IMPACT on Relapsed/Refractory Acute Myeloid Leukemia: the urgency of a new therapeutic paradigm

More than 22.000 patients are suffering from R/R AML in Europe every year.

To date, diagnostic and treatment algorithms for R/R AML are not established yet.

The survival rates at one year following chemotherapy reinduction are notably dissatisfactory, being less than 20%.

Access to allogeneic transplant is not widespread and easy across Europe.

Objectives of the project

1

Objectives of the project

Establish an inclusive framework for R/R AML patients.
2

Develop Standard Operating Procedures

Develop Standard Operating Procedures (SOPs) for local biobanking, including samples for measurable residual disease (MRD) quantification to enhance biological knowledge in R/R AML.
3

Randomized Pragmatic Clinical Trial

Design and perform a Randomized Pragmatic Clinical Trial (RPCT) comparing low-intensity and standard chemotherapy rescue.
4

Retrieve high-quality data

Retrieve high-quality data to address treatment interventions for refractory cancers.
5

International trials for childhood

Facilitate the creation of international trials for childhood AML through pragmatic approaches.

6

Affordably ensure data quality

Affordably ensure data quality with an innovative system of risk-oriented, minimal impact data monitoring.
7

Collect and analyze data

Collect and analyze data on the effectiveness of low-intensity and high-intensity rescue as measured by the increase in survival.
8

Develop enlightening cohort studies

Develop enlightening cohort studies, exploratory trials, and additional randomized trials, alongside conducting industry-initiated prospective clinical trials in underserved populations.
9

Project results

Disseminate and exploit project results at different levels.

What is Relapsed/ Refractory Leukemia

Refractory AML
While the majority of patients attain a remission, marked by the absence of signs and symptoms, following the initial treatment for acute myeloid leukemia, certain individuals retain leukemic cells in their bone marrow despite intensive therapy. Those who do not reach complete remission after two rounds of induction chemotherapy are typically classified as having “refractory AML.”

Relapsed AML
After achieving remission, certain patients experience a resurgence of leukemia cells in the marrow and a decline in normal blood cells, termed a “relapse” of the disease. It is standard practice to conduct repeat genetic testing of the leukemia cells at the time of relapse because the mutations may differ from the initial diagnosis, influencing treatment decisions.