Recruiting

NCT Number: NCT06717958

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

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

Recruiting

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Key information

Conditions

AML MDS

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Universitätsklinikum Aachen, Aachen, Germany

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ivosidenib 250 MG (milligram)

Drug

oral

Primary outcomes

event-free survival

Time frame: 24 months

Study contacts

Contact information is provided by the study sponsor or research team.

Friedrich Stölzel, Prof. Dr. med.

CONTACT

[email protected]

+493514583192

Jan Moritz Middeke, Dr. med.

CONTACT

[email protected]

+493514583192

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

A Prospective, Single-arm, Open-label, Multicenter Phase II Trial Evaluating the Efficacy and Safety of Ivosidenib Maintenance Therapy After Allogeneic Stem Cell Transplantation (alloSCT) in Patients With Acute Myeloid Leukemia (AML) and Myelodysplastic Neoplasia (MD) Carrying an IDH1 Mutation

Acronym: PIVOT

Important dates

Study start: 2025
Primary completion: 2029
Study completion: 2030
First posted: Dec 5, 2024
Registry last updated: Jul 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Recruiting