Actively Recruiting
A Phase 1 Study to Evaluate Safety, Tolerability, and Efficacy of Karonudib in Patients with Hematological Malignancies
Led by Thomas Helleday Foundation · Updated on 2025-12-19
9
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and tolerability of Karonudib, a drug being studied for treating various advanced blood cancers including Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Diffuse Large B-Cell Lymphoma (DLBCL), Burkitt's lymphoma, Multiple Myeloma (MM), and high-risk Myelodysplastic Syndrome (MDS). This phase 1 study also aims to find the recommended dose and treatment schedule for Karonudib, study how the drug moves through the body, and look for early signs of treatment effects. Overall survival will be recorded to understand longer-term outcomes. Participants will receive Karonudib as an oral solution taken every other day in escalating dose groups. The study has multiple dose cohorts and includes an extension phase where Karonudib is given twice a week combined with standard care treatment Idarubicin and possibly other anti-cancer agents. The study focuses on patients with relapsed or refractory disease who have limited treatment options and may have received prior therapies under specific conditions. During the study, participants will be monitored closely for safety and tolerability during the first 28-day treatment cycle. Researchers will assess measurable disease through blood, bone marrow, or imaging exams and evaluate heart, liver, and kidney function. The study includes assessments of side effects, drug effects, and patient status using standard clinical and laboratory tests. The total participation duration and follow-up extend through treatment cycles and safety observation periods as planned.
CONDITIONS
Brief Title
A Study in Leukemia Patients With Karonudib
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent.
- Age between 18 and 75 years (extension possible if medically fit).
- Diagnosed with relapsed, refractory, or progressive AML, ALL, DLBCL, Burkitt lymphoma, multiple myeloma, or high-risk MDS.
- Received standard treatments with no suitable options remaining.
- For expansion cohort: limited prior anthracycline exposure (maximum 70% lifetime dose).
- Life expectancy of at least 8 weeks.
- ECOG performance status between 0 and 2.
- Measurable disease by blood, bone marrow, or imaging.
- Normal left ventricular ejection fraction.
- Adequate liver function (bilirubin, AST, ALT within limits).
- Adequate kidney function (GFR at least 30 ml/min).
- Platelet count 10 x 10^9/L or higher (transfusion allowed).
- Able to take oral medication.
- 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 (exceptions apply).
- Less than 1 week since stopping palliative radiotherapy.
- Less than 2 weeks since surgery (except minor access procedures).
- Less than 6 months since serious cardiovascular events.
- Congestive heart failure above NYHA class II.
- History or presence of significant arrhythmias (some exceptions).
- Use of certain medications (Fentanyl, antioxidants, specific antidepressants) not stopped in required time.
- Severe medical conditions increasing risk or interfering with study.
- Active brain involvement unless stable for 8 weeks.
- Active hepatitis B or C infection (except stable DNA-negative cases).
- HIV infection.
- Pregnant or breastfeeding women.
- Not using effective contraception if of reproductive potential.
- Participation in another drug trial within specified washout periods.
- Acute promyelocytic leukemia (AML M3).
- Uncontrolled infections.
- Unable to follow study procedures.
- Peripheral neurological toxicity grade 2 or higher (CTCAE).
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days per treatment cycle
Participants receive escalating doses of Karonudib as an oral solution every other day. In the extension part, participants receive Karonudib twice a week along with Idarubicin on days 1 to 3.
Regular visits during each 28-day treatment cycle
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
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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