relapsed/refractory acute myeloid leukemia
Conditions
Brief summary
Phase I: Determination of MTD by recording frequency and severity of adverse events graded by CTCAE v5.0., Phase I: Determination of a biologically relevant Phase II regimen, Phase II: Combined rate of complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) within three months
Detailed description
Phase I: PD parameters such as a modified PIA assay, Phase I: PK analysis, Phase II: Determination of GLI1/2 levels in circulating AML cells before and under treatment, Phase II: Determination of Event free and Overall survival, Phase II: Determination of subclonal response by NGS, Phase II: Performing minimal residual disease assessment (MRD) in responding patients by NGS
Interventions
Sponsors
University Medical Center Hamburg-Eppendorf
Eligibility
Sex/Gender
All
Age
65 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Determination of MTD by recording frequency and severity of adverse events graded by CTCAE v5.0., Phase I: Determination of a biologically relevant Phase II regimen, Phase II: Combined rate of complete remission (CR) and morphologic complete remission with incomplete blood count recovery (CRi) within three months | — |
Secondary
| Measure | Time frame |
|---|---|
| Phase I: PD parameters such as a modified PIA assay, Phase I: PK analysis, Phase II: Determination of GLI1/2 levels in circulating AML cells before and under treatment, Phase II: Determination of Event free and Overall survival, Phase II: Determination of subclonal response by NGS, Phase II: Performing minimal residual disease assessment (MRD) in responding patients by NGS | — |
Countries
Germany
Outcome results
None listed