At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ivosidenib (drug), Azacitidine (drug)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- 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.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 48
- Started
- 2024-12-03
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for hypomethylating agent (hma) naive myelodysplastic syndromes (mds)
- • Phase3 - 48 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with hypomethylating agent (hma) naive myelodysplastic syndromes (mds)
Where?
- • Edinburgh - Western General Hospital
- • Leeds - St James' University Hospital
- • London - University College London Hospital
- • London - Kings College Hospital
- • +2 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓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...
- ✓Low and moderate low-risk MDS per IPSS-M score must:
- ✓Have cytopenias related to MDS, defined as: \<100 platelets/microliter, or infection-fighting white blood cell count (ANC)...
- ✓Have a blast count between 5-19% AND
Who cannot take part
- ✗\>20% blasts by morphology or immunohistochemistry on screening bone marrow aspirate/biopsy
See the full criteria
Where Is This Study? (6 UK sites)
Western General Hospital
Edinburgh EH4 2XU, United Kingdom
St James' University Hospital
Leeds LS9 7TF, United Kingdom
University College London Hospital
London NW1 2PG, United Kingdom
Rajinder Sidhu - Associate Director, Research Governance and Operations
uclh.jro-communications@nhs.net020 3447 9825Kings College Hospital
London, United Kingdom
Churchill Hospital
Oxford OX3 7LE, United Kingdom
Torbay Hospital
Torquay TQ2 7AA, United Kingdom
How to Get in Touch
Institut de Recherches Internationales Servier (I.R.I.S.), Clinical Studies Department
Sponsor contactCONTACT