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NCT07830004
Plasmatic Biomarkers Associated With Short-term Luspatercept Treatment of Lower Risk Myelodysplastic Syndromes (MDS) Patients
Conditions: Myelodysplasia
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 150
Sponsor: University Hospital, Grenoble
Summary
Our project aims to identify metabolites and biomarkers associated with luspatercept-related asthenia in a prospective French study of low-risk MDS patients treated per EMA guidelines.
This is a prospective cohort of patients with MDS treated with luspatercept. The main comparisons will consist in exploring differences in biomarkers plasma levels between patients experiencing fatigue after luspatercept initiation, vs those who do not.
Eligibility Criteria
Inclusion criteria:
1. Signed Written Informed Consent
2. Participants must be ≥ 18 years of age
3. Type of Participant and Target Disease Characteristics:
Participant had documented diagnosis of MDS according to World Health Organization (WHO 2022) classification
4. IPSS-R : very low, low, or intermediate-risk disease
5. Less than 5% blasts (\< 5%) (in bone marrow and \< 1% PB blasts)
6. Performance status: Eastern (ECOG) score of 0, 1, or 2
7. Anemic patients with Hb ≤10g/dL
8. First line therapy by luspatercept for lower risk MDS RS+ and MDS-RS- patients
9. Or Second line therapy by luspatercept for MDS-RS+ refractory or intolerant to prior ESA treatment, as defined by any one of the following:
* Refractory to prior ESA treatment: documentation of nonresponse or response that was no longer maintained to prior ESA-containing regimen, either as a single agent or in combination (eg, with G-CSF).
* Intolerant to prior ESA treatment: Documentation of discontinuation of prior ESA-containing regimen, either as a single agent or in combination (eg, with G-CSF), at any time after introduction due to intolerance or an AE
10. Patient or his entourage having a smartphone to load the application for Fidelio ( the chatbot)
11. Affiliated to SS
Exclusion critéria:
1. Higher risk MDS, del 5q syndrome, MDS-RS-T, MD- CMML
2. Participant which has known clinically significant anaemia due to iron, vitamin B12, or folate deficiencies, iron deficiency anaemia or autoimmune haemolytic anaemia
3. Prior allogeneic or autologous stem cell transplant
4. Use of any of the following within 2-weeks prior to treatment:
Anticancer cytotoxic chemotherapeutic agent or treatment Any investigational agents within 30 days
5. Pregnancy
6. Psychiatric contraindications
7. Protected people according to articles L1121-5 à L1121-8 of CSP
Source: ClinicalTrials.gov (NCT07830004). StuddyBuddy aggregates publicly available trial information.