A Phase I/II Study of NMS-03592088, a FLT3, KIT and CSF1R Inhibitor, in Patients with Relapsed or Refractory AML or CMML

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-508655-39-00

Acronym

MKIA-088-001

Enrollment

143

Registered

2023-12-14

Start date

2019-02-13

Completion date

2024-08-29

Last updated

2024-01-22

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

Conditions

Acute Myeloid Leukemia (AML) or Chronic Myelomonocytic Leukemia(CMML) relapsed or refractory

Brief summary

Phase I • Drug related first-cycle dose limiting toxicities (DLTs) Phase II • FLT3-ITD mut AML: Composite Complete Remission (CRc) Rate, i.e. Complete Remission (CR) + Complete Remission with Incomplete Hematologic Recovery (CRi), as defined by the Investigators based on the 2022 European LeukemiaNet (ELN) recommendations

Interventions

None listed

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Phase I • Drug related first-cycle dose limiting toxicities (DLTs) Phase II • FLT3-ITD mut AML: Composite Complete Remission (CRc) Rate, i.e. Complete Remission (CR) + Complete Remission with Incomplete Hematologic Recovery (CRi), as defined by the Investigators based on the 2022 European LeukemiaNet (ELN) recommendations	—

Countries

France, Italy, Spain

Outcome results