Clin2
NCT06465953Possibly a fitRecruiting

Ivosidenib vs azacitidine for IDH1-mutated MDS

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

Treatments studied

Part of Blood & lymphatic clinical trials.

This trial tests if the drug ivosidenib alone or azacitidine alone can help people with a specific type of MDS that has an IDH1 mutation. It is for people who have not had strong MDS treatments yet.

Summary written for real people, not researchers, by Clin2.

Phase
Phase 3
Enrollment
48 people
Ages
18 years and older
Study type
Interventional

Who can take part

  • You have been diagnosed with MDS (myelodysplastic syndromes) and have a specific change in a gene called IDH1 (R132 C, G, H, L, or S).
  • You have not had any previous MDS treatments like hypomethylating agents (azacitidine), chemotherapy, or IDH inhibitors. (Some lower-risk patients can have had growth factors or luspatercept.)
  • Your bone marrow has less than 20% blasts (immature cells). For lower-risk patients, blasts must be between 5% and 19%.
  • The study is for people with moderate- to very-high-risk MDS, or lower-risk MDS that has low blood counts (low platelets, low neutrophils, or low hemoglobin).
  • If your MDS is lower risk, you must have low blood counts and blasts between 5% and 19% to join.

View the official record on ClinicalTrials.gov

Quick eligibility check

Answer a few plain-language questions, based on this study's own requirements, to get a preliminary sense of fit.

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