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

Part of paid clinical trials in Denver, Colorado.

Sponsor
Institut de Recherches Internationales Servier
Study ID
NCT06465953
Phase
PHASE3
Status
Recruiting
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Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ivosidenib — DRUG
    Two 250 mg tablets, totaling 500 mg, administered orally once daily until disease relapse or progression, unacceptable toxicity, confirmed pregnancy, undergoing HSCT, death, withdrawal of consent, lost to follow-up, or Sponsor ending the study, whichever occurs first.
  • Azacitidine — DRUG
    Azacitidine 75mg/m\^2/day administered by subcutaneous (SC) or intravenous (IV) injection for 1 week (7 days) of each 4-week (28 day) treatment cycle until disease relapse or progression, unacceptable toxicity, confirmed pregnancy, undergoing HSCT, death, withdrawal of consent, lost to follow-up, or Sponsor ending the study, whichever occurs first.

Study Details

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.

Key Dates

Start date
Dec 3, 2024
Status verified
May 2026
Primary completion
Nov 1, 2027
Completion
Dec 1, 2028

Study Design

Enrollment
48 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ivosidenib monotherapy
  • Experimental: Azacitidine monotherapy

Primary Outcome Measure

Number of participants achieving CR and PR by 4 months [ Time Frame: Through 4 months after starting treatment ]

Central Contacts

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

Locations (9)

FacilityCityStateZIPSite coordinators
Presbyterian / St. Luke'S Medical CenterDenverColorado80218-
University of Chicago, Duchossois Center for Advanced Medicine (DCAM)ChicagoIllinois60637-
Massachusetts General HospitalBostonMassachusetts02114
Andrew Brunner
[email protected]
617-724-1124
MSKCCNew YorkNew York10065-
Unc Lineberger Comprehensive Cancer CenterChapel HillNorth Carolina27514-
Ohio State University Comprehensive Cancer CenterColumbusOhio43210-
Oncology Associates of OregonEugeneOregon97401-
University of Texas UT Southwestern Comprehensive Cancer CenterDallasTexas75235-
MD Anderson Cancer CentreHoustonTexas77030-

Find similar trials in Denver, CO

By research site
Presbyterian / St. Luke'S Medical Center· Denver, COUniversity of Chicago, Duchossois Center for Advanced Medicine (DCAM)· Chicago, ILMassachusetts General Hospital· Boston, MAMSKCC· New York, NYUnc Lineberger Comprehensive Cancer Center· Chapel Hill, NCOhio State University Comprehensive Cancer Center· Columbus, OH

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