@hsr.it
Facility Name
ISTITUTO EUROPEO DI ONCOLOGIA IRCCS - MILANO - DIVISIONE DI ONCOEMATOLOGIA 176 Milano Divisione di Onco-Ematologia Istituto Europeo
City
Milano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elisabetta Todisco
Email
Elisabetta.Todisco@ieo.it
Facility Name
Aou Di Modena - Sc Ematologia
City
Modena
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Luppi
Email
mario.luppi@unimore.it
Facility Name
Ao Di Rilievo Nazionale Antonio Cardarelli - Napoli - Uoc Ematologia Con Trapianto Di Midollo
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Felicetto Ferrara
Phone
3388272964
Email
felicettoferrara@katamail.com
Facility Name
Aou Federico Ii - Napoli - Uoc Ematologia
City
Napoli
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Fabrizio Pane
Email
fabrizio.pane@unina.it
Facility Name
Aou San Luigi Gonzaga - Orbassano - Scdu Ematologia Generale E Oncoematologia
City
Orbassano
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniela Cilloni
Email
daniela.cilloni@unito.it
Facility Name
Asl Salerno, Presidio Ospedaliero Tortora Pagani - Ematologia
City
Pagani
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catello Califano
Email
c.califano@aslsalerno.it
Facility Name
Ao Ospedali Riuniti Villa Sofia Cervello - Palermo - Uo Ematologia Con Utmo
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonino Mulè
Email
a.mule@villasofia.it
Facility Name
Aou Policlinico P. Giaccone - Palermo - Uo Ematologia
City
Palermo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Enza Mitra
Email
memitra@yahoo.com
Facility Name
Fondazione Ircss Policlinico San Matteo - Pavia - Uo Ematologia
City
Pavia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizia Zappasodi
Email
p.zappasodi@smatteo.pv.it
Facility Name
Ao Di Perugia, Ospedale S. Maria Della Misericordia - Ematologia E Trapianto Midollo Osseo
City
Perugia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Paola Martelli
Email
mpmartelli@libero.it
Facility Name
Ao Ospedali Riuniti Marche Nord - Ospedale San Salvatore - Pesaro - Uoc Ematologia E Centro Trapianti
City
Pesaro
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Visani
Email
giuseppe.visani@ospedalimarchenord.it
Facility Name
Asl Pescara, Presidio Ospedaliero 'Spirito Santo' - Uoc Ematologia Clinica
City
Pescara
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Prassede Salutari
Email
prassede.salutari@gmail.com
Facility Name
Asl Di Piacenza, Ospedale "Guglielmo Da Saliceto" - Ematologia E Centro Trapianti
City
Piacenza
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniele Vallisa
Email
d.vallisa@ausl.pc.it
Facility Name
Ausl Della Romagna, Ospedale "Santa Maria Delle Croci" - Ravenna - Ematologia
City
Ravenna
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michela Rondoni
Email
michela.rondoni@auslromagna.it
Facility Name
Ausl Di Reggio Emilia - Arcispedale Santa Maria Nuova, Irccs - Sc Ematologia
City
Reggio Emilia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alessia Tieghi
Email
alessia.tieghi@ausl.re.it
Facility Name
Ausl Della Romagna, Ospedale "Infermi" - Rimini - Uo Ematologia
City
Rimini
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Maria Mianulli
Email
annamariamianulli@libero.it
Facility Name
Ao Complesso Ospedaliero San Giovanni / Addolorata - Roma - Uoc Ematologia
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura Cudillo
Email
lcudillo@hsangiovanni.roma.it
Facility Name
AOU Policlinico Tor Vergata- UOC Trapianto cellule staminali
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adriano Venditti
Email
adriano.venditti@uniroma2.it
Facility Name
Aou Sant'Andrea - Roma - Uoc Ematologia
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Agostino Tafuri
Email
agostino.tafuri@ospedalesantandrea.it
Facility Name
Fondazione Policlinico Universitario Agostino Gemelli Irccs - Roma - Area Ematologica
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrizia Chiusolo
Email
patrizia.chiusolo@Unicatt.it
Facility Name
Istituti Fisioterapici Ospitalieri - Ifo - Istituto Regina Elena - Roma - Uosd Ematologia
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrea Mengarelli
Email
andreamengarelli@libero.it
Facility Name
Policlinico Universitario Campus Bio Medico - Roma - Uoc Ematologia E Trapianto Di Cellule Staminali
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giuseppe Avvisati
Email
g.avvisati@unicampus.it
Facility Name
Università Degli Studi Di Roma "Sapienza" - Dipartimento Di Medicina Traslazionale E Di Precisione - U.O.C. Ematologia
City
Roma
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maurizio Martelli
Email
martelli@bce.uniroma1.it
Facility Name
Ente Ecclesiastico Casa Sollievo Della Sofferenza - San Giovanni Rotondo - Ematologia
City
San Giovanni Rotondo
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicola Cascavilla
Email
n.cascavilla@operapadrepio.it
Facility Name
Aou Di Sassari - Cliniche Universitarie - Stabilimento Cliniche Di San Pietro - Uoc Ematologia
City
Sassari
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claudio Fozza
Email
cfozza@uniss.it
Facility Name
Aou Città Della Salute E Della Scienza, Ospedale S. Giovanni Battista Molinette - Torino - Sc Ematologia 2
City
Torino
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ernesta Audisio
Email
eaudisio@cittadellasalute.to.it
Facility Name
Unità Operativa Di Ematologia - Presidio Ospedaliero Di Treviso - Azienda Ulss N.2 Marca Trevigiana
City
Treviso
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Endri Mauro
Email
endri.mauro@aas5.sanita.fvg.it
Facility Name
Azienda Sanitaria Universitaria Integrata Di Trieste - Sc Ematologia
City
Trieste
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesco Zaja
Email
francesco.zaja@asuits.sanita.fvg.it
Facility Name
Asui Di Udine - Presidio Ospedaliero "Santa Maria Della Misericordia" - Clinica Ematologica
City
Udine
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Candoni
Email
candoni.anna@aoud.sanita.fvg.it

12. IPD Sharing Statement

Learn more about this trial

Gemtuzumab Chemotherapy MRD Levels; Glasdegib Post-transplant, Adult Untreated, de Novo, Fav Interm Risk AML

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