Relapse or refractory (r/r) acute myeloid leukaemia (AML) and r/r higher-risk (HR) myelodysplastic syndrome (MDS)
Conditions
Brief summary
Safety, and toxicity will be described by observed frequency and severity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0., including dose limiting toxicity (DLT) rate, adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation.
Detailed description
Plasma concentration-time profiles, and PK parameters of LB-208., Response according to the revised European LeukemiaNet (ELN) Response Criteria in AML (Döhner et al., 2022) and revised International Working Group 2023 (IWG 2023) in HR-MDS (Zeidan, Platzbecker, et al., 2023). Response for all patients will be assessed by the site Investigators.
Interventions
DRUGLB-208
Sponsors
Aop Orphan Pharmaceuticals GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety, and toxicity will be described by observed frequency and severity graded using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 5.0., including dose limiting toxicity (DLT) rate, adverse events (AEs), serious adverse events (SAEs), and AEs leading to discontinuation. | — |
Secondary
| Measure | Time frame |
|---|---|
| Plasma concentration-time profiles, and PK parameters of LB-208., Response according to the revised European LeukemiaNet (ELN) Response Criteria in AML (Döhner et al., 2022) and revised International Working Group 2023 (IWG 2023) in HR-MDS (Zeidan, Platzbecker, et al., 2023). Response for all patients will be assessed by the site Investigators. | — |
Outcome results
None listed