Trial · NCT06199557
A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients
NCT06199557, Phase 1, Phase 2, Recruiting, Haukeland University Hospital
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients. Trials, record NCT06199557. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06199557
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients
- NCT number
- NCT06199557
- Status
- Recruiting
- Phases
- Phase 1, Phase 2
- Enrollment
- 48 participants, estimated
- Lead sponsor
- Haukeland University Hospital
- Conditions
- Acute Myeloid Leukemia, Adult, Myelodysplastic Syndromes, Adult
- Interventions
- Hydroxyurea, Hydroxycarbamide, Valproic acid, 6-Mercaptopurine (6-MP)
- First posted
- 2024-01-10
- Last updated
- 2025-06-29
Source ClinicalTrials.gov
Registered outcomes13
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| 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. |
1 to 10 of 13Source ClinicalTrials.gov
See all 13 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers54
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT06199557
GET https://conductscience.org/api/trials/v1/NCT06199557/papers?page=2