NCT07607418 Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS
| NCT ID | NCT07607418 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Ruijin Hospital |
| Condition | AML (Acute Myeloid Leukemia) |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-05-22 |
| Primary Completion | 2027-05-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-05-22 with a primary completion date of 2027-05-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
Inclusion Criteria: * 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). * Eastern Cooperative Oncology Group (ECOG) performance status score ≤2. * Signed informed consent. * For women of childbearing potential: must have practiced contraception for at least one month prior to screening and commit to using contraception throughout the study period and for the required period after study completion. * Female participants of childbearing potential and male participants with female partners of childbearing potential must agree to use highly effective methods of contraception from the time of signing informed consent until 180 days after the last dose of the study drug. Exclusion Criteria: Participants with any of the following criteria will be excluded from the study: * 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. * Major surgery within 28 days prior to the first dose, or planned surgery during the study period. * Diagnosis of any other malignancy within 5 years prior to the first dose, with the exception of early-stage malignancies that have been cured by radical treatment, such as carcinoma in situ of the lung, non-melanoma skin cancer, basal cell or squamous cell carcinoma of the skin, or cervical carcinoma in situ. Whether to exclude such patients will be determined by the investigator's assessment. * Severe cardiovascular disease, such as New York Heart Association (NYHA) class 2 heart failure, unstable angina, unstable arrhythmia, myocardial infarction or cerebrovascular accident within 3 months prior to randomization. * Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS); active hepatitis B (HBV DNA≥1000 IU/ml); hepatitis C (positive for anti-HCV antibodies and HCV-RNA above the lower limit of detection of the assay); or co-infection with hepatitis B and hepatitis C. * Known history of psychoactive substance abuse or drug addiction. * Presence of any other serious physical or mental illness, or abnormal laboratory findings that may increase the risk of study participation, interfere with the study results, or make the patient unsuitable for study participation in the opinion of the investigator. * Inability to swallow, intestinal obstruction, or other factors affecting drug administration or absorption. * Previous concomitant treatment with both drugs of the combination therapy targeting the same pathway as in this study. * History of allergy to the study drug or any of its excipients.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07607418 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying AML (Acute Myeloid Leukemia). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07607418 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07607418 currently recruiting?
Yes, NCT07607418 is actively recruiting participants. Contact the research team at zbruce.zhang@hotmail.com for enrollment information.
Where is the NCT07607418 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT07607418 clinical trial?
NCT07607418 is sponsored by Ruijin Hospital. The trial plans to enroll 20 participants.
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