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

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

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06717958

Acronym

PIVOT

Enrollment

Registered

2024-12-05

Start date

2025-06-17

Completion date

2030-02-01

Last updated

2026-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

AML, MDS

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.

Interventions

DRUGIvosidenib 250 MG (milligram)

oral

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

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

Design outcomes

Primary

Measure	Time frame
event-free survival	24 months

Countries

Germany

Contacts

CONTACTJan Moritz Middeke, Dr. med.

pivot@ukdd.de+493514583192

CONTACTFriedrich Stölzel, Prof. Dr. med.