AML
Conditions
Brief summary
Frequency of Dose-limiting toxicities (DLTs) during the first course of therapy
Detailed description
1. Safety and tolerability: frequency of AEs, frequency of clinically significant laboratory abnormalities and number of toxic deaths 2. Measures of anti-leukemic activity3. Overall patient survival and relapse-free survival 4. Number of patients undergoing HSCT after treatment. 5. Serum and intracellular pharmacokinetic parameters 6. Relationship between response (ORR) and Ara-CTP accumulation 7.Correlation between duration of response and measurable residual disease assessed by flow-cytometry
Interventions
Sponsors
Prinses Maxima Centrum voor Kinderoncologie B.V.
Eligibility
Sex/Gender
All
Age
0 Years to 64 Years
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of Dose-limiting toxicities (DLTs) during the first course of therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Safety and tolerability: frequency of AEs, frequency of clinically significant laboratory abnormalities and number of toxic deaths 2. Measures of anti-leukemic activity3. Overall patient survival and relapse-free survival 4. Number of patients undergoing HSCT after treatment. 5. Serum and intracellular pharmacokinetic parameters 6. Relationship between response (ORR) and Ara-CTP accumulation 7.Correlation between duration of response and measurable residual disease assessed by flow-cytometry | — |
Countries
Austria, Denmark, Germany, Italy, Netherlands, Spain
Outcome results
None listed