BridgeMD
A Phase 3, multicenter, open label, randomized, non-comparative two-arm study of ivosidenib monotherapy (IVO) and azacitidine monotherapy (AZA) in adult patients with hypomethylating agent (HMA) naive myelodysplastic syndromes (MDS) with an IDH1 mutation (PyramIDH study).
EU CTIS ID: 2023-510155-37-00
What this study is testing
To assess the efficacy of IVO monotherapy in participants with HMA naive MDS with an IDH1m
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Diagnosis of HMA naive IDH1 R132 mutated MDS defined according to World Health Organization (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: o Have cytopenias related to MDS, defined as: <100 platelets/μL, or absolute neutrophil count (ANC) <1000/mm3, or Hgb <10g/dL AND o Have a blast count between 5-19% AND o 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.
You likely can't join if
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- United Kingdom
- United States
- Australia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; United Kingdom; United States; Australia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.