Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRuijin Hospital
About this trial
This study will explore the efficacy and safety of ivosidenib as maintenance therapy in patients with IDH1-mutated AML and high-risk MDS who are ineligible for transplantation, along with accompanying molecular biomarker research. Patients who meet the eligibility criteria will receive ivosidenib treatment until disease progression or unacceptable toxicity. This study will provide an effective maintenance treatment option for transplant-ineligible patients with IDH1-mutated AML and high-risk MDS.
Eligibility criteria
Qualifiers
Age ≥18 years, male or female.
Molecularly confirmed diagnosis of IDH1-mutated acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS).
Achieved complete remission (CR) or partial remission (PR) after induction therapy.
Ineligible for allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Disqualifiers
Prior treatment with an IDH1 inhibitor.
Diagnosis of M3 subtype (acute promyelocytic leukemia, APL).
Presence of severe hepatic or renal dysfunction.
Active infection or other serious comorbidities.
Trial design
Treatments tested in this trial
- Ivosidenib
Treatment groups
20 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov