Treatment for Myelodysplastic Syndromes with IDH1 Mutation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial enrolls patients with myelodysplastic syndromes (MDS) who have an IDH1 mutation and have not previously received hypomethylating agents. Participants will be randomly assigned to receive either ivosidenib (IVO) or azacitidine (AZA) as monotherapy. IVO will be taken daily for 28-day cycles, while AZA will be administered for the first 7 days of each cycle. The study includes regular visits for monitoring and assessments, including blood tests and bone marrow evaluations, to determine the effectiveness and safety of the treatments.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• Presbyterian / St. Luke'S Medical Center
  Denver, Colorado, United States Recruiting
• University of Chicago, Duchossois Center for Advanced Medicine (DCAM)
  Chicago, Illinois, United States Recruiting
• Massachusetts General Hospital
  Boston, Massachusetts, United States Recruiting
• Mskcc
  New York, New York, United States Recruiting
• Unc Lineberger Comprehensive Cancer Center
  Chapel Hill, North Carolina, United States Recruiting
• Ohio State University Comprehensive Cancer Center
  Columbus, Ohio, United States Recruiting

+12 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
• Email: scientificinformation@servier.com
• Phone: +33 1 55 72 60 00

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Evaluating the response to a biosimilar treatment for anemia in MDS patients

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• Using Darzalex Faspro to lower antibody levels before stem cell transplant

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.