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Ivosidenib as Maintenance Therapy in Transplant-Ineligible IDH1-mutated AML and HR-MDS

ConditionsAML (Acute Myeloid Leukemia)MDS (Myelodysplastic Syndrome)
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

This trial does not accept healthy volunteers

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

Design model

Single group

Treatments tested in this trial

  • Ivosidenib

    Drug

    Ivosidenib: 500 mg, PO, QD, 28-day cycles

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: IvosidenibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Disease free survival (DFS)

The time from surgery to the onset of tumor recurrence or death from any cause.

Time frame
12 months

Secondary outcomes

1

Complete response (CR)

The proportion of patients achieved complete response (CR).

Time frame
4 months
2

Overall survival (OS)

The time from randomization to the time of death from any cause.

Time frame
36 months
3

Adverse events

The severity of adverse events will be evaluated according to the NCI CTCAE 5.0 standard.

Time frame
12 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov
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