chronic myelomonocytic Leukemia
Conditions
Brief summary
The primary outcome measure is the response rate defined as CR or mCR or PR after 3 cycles of treatment., Response will be assessed according to Savona et al., 20151.
Detailed description
Adverse events (AEs) and serious adverse events (SAEs), clinical laboratory values, vital signs, ECG, and ECHO/MUGA parameters, Overall survival (OS), time to leukemia transformation (TLT), median duration of response until EOT, Proportion of patients achieving hematologic improvement after 3 cycles of treatment (IWG 2018/2023 criteria), Proportion of patients achieving transfusion independence after 3 cycles of treatment (IWG 2018/2023 criteria), Change of quality of life after 3 cycles and 12 cycles of treatment compared to baseline
Interventions
DRUGVenetoclax
Sponsors
GCP-Service International West GmbH
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Adverse events (AEs) and serious adverse events (SAEs), clinical laboratory values, vital signs, ECG, and ECHO/MUGA parameters, Overall survival (OS), time to leukemia transformation (TLT), median duration of response until EOT, Proportion of patients achieving hematologic improvement after 3 cycles of treatment (IWG 2018/2023 criteria), Proportion of patients achieving transfusion independence after 3 cycles of treatment (IWG 2018/2023 criteria), Change of quality of life after 3 cycles and 12 cycles of treatment compared to baseline | — |
Primary
| Measure | Time frame |
|---|---|
| The primary outcome measure is the response rate defined as CR or mCR or PR after 3 cycles of treatment., Response will be assessed according to Savona et al., 20151. | — |
Countries
Germany, Italy, Spain
Outcome results
None listed