MM1MDS-A01 for Higher-Risk IDH2 Mutated MDS (Myelodysplastic Syndrome) - Clinical Trial
What is the Purpose of this Study?
We are doing this study to find out if adding a drug called enasidenib (the study drug) to the standard treatment for myelodysplastic syndrome (MDS) can improve the likelihood of achieving complete remission. The study drug is approved for acute myeloid leukemia (AML), but is not approved for the treatment of MDS.
Higher-Risk Myelodysplastic Syndrome (MDS) with Changes to the IDH2 Gene
Who Can Participate in the Study?
Adults ages 18+ who:
- Are diagnosed with MDS that has changes to the IDH2 gene
- Are enrolled in the myeloMATCH Master Screening and Reassessment Protocol
- Have not received prior anti-cancer therapy for AML or MDS
For more information, contact the study team at nick.jeffries@duke.edu.
What is Involved?
Si decide unirse a este estudio, recibirá una asignación aleatoria (como lanzar una moneda al aire) a 1 de 2 grupos.
Group 1: If you are in this group, you will get ASTX727 as a pill you take by mouth once a day for the first 5 days of the cycle. Each cycle lasts 28 days. You will continue on treatment indefinitely if you achieve a remission or are having clinical benefit and do not go on another myeloMATCH treatment study or onto receive an allogeneic stem cell transplant. ASTX727 is a standard, approved drug for the treatment of MDS.
If your disease does not have a complete remission after 6 cycles, you may be offered the opportunity to begin taking the study drug along with ASTX727. If you do take part, you will get ASTX727 as pills you take by mouth once a day for the first 5 days of the cycle and enasidenib as pills you take by mouth once a day for 28 days. Each cycle lasts for 28 days
Group 1: If you are in this group, you will get the study drug plus ASTX727. You will get ASTX727 as pills you take by mouth once a day for the first 5 days of the cycle and the study drug as pills you take by mouth once a day for 28 days. Each cycle lasts 28 days. You will continue on treatment indefinitely if you achieve a remission or are having clinical benefit and do not go on another myeloMATCH treatment study or onto receive an allogeneic stem cell transplant.
Study Details
