Luspatercept
DrugThe main comparisons will consist in exploring differences in biomarkers plasma levels between patients experiencing fatigue after luspatercept initiation, vs those who do not.
NCT Number: NCT07830004
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Phase 4
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Participant had documented diagnosis of MDS according to World Health Organization (WHO 2022) classification
Exclusion critéria:
Anticancer cytotoxic chemotherapeutic agent or treatment Any investigational agents within 30 days
The main comparisons will consist in exploring differences in biomarkers plasma levels between patients experiencing fatigue after luspatercept initiation, vs those who do not.
Time frame: 6 months of treatement
Plasma biomarkers, including metabolites (energy metabolism, amino acids, lipid mediators), cortisol, iron-metabolism markers, serotonin, inflammatory cytokines, and selected exosomes derived microRNAs, will be explored, and associated with asthenia evaluated using CTCAE v 6.0. and PROs within the first 6 months of treatment with luspatercept. Fatigue will be graded as follows:
Time frame: baseline, Week6, Week12, Week18, Week24
Fatigue will be assessed over time through different ways:
(i) EORTC QLQ C30 , assessed at baseline, Week6, Week12, Week18, Week24 (ii) pro-CTCAE (fatigue) , assessed weekly (iii) FACIT-F , assessed at baseline, Week6, Week12, Week18, Week24 (iv) AI-assisted evaluation of fatigue (Fidelio - chatbot): Fidelio will estimate the CTCAE grading, as well as the main treatment-related adverse events and their impact on daily life, as reported by patients. This will be collected continuously according to patient use of the chatbot, and reports will be produced on a weekly basis to the coordinator (v) CTCAE fatigue grading, assessed at baseline, Week6, Week12, Week18, Week24.
Time frame: V0 to V 4 (Week0, Week6, Week12, Week24 except Month 4.5)
Metabolites and plasma biomarkers will be the same as already described for the primary objective from V0 to V 4 (Week0, Week6, Week12, Week24 except Month 4.5). The response to luspatercept will be measured using IWG 2018 criteria
Time frame: baseline, Week6, Week12, Week18, Week24 and weekly by chatbot up to 24 weeks
CTCAE fatigue grading will be made by the investigator at baseline, Week6, Week12, Week18, Week24 and estimated by the chatbot Fidelio on a continuous basis (with weekly reports until 24 weeks). Investigators will be blinded to chatbot reports in order to limit bias in the estimation of agreement.
Time frame: Weekly and at the end of the trial up to 24 weeks
Adherence to the chatbot will be evaluated each week as (i) presence/absence of a discussion during the week, and (ii) time spent discussing with the chatbot. (iii) A satisfaction questionnaire of the chatbot will be proposed at the end of the trial on a scale from 0 to 10 (and several qualitative questions yes/no).
Time frame: baseline, Week6, Week12, Week18, Week24
Patient reported AE and grading according to CTCAE will be collected at each 6 weeks visits
Trial opening soon.
Get NotifiedUniversity Hospital, Grenoble
Other
Acronym: LUSPAMARK
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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