NCT05025098 Precision Therapy Versus Standard Therapy in AML and MDS in Elderly
| NCT ID | NCT05025098 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Hospital, Akershus |
| Condition | AML, Adult |
| Study Type | INTERVENTIONAL |
| Enrollment | 36 participants |
| Start Date | 2021-06-22 |
| Primary Completion | 2026-06-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 36 participants in total. It began in 2021-06-22 with a primary completion date of 2026-06-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Patients with a diagnosis of AML and related precursor neoplasms according to WHO 2016 classification (excluding acute promyelocytic leukemia) including secondary AML (after an antecedent hematological disease and therapy-related AML (not if they have received antileukemic/mds treatment)), or * acute leukemias of ambiguous lineage according to WHO 2016 or a diagnosis of myelodysplastic syndrome (MDS) with IPSS-R \> 4.5.1 * Patients 60 years and older. * Patients must NOT be eligible for intensive chemotherapy or allogeneic stem cell therapy (See Chapter 23.3) * WBC ≤ 25 x109/L (prior hydroxyurea allowed for a maximum of 14 days, stopped before start of treatment) * Adequate renal and hepatic functions unless clearly disease related as indicated by the following laboratory values: * WHO performance status 0, 1 or 2 for subjects ≥ 75 years of age OR 0 to 3 for subjects ≥ 60 to 74 years of age. * Life-expectancy above 3 months * Signed Informed Conscent * Male Subjec
Frequently Asked Questions
Who can join the NCT05025098 clinical trial?
This trial is open to participants of all sexes, aged 60 Years or older, studying AML, Adult. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05025098 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05025098 currently recruiting?
Yes, NCT05025098 is actively recruiting participants. Visit ClinicalTrials.gov or contact University Hospital, Akershus to inquire about joining.
Where is the NCT05025098 trial being conducted?
This trial is being conducted at Lørenskog, Norway.
Who is sponsoring the NCT05025098 clinical trial?
NCT05025098 is sponsored by University Hospital, Akershus. The trial plans to enroll 36 participants.