IDEAL STUDY - A single-arm phase II multicenter study of IDH2 (AG-221) inhibitor in patients with IDH2 mutated myelodysplastic syndrome

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513858-29-01

Acronym

AG221CLMDSGFM13217

Enrollment

Registered

2024-12-31

Start date

2019-02-06

Completion date

Unknown

Last updated

2025-01-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

myelodysplastic syndrome with IDH2 mutated

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 IPSS-R 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 IDH2 VAF on therapy, Adverse events and toxicity as measured by NCI CTCAE 5

Interventions

DRUGEnasidenib Mesilate 50 mg

DRUGEnasidenib Mesilate 100 mg

DRUGVidaza 25 mg/ml powder for suspension for injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Secondary

Measure	Time frame
Response duration and Time response, Time to IPSS and IPSS-R 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 IDH2 VAF on therapy, Adverse events and toxicity as measured by NCI CTCAE 5	—

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	—

Countries

France, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026