Acute Myeloid LeukemiaPhase 2MIVONUNCT07463768
Study Evaluating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy.
A Phase 2 study testing Ivosidenib + oral azacitidine in people with Acute Myeloid Leukemia, run by French Innovative Leukemia Organisation at 20 sites in France.
Trial summary
After remission post-induction and consolidation, maintenance therapy by an ivosidenib and oral azacitidine combination is susceptible to improve the prevention of AML relapse, which remains a major issue in the study population. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Acute Myeloid Leukemia
- What is being tested?
- Ivosidenib + oral azacitidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 20 sitesFrance
- Study dates
- Sep 2026to Sep 2030
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 55 years of age at the time of signing informed consent
- Patients with confirmation of newly diagnosed AML by 2022 WHO criteria
- Presence of IDH1 R132 mutation at AML diagnosis
- Achievement CR or CRi following induction therapy by intensive chemotherapy (according to ELN 2022, appendix 2), within 17 weeks prior to enrollment.
- Received at least 2 consolidations :
- with intermediate dose of cytarabine (IDAC)
Show all 27Show fewer
- or with standard dose cytarabine and idarubicin (5+1)
- Adequate BM function: ANC ≥1 × 109/L and platelet count ≥50 × 109/L at the time of inclusion
- Patients who are not candidate for Allo-HSCT
- Adequate baseline organ function defined by the following criteria:
- Estimated Glomerular Filtration Rate (eGFR) ≥ 30 ml/min (using CKD-EPI).
- aspartate aminotransferase (AST) ≤ 2.5 × ULN
- alanine aminotransferase (ALT) ≤ 2.5× ULN
- bilirubin ≤ 1.5 × ULN
- ECOG < 3 (appendix 1)
- Absence of any psychological, familial, sociological, or geographical conditions potentially hampering compliance with the study protocol and follow-up schedule
- Patient suitable for oral administration of study drug.
- A female subject is eligible to participate if she is not pregnant and at least one of the following conditions applies:
- Not a woman of childbearing potential (WOCBP) as defined in post-menopausal (defined as at least 1 year without any menses) prior to Screening, or documented as surgically sterile (at least 1 month prior to Screening)
- WOCBP agrees to follow the contraceptive treatment starting at screening and continued throughout the study period, and for at least 180 days after the final study drug administration.
- WOCBP agrees to perform planned pregnancy tests in the study
- Female subject must agree not to breastfeed starting at screening and throughout the study period, and for one month after the final study drug administration.
- Female subject must not donate ova starting at screening and throughout the study period, and for 180 days after the final study drug administration.
- A male subject with a partner(s) of childbearing potential must agree to use contraception starting at screening and continue throughout the study period, for at least 90 days after the final study drug administration.
- A male subject must not donate sperm starting at screening nor throughout the study period and for 90 days after the final study drug administration
- Patient must be affiliated to the French social security (health insurance)
- Signed written informed consent for the study
Who cannot join
- Acute promyelocytic leukemia (FAB M3) with t(15;17) or its molecular equivalents (PML::RARA)
- AML associated with t(9;22) or molecular evidence of such a translocation
- Prior BM or hematopoietic stem cell transplantation
- CR/CRi following treatment with hypomethylating agents
- Proven central nervous system leukemia
- Candidate for Allo-HSCT at screening
Show all 25Show fewer
- Diagnosis of malignant disease within the previous 12 months (excluding MDS or CMML, basal cell carcinoma of the skin without complications, "in- situ" carcinoma of the cervix or breast, or other local malignancy excised or irradiated with a high probability of cure)
- Abnormal cardiac status with any of the following:
- Unstable angina
- Myocardial infarction within the last 6 months
- Significant cardiac arrhythmia
- New York Heart Association (NYHA) class 3 or 4 congestive heart failure
- Congenital long QT syndrome, familial history of sudden death or polymorphic ventricular arrhythmias and QT/QTc interval > 500 msec regardless of the correction method.
- For subject with 450 ≤ QTc ≤ 500 ms, practitioners should thoroughly reassess the benefit/risk of initiating ivosidenib. In case QTc interval prolongation is between 480 msec and 500 msec, initiation of treatment with ivosidenib should remain exceptional and be accompanied by close monitoring. This issue will be discussed with coordinating investigator.
- Uncontrolled systemic fungal, bacterial or viral infection (defined as ongoing signs/symptoms related to the infection without improvement despite appropriate antibiotics or other treatment)
- Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he/she were to participate in the study
- Severe medical or mental condition precluding the administration of protocol treatments
- Persons deprived of their liberty by judicial or administrative decision, persons subject to a legal protection measure (guardianship, curatorship, legal protection), persons under psychiatric care
- Other comorbidity that the physician judges to be incompatible with the study design
- Any condition causing an inability to swallow tablets or known hypersensitivity to the study medication
- Any condition that would impair absorption of the study medication (i.e. short gut, malabsorption syndrome)
- Subject requiring treatment with concomitant drugs that are strong inducers/inhibitors of cytochrome P450 (CYP)3A /PGP or dabigatran (PGP substrate) (see appendix 6) or QT-prolongating agent other than 5-HT3 antagonists (see appendix 8) or other forbidden medications listed in section 10.7
- Subject with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- Subject with positive HIV test treated or planned to be treated with drugs with potential drug-drug interactions. HIV testing will be performed at screening, if required per local guidelines or institutional standards.
- Subject known to be positive for hepatitis B virus (HBV), or hepatitis C virus (HCV) infection. Inactive hepatitis carrier status with undetectable PCR viral load on antivirals (non-exclusionary medications) are not excluded.
Trial locations and contacts
20 sites in 1 country. Contact the study team or a site near you to ask about taking part.
20 sites in 1 country
France20 sites
CHU Angers
Angers, 49933
Mathilde HUNAULT, +33241354472, MaHunault@chu-angers.fr
CH côte Basque
Bayonne, 64109
Harmony LEROY, +33559443832, hleroy@ch-cotebasque.fr
CHU Besançon
Besançon, 25030
Lise BENJEMIA, +33381668232, lbenjemia@chu-besancon.fr
Hopital d'Instruction des Armées Percy
Clamart, 92140
Pierre ARNAUTOU, +33141466301, pierre.arnautou@intradef.gouv.fr
CHU Henri Mondor
Créteil, 94000
Mathieu LECLERC, +33149812057, mathieu.leclerc@aphp.fr
CHU Grenoble
Grenoble, 38043
Martin CARRE, +33476765755, mcarre1@chu-grenoble.fr
Chru de Lille - Hopital Claude Huriez
Lille, 59037
Céline BERTHON, +33320444290, Celine.BERTHON@chu-lille.fr
CHU de Limoges
Limoges, 87000
Pascal TURLURE, +33555058039, pascal.turlure@chu-limoges.fr
CHU de Nantes
Nantes, 44093
Pierre PETERLIN, +33240083333, pierre.peterlin@chu-nantes.fr
CHU de Nîmes - Institut de Cancérologie du Gard
Nîmes, 30029
Samy CHRAIBI, +33466684033, samy.chraibi@chu-nimes.fr
Hôpital Saint Louis
Paris, 75010
Emmanuel RAFFOUX, +33142499637, emmanuel.raffoux@aphp.fr
CH de Perpignan
Perpignan, 66046
Alexandre KARANGWA, +33468618901, alexandre.karangwa@ch-perpignan.fr
Hôpital Haut-Lévêque
Pessac, 33604
Arnaud PIGNEUX, +33557656511, arnaud.pigneux@chu-bordeaux.fr
Hôpital Lyon-Sud
Pierre-Bénite, 69310
Chu de Rennes - Hopital Pontchaillou
Rennes, 35033
Marc BERNARD, +33299284291, marc.bernard@chu-rennes.fr
Centre Henri Becquerel
Rouen, 76038
Emilie LEMASLE, +33232082221, emilie.lemasle@chb.unicancer.fr
CHU de TOULOUSE - IUCT ONCOPOLE
Toulouse, 31059
Sarah BERTOLI, +33531156306, bertoli.sarah@iuct-oncopole.fr
Chru Bretonneau
Tours, 37044
Nicolas VALLET, +33247473712, nicolas.vallet@chu-tours.fr
CHRU Nancy
Vandœuvre-lès-Nancy, 54500
Gabrielle ROTH-GUEPIN, +33383153282, g.roth-guepin@chru-nancy.fr
Gustave Roussy
Villejuif, 94800
Stephane DE BOTTON, +33142114211, Stephane.DEBOTTON@gustaveroussy.fr
About this study
Official title: A Single Arm Phase II Study Investigating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy. A Study of the French AML Intergroup.
After remission post-induction and consolidation, maintenance therapy by an ivosidenib and oral azacitidine combination is susceptible to improve the prevention of AML relapse, which remains a major issue in the study population. We assume that the combination of ivosidenib with oral azacitidine will not be less well tolerated than in combination with the subcutaneous form, therapeutic regimen authorized until progression or toxicity. Ivosidenib and Onureg®, being already authorized treatments, it has been decided to use the classic administration schedules and dosages in combination.
The primary objective of the study is to evaluate relapse free survival (RFS) at 24 months in patients receiving oral azacitidine with ivosidenib.
Read the detailed description
According to data from the Institut de Veille Sanitaire, the frequency of Acute Myeloid Leukemia (AML) is about 3 cases per 100,000 inhabitants, a frequency which increases with age to reach 20 / 100,000 at 70 years. AML is characterized by recurrent molecular and cytogenetic abnormalities. Among mutations arising with age, those of IDH1 (isocitrate dehydrogenase 1) and IDH2 ((isocitrate dehydrogenase 2) are considered as early molecular events driving AML transformation, characterized by a DNA hypermethylation signature. Somatic mutations in the gene encoding IDH1 occur in 6 to 16% of patients with AML.
In intensively treated (ICT) patients, IDH1 mutations are associated with a poorer outcome in patients treated with ICy34, even in case of favorable-ELN risk. Hematopoietic stem cell transplantation (HSCT) for IDH1mut patients in CR1 after ICT drastically improves OS (HR, 0.48; P = .048). However, in real life settings, and more specifically in elderly patients, only 40% of patients with HSCT indication are effectively transplanted.
For patients who are not candidates for HSCT, effective AML maintenance therapies are needed that can reduce the risk of relapse and prolong overall survival without causing undue adverse effects or compromising health-related quality of life. Indeed, relapse rates after IC without HSCT remain high with limited therapeutic options in this setting. There is a clear unmet medical need to improve the outcome of patients treated with IC who are not candidate for HSCT.
Oral azacitidine is approved as maintenance therapy in adult AML patients who achieve CR or CR without blood count recovery (CRi), following induction therapy and are not eligible for allo-HCT. Nevertheless, according to results of the pivotal QUAZAR-AML-001 placebo-controlled trial, estimated 5-year overall survival reached only 26% in the oral azacitidine arm versus 20% in the placebo arm.
Ivosidenib, a first-in-class, oral, potent, targeted small-molecule inhibitor of mutant IDH1, has shown clinical activity as a single agent in studies involving patients with hematologic and solid-tumors. In a phase 1 dose-escalation and dose-expansion study of ivosidenib monotherapy in IDH1-mutated relapsed or refractory AML, the rate of CR or CRi was 30,4%.
For newly diagnosed patients with IDH1 mutation, results from a randomized study (AGILE trial) indicate that the IDH1 inhibitor ivosidenib plus azacitidine improves event-free survival (EFS) (hazard ratio, 0.33; 95% CI, 0.16-0.69), clinical response (CR/CRh, 52.8 vs 17.6%), and median OS (29.3 vs 7.9 months) compared with azacitidine plus placebo.
After remission post-induction and consolidation, maintenance therapy by an ivosidenib and oral azacitidine combination is susceptible to improve the prevention of AML relapse, which remains a major issue in the study population. We assume that the combination of ivosidenib with oral azacitidine will not be less well tolerated than in combination with the subcutaneous form, therapeutic regimen authorized until progression or toxicity. Ivosidenib and Onureg®, being already authorized treatments, it has been decided to use the classic administration schedules and dosages in combination
- Conditions
- Acute Myeloid Leukemia
- Being tested
- Ivosidenib + oral azacitidine
- Keywords
- acute myeloid leukemia and IDH1 mutation, complete remission after intensive chemotherapy, ivosidenib and oral azacitidine
- 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.
Ivosidenib + oral azacitidineDrug
Subjects will be administered treatment over 28-day cycles until progression or another reason (unacceptable toxicity, patient choice to discontinue study treatment, sponsor decision, HSCT at any time, patients who require the use of any of the excluded therapies).
The treatment is the association of ivosidenib with oral azacitidine.
- The investigational medicinal product is ivosidenib. Two tablets (500 mg) will be administered as a single dose, once daily, during 28 days-cycles until discontinuation.
- The auxiliary treatment is oral azacitidine. Oral AZA 300 mg will be given once-daily for 14 days of repeated 28-day treatment cycles. For all patients, oral AZA will be interrupted systematically after day 14 of each 28-days cycle.
| Study group | Role | What they receive |
|---|---|---|
| ivosidenib + Oral azacitidine | Experimental | cf intervention Receives: Drug: Ivosidenib + oral azacitidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
RFS 24 months
relapse-free-survival (RFS) at 24 months in patients receiving oral azacitidine with ivosidenib
Measured: 24 months
Secondary outcomes (4)
RFS 12 months
RFS at 12 months, with the same definition for RFS as for the primary endpoint
Measured: 12 months
Overall survival
Overall survival defined as the time between inclusion assignment and death from any cause, at 12 and 24 months
Measured: 24 months
EFS MRD neg
EFS MRD-, defined in patients who were MRD negative at baseline to MRD relapse (by FCM or RT-qPC for NPM1) or death from any cause, whichever occurred first
Measured: 24 months
TEAEs
Number of participants with Treatment Emergent Adverse Events (TEAEs), according the CTCAE v5.0 classification
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2026
- Study startSep 2026 (estimated)
- Primary completionSep 2030 (estimated)
- Study completionSep 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myeloid LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- French Innovative Leukemia Organisation
- Sponsor type
- University, hospital or other
- Collaborators
- Servier Affaires Médicales
- Responsible party
- Sponsor
- Investigators
- Arnaud PIGNEUX, Principal investigator, University Hospital, BordeauxStephane DE BOTTON, Principal investigator, Gustave Roussy, Cancer Campus, Grand ParisMaël HEIBLIG, Principal investigator, Centre Hospitalier Lyon SudYohan DESBROSSES, Principal investigator, CHRU Jean Minjoz Besançon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07463768
- Sponsor's protocol ID
- FILO-AML-01-MIVONU
- Acronym
- MIVONU
- Status last verified
- Mar 2026
- First submitted
- 18 Feb 2026
- Last updated
- 11 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Phase II Study Investigating the Efficacy and Safety of the Addition of Ivosidenib to Oral Azacitidine (Onureg®) in Patients Over 55 With Acute Myeloid Leukemia (AML) and IDH1 Mutation, in Complete Remission After Intensive Chemotherapy. A Study of the French AML Intergroup.
- ClinicalTrials.gov ID
- NCT07463768
- Acronym / sponsor ID
- MIVONU / FILO-AML-01-MIVONU
- Conditions
- Acute Myeloid Leukemia
- Keywords
- acute myeloid leukemia and IDH1 mutation, complete remission after intensive chemotherapy, ivosidenib and oral azacitidine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- French Innovative Leukemia OrganisationUniversity, hospital or other
- Collaborators
- Servier Affaires Médicales
- Study start
- Sep 2026 (estimated)
- Primary completion
- Sep 2030 (estimated)
- Study completion
- Sep 2030 (estimated)
- First posted
- 11 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After remission post-induction and consolidation, maintenance therapy by an ivosidenib and oral azacitidine combination is susceptible to improve the prevention of AML relapse, which remains a major issue in the study population. We assume that the combination of ivosidenib with oral azacitidine will not be less well tolerated than in combination with the subcutaneous form, therapeutic regimen authorized until progression or toxicity. Ivosidenib and Onureg®, being already authorized treatments, it has been decided to use the classic administration schedules and dosages in combination.
The primary objective of the study is to evaluate relapse free survival (RFS) at 24 months in patients receiving oral azacitidine with ivosidenib.
Detailed description
According to data from the Institut de Veille Sanitaire, the frequency of Acute Myeloid Leukemia (AML) is about 3 cases per 100,000 inhabitants, a frequency which increases with age to reach 20 / 100,000 at 70 years. AML is characterized by recurrent molecular and cytogenetic abnormalities. Among mutations arising with age, those of IDH1 (isocitrate dehydrogenase 1) and IDH2 ((isocitrate dehydrogenase 2) are considered as early molecular events driving AML transformation, characterized by a DNA hypermethylation signature. Somatic mutations in the gene encoding IDH1 occur in 6 to 16% of patients with AML.
In intensively treated (ICT) patients, IDH1 mutations are associated with a poorer outcome in patients treated with ICy34, even in case of favorable-ELN risk. Hematopoietic stem cell transplantation (HSCT) for IDH1mut patients in CR1 after ICT drastically improves OS (HR, 0.48; P = .048). However, in real life settings, and more specifically in elderly patients, only 40% of patients with HSCT indication are effectively transplanted.
For patients who are not candidates for HSCT, effective AML maintenance therapies are needed that can reduce the risk of relapse and prolong overall survival without causing undue adverse effects or compromising health-related quality of life. Indeed, relapse rates after IC without HSCT remain high with limited therapeutic options in this setting. There is a clear unmet medical need to improve the outcome of patients treated with IC who are not candidate for HSCT.
Oral azacitidine is approved as maintenance therapy in adult AML patients who achieve CR or CR without blood count recovery (CRi), following induction therapy and are not eligible for allo-HCT. Nevertheless, according to results of the pivotal QUAZAR-AML-001 placebo-controlled trial, estimated 5-year overall survival reached only 26% in the oral azacitidine arm versus 20% in the placebo arm.
Ivosidenib, a first-in-class, oral, potent, targeted small-molecule inhibitor of mutant IDH1, has shown clinical activity as a single agent in studies involving patients with hematologic and solid-tumors. In a phase 1 dose-escalation and dose-expansion study of ivosidenib monotherapy in IDH1-mutated relapsed or refractory AML, the rate of CR or CRi was 30,4%.
For newly diagnosed patients with IDH1 mutation, results from a randomized study (AGILE trial) indicate that the IDH1 inhibitor ivosidenib plus azacitidine improves event-free survival (EFS) (hazard ratio, 0.33; 95% CI, 0.16-0.69), clinical response (CR/CRh, 52.8 vs 17.6%), and median OS (29.3 vs 7.9 months) compared with azacitidine plus placebo.
After remission post-induction and consolidation, maintenance therapy by an ivosidenib and oral azacitidine combination is susceptible to improve the prevention of AML relapse, which remains a major issue in the study population. We assume that the combination of ivosidenib with oral azacitidine will not be less well tolerated than in combination with the subcutaneous form, therapeutic regimen authorized until progression or toxicity. Ivosidenib and Onureg®, being already authorized treatments, it has been decided to use the classic administration schedules and dosages in combination
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ivosidenib + Oral azacitidine | Experimental | Drug: Ivosidenib + oral azacitidinecf intervention |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- Male or female ≥ 55 years of age at the time of signing informed consent
- Patients with confirmation of newly diagnosed AML by 2022 WHO criteria
- Presence of IDH1 R132 mutation at AML diagnosis
- Achievement CR or CRi following induction therapy by intensive chemotherapy (according to ELN 2022, appendix 2), within 17 weeks prior to enrollment.
- Received at least 2 consolidations :
Key exclusion criteria (25 listed)
- Acute promyelocytic leukemia (FAB M3) with t(15;17) or its molecular equivalents (PML::RARA)
- AML associated with t(9;22) or molecular evidence of such a translocation
- Prior BM or hematopoietic stem cell transplantation
- CR/CRi following treatment with hypomethylating agents
- Proven central nervous system leukemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ivosidenib + oral azacitidineSubjects will be administered treatment over 28-day cycles until progression or another reason (unacceptable toxicity, patient choice to discontinue study treatment, sponsor decision, HSCT at any time, patients who require the use of any of the excluded therapies). The treatment is the association of ivosidenib with oral azacitidine. * The investigational medicinal product is ivosidenib. Two tablets (500 mg) will be administered as a single dose, once daily, during 28 days-cycles until discontinuation. * The auxiliary treatment is oral azacitidine. Oral AZA 300 mg will be given once-daily for 14 days of repeated 28-day treatment cycles. For all patients, oral AZA will be interrupted systematically after day 14 of each 28-days cycle. | Drug | ivosidenib + Oral azacitidine |
Primary outcome
RFS 24 months
Time frame: 24 months
relapse-free-survival (RFS) at 24 months in patients receiving oral azacitidine with ivosidenib
4 secondary outcomes
RFS 12 months
Time frame: 12 months
Overall survival
Time frame: 24 months
EFS MRD neg
Time frame: 24 months
TEAEs
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Arnaud PIGNEUX principal investigator
University Hospital, Bordeaux
Stephane DE BOTTON principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
Maël HEIBLIG principal investigator
Centre Hospitalier Lyon Sud
20 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ivosidenib + oral azacitidine in people with Acute Myeloid Leukemia, run by French Innovative Leukemia Organisation at 20 sites in France.
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 27 inclusion and 25 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: opening soon, as of the sponsor's last update on 11 Mar 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 France. 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 Cindy FENOLL (+33607065843, c.fenoll@filo-leucemie.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
RFS 24 months (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Mar 2026.