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 (PIVOT)

Technische Universität Dresden

Status and phase: Enrolling; Phase 2

Conditions: AML; MDS

Treatments: Drug: Ivosidenib 250 MG (milligram)

Study type: Interventional

Funder types: Other

Identifiers

NCT06717958

TUD-PIVOT1-085

Details and patient eligibility

About

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

Full description

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

Enrollment: 76 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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76 participants in 1 patient group

Ivosidenib

Experimental group

Treatment:

Drug: Ivosidenib 250 MG (milligram)