AzTrials
AzTrials

Leukemia, Myeloid, AcutePhase 2NCT04687098

Risk-adapted Therapy for Primary Acute Myeloid Leukemia

A Phase 2 study testing Idarubicin, Ara-C and G-CSF in people with Leukemia, Myeloid, Acute, run by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias at 15 sites in Spain.

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 AML-12 study investigates the efficacy and toxicity of standard induction chemotherapy with idarubicin and cytarabine (IC) with G-CSF priming followed by a risk-adapted post remission therapy for patients up to the age of 70 diagnosed with de novo acute myeloid leukemia (AML). Read more about this study

Who is it for?
Ages 17 to 70 years
Conditions the study is for
Leukemia, Myeloid, Acute
What is being tested?
Idarubicin, Ara-C and G-CSF
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,034 participants
Where
15 sitesSpain
Study dates
1 Feb 2012to 10 Nov 2022
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 17 to 70 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients with newly diagnosed AML, classified using the World Health Organization (WHO) 2017 criteria.
  • Patients with 70 years old or younger.

Who cannot join

  • Patients previously treated for the AML with chemotherapy different from hydroxyurea.
  • Acute promyelocytic leukemia with t(15;17).
  • Chronic myeloid leukemia in blastic phase.
  • Secondary AML or therapy related AML.
  • Presence of concomitant active neoplastic disease.
  • Abnormal renal and hepatic functions with creatinin and/or bilirubin 2 times higher than the normal threshold, except when the alteration should be attributed to the leukemia.
Show all 9Show fewer
  • Patients with a cardiac ejection fraction below 45%, symptomatic cardiac deficiency or both.
  • Patients with neurological or concomitant psychiatric disease.
  • HIV infection.

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Spain15 sites

  • ICO Badalona-Hospital Universitari Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Vall d'Hebron

    Barcelona, 08035

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • ICO-Girona Hopital Universitari de Girona Dr. Josep Trueta

    Girona, 17007

  • ICO Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitari Arnau de Vilanova

    Lleida, 25006

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • Hospital Universitari Son Espases

    Palma de Mallorca, Mallorca, 07198

  • Hospital Universitari Son Llatzer

    Palma de Mallorca, Mallorca

  • ICO Tarragona-Hospital Universitari Joan XXIII

    Tarragona, 43007

  • Mutua de Terrassa

    Terrassa, 08225

  • Hospital Verge de la Cinta

    Tortosa, Tarragona, 43517

  • Hospital Clínico Universitario de Valencia

    Valencia, 496010

Other trials in Spain

About this study

Official title: Risk-adapted Therapy for Primary Acute Myeloid Leukemia (AML) in Adult Patients up to 70 Years Old

The AML-12 study investigates the efficacy and toxicity of standard induction chemotherapy with idarubicin and cytarabine (IC) with G-CSF priming followed by a risk-adapted post remission therapy for patients up to the age of 70 diagnosed with de novo acute myeloid leukemia (AML).

Modifications from the previous protocol AML-03 (NCT01723657) include removal of etoposide in induction, limitation of the GCSF priming to the induction phase and categorization of post remission therapy (stem cell transplant or 2 high dose cytarabine consolidations) according to diagnostic genetics as well as post-remission clearance of measurable residual disease.

The aims of these modifications are to improve the overall survival and leukemia free survival of acute myeloid leukemia patients with a risk-adapted approach.

Read the detailed description

Induction chemotherapy: Idarubicin (12mg/m2/day intravenous, days 1-3), Low-dose cytarabine (200mg/m2/day, intravenous in continuous infusion, days 1-7) and G-CSF priming 150mcg/m2/day, subcutaneous from day 0 to the last day of chemotherapy if white blood cell count (WBC) <30x10E9/L.

This induction chemotherapy can be repeated twice in the case of partial response (PR) to achieve complete response (CR).

Once CR is achieved (with one or two induction cycles), all patients receive a consolidation course with high-dose cytarabine (3000mg/m2/12h days 1, 3 and 5) and pegfilgrastim 6mg on day 6.

After this, patients will be allocated to the different risk groups as follows:

  • Favorable risk group [patients with t(8;21)(q22;q22)/RUNX1/RUNX1T1, inv(16)(p12;q22) or t(16;16)/CBFB/MYH11; Intermediate risk cytogenetics (MRC 2010) and NPM1 mutation with FLT3 wild type or low ratio of FLT3 internal tandem duplication (ITD)/wild type (<0.5); or CEBPA biallelic mutation]. Patients in this group will receive 2 additional courses of consolidation therapy
  • Intermediate risk group [Intermediate risk cytogenetics (MRC 2010) without NPM1 mutations, FLT3-ITD, or CEBPA biallelic mutation]. Patients in this group receive an allogeneic stem cell transplant in first CR. Patients without an available donor can be autografted per center decision
  • Adverse risk group [Adverse risk cytogenetics (MRC 2010), intermediate cytogenetics with FLT3-ITD without NPM1 mutation or NPM1-FLT3-ITD high ratio or MLL rearrangement; any favorable or intermediate risk patients with positive MRD following 1 (intermediate) or 2 (favorable) consolidation courses]. Intention to treat of those patients is allogeneic stem cell transplant from any source.
Being tested
Idarubicin, Ara-C, G-CSF, Allogeneic matched or unrelated donor transplant., Autologous peripheral blood stem cell transplant
Keywords
Leukemia, Myeloid
Medical subject headings
Leukemia, Myeloid, Acute, Leukemia

What participants receive

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

  • IdarubicinDrug

    Also called Ida

    12 mg/m2/day; intravenous, administration at induction phase, days 1 to 3.

  • Ara-CDrug

    Also called HDAC

    200mg/m2/day, intravenous at induction phase; days 1-7.

    • High dose during consolidation phase. In patients up to 60 years 3g/m2/12hours days 1,3,5, and patients 60 to 70 years: 1.5g/m2/12hours days 1,3,5.

  • G-CSFDrug

    Also called Pegfilgrastim

    • Administration at induction phase to remission days 1 to 7. G-CSF will not be initiated if the leukocyte count is over 30x10e9/L at diagnosis or will be interrupted if the leukocyte count during treatment arises 30x10e9/L.
    • Administration at consolidation phase day 7.

  • Allogeneic matched or unrelated donor transplant.Procedure or surgery

    To be performed in patients in the intermediate or adverse risk groups.

  • Autologous peripheral blood stem cell transplantProcedure or surgery

    To be considered in patients in the intermediate risk group without an available allogeneic donor and negative measurable residual disease, per center decision.

  • Measurable residual diseaseProcedure or surgery

    Also called MRD

    To be performed either with molecular monitoring or, if not applicable, by flow cytometry. Pre-stablished cut-off values are defined for decision-making.

Study groups in NCT04687098
Study groupRoleWhat they receive
Risk-adapted postremission treatment.OtherInduction (idarubicin, cytarabine), first consolidation (high dose cytarabine), risk- stratification: allogeneic matched related or unrelated donor transplant vs. consolidation courses.
Receives: Drug: Idarubicin; Drug: Ara-C; Drug: G-CSF; Procedure: Allogeneic matched or unrelated donor transplant.; Procedure: Autologous peripheral blood stem cell transplant; Procedure: Measurable residual disease

What is being measured

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

  1. Complete remission rate (CRR)

    Analyze the efficacy and toxicity of the current doses of IC (Idarubicin and cytarabine) with G-CSF priming to achieve complete remission in patients tih AML up to 70yo.

    Measured: 2 months

  2. Disease free survival (DFS)

    Analyze the disease free survival in the whole cohort of AML patients.

    Measured: 4 years

  3. Relapse rate (RR)

    Analyze the relapse rate of all patients achieving remission with intensive induction followed by risk-adapted consolidation strategies.

    Measured: 4 years

Secondary outcomes (4)

  1. Feasibility of treatment completion

    Increase the number of patients who complete all treatment phases

    Measured: 4 years

  2. Survival outcome analysis of the 3 risk-adapted categories (favourable, intermediate and adverse)

    Evaluate the feasibility of the consolidation treatments in the different risk groups by comparison of overall survival (OS), RR and DFS.

    Measured: 4 years

  3. Feasibility of centralized monitoring of measurable residual disease (MRD)

    Survival outcomes in positive vs negative MRD patients. Number of patients with modified risk due to positive MRD.

    Measured: 4 years

  4. Comparison of global outcomes with previous protocol (AML-03) and other published protocols.

    Comparison of CRR, OS, RR and DFS

    Measured: 4 years

Timeline

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

  1. First posted29 Dec 2020
  2. Study start1 Feb 2012
  3. Primary completion31 Jul 2022
  4. Study completion10 Nov 2022

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
1,034 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04687098
Sponsor's protocol ID
AML-12
Status last verified
Jun 2023
First submitted
18 Dec 2020
Last updated
27 Jun 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Onate G, Pratcorona M, Garrido A, Artigas-Baleri A, Bataller A, Tormo M, Arnan M, Vives S, Coll R, Salamero O, Vall-Llovera F, Sampol A, Garcia A, Cervera M, Avila SG, Bargay J, Ortin X, Nomdedeu JF, Esteve J, Sierra J; Spanish Cooperative Group for the Study and Treatment of Acute Leukemias and Myelodysplasias (CETLAM). Survival improvement of patients with FLT3 mutated acute myeloid leukemia: results from a prospective 9 years cohort. Blood Cancer J. 2023 May 5;13(1):69. doi: 10.1038/s41408-023-00839-1.

    PubMed 37147301

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Idarubicin, Ara-C and G-CSF in people with Leukemia, Myeloid, Acute, run by Grupo Cooperativo de Estudio y Tratamiento de las Leucemias Agudas y Mielodisplasias at 15 sites in Spain.

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 2 inclusion and 9 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 27 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Spain. 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?

Complete remission rate (CRR) (time frame: 2 months). The study lists 3 primary outcomes in all. 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 NCT04687098, which also lists 1 linked publication.

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 27 Jun 2023.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in