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Acute Myeloid LeukemiaPhase 2AML1310NCT01452646

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

A Phase 2 study testing Risk-adapted, MRD-directed therapy in people with Acute Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 61 sites in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Acute Myeloid Leukemia
What is being tested?
Risk-adapted, MRD-directed therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
515 participants
Where
61 sitesItaly
Study dates
Jan 2012to 10 Jul 2018
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
Show all 14Show fewer
  • 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.

Trial locations and contacts

61 sites in 1 country.

61 sites in 1 country

Italy61 sites

  • S.O.C. di Ematologia - Azienda Ospedaliera - SS. Antonio e Biagio e Cesare Arrigo

    Alessandria

  • Azienda Ospedaliera - Nuovo Ospedale "Torrette"

    Ancona

  • Az. Ospedaliera S. G. Moscati

    Avellino

  • Unità Operativa Ematologia 1 - Università degli Studi di Bari

    Bari, 70010

  • UOC Ematologia Ospedale " Monsignor Raffaele Dimiccoli"

    Barletta

  • Ist.Ematologia e Oncologia Medica L.e A. Seragnoli

    Bologna

  • Divisione di Ematologia Ospedale A. Perrino

    Brindisi

  • Servizio di Ematologia - CTMO - ASL 8 P.O. Binaghi

    Cagliari

  • Unità Operativa Complessa di Onco-Ematologia - A.O. S.Anna e S.Sebastiano

    Caserta

  • Università di Catania - Cattedra di Ematologia - Ospedale "Ferrarotto"

    Catania

  • Azienda Ospedaliera Pugliese Ciaccio

    Catanzaro, 88100

  • Marche U.O. di Medicina Interna - ASUR Marche 8 - Ospedale Civile

    Civitanova Alta

  • Azienda Ospedaliero Universitaria Arcispedale Sant'Anna Dipartimento di Scienze Mediche Sezione di Ematologia e Fisiopatologia dell'Emostasi

    Cona

  • Sezione di Ematologia C.T.M.O. Istituti Ospitalieri

    Cremona

  • Sez.Ematologia e Dip. scienze Biomediche Arcispedale S. Anna

    Ferrara, 44100

  • Struttura Complessa di Ematologia Ospedali Riuniti Foggia - Azienda Ospedaliero-Universitaria

    Foggia

  • Clinica Ematologica - Università degli Studi

    Genova

  • Divisione di Ematologia Ospedale "Santa Maria Goretti"

    Latina

  • ASL Le/1 P.O. Vito Fazzi - U.O. di Ematol

    Lecce

  • Istituto Scientifico Romagnoli per lo Studio e la Cura dei Tumori- IRST

    Meldola

  • Azienda Ospedaliera Universitaria - Policlinico G. Martino Dipartimento di Medicina Interna - U.O. Messina

    Messina

  • Divisione di Ematologia - Azienda Ospedaliera Ospedali Riuniti "Papardo Piemonte"

    Messina

  • Ospedale Niguarda " Ca Granda"

    Milan

  • UO Centro Trapianti di Midollo - IRCCS Ospedale Maggiore Policlinico

    Milan

  • Centro Oncologico Modenese - Dipartimento di Oncoematologia

    Modena

  • Azienda Ospedaliera Universitaria - Università degli Studi di Napoli "Federico II" - Facoltà di Medicina e Chirurgia

    Naples

  • Pr. Alfonso Maria D'Arco

    Nocera Inferiore

  • S.C.D.U. Ematologia - DIMECS e Dipartimento Oncologico - Università del Piemonte Orientale Amedeo Avogadro

    Novara

  • Ospedale S. Luigi Gonzaga

    Orbassano, 10043

  • Università degli Studi di Padova - Ematologia ed Immunologia Clinica

    Padova

  • Ospedale Riuniti "Villa-Sofia-Cervello"

    Palermo, 90146

  • Divisione di Ematologia con trapianto di midollo - A.U. Policlinico "Paolo Giaccone"

    Palermo

  • Cattedra di Ematologia CTMO Università degli Studi di Parma

    Parma

  • Sezione di Ematologia ed Immunologia Clinica - Ospedale S.Maria della MIsericordia

    Perugia

  • Div. di Ematologia di Muraglia - CTMO Ospedale San Salvatore

    Pesaro

  • Azienda ASL di Pescara

    Pescara, 61100

  • Unità Operativa Ematologia e Centro Trapianti - Dipartimento di Oncologia ed Ematologia - AUSL Ospedale di Piacenza

    Piacenza

  • Università di Pisa - Azienda Ospedaliera Pisana - Dipartimento di Oncologia, dei Trapianti e delle nuove Tecnologie in Medicina - Divisione di Ematologia

    Pisa

  • Ematologia - Ospedale San Carlo

    Potenza

  • Ospedale S.Maria delle Croci

    Ravenna, 48100

  • Dipartimento Emato-Oncologia A.O."Bianchi-Melacrino-Morelli"

    Reggio Calabria

  • Unità Operativa Complessa di Ematologia - Arcispedale S. Maria Nuova

    Reggio Emilia

  • Ospedale "Infermi"

    Rimini

  • Complesso Ospedaliero S. Giovanni Addolorata

    Roma, (RM), 00184

  • Divisione Ematologia - Università Campus Bio-Medico

    Roma, 00128

  • Università Cattolica del Sacro Cuore - Policlinico A. Gemelli

    Roma, 00168

  • Az. Ospedaliera "Sant' Andrea"-Università la Sapienza Seconda Facoltà di Medicina e Chirurgia

    Roma

  • S.C. di Ematologia e Trapianti - I.F.O. Istituto Nazionale Tumori Regina Elena

    Roma

  • Università degli Studi "Sapienza" - Dip Biotecnologie Cellulari ed Ematologia - Divisione di Ematologia

    Roma

  • Policlinico di Tor Vergata

    Rome, (RM), 00133

  • Ospedale S. Camillo

    Rome

  • U.O.C. Ematologia - Ospedale S.Eugenio

    Rome

  • Sezione di Ematologia Cancer Center Humanitas

    Rozzano

  • Istituto di Ematologia - IRCCS Ospedale Casa Sollievo della Sofferenza

    San Giovanni Rotondo

  • Serv. di Ematologia Ist. di Ematologia ed Endocrinologia

    Sassari

  • U.O.C. Ematologia e Trapianti - A.O. Senese - Policlinico " Le Scotte"

    Siena

  • UOC di Ematologia Generale P.O. S.Vincenzo

    Taormina

  • U.O.C. di Ematolgia - A.O. " SS Annunziata" - P.O. S.G. Moscati

    Taranto

  • Azienda U.L.S.S.9 - U.O. di Ematologia

    Treviso

  • U.O. di Ematologia - Azienda Ospedaliera - Pia Fondazione di Culto e di Religione Card. G.Panico

    Tricase, (LE)

  • Policlinico Universitario - Clinica Ematologia

    Udine, 33100

Other trials in Italy

About this study

Official title: Risk-adapted, MRD-directed Therapy for Young Adults With Newly Diagnosed Acute Myeloid Leukemia. GIMEMA Protocol AML1310. EudraCT Number 2010-023809-36

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.

Read the 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.

Being tested
Risk-adapted, MRD-directed therapy
Keywords
acute myeloid leukemia, risk-adapted therapy, MRD-directed therapy, young adults
Medical subject headings
Leukemia, Myeloid, Acute

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Risk-adapted, MRD-directed therapyOther

    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.

Study groups in NCT01452646
Study groupRoleWhat they receive
MRD-directed therapyExperimentalNot described
Receives: Other: Risk-adapted, MRD-directed therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 24 months from study entry.

Secondary outcomes (8)

  1. 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.

    Measured: At 24 months from study entry

  2. 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.

    Measured: at 24 months from study entry

  3. Rate of patients in CR after induction therapy

    Measured: 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

  4. Toxicity according to Common Toxicity Criteria for Adverse Events (CTCAE) version 4.0

    Measured: From study entry to study completion (6 months therapy + 18 months follow-up)

  5. 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.

    Measured: At 24 months from study entry

  6. Estimation of OS, EFS, DFS and CIR according to the Minimal Residual Disease (MRD) level at each evaluation step

    Measured: At 24 months from study entry

  7. 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.

    Measured: At 24 months from study entry

  8. Quality of Life evaluation

    QoL should be measured at three different time points:

    1. At Baseline (before treatment starts).
    2. 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).
    3. At one year after baseline evaluation.

    Measured: Before treatment starts, after induction, at one year after baseline evaluation.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Oct 2011 (estimated)
  2. Study startJan 2012
  3. Primary completionJul 2017
  4. Study completion10 Jul 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
515 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01452646
Sponsor's protocol ID
AML1310
Acronym
AML1310
Status last verified
Aug 2018
First submitted
12 Oct 2011
Last updated
6 Aug 2018
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34731884

  • 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.

    PubMed 31395600

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Risk-adapted, MRD-directed therapy in people with Acute Myeloid Leukemia, run by Gruppo Italiano Malattie EMatologiche dell'Adulto at 61 sites in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 61 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Treatment strategy in terms of Overall Survival (OS) at 24 months. (time frame: 24 months from study entry.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01452646, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2018.

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