CompletedNot Applicable

Mesenchymal Stem Cells in NPM1 Mutated Low Risk Acute Myeloid Leukemia: a Study of the Tumor Microenvironment and Its Contribution to the Outcome

Italy70 participantsStarted 2023-03-15

Plain-language summary

Acute Myeloid Leukemia (AML) arises from the somatic acquisition of genetic alterations in hematopoietic progenitor or stem cells. One of the main hallmarks of AML is heterogeneity in terms of morphology, immunophenotype, cytogenetics, and molecular abnormalities, this heterogeneity leads to an important clinical heterogeneity in term of response to chemotherapy and prognosis. , The European Leukemia Net recognizes three different prognostic risk group (favorable, intermediate and high). Patients with favorable or intermediate risk AML, theoretically, should be cured with pharmacological treatment only (chemo and in some cases targeted therapies). However, more of the 50% of patients with favorable or intermediate risk AML experience relapse. This heterogeneity in outcome is not only explained by genetics and it's probably due to the persistence of chemo-resistant leukemic stem cell (LSC) clone, and to its interaction with the bone marrow (BM) microenvironment. This research project is focused on the analysis of the mesenchymal stem cells (MSCs) of the BM in order to deepen their connections with the LSC and their correlation with different genetic AML subgroups, and to evaluate their contribution to the outcome of favorable risk AML with Nucleophosmin 1 (NPM1) gene mutation.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Adult patients with new onset Acute Myeloid Leukemia diagnosed. Exclusion Criteria: \-

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

To characterize the BM-MSCs of subjects affected by AML NPM1mut as possible novel indicators of patient clinical outcome

Timeframe: Baseline

Trial details

NCT IDNCT07379528

SponsorFondazione IRCCS Policlinico San Matteo di Pavia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2025-02-01

View on ClinicalTrials.gov More Acute Myeloid Leukaemia (AML) trials

Plain-language summary