Actively Recruiting
A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients
Led by Haukeland University Hospital · Updated on 2025-06-29
48
Participants Needed
1
Research Sites
279 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of this study is to investigate the safety, tolerability, and preliminary efficacy of the combination treatment of hydroxyurea capsules and valproic acid capsules, or the combination treatment of 6-mercaptopurine tablets and valproic acid capsules in male and female patients aged 18 years or older with acute myeloid leukemia or high- risk myelodysplastic syndrome. The population to be studied is newly diagnosed AML patients who are considered unfit for standard induction chemotherapy, HR-MDS unfit/ineligible for standard treatment, and relapsed/refractory AML/HR-MDS patients who are considered unfit for standard therapy ,or are, for some reason, ineligible for another type of therapy. Clinically, hydroxyurea, valproic acid and 6-mercaptopurine are historically very well-known therapeutic agents with low toxicity profiles. The rationale for this study is that the combination of these drugs with low toxicity will be well tolerated in elderly AML patients with comorbidities, or lower performance status. This combination could have a beneficial therapeutic effect on overall survival and contribute to a better quality of life.
CONDITIONS
Official Title
A Study to Investigate Treatment of HU and VPA, or 6-MP and VPA in Unfit AML/HR-MDS Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 18 years or older
- Written informed consent provided
- Diagnosis of newly diagnosed AML or relapsed/refractory AML unfit for or declining standard therapy
- Diagnosis of newly diagnosed or relapsed/refractory high-risk MDS unfit for or declining standard therapy
- Secondary AML (MDS-related or therapy-induced) or acute promyelocytic leukemia not eligible for standard therapy
- Adequate kidney and liver function as defined by specified laboratory values
- ECOG performance status of 0, 1, 2, or 3
- Female patients of childbearing potential must have a negative pregnancy test and agree to effective contraception throughout the study and 3 months after
You will not qualify if you...
- Receiving any anti-leukemic treatment within 2 weeks before enrollment
- Active malignancy within the past 6 months except certain skin or cervical cancers
- Severe or uncontrolled medical conditions at investigator's discretion
- Breastfeeding women
- Recent heart problems including myocardial infarction, severe heart failure, unstable angina, or arrhythmias
- COVID-19 infection or vaccination within 7 days before study start
- Known non-compliance or unreliability regarding medical regimens
- Serious medical conditions compromising study participation
- Psychiatric disorders preventing informed consent
- Concurrent chemotherapy, radiation, or immunotherapy not specified in protocol
- Known allergy to study drugs or their components
- Psychological, social, or geographic conditions hindering compliance with the study protocol
AI-Screening
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Trial Site Locations
Total: 1 location
1
Haukeland University Hospital
Bergen, Bergen, Norway, 5021
Actively Recruiting
Research Team
B
Bjørn Tore Gjertsen, MD, PhD
CONTACT
I
Irini Ktoridou-Valen, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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