OncoMatch/Clinical Trials/NCT05025098
Precision Therapy Versus Standard Therapy in AML and MDS in Elderly
Is NCT05025098 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Standard therapy and Precision therapy for aml, adult.
Treatment: Standard therapy · Precision therapy — This is a randomized clinical trial that randomizes between treatment principles. The study will investigate if precision therapy determined by a tumour board is better than standard treatment for acute myeloid leukaemia (AML) and myelodysplastic syndrome (MDS) in elderly. The tumour board will decide the precision therapy based on identified genetic changes that can guide customized therapy. There are currently 40-50 targeted therapies approved for various cancers in Norway. The precision therapy will be given in addition to the standard treatment. The primary study objective will be to evaluate the cost-effectiveness of a precision therapy strategy compared with standard treatment. Other objectives will mesaure efficacy and satety of the treatment, and impact on life quality of the patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Myelodysplastic Syndrome
Biomarker criteria
Excluded: RUNX1 RUNX1-RUNX1T1
t(8;21)(q22;q22.1); RUNX1-RUNX1T1
Excluded: CBFB CBFB-MYH11
inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11
Excluded: NPM1 mutation
mutated NPM1 without FLT3-ITD or with FLT3-ITDlow
Excluded: FLT3 ITD
FLT3-ITDlow
Excluded: CEBPA biallelic mutation
Biallelic mutated CEBPA
Performance status
WHO 0–2
Prior therapy
Cannot have received: antileukemic therapy
Patients previously treated for AML or MDS (any antileukemic therapy or MDS treatment including investigational agents)
Lab requirements
Kidney function
Adequate renal function unless clearly disease related as indicated by laboratory values
Liver function
Adequate hepatic function unless clearly disease related as indicated by laboratory values
Cardiac function
No unstable angina, NYHA Class ≥ 2, or unstable cardiac arrhythmias
Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values: ... Cardiac dysfunction as defined by: Unstable angina or New York Heart Association Class ≥ 2 ... or Unstable cardiac arrhythmias
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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