Actively Recruiting
A Study in Leukemia Patients With Karonudib
Led by Thomas Helleday Foundation · Updated on 2025-12-19
9
Participants Needed
6
Research Sites
369 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary objective of this study is to determine safety and tolerability of Karonudib for the treatment of hematological malignancies. Secondary objectives are to determine a recommended RP2D and schedule for further development of Karonudib, to determine the pharmacokinetics of Karonudib, to look for evidence of treatment efficacy. Overall survival will also be recorded.
CONDITIONS
Official Title
A Study in Leukemia Patients With Karonudib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provided written informed consent
- Aged 18 to 75 years (may include older if medically fit)
- Diagnosed with AML, ALL, DLBCL, Burkitt lymphoma, multiple myeloma, or high-risk MDS per WHO 2016 criteria
- Have relapsed, refractory, or progressive disease after standard treatments with no suitable options
- For expansion cohort, received no more than 70% of lifetime anthracycline dose
- Life expectancy estimated at least 8 weeks
- ECOG performance status 0 to 2
- Measurable disease by blood, bone marrow, or imaging
- Normal left ventricular ejection fraction
- Adequate liver and kidney function (bilirubin, AST, ALT, GFR levels within specified limits)
- Platelet count at least 10 x 10^9/L (transfusion allowed)
- Able to take oral medications
- Negative pregnancy test for women of childbearing potential
You will not qualify if you...
- Under 18 years old
- Less than 4 weeks since last systemic chemotherapy except some stable medications
- Less than 1 week since last palliative radiotherapy
- Less than 2 weeks since surgery except minor access procedures
- Less than 6 months since major cardiovascular events
- Congestive heart failure NYHA class greater than II
- History of arrhythmias except certain stable types
- Need for certain anti-arrhythmic drugs
- Baseline QTc interval over 470 ms
- Recent use of Fentanyl, antioxidant vitamins, acetylcysteine, or certain antidepressants
- Severe acute or chronic medical conditions increasing risk or interfering with study
- Active brain disease or progression within 8 weeks
- Known hepatitis B or C infection (except stable DNA-negative hepatitis B)
- Known HIV infection
- Pregnant or breastfeeding women
- Not using effective contraception if of reproductive potential
- Participation in other drug trials recently
- Acute promyelocytic leukemia (AML M3)
- Uncontrolled infection
- Unable to follow study procedures
- Peripheral neurological toxicity grade 2 or higher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 6 locations
1
Aarhus University Hospital
Aarhus, Denmark
Actively Recruiting
2
Rigshospitalet Copenhagen University Hospital
Copenhagen, Denmark
Actively Recruiting
3
University Clinical Center Belgrade
Belgrade, Serbia
Actively Recruiting
4
University Clinical Center Kragujevac
Kragujevac, Serbia
Actively Recruiting
5
Karolinska University Hospital
Huddinge, Sweden
Actively Recruiting
6
Örebro University Hospital
Örebro, Sweden
Actively Recruiting
Research Team
M
Maria Klockare, BSc
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
1
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