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New treatment option for Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS)
Official title Ivosidenib (IVO) Monotherapy and Azacitidine (AZA) Monotherapy in Patients With Hypomethylating Agent (HMA) Naive Myelodysplastic Syndromes (MDS) With an IDH1 Mutation
ClinicalTrials.gov ID: NCT06465953
What this study is testing
What is Ivosidenib?
Ivosidenib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for hypomethylating agent (hma) naive myelodysplastic syndromes (mds).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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 blast counts 0-19%.
- Low and moderate low-risk MDS per IPSS-M score must:
- Have cytopenias related to MDS, defined as: \<100 platelets/microliter, or absolute neutrophil count (ANC) \<1000/mm3, or hemoglobin \<10g/dL AND
- Have a blast count between 5-19% AND
You likely can't join if
- Received prior anticancer/disease modifying treatment for MDS (including HMA's, cytotoxic chemotherapy, investigational agents, bcl-2 inhibitor...
- \>20% blasts by morphology or immunohistochemistry on screening bone marrow aspirate/biopsy
See the full eligibility criteria
- 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 blast counts 0-19%.
- Low and moderate low-risk MDS per IPSS-M score must:
- Have cytopenias related to MDS, defined as: \<100 platelets/microliter, or absolute neutrophil count (ANC) \<1000/mm3, or hemoglobin \<10g/dL AND
- Have a blast count between 5-19% AND
- 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
- 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...
- \>20% blasts by morphology or immunohistochemistry on screening bone marrow aspirate/biopsy
The study team makes the final eligibility decision.
Where it's taking place
- Denver, Colorado, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- New York, New York, United States
- Chapel Hill, North Carolina, United States
- Columbus, Ohio, United States
- Eugene, Oregon, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Adelaide, Australia
- Clayton, Australia
- Epping, Australia
- Liverpool, Australia
- Nedlands, Australia
- Waratah, Australia
- Curitiba, Brazil
- São Paulo, Brazil
- Nantes, France
- Nice, France
- Paris, France
+ 35 more site(s).
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 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Denver, Colorado, United States; Chicago, Illinois, United States; Boston, Massachusetts, United States; New York, New York, United States; Chapel Hill, North Carolina, United States; Columbus, Ohio, United States and 49 more location(s). 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 ClinicalTrials.gov; the study team decides eligibility.