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Ivosidenib or Azacitidine for IDH1-Mutated MDS

This study is for people with myelodysplastic syndromes (MDS), a type of blood cancer, who have a specific change in their IDH1 gene. You can join if you haven't received a hypomethylating agent (HMA) treatment before. Participants will be randomly assigned to receive either ivosidenib (IVO) or azacitidine (AZA). IVO is a pill taken daily, and AZA is given by injection for 7 days each month. Researchers want to see how many participants achieve a complete or partial response to treatment within 4 months. The study is currently recruiting about 48 participants, but its overall status is unclear.

Study design
This is an interventional study that plans to enroll 48 participants. You will be randomly assigned to receive either ivosidenib or azacitidine.
What's involved
You will have weekly visits during the first month, then monthly visits. Treatment continues until your disease gets worse, side effects are too strong, or other reasons.
Compensation
Not stated in the trial record.
Follow-up
After your last dose of treatment, you will have a safety follow-up visit and then be followed to assess how long you live.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06465953

Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation

Recruiting
PHASE3Ages 18+InterventionalTreatment
Institut de Recherches Internationales Servier
~48 participants
Updated 2026-08-05 on ClinicalTrials.gov
What's tested:IvosidenibAzacitidine

At a glance

Recruiting sites
53 of 62 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants achieving CR and PR by 4 months
Measured over Through 4 months after starting treatment

Conditions

Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS)
Myelodysplastic Syndromes (MDS)

Explore related trials

Myelodysplastic SyndromeIDH1 Gene

Where it's being run

62 sites across 18 states
Brazil8
Italy7
Spain7
Australia6
France6
United Kingdom6
Germany5
Japan5

Who to contact

Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
[email protected]
+33 1 55 72 60 00
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Diagnosis of HMA naive IDH1 R132 mutated MDS defined according to WHO criteria (5th edition):
Moderate high, high and very high-risk MDS per IPSS-M score will be eligible regardless of blood counts and with blast counts 0-19%.
Low and moderate low-risk MDS per IPSS-M score must:
Have cytopenias related to MDS, defined as: \<100 platelets/microliter, or absolute neutrophil count (ANC) \<1000/mm3, or hemoglobin \<10g/dL AND
Have a blast count between 5-19% AND
Be eligible for HMA therapy (very low risk participants are to be excluded)
Locally or centrally confirmed IDH1 R132 C/G/H/L/S mutation

Exclusion

Received prior anticancer/disease modifying treatment for MDS (including HMA's, cytotoxic chemotherapy, investigational agents, bcl-2 inhibitor based-regimens, hematopoietic stem cell transplant (HSCT), IDH1 inhibitors). For LR-MDS patients, prior treatment with growth factors, luspatercept, lenalidomide, and imetelstat are allowed.
\>20% blasts by morphology or immunohistochemistry on screening bone marrow aspirate/biopsy

What this trial measures

  • Number of participants achieving CR and PR by 4 monthsThrough 4 months after starting treatment

    Complete remission (CR) or Partial remission (PR) as per International Working Group (IWG) 2006 criteria