myelodysplastic syndrome with IDH1 mutated
Conditions
Brief summary
Overall hematological response at 3 and 6 months (including CR, PR, stable disease with HI according to IWG 2006) for cohort A and B; SAFETY FOR COHORT C
Detailed description
Response duration and time response, Time to IPSS and R-IPSS progression, Rate and time to AML evolution, Overall survival, Cytogenetic and molecular response, Prognostic factors of response, including IPSS-R, IPSS-karyotype and somatic mutations, Evolution of IDH1 VAF on therapy, Adverse events and toxicity as measured by NCI CTCAE 5
Interventions
Sponsors
Groupe Francophone Des Myelodysplasies, Groupe Francophone Des Myelodysplasies
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Overall hematological response at 3 and 6 months (including CR, PR, stable disease with HI according to IWG 2006) for cohort A and B; SAFETY FOR COHORT C | — |
Secondary
| Measure | Time frame |
|---|---|
| Response duration and time response, Time to IPSS and R-IPSS progression, Rate and time to AML evolution, Overall survival, Cytogenetic and molecular response, Prognostic factors of response, including IPSS-R, IPSS-karyotype and somatic mutations, Evolution of IDH1 VAF on therapy, Adverse events and toxicity as measured by NCI CTCAE 5 | — |
Countries
France
Outcome results
None listed