OncoMatch/Clinical Trials/NCT06465953
Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation
Is NCT06465953 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Ivosidenib and Azacitidine for hypomethylating agent (hma) naive myelodysplastic syndromes (mds).
Treatment: Ivosidenib · Azacitidine — This study will enroll participants with myelodysplastic syndromes (MDS) with an Isocitrate dehydrogenase protein, 1 (IDH1) mutation, who have not received treatment with a hypomethylating agent previously. Participants will be randomized to receive either ivosidenib (IVO) alone or azacitidine (AZA) alone. IVO will be administered daily throughout the 28-day treatment cycle and AZA will be administered for the first 7 days of each 28-day cycle. Study visits will be conducted every week during Cycle 1 (Days 1, 8, 15, and 22), and Day 1 of each cycle thereafter. After the last dose of treatment, participants will attend an safety follow-up visit and participants will be followed to assess overall survival. Study visits may include a bone marrow aspirate, physical exam, echocardiogram (ECHO), electrocardiogram (ECG), blood and urine analysis, and questionnaires.
Check if I qualifyExtracted eligibility criteria
Cancer type
Myelodysplastic Syndrome
Biomarker criteria
Required: IDH1 r132c
Required: IDH1 r132g
Required: IDH1 r132h
Required: IDH1 r132l
Required: IDH1 r132s
Disease stage
Required: Stage MODERATE HIGH, HIGH, VERY HIGH, LOW, MODERATE LOW (IPSS-M)
Excluded: Stage VERY LOW
Moderate high, high and very high-risk MDS per IPSS-M score will be eligible... Low and moderate low-risk MDS per IPSS-M score must... very low risk participants are to be excluded
Prior therapy
Cannot have received: hypomethylating agent
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.
Cannot have received: cytotoxic chemotherapy
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.
Cannot have received: investigational agent
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.
Cannot have received: BCL2 inhibitor based-regimen
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.
Cannot have received: hematopoietic stem cell transplant
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.
Cannot have received: IDH1 inhibitor
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- Presbyterian / St. Luke'S Medical Center · Denver, Colorado
- University of Chicago, Duchossois Center for Advanced Medicine (DCAM) · Chicago, Illinois
- Massachusetts General Hospital · Boston, Massachusetts
- MSKCC · New York, New York
- Unc Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina
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