Low risk myelodysplastic syndrom without RS having failed or being ineligible to Erythroid Stimulating Agent
Conditions
Brief summary
Part A : The dose finding study aims at determining the optimal dose (OD) that is both tolerable and has an indication of therapeutic benefit for those patients. It will use both toxicity and efficacy binary outcomes: Dose limiting toxicity (DLT), with an observation period up to day 42 of cycle 1 ; Efficacy: Treatment response will be defined at day 21 of cycle 1 by an increase in hemoglobin level of 1.5 g/dl or above., Part B: Erythroide response (HI-E) according to IWG2018 criteria at week 25 following randomization
Detailed description
Duration of response, Progression-free-survival, Overall survival
Interventions
Sponsors
Groupe Francophone Des Myelodysplasies
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Part A : The dose finding study aims at determining the optimal dose (OD) that is both tolerable and has an indication of therapeutic benefit for those patients. It will use both toxicity and efficacy binary outcomes: Dose limiting toxicity (DLT), with an observation period up to day 42 of cycle 1 ; Efficacy: Treatment response will be defined at day 21 of cycle 1 by an increase in hemoglobin level of 1.5 g/dl or above., Part B: Erythroide response (HI-E) according to IWG2018 criteria at week 25 following randomization | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response, Progression-free-survival, Overall survival | — |
Countries
France, Italy
Outcome results
None listed