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Acute Myeloid Leukemia With Gene MutationsPhase 2DECISIVONCT07507760

Oral Decitabine Plus Ivosidenib as First Line for Older/Unfit Adult AML Patients

A Phase 2 study testing Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET, Ivosidenib Oral Tablet and Hydroxyurea in people with Acute Myeloid Leukemia With Gene Mutations, run by PETHEMA Foundation at 20 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
Search all trials

Trial summary

The goal of this clinical trial is to learn if the combination of oral decitabine plus ivosidenib works to treat naïve adult patients with acute myeloid leukemia (AML) with IDH1 R132 mutation older than 60 years old or those who are older than 18 years old with defined comorbidities that make them not suitable for… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET, Ivosidenib Oral Tablet and Hydroxyurea
Could I receive a placebo?
No, everyone receives an active treatment
How many people
50 participants
Where
20 sitesin 2 countries
Study dates
12 Jun 2026to Apr 2029
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Morphological diagnosis of AML (WHO criteria 2022)
  • Newly diagnosed AML.
  • IDH1 R132 mutations (centrally assessed by PCR and NGS). A patient will be allowed to be included with local result after approval of the medical monitor.
  • Subject must have an Eastern Cooperative Oncology Group (ECOG) Performance status of 0 to 2 if ≥ 60 years of age, or 0 to 3 if ≥ 18 to 60 years.
  • Age ≥ 18 years with comorbidities contraindicating intensive chemotherapy; or age ≥ 60 years.
  • ≥ 60 years of age;
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  • or ≥ 18 to 60 with at least one of the following co-morbidities:
  • ECOG Performance Status of 2 or 3;
  • Cardiac history of CHF requiring treatment or Ejection Fraction ≤ 55% or chronic stable angina;
  • DLCO ≤ 65% or FEV1 ≤ 65% or significant history of chronic pulmonary obstructive;
  • Creatinine clearance ≥ 25 mL/min to < 50 ml/min
  • Moderate hepatic impairment with total bilirubin > 1.5 to ≤ 3.0 × ULN
  • Non active/controlled prior neoplastic disease
  • Any other patient´s comorbidity or disease condition that the physician judges to be incompatible with intensive chemotherapy must be reviewed and approved by the PETHEMA medical monitor before study enrolment (e.g, prior MDS or MPS, high-risk cytogenetics)
  • Patients <70 years, with favorable risk AML according to ELN will be included only if they are not candidates to standard treatment with intensive chemotherapy.
  • Adequate renal function as demonstrated by a creatinine clearance ≥ 25 mL/min (calculated by the Cockcroft Gault formula).
  • Adequate liver function as demonstrated by: aspartate aminotransferase (AST) ≤ 5.0 × ULN, alanine aminotransferase (ALT) ≤ 5.0 × ULN, bilirubin ≤ 2.5 × ULN (unless considered to be due to leukemic disease, in which case it should be approved by the PETHEMA medical monitor).
  • Subject has a white blood cell count < 30 × 109/L (Hydroxyurea is permitted to meet this criterion)
  • Female subjects must be either postmenopausal OR permanently surgical sterile (bilateral oophorectomy, bilateral salpingectomy or hysterectomy) OR Women of Childbearing Potential (WOCBP) practicing at least one protocol specified method of birth control. Female subjects of childbearing potential must have negative results for pregnancy tests performed along the study (screening and every three cycles). A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy. A postmenopausal state is defined as no menses for 12 months without an alternative medical cause. A man is considered fertile after puberty unless permanently sterile by bilateral orchidectomy.
  • Male subjects who are sexually active, must agree, from Study Day 1 through at least 90 days after the last dose of study drug, to practice the protocol specified contraception.
  • Subject must voluntarily sign and date an informed consent, approved by an Independent Ethics Committee (IEC)/Institutional Review Board (IRB), prior to the initiation of any screening or study specific procedures.

Who cannot join

  • Subject has history of myeloproliferative neoplasm [MPN] with BCR-ABL1 translocation and AML with BCR-ABL1 translocation.
  • Prior therapy for AML (except hydroxiurea).
  • Genetic diagnosis of acute promyelocytic leukemia.
  • Subject is known to be positive for HIV (HIV testing is not required.)
  • Subject is known to be positive for hepatitis B or C infection with the exception of those with an undetectable viral load within 3 months. (Hepatitis B or C testing is not required).
  • Subject has chronic respiratory disease that requires continuous oxygen, or significant history of renal, neurologic, psychiatric, endocrinologic, metabolic, immunologic, hepatic, cardiovascular disease, any other medical condition or known hypersensitivity to any of the study medications including excipients that in the opinion of the investigator would adversely affect his/her participating in this study.
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  • Any severe uncontrolled systemic infection.
  • Subject has a history of other malignancies within 1 year prior to study entry which is not controlled and/or requiring active therapy which may compromise the administration of IVO and oral decitabine.
  • Creatinine clearance <25 mL/min (calculated by the Cockcroft-Gault formula).
  • Inadequate liver function as demonstrated by AST or ALT > 5.0 × ULN, or bilirubin > 2.5 × ULN (unless considered to be due to leukemic disease, in which case it should be approved by the PETHEMA medical monitor)
  • Subject has a white blood cell count > 30 × 109/L that is not controlled using hydrea or 1 gr/sqm/day per 1 day of cytarabine.
  • Contraindications for IVO or oral decitabine according to the SmPC.
  • Patient has a heart rate-corrected QT interval using Fridericia's method QT for corrected heart rate (QTcF) ≥450 msec or any other factor that increases the risk of QT prolongation or arrhythmic events (e.g., hypokalemia, family history of long QT interval syndrome). Patients with prolonged QTcF interval in the setting of bundle branch block may participate in the trial.

Trial locations and contacts

20 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Pau Montesinos contact

+34 96 1244925

montesinos_pau@gva.es

Juan José Lahuerta contact

jjlahuerta@telefonica.net

20 sites in 2 countries

Spain15 sites, 15 recruiting

  • Complejo Hospitalario de Albacete

    Albacete, 02006

    Jesús Lorenzo Algarra Algarra

    Not yet recruiting

  • Hospital General Universitario Dr. Balmis

    Alicante

    Carmen Botella, Dr

    Not yet recruiting

  • Hospital Universitario de Burgos

    Burgos, 09006

    Jorge Labrador

    Recruiting

  • Hospital San Pedro Alcántara

    Cáceres

    Juan Bergua

    Recruiting

  • Complejo Hospitalario Regional Reina Sofía

    Córdoba, 14004

    Josefina Serrano López

    Recruiting

  • Hospital Universitario de Gran Canaria Doctor Negrín

    Las Palmas

    Carlos Rodríguez

    Not yet recruiting

  • Hospital Universitario de Canarias

    Las Palmas de Gran Canaria

    Carolina Lacalzada

    Not yet recruiting

  • Hospital Universitario Lucus Augusti

    Lugo

    Aitor Abuín, Dr

    Not yet recruiting

  • Fundación Jiménez Díaz

    Madrid, 28040

    José Luis López Lorenzo

    Not yet recruiting

  • H. 12 de Octubre

    Madrid

    Pilar Martínez Sánchez

    Not yet recruiting

  • Hospital Univeristario Ramón y Cajal

    Madrid

    Pilar Herrera

    Not yet recruiting

  • Hospital Virgen de la Victoria

    Málaga

    Maria García Fortes, Dr

    Recruiting

  • Hospital Universitario Virgen Del Rocío

    Seville

    Eduardo Rodríguez Arbolí

    Eduardo Rodríguez Arbolí

    Recruiting

  • H. Dr. Peset

    Valencia

    María José Sayas

    María Pedreño, MD

    Not yet recruiting

  • Hospital Universitari i Politècnic La Fe

    Valencia

    Irene Navarro

    Recruiting

Other trials in Spain

Portugal5 sites, 5 recruiting

  • ULS Região de Aveiro

    Aveiro

    Cátia Sol dos Reis

    Not yet recruiting

  • Hospital Central do Funchal

    Funchal

    Rebeca Brito

    Not yet recruiting

  • Hospital Santa Maria

    Lisbon

    Joana Brioso

    Not yet recruiting

  • ULS São José

    Lisbon

    Luís Monteiro

    Not yet recruiting

  • Hospital Pedro Hispano

    Porto

    Ilídia Moreira

    Not yet recruiting

Other trials in Portugal

About this study

Official title: A Phase II, Multicentre, Open Label Clinical Trial Evaluating the Efficacy and Safety of Oral Decitabine Plus Ivosidenib in Adult Patients With Newly Diagnosed Acute Myeloid Leukemia Older Than 60 Years Old and/or Who Are Ineligible for Standard Induction Chemotherapy

The goal of this clinical trial is to learn if the combination of oral decitabine plus ivosidenib works to treat naïve adult patients with acute myeloid leukemia (AML) with IDH1 R132 mutation older than 60 years old or those who are older than 18 years old with defined comorbidities that make them not suitable for standard induction therapy. The main objectives of this clinical trial are:

  • Asses the Complete Remission (CR) and Complete Remission with incomplete marrow recovery (CRi) rates of this treatment.
  • Determine the incidence and severity of all adverse events (AEs).

All participants will receive oral ivosidenib and oral decitabine in treatment cycles of 28 days until disease progression, lack of clinical benefit or the end of the study. Patients who achieve CR/CRi will be elegible to receive allogeneic stem cell transplantation.

Read the detailed description

A total of 50 participants will be assigned to the single treatment arm which will have treatment cycles of 28 days with Ivosidenib 500 mg/orally on Days 1-28 plus oral decitabine-cedazuridine (one tablet once daily containing 35 mg decitabine and 100 mg cedazuridine as a fixed-dose combination) on days 1-5.

Hydroxiurea or maximum 1 gram/sqm of cytarabine is allowed to control hyperleukocytosis during the screening period as well as during the first two cycles of induction.

Participants will continue their study treatment until documented disease progression per Investigator assessment, unacceptable toxicity, withdrawal of consent, the subject meets other protocol criteria for discontinuation or study completion (whichever occurs first).

Participants who are considered eligible for an allogeneic stem cell transplant after achieving CR/CRi will perform a pre-transplant visit into the study, collecting MRD stats and characteristics of transplant. They will be allowed to resume ivosidenib after day +60 of transplant. The post-transplant schedule can be administered for up to 2 years. If they do not resume ivosidenib they will perform end of trial visit (and if this is not possible the pre-transplant visit will be considered as en of trial visit).

Being tested
Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET, Ivosidenib Oral Tablet, Hydroxyurea, Cytarabine, Allogeneic stem cell transplantation
Keywords
AML, older adult, unfit, IDH1 R132 mutation, Decitabine, Ivosidenib, allogeneic stem cell transplant

What participants receive

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

  • Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLETDrug

    Oral Decitabine (Decitabine/Cedazuridine 35 Mg-100 Mg) will be administerd on Days 1-5 of each treatment cycle

  • Ivosidenib Oral TabletDrug

    Ivosidenib 500 mg/orally on Days 1-28 of each treatment cycle

  • HydroxyureaDrug

    0.5-6 gram/day orally during the screening period and the two first treatment cycles if hyperleukocytosis at diagnosis

  • CytarabineDrug

    Maximum 1 gram/sqm/day during the screening period and the two first treatment cycles if hyperleukocytosis at diagnosis

  • Allogeneic stem cell transplantationProcedure or surgery

    Only for those participants achieving CR/CRi

Study groups in NCT07507760
Study groupRoleWhat they receive
Decitabine+IvosidenibExperimentalParticipants will receive treatment cycles of 28 days with Ivosidenib 500 mg/orally on Days 1-28 plus oral decitabine-cedazuridine (one tablet once daily containing 35 mg decitabine and 100 mg cedazuridine as a fixed-dose combination) on days 1-5. Hydroxiurea or maximum 1 gram/sqm of cytarabine is allowed to control hyperleukocytosis during the screening period as well as during the first two cycles of induction. Participants who achieve CR/CRi can be submitted to allogeneic stem cell transplant and will be allowed to resume ivosidenib after day +60 of transplant. The post-transplant schedule can be administered for up to 2 years.
Receives: Drug: Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET; Drug: Ivosidenib Oral Tablet; Drug: Hydroxyurea; Drug: Cytarabine; Procedure: Allogeneic stem cell transplantation

What is being measured

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

  1. Rate of CR/CRi

    To assess the rates of Complete Remission (CR) and Complete Remission with incomplete marrow recovery (CRi) of participants treated with Ivosidenib plus Decitabine

    Measured: 3 years

Secondary outcomes (6)

  1. Rate CR/CRi compared to historical cohort

    To evaluate the CR (Complete Remission)/CRi (Complete Remission with incomplete marrow recovery) rates after 2, 3 and 6 cycles of Ivosidenib and oral Decitabine, and compare with a matched historical cohort.

    Measured: 3 years

  2. OS compared to historical cohort

    To assess OS (overall survival, measured as the number of days from the date of enrollment to the date of death, whatever the cause of death) and compare the median between Ivosidenib with oral Decitabine and a matched historical cohort.

    Measured: 3 years

  3. EFS compared to historical cohort

    To evaluate EFS (event-free survival, defined as the number of days from enrollment until the date of progressive disease, relapse from CR or CRi, failure to achieve CR or CRi, or death from any cause) and compare with a matched historical control cohort

    Measured: 3 years

  4. Hematologic and non-hematologic toxicity and AE

    Toxicity and adverse events (AE) will be recorded and evaluated to determine treatment safety. Toxicity will be graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) version 4.019.

    Measured: 3 years

  5. Quality of CR

    The quality of the Complete Remission (CR) will measured by the study of minimal residual disease percentages in the bone marrow using multiparametric flow cytometry and Next Generation Sequencing

    Measured: 3 years

  6. Early mortality

    To evaluate the mortality rate during the first 60 days of treatment

    Measured: 3 years

Timeline

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

  1. First posted2 Apr 2026
  2. Study start12 Jun 2026
  3. Primary completionApr 2029 (estimated)
  4. Study completionApr 2029 (estimated)

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
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07507760
Sponsor's protocol ID
DECISIVO
Acronym
DECISIVO
Status last verified
Mar 2026
First submitted
27 Mar 2026
Last updated
22 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Decitabine/Cedazuridine 35 Mg-100 Mg ORAL TABLET, Ivosidenib Oral Tablet and Hydroxyurea in people with Acute Myeloid Leukemia With Gene Mutations, run by PETHEMA Foundation at 20 sites in 2 countries.

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 21 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in Spain, Portugal. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Pau Montesinos (+34 96 1244925, montesinos_pau@gva.es), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of CR/CRi (time frame: 3 years). 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 NCT07507760.

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 22 Sep 2026.

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