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 2RecruitingNCT06717958

Technische Universität Dresden76 enrolled

Overview

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

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

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

AML MDS

Interventions

Ivosidenib 250 MG (milligram)DRUG

oral

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion criterion: * AML or MDS with IDH1 mutation Exclusion criteria: * active GvHD (graft vs host disease) grade III-IV according to Harris criteria requiring steroids \>1mg/ kg prednisolone equivalent

Locations (17)

Universitätsklinikum Aachen

Aachen, Germany

RECRUITING

Klinikum Chemnitz gGmbH

Chemnitz, Germany

Outcomes

Primary Outcomes

event-free survival

Time frame: 24 months

Central Contacts

Jan Moritz Middeke, Dr. med.

CONTACT

+493514583192 pivot@ukdd.de

Friedrich Stölzel, Prof. Dr. med.

CONTACT

+493514583192 pivot@ukdd.de

Data from ClinicalTrials.gov

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