Trial · NCT06199557
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 13 of 13
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Safety and tolerability of the treatment combinations of hydroxyurea + valproic acid, and 6-mercaptopurine + valproic acid administered at established clinical doses. | Evaluation every 4th week, i.e. after each treatment cycle. | Safety and tolerability assessed by monitoring the incidence, frequency, and severity of AEs by using CTCAE v5.0, including evaluation of the following: * DLTs * Physical examinations * Clinical laboratory blood samples |
| Primary | Preliminary efficacy of the treatment combination of hydroxyurea and valproic acid administered at established clinical doses. | Evaluation every 4th week, i.e. after each treatment cycle. | Clinical benefit in patients receiving hydroxyurea in combination with valproic acid. Clinical benefit in patients receiving 6-mercaptopurine in combination with valproic acid. Clinical benefit, in this protocol, is defined as stable disease, partial response (decrease of bone marrow blast percentage to between 5% to 25% and decrease of pre-treatment bone marrow blast percentage by at least 50%), or better response \[European Leukemia Net (ELN) 2022 response criteria in AML\], and/or stable or improved ECOG performance status. |
| Primary | Changes in patients performance status from baseline and during the study period. | Evaluation at baseline, i.e. before onset treatment, after 4 weeks on treatment (i.e.after first cycle), and every 4th week to a total of 24 weeks. (i.e. after each treatment cycle, up to a total of 6 cycles). | Baseline and longitudinal ECOG performance status of the patient (Eastern Cooperative Oncology Group). The ECOG performance status scale is best at 0 (fully active, able to carry on all pre-disease performance without restriction), and worst at 5 (dead). |
| Secondary | Clinical benefit. | After 3 and 6 cycles (i.e. after 3 and 6 months from the treatment onset). | The percentage of patients with clinical benefit (as described over) in each group (A1, A2, B1, B2). |
| Secondary | Duration of clinical benefit. | During the treatment period of 6 months, and during follow-up, up to 6 months after end treatment. | The duration of clinical benefit (in days), in each group (A1, A2, B1, B2). |
| Secondary | Time to progression. | From the treatment onset, during the treatment period of 6 months, and during follow-up, up to 6 months after end treatment. | The time to progression (days), in each group (A1, A2, B1, B2). |
| Secondary | Changes in reported Quality of Life (QoL) compared to baseline. | At baseline, i.e. before onset treatment, after 4 weeks on treatment (i.e.after first cycle), and after each treatment cycle (every 4th week). | Use of health-related quality of life questionnaires: * EQ -5D-5L * QLQ-C30 * NCI- PRO-CTCAE |
| Secondary | Survival analyses, ORR. | After 3 and 6 cycles (i.e. after 3 and 6 months from the treatment onset). | The overall response rate (ORR) defined as the percentage of patients with a response of complete remission (CR), complete remission with incomplete hematologic recovery (CRi), morphologic leukemia-free state (MLFS), partial remission (PR), or no response, all as assessed by ELN response criteria 2022, in each group (A1, A2, B1, B2). |
| Secondary | Survival analyses, OS. | From the treatment onset, during the treatment period of 6 months, and during follow-up, up to 6 months after end-treatment. | The overall survival (OS), in each group (A1, A2, B1, B2). |
| Secondary | Hospitalization rate per month per patient. | Before the treatment onset, during the treatment period of 6 months, and during follow-up, up to 6 months after end treatment. | The number of hospital admissions per month before, during, and after study investigation. |
| Secondary | Transfusion rate per month per patient. | Before the treatment onset, during the treatment period of 6 months, and during follow-up, up to 6 months after end treatment. | The number of blood-/platelet transfusions per month, during and after study investigation. |
| Other | Biomarkers (exploratory). | Through study completion, an average of 5 years, or prolonged if necessary. | Detecting changes in the expression level of intracellular or extracellular signaling markers, may predict positive pharmacological activity of the investigational combinations, and therefore treatment response. These parameters are exploratory and will be measured by mass cytometry on baseline patient samples before treatment onset, and longitudinally with the treatment, sampled every 4th week. |
| Other | Relation of serum concentrations of VPA to treatment response (exploratory). | Exploratory outcome, during the study period, an average of 5 years. | Measure of VPA concentrations in serum (normal reference values: 300 - 700 µmol/L). |
Source ClinicalTrials.govtrials-2026-11-12-0.5.0
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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