Acute Myeloid Leukemia (AML)
Conditions
Brief summary
Safety and tolerability assessed by monitoring the incidence, frequency and severity of AEs, including evaluation of the following: i. DLTs ii. Physical examinations iii. Clinical laboratory blood and urine samples, Determine clinical benefit (as defined by this protocol) in patients receiving hydroxyurea in combination with valproic acid, Determine clinical benefit* in patients receiving 6-mercaptopurine in combination with valproic acid, Baseline and longitudinal ECOG status of the patient (Eastern Cooperative Oncology Group)
Detailed description
(a) The percentage of patients with clinical benefit after 3 and 6 cycles in each arm ( A1, A2, B1, B2) (b) Overall response rate (ORR; defined as the percentage of patients with a response of CR, CRh, CRi, MLFS, PR or no response as assessed by ELN response criteria 2022) (c) Duration of clinical benefit (d) Time to progression (e) Overall Survival (OS), Usage of health-related quality of life questionnaires: i. EQ -5D-5L ii. SF-36, QLQ-C30 iii. NCI- PRO-CTCAE (b) Lower number of hospital admissions and blood-/platelet transfusions during and after study investigation compared to baseline.
Interventions
Sponsors
Helse Bergen HF
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety and tolerability assessed by monitoring the incidence, frequency and severity of AEs, including evaluation of the following: i. DLTs ii. Physical examinations iii. Clinical laboratory blood and urine samples, Determine clinical benefit (as defined by this protocol) in patients receiving hydroxyurea in combination with valproic acid, Determine clinical benefit* in patients receiving 6-mercaptopurine in combination with valproic acid, Baseline and longitudinal ECOG status of the patient (Eastern Cooperative Oncology Group) | — |
Secondary
| Measure | Time frame |
|---|---|
| (a) The percentage of patients with clinical benefit after 3 and 6 cycles in each arm ( A1, A2, B1, B2) (b) Overall response rate (ORR; defined as the percentage of patients with a response of CR, CRh, CRi, MLFS, PR or no response as assessed by ELN response criteria 2022) (c) Duration of clinical benefit (d) Time to progression (e) Overall Survival (OS), Usage of health-related quality of life questionnaires: i. EQ -5D-5L ii. SF-36, QLQ-C30 iii. NCI- PRO-CTCAE (b) Lower number of hospital admissions and blood-/platelet transfusions during and after study investigation compared to baseline. | — |
Countries
Norway
Outcome results
None listed