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New treatment option for AML (Acute Myeloid Leukemia)
Official title Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS
ClinicalTrials.gov ID: NCT07607418
What this study is testing
What is Ivosidenib?
Ivosidenib is an investigational medicine, being studied as a potential treatment for aml (acute myeloid leukemia).
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 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.
- Phase 2: a mid-size study of how well it works
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
- 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.
You likely can't join if
- 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.
See the full eligibility 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...
- 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...
- 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...
- 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...
- 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
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 Shanghai, Shanghai Municipality, China. 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.