Study Evaluating Combination of Luspatercept in LR-MDS Without RS Having Failed or Being I
Study of the combination of luspatercept in low-risk myelodysplastic syndrom (LR-MDS) without ring sideroblasts (RS) having failed or being ineligible to ESA
| Condition(s) | MDS, Myelodysplastic Syndromes |
|---|---|
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Study type | Interventional |
| Summary | Study of the combination of luspatercept in low-risk myelodysplastic syndrom (LR-MDS) without ring sideroblasts (RS) having failed or being ineligible to ESA |
| Who can participate | Inclusion Criteria: Patients must meet all of the following criteria to participate in the study: * Myelodysplastic syndrome according to current WHO classification * Age ≥ 18 years * Patients with lower risk MDS according to IPSS classification (LOW, INT-1) without RS who failed to achieved a response or who subsequently relapse after ESA (at least 60000 U EPO-a over at least 12weeks or equivalent), without disease progression (or ineligible to ESA defined by EPO \> 500 UI/l) * Hemoglobin \< 9 gr/dl or Transfusion dependant (at least 3 RBCs in 16 wk in at least 2 transfusion episodes) * Non del(5q) syndrome * Adequat renal function, defined by creatinine less than 1.5 times the upper limit of normal, creatinine clearance ≥ 40 mL/min (MDRD formula). * Adequat liver function, defined by tot |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Groupe Francophone des Myelodysplasies |
| Locations | Amiens, France; Amiens, France; Angers, France; Argenteuil, France; Avignon, France; Bayonne, France (+34 more sites) |
| Start date | 2022-05-18 |
| NCT ID | NCT05181735 |
| Official listing | https://clinicaltrials.gov/study/NCT05181735 |