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

ConditionsAML MDS

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18-75

SponsorTechnische Universität Dresden

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

AML or MDS with IDH1 mutation

Disqualifiers

active GvHD (graft vs host disease) grade III-IV according to Harris criteria requiring steroids >1mg/ kg prednisolone equivalent

Trial design

Design model

Single group

Treatments tested in this trial

Ivosidenib 250 MG (milligram)
Drug
oral

Treatment groups

76 Participants

are divided into 1 treatment group

Group A: IvosidenibExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

event-free survival

Time frame

24 months

Locations17

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Sponsors and contacts

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Technische Universität Dresden

Lead sponsor

Source ClinicalTrials.gov

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