Phase 2 Leukaemia Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- Adults aged 18 years or older, of any gender
- People who have given written consent to participate
- People who have been newly diagnosed with AML (a type of blood cancer), or whose AML has come back or stopped responding to treatment, and who are either considered too unwell for standard treatment, are not expected to benefit from or tolerate standard treatment in the doctor's opinion, or have chosen not to have standard treatment
- People who have been newly diagnosed with high-risk MDS (a bone marrow condition), or whose MDS has come back or stopped responding to treatment, and who meet the same conditions listed above regarding standard treatment
- People with a secondary form of AML that developed from MDS or as a result of previous cancer treatment
- People with a specific subtype of AML called acute promyelocytic leukemia who are not suitable for standard treatment
- People whose kidneys and liver are working adequately (based on specific blood test results), unless any abnormalities are clearly caused by the disease itself
- People with a general health and activity level rated 0 to 3 on a standard medical scale (confirm with trial site)
- Women who could become pregnant must have a negative pregnancy blood test within 3 days before starting the study medication
- All participants who could father or become pregnant must agree to use highly effective contraception throughout the study and for more than 3 months after the last dose of study medication
Who may not be able to join:
- People currently receiving any treatment for AML, or who received such treatment less than 2 weeks before joining the study
- People who have had another active cancer in the 6 months before diagnosis, except for certain skin cancers or early-stage cervical changes
- People with serious or poorly controlled other health conditions, such as uncontrolled diabetes, active infection, high blood pressure, or lung disease (as determined by the doctor)
- Women who are currently breastfeeding
- People who have had a heart attack in the last 3 months, severe heart failure, unstable chest pain, or unstable irregular heart rhythms
- People who have had a COVID-19 infection within 7 days of starting the study, or who received a COVID-19 vaccine within 7 days of starting the study
- People who have a history of not following medical treatment plans or who are considered unlikely to comply with study requirements
- People with any other serious health condition that the doctor believes could interfere with safe participation in the study
- People with dementia, significant cognitive impairment, or a psychiatric condition that would prevent them from understanding and consenting to participation
- People currently receiving chemotherapy, radiation therapy, or immunotherapy that is not part of this study's protocol
- People with a known allergy or sensitivity to the study medications or any of their ingredients
- People whose personal, family, social, or geographic circumstances could make it difficult to follow the study schedule or requirements
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Bjørn Tore Gjertsen, MD, PhD, Helse-Bergen HF
Phone: 004741566248
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Safety and tolerability of the treatment combinations of hydroxyurea + valproic acid, and 6-mercaptopurine + valproic acid administered at established clinical doses.; Preliminary efficacy of the treatment combination of hydroxyurea and valproic acid administered at established clinical doses.; Changes in patients performance status from baseline and during the study period.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.