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Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia (AML1310)

Primary Purpose

Acute Myeloid Leukemia

Status
Completed
Phase
Phase 2
Locations
Italy
Study Type
Interventional
Intervention
Risk-adapted, MRD-directed therapy
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 acute myeloid leukemia, risk-adapted therapy, MRD-directed therapy, young adults

Eligibility Criteria

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

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 (with the exception of no more than 7 days hydroxyurea (HU)), radiotherapy or more than 7 days corticosteroids
  • Unequivocal diagnosis of untreated de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), with FAB classification other than M3 (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 more than 6 months duration)
  • WHO performance status 0-3
  • Adequate renal (serum creatinine < 2 x the institutional Upper Limit of Normal (ULN)) and liver (total serum bilirubin < 2 x ULN; serum ALT and AST ≤ 3 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 aged less than 18 or more than 60 years
  • Patients already treated for their AML by other chemotherapeutic agents (with the exception of no more than 7 days HU), radiotherapy or more than 7 days corticosteroids
  • Acute promyelocytic leukaemia
  • Blast crisis of chronic myeloid leukaemia
  • AML supervening after other myeloproliferative disease
  • AML supervening after antecedent myelodysplastic syndromes of more than 6 months duration
  • Other progressive malignant diseases. However, secondary AML following previously cured malignancies may be included as well as secondary AML following previous exposure to alkylating agents or radiation for other reason
  • Inadequate renal or liver function (metabolic abnormalities > 3 times the normal upper limit)
  • Severe heart failure requiring diuretics
  • Ejection fraction < 50%
  • Uncontrolled infections
  • WHO performance status = 4
  • 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 hrs prior to administration of chemotherapy. Post-menopausal women must be amenorrhoeic 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 up to 3 months following discontinuation of study drug.

Sites / Locations

  • U.O. di Ematologia - Azienda Ospedaliera - Pia Fondazione di Culto e di Religione Card. G.Panico
  • Complesso Ospedaliero S. Giovanni Addolorata
  • Policlinico di Tor Vergata
  • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
  • Azienda Ospedaliera - Nuovo Ospedale "Torrette"
  • Az. Ospedaliera S. G. Moscati
  • Unità Operativa Ematologia 1 - Università degli Studi di Bari
  • UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"
  • Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
  • Divisione di Ematologia Ospedale A. Perrino
  • Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi
  • Unità Operativa Complessa di Onco-Ematologia - A.O. S.Anna e S.Sebastiano
  • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
  • Azienda Ospedaliera Pugliese Ciaccio
  • Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile
  • Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
  • Sezione di Ematologia C.T.M.O. Istituti Ospitalieri
  • Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
  • Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
  • Clinica Ematologica - Università degli Studi
  • Divisione di Ematologia Ospedale "Santa Maria Goretti"
  • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematol
  • Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
  • Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
  • Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
  • Ospedale Niguarda " Ca Granda"
  • UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico
  • Centro Oncologico Modenese - Dipartimento di Oncoematologia
  • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
  • Pr. Alfonso Maria D'Arco
  • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
  • Ospedale S. Luigi Gonzaga
  • Università degli Studi di Padova - Ematologia ed Immunologia Clinica
  • Ospedale Riuniti "Villa-Sofia-Cervello"
  • Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
  • Cattedra di Ematologia CTMO Università degli Studi di Parma
  • Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della MIsericordia
  • Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
  • Azienda ASL di Pescara
  • Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
  • Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
  • Ematologia - Ospedale San Carlo
  • Ospedale S.Maria delle Croci
  • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
  • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
  • Ospedale "Infermi"
  • Divisione Ematologia - Università Campus Bio-Medico
  • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
  • Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
  • S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
  • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
  • Ospedale S. Camillo
  • U.O.C. Ematologia - Ospedale S.Eugenio
  • Sezione di Ematologia Cancer Center Humanitas
  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
  • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
  • U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
  • UOC di Ematologia Generale P.O. S.Vincenzo
  • U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati
  • Azienda U.L.S.S.9 - U.O. di Ematologia
  • Policlinico Universitario - Clinica Ematologia

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MRD-directed therapy

Arm Description

Outcomes

Primary Outcome Measures

Treatment strategy in terms of Overall Survival (OS) at 24 months.
OS is defined as the time interval between the date of study entry and death for any cause; patients still alive will be censored at the time of the last follow-up.

Secondary Outcome Measures

Estimation of Disease Free Survival (DFS) from Complete Response (CR) evaluation.
DFS is defined as the time interval between the evaluation of CR -after induction phase- and relapse or death in CR; patients still alive, in first CR, will be censored at the time of the last follow-up.
Estimation of Event Free Survival (EFS) from study entry.
EFS is defined as the time interval between the date of study entry dose and failure during induction phase, relapse or death whichever comes first; patients still alive, in first CR, will be censored at the time of the last follow-up.
Rate of patients in CR after induction therapy
Toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
Estimation of OS, EFS, DFS and Cumulative Incidence of Relapse (CIR) according to risk groups (Low, Intermediate, High)
CIR is calculated from the date of achievement of the CR -after induction phase-, using the cumulative incidence method, considering death in CR as a competing risk. Patients still alive, without relapse, will be censored at the time of the last follow-up.
Estimation of OS, EFS, DFS and CIR according to the Minimal Residual Disease (MRD) level at each evaluation step
Rate of CR patients and estimation OS, EFS, DFS and CIR according to baseline characteristics such as age, performance status, white blood cell (WBC), morphology, cytogenetic and molecular features.
Quality of Life evaluation
QoL should be measured at three different time points: At Baseline (before treatment starts). At the end of Induction phase (after evaluation of response and before start of consolidation therapy for patients in CR or salvage therapy for patients not achieving a CR). At one year after baseline evaluation.

Full Information

First Posted
October 12, 2011
Last Updated
August 3, 2018
Sponsor
Gruppo Italiano Malattie EMatologiche dell'Adulto
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1. Study Identification

Unique Protocol Identification Number
NCT01452646
Brief Title
Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia
Acronym
AML1310
Official Title
Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia. GIMEMA Protocol AML1310. EudraCT Number 2010-023809-36
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
January 2012 (Actual)
Primary Completion Date
July 2017 (Actual)
Study Completion Date
July 10, 2018 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine whether a risk-adapted, minimal-residual-disease directed therapy for young adults with newly diagnosed acute myeloid leukemia has positive results in terms of overall survival at 24 months.
Detailed Description
The general objective of this study is that of setting up a multicentre, risk-adapted study that relies on pre-treatment cytogenetic/genetic features and post-consolidation assessment of Minimal Residual Disease (MRD) to establish the final risk assignment and treatment of younger (≤ 60 years) patients with Acute Myeloid Leukemia (AML). Aim of this clinical trial is to verify whether the delivery of a post remission therapy whose intensity is risk-driven will improve the outcome in terms of both increased anti-leukemic efficacy and reduced therapy-related toxicity. All patients will receive induction and consolidation chemotherapy according to the Gruppo Italiano Malattie EMatologiche dell'Adulto (GIMEMA) LAM99P protocol. After the first consolidation, patients belonging to the low-risk category (core binding factor positive AML without c-Kit mutations, NPM1 positive FLT3 negative AML) will receive autologous stem cell transplantation, patients with high-risk features (adverse-risk karyotype, FLT3-ITD mutations), will be assigned to allogeneic stem cell transplantation. Patients with FLT3-TKD mutations or c-Kit mutated core binding factor positive AML and those belonging to the intermediate-risk karyotype category will be stratified according to MRD by flow cytometry and will receive risk-adapted treatment (autologous vs. allogeneic stem cell transplantation). All patients who meet the criteria for high-risk definition will be offered the allogeneic transplantation option regardless of the availability of a Human Leukocyte Antigen (HLA) identical sibling. In fact, for those lacking a HLA identical sibling all the other sources of hematopoietic stem cells (matched unrelated donor from international registry, unrelated cord blood, family haploidentical donor) will be considered. Autologous or allogeneic stem cell transplantation will be performed within 3 months from the end of consolidation therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia
Keywords
acute myeloid leukemia, risk-adapted therapy, MRD-directed therapy, young adults

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
515 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MRD-directed therapy
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Risk-adapted, MRD-directed therapy
Intervention Description
The general objective of this study is that of setting up a multicentre, risk-adapted study that relies on pre-treatment cytogenetic/genetic features and post-consolidation assessment of MRD to establish the final risk assignment and treatment of younger (≤ 60 years) patients with AML. Aim of this clinical trial is to verify whether the delivery of a post remission therapy whose intensity is risk-driven will improve the outcome in terms of both increased anti-leukemic efficacy and reduced therapy-related toxicity.
Primary Outcome Measure Information:
Title
Treatment strategy in terms of Overall Survival (OS) at 24 months.
Description
OS is defined as the time interval between the date of study entry and death for any cause; patients still alive will be censored at the time of the last follow-up.
Time Frame
24 months from study entry.
Secondary Outcome Measure Information:
Title
Estimation of Disease Free Survival (DFS) from Complete Response (CR) evaluation.
Description
DFS is defined as the time interval between the evaluation of CR -after induction phase- and relapse or death in CR; patients still alive, in first CR, will be censored at the time of the last follow-up.
Time Frame
At 24 months from study entry
Title
Estimation of Event Free Survival (EFS) from study entry.
Description
EFS is defined as the time interval between the date of study entry dose and failure during induction phase, relapse or death whichever comes first; patients still alive, in first CR, will be censored at the time of the last follow-up.
Time Frame
at 24 months from study entry
Title
Rate of patients in CR after induction therapy
Time Frame
At 31 days from study entry if pts are in CR or at 69 days from study entry if pts are in PR after 1 induction cycle
Title
Toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0
Time Frame
From study entry to study completion (6 months therapy + 18 months follow-up)
Title
Estimation of OS, EFS, DFS and Cumulative Incidence of Relapse (CIR) according to risk groups (Low, Intermediate, High)
Description
CIR is calculated from the date of achievement of the CR -after induction phase-, using the cumulative incidence method, considering death in CR as a competing risk. Patients still alive, without relapse, will be censored at the time of the last follow-up.
Time Frame
At 24 months from study entry
Title
Estimation of OS, EFS, DFS and CIR according to the Minimal Residual Disease (MRD) level at each evaluation step
Time Frame
At 24 months from study entry
Title
Rate of CR patients and estimation OS, EFS, DFS and CIR according to baseline characteristics such as age, performance status, white blood cell (WBC), morphology, cytogenetic and molecular features.
Time Frame
At 24 months from study entry
Title
Quality of Life evaluation
Description
QoL should be measured at three different time points: At Baseline (before treatment starts). At the end of Induction phase (after evaluation of response and before start of consolidation therapy for patients in CR or salvage therapy for patients not achieving a CR). At one year after baseline evaluation.
Time Frame
Before treatment starts, after induction, at one year after baseline evaluation.

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 (with the exception of no more than 7 days hydroxyurea (HU)), radiotherapy or more than 7 days corticosteroids Unequivocal diagnosis of untreated de novo AML according to WHO diagnostic criteria (at least 20% blasts in the bone marrow), with FAB classification other than M3 (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 more than 6 months duration) WHO performance status 0-3 Adequate renal (serum creatinine < 2 x the institutional Upper Limit of Normal (ULN)) and liver (total serum bilirubin < 2 x ULN; serum ALT and AST ≤ 3 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 aged less than 18 or more than 60 years Patients already treated for their AML by other chemotherapeutic agents (with the exception of no more than 7 days HU), radiotherapy or more than 7 days corticosteroids Acute promyelocytic leukaemia Blast crisis of chronic myeloid leukaemia AML supervening after other myeloproliferative disease AML supervening after antecedent myelodysplastic syndromes of more than 6 months duration Other progressive malignant diseases. However, secondary AML following previously cured malignancies may be included as well as secondary AML following previous exposure to alkylating agents or radiation for other reason Inadequate renal or liver function (metabolic abnormalities > 3 times the normal upper limit) Severe heart failure requiring diuretics Ejection fraction < 50% Uncontrolled infections WHO performance status = 4 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 hrs prior to administration of chemotherapy. Post-menopausal women must be amenorrhoeic 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 up to 3 months following discontinuation of study drug.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriano VENDITTI, Pr.
Organizational Affiliation
Policlinico Tor Vergata di Roma
Official's Role
Principal Investigator
Facility Information:
Facility Name
U.O. di Ematologia - Azienda Ospedaliera - Pia Fondazione di Culto e di Religione Card. G.Panico
City
Tricase
State/Province
(le)
Country
Italy
Facility Name
Complesso Ospedaliero S. Giovanni Addolorata
City
Roma
State/Province
(rm)
ZIP/Postal Code
00184
Country
Italy
Facility Name
Policlinico di Tor Vergata
City
Rome
State/Province
(rm)
ZIP/Postal Code
00133
Country
Italy
Facility Name
S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo
City
Alessandria
Country
Italy
Facility Name
Azienda Ospedaliera - Nuovo Ospedale "Torrette"
City
Ancona
Country
Italy
Facility Name
Az. Ospedaliera S. G. Moscati
City
Avellino
Country
Italy
Facility Name
Unità Operativa Ematologia 1 - Università degli Studi di Bari
City
Bari
ZIP/Postal Code
70010
Country
Italy
Facility Name
UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"
City
Barletta
Country
Italy
Facility Name
Ist.Ematologia e Oncologia Medica L.e A. Seragnoli
City
Bologna
Country
Italy
Facility Name
Divisione di Ematologia Ospedale A. Perrino
City
Brindisi
Country
Italy
Facility Name
Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi
City
Cagliari
Country
Italy
Facility Name
Unità Operativa Complessa di Onco-Ematologia - A.O. S.Anna e S.Sebastiano
City
Caserta
Country
Italy
Facility Name
Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"
City
Catania
Country
Italy
Facility Name
Azienda Ospedaliera Pugliese Ciaccio
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile
City
Civitanova
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi
City
Cona
Country
Italy
Facility Name
Sezione di Ematologia C.T.M.O. Istituti Ospitalieri
City
Cremona
Country
Italy
Facility Name
Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna
City
Ferrara
ZIP/Postal Code
44100
Country
Italy
Facility Name
Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria
City
Foggia
Country
Italy
Facility Name
Clinica Ematologica - Università degli Studi
City
Genova
Country
Italy
Facility Name
Divisione di Ematologia Ospedale "Santa Maria Goretti"
City
Latina
Country
Italy
Facility Name
ASL Le/1 P.O. Vito Fazzi - U.O. di Ematol
City
Lecce
Country
Italy
Facility Name
Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST
City
Meldola
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina
City
Messina
Country
Italy
Facility Name
Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"
City
Messina
Country
Italy
Facility Name
Ospedale Niguarda " Ca Granda"
City
Milano
Country
Italy
Facility Name
UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico
City
Milano
Country
Italy
Facility Name
Centro Oncologico Modenese - Dipartimento di Oncoematologia
City
Modena
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia
City
Napoli
Country
Italy
Facility Name
Pr. Alfonso Maria D'Arco
City
Nocera Inferiore
Country
Italy
Facility Name
S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro
City
Novara
Country
Italy
Facility Name
Ospedale S. Luigi Gonzaga
City
Orbassano
ZIP/Postal Code
10043
Country
Italy
Facility Name
Università degli Studi di Padova - Ematologia ed Immunologia Clinica
City
Padova
Country
Italy
Facility Name
Ospedale Riuniti "Villa-Sofia-Cervello"
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"
City
Palermo
Country
Italy
Facility Name
Cattedra di Ematologia CTMO Università degli Studi di Parma
City
Parma
Country
Italy
Facility Name
Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della MIsericordia
City
Perugia
Country
Italy
Facility Name
Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore
City
Pesaro
Country
Italy
Facility Name
Azienda ASL di Pescara
City
Pescara
ZIP/Postal Code
61100
Country
Italy
Facility Name
Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza
City
Piacenza
Country
Italy
Facility Name
Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia
City
Pisa
Country
Italy
Facility Name
Ematologia - Ospedale San Carlo
City
Potenza
Country
Italy
Facility Name
Ospedale S.Maria delle Croci
City
Ravenna
ZIP/Postal Code
48100
Country
Italy
Facility Name
Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"
City
Reggio Calabria
Country
Italy
Facility Name
Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova
City
Reggio Emilia
Country
Italy
Facility Name
Ospedale "Infermi"
City
Rimini
Country
Italy
Facility Name
Divisione Ematologia - Università Campus Bio-Medico
City
Roma
ZIP/Postal Code
00128
Country
Italy
Facility Name
Università Cattolica del Sacro Cuore - Policlinico A. Gemelli
City
Roma
ZIP/Postal Code
00168
Country
Italy
Facility Name
Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia
City
Roma
Country
Italy
Facility Name
S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena
City
Roma
Country
Italy
Facility Name
Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia
City
Roma
Country
Italy
Facility Name
Ospedale S. Camillo
City
Rome
Country
Italy
Facility Name
U.O.C. Ematologia - Ospedale S.Eugenio
City
Rome
Country
Italy
Facility Name
Sezione di Ematologia Cancer Center Humanitas
City
Rozzano
Country
Italy
Facility Name
Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza
City
San Giovanni Rotondo
Country
Italy
Facility Name
Serv. di Ematologia Ist. di Ematologia ed Endocrinologia
City
Sassari
Country
Italy
Facility Name
U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"
City
Siena
Country
Italy
Facility Name
UOC di Ematologia Generale P.O. S.Vincenzo
City
Taormina
Country
Italy
Facility Name
U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati
City
Taranto
Country
Italy
Facility Name
Azienda U.L.S.S.9 - U.O. di Ematologia
City
Treviso
Country
Italy
Facility Name
Policlinico Universitario - Clinica Ematologia
City
Udine
ZIP/Postal Code
33100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34731884
Citation
Buccisano F, Palmieri R, Piciocchi A, Arena V, Candoni A, Melillo L, Calafiore V, Cairoli R, de Fabritiis P, Storti G, Salutari P, Lanza F, Martinelli G, Luppi M, Capria S, Maurillo L, Del Principe MI, Paterno G, Irno Consalvo MA, Ottone T, Lavorgna S, Voso MT, Fazi P, Vignetti M, Arcese W, Venditti A. ELN2017 risk stratification improves outcome prediction when applied to the prospective GIMEMA AML1310 protocol. Blood Adv. 2022 Apr 26;6(8):2510-2516. doi: 10.1182/bloodadvances.2021005717.
Results Reference
derived
PubMed Identifier
31395600
Citation
Venditti A, Piciocchi A, Candoni A, Melillo L, Calafiore V, Cairoli R, de Fabritiis P, Storti G, Salutari P, Lanza F, Martinelli G, Luppi M, Mazza P, Martelli MP, Cuneo A, Albano F, Fabbiano F, Tafuri A, Chierichini A, Tieghi A, Fracchiolla NS, Capelli D, Foa R, Alati C, La Sala E, Fazi P, Vignetti M, Maurillo L, Buccisano F, Del Principe MI, Irno-Consalvo M, Ottone T, Lavorgna S, Voso MT, Lo-Coco F, Arcese W, Amadori S. GIMEMA AML1310 trial of risk-adapted, MRD-directed therapy for young adults with newly diagnosed acute myeloid leukemia. Blood. 2019 Sep 19;134(12):935-945. doi: 10.1182/blood.2018886960. Epub 2019 Aug 8.
Results Reference
derived
Links:
URL
http://www.gimema.it/en/index.php
Description
GIMEMA Foundation Website

Learn more about this trial

Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia

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