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Prospective Evaluation of Ivosidenib Maintenance Following Allogeneic Stem Cell Transplantation in Patients With Acute Myeloid Leukemia or High-risk Myelodysplastic Neoplasia With IDH1 (Isocitrate Dehydrogenase 1) Mutation

Phase 2
Not yet recruiting
Conditions
AML
MDS
Interventions
Registration Number
NCT06717958
Lead Sponsor
Technische Universität Dresden
Brief Summary

maintenance of AML or MDS patients with known IDH1 mutation after allogeneic stem cell transplantation within past 100 days

Detailed Description

Determination of the efficacy of Ivosidenib to improve event-free survival when given as maintenance therapy following alloSCT.

Recruitment & Eligibility

Status
NOT_YET_RECRUITING
Sex
All
Target Recruitment
76
Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
IvosidenibIvosidenib 250 MG (milligram)-
Primary Outcome Measures
NameTimeMethod
event-free survival24 months
Secondary Outcome Measures
NameTimeMethod
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