Health Trials

Precision Therapy Versus Standard Therapy in AML and MDS in Elderly

ConditionsAML, AdultMDS
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age60+
SponsorUniversity Hospital, Akershus

About this trial

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

Qualifiers

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)

Disqualifiers

Acute promyelocytic leukemia.

AML with favourable cytogenetic or genetic changes in patients who are fit for intensive chemotherapy. Favourable genetics are: t(8;21)(q22;q22.1); RUNX1-RUNX1T1; inv(16)(p13.1q22) or t(16;16)(p13.1;q22); CBFB-MYH11; mutated NPM1 without FLT3-ITD or with FLT3-ITDlow†; Biallelic mutated CEBPA

Patients previously treated for AML or MDS (any antileukemic therapy or MDS treatment including investigational agents).

Patients where it is not possible to get bone-marrow for NGS, i.e., "dry tap".

Trial design

Treatments tested in this trial

  • Standard therapy
  • Precision therapy

Treatment groups

36 Participants
are divided into 2 treatment groups

Locations

1

Map coordinates are unavailable for these locations. Locations are shown below instead.

Akershus UniversitetssykehusRecruiting LørenskogNorwayNorway

Sponsors and collaborators

University Hospital, Akershus

Lead sponsor

Source ClinicalTrials.gov