LeukemiaPhase 1MAATEONCT04077307
A Study in Leukemia Patients With Karonudib
A Phase 1 study testing Karonudib in people with Leukemia, run by Thomas Helleday Foundation at 7 sites in 3 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Leukemia
- What is being tested?
- Karonudib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 7 sitesin 3 countries
- Study dates
- 3 Dec 2019to 30 Apr 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Written informed consent.
- Age 18-75 years (may be extended to older if deemed fit).
- The patient has received standard of care treatments and has refractory or relapsed or progressive disease with no suitable standard of care options available.
- For expansion cohort (Cohort V): Patients can only have received a maximum of 70% of anthracycline lifetime exposure to date of proposed dosing day.
- Cohorts I-IV: AML, ALL, DLBCL, Burkitt lymphoma, multiple myeloma or high-risk MDS, according to the WHO 2016 criteria.
- Expansion cohort (Cohort V): Relapsed, Recurrent or Progressive AML or MDS according to the ELN 2017 criteriaWHO 2016 criteria.
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- For expansion cohort (Cohort V): Patients can only have received a maximum of 70% of anthracycline lifetime exposure to date of proposed dosing day.
- The patient has received standard of care treatments and has refractory or relapsed disease with only experimental therapies as further treatment options.
- Life expectancy of at least 8 weeks (as per investigators clinical assessment).
- ECOG PFS 0-2
- Patients must have measurable disease by blood or bone marrow or imaging examination.
- Have a normal left ventricular ejection fraction (LVEF) based on institutional ranges.
- Adequate hepatic and renal function defined as:
- Total bilirubin < 3 x ULN (does not apply to patients with Gilberts Syndrome).
- AST and ALT ≤ 5 x ULN.
- The calculated GFR is at least 30 ml/min using Cockcroft-Gault method.
- Platelet count≥10 x 109/L. (Can be supported by platelet transfusion)
- Subject must be able to take oral medication.
- Negative pregnancy test according to CTFG guidance 2014 for females of child-producing potential.
Who cannot join
- Age less than 18 years.
- Less than 4 weeks since stopping previous systemic chemotherapy treatment with the exception of stable dose Hydroxyurea, Trophosphamide, oral Cyclophosphamide, ImID or Thioguanine which needs to be stopped 10 x t1/2 prior to Karonudib administration.
- Less than 1 week since stopping palliative radiotherapy.
- Less than 2 weeks after surgery except access surgical procedures.
- Less than 6 months since a clinically significant cardiovascular event such as myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke or TIA.
- Congestive heart failure NYHA class > II.
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- History of arrhythmias or arrhythmias discovered during the screening period (apart from atrial fibrillation without ventricular tachycardia and premature extra beats).
- Patients requiring anti-arrhythmic drugs except for stable dose beta-blocking or calcium channel blocking agents.
- QTc interval >470 ms at baseline (Fridericia correction).
- Use of Fentanyl (must be stopped at least 1 week prior to initiation of Karonudib).
- Use of anti-oxidants vitamins and Acetylcysteine (must be stopped within 48 hours of starting treatment with Karonudib).
- Use of antidepressant medications which are substrate for CYP2D6 (must be stopped at least 3 weeks prior to starting treatment with Karonudib).
- Any severe acute or chronic medical condition that places the patient at increased risk or interferes with the interpretation of study results.
- Intracerebral engagement (patient with previously known engagement are eligible provided that there is no evidence of disease progression for a minimum of 8 weeks prior to inclusion.
- Known acute or chronic infection with hepatitis B or C except for DNA-negative hepatitis B with stable dose anti-viral agents.
- Known HIV infection.
- Pregnant or breast-feeding women.
- Patients with reproductive potential not implementing accepted and effective means of contraception.
- Participation in any other clinical trial with a pharmaceutical product within 5 x t½, or minimum 1 week, since last dosing of the IMP, whichever is the shorter.
- Acute promyelocytic leukemia (AML M3).
- Uncontrolled ongoing systemic or localized infection.
- Unable to comply with study procedures.
- Peripheral neurological toxicity CTCAE grade 2 or higher.
Trial locations and contacts
7 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 3 countries
Serbia3 sites, 3 recruiting
- Recruiting
University Clinical Center Belgrade
Belgrade
Ana Vidović, MD
- Recruiting
Vojnomedicinska akademija, Klinika za hematologiju
Belgrade
Dr Lavinika Atanaskovic, MD, +38163697456
- Recruiting
University Clinical Center Kragujevac
Kragujevac
Danijela Jovanovic, MD
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus
Hans Beier Ommen, MD
- Recruiting
Rigshospitalet Copenhagen University Hospital
Copenhagen
Claudia Schoellkopf, MD
Sweden2 sites, 2 recruiting
- Recruiting
Karolinska University Hospital
Huddinge
Stefan Deneberg, MD, PhD
Stefan Deneberg, MD, PhD
- Recruiting
Örebro University Hospital
Örebro
Bertil Uggla, MD
About this study
Official title: A Phase 1 Study in Patients With Hematological Malignancies to Evaluate Safety, Tolerability and Efficacy of Karonudib
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.
Read the detailed description
Primary Objective Part I
- To determine the safety and tolerability of Karonudib in escalating doses for the treatment of patients with advanced relapsed/refractory Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) , Diffuse Large B-Cell Lymphoma, Multiple Myeloma (MM) and high-risk Myelodysplastic Syndrome (MDS)AML, ALL, DLBCL, Burkitt´s lymphoma, multiple myeloma and high-risk MDS Primary Objective Part II
- To determine the safety and tolerability of Karonudib in combination with standard of care treatment, Idarubicinother anti-cancer agents for the treatment of patients with advanced progressive, relapsed/refractory AML, and high-risk MDS
- Conditions
- Leukemia
- Being tested
- Karonudib
- Keywords
- AML, ALL, MDS, Multiple myeloma, B cell lymphoma
- Medical subject headings
- Leukemia, Multiple Myeloma, Lymphoma, B-Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KaronudibDrug
First part of the study - four different dose cohorts Extension part of the study - karonudib BID (twice a week) and Idarubicin days 1-3.
| Study group | Role | What they receive |
|---|---|---|
| Dose escalation | Experimental | Karonudib is an oral inhibitor of MTH1 and will be supplied as an oral solution to be taken every other day. There are three planned dose cohorts. Patients will be given every second day dosing. Receives: Drug: Karonudib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of Karonudib (TH1579)
Grade and frequency of AE and SAE using the CTCAE version 5.0
Measured: 28 days, first treatment cycle for the patient.
Tolerability of Karonudib (TH1579)
Grade and frequency of AE and SAE using the CTCAE version 5.0
Measured: 28 days, first treatment cycle for the patient.
Secondary outcomes (1)
Preliminary signs of clinical efficacy of Karonudib.
ELN/IWG response criteria
Measured: 28 days, first treatment cycle for the patient.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2019
- Study start3 Dec 2019
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- First part of the study - 3 different dose cohorts with escalating doses are planned. Extension part of the study - up to 50 patients with diagnosis of Relapsed, Refractory or Progressive AML and MDS to be enrolled and treated with RP2D.
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Thomas Helleday Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Deneberg, MD, Principal investigator, Karolinska University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04077307
- Sponsor's protocol ID
- MAATEO
- Acronym
- MAATEO
- Status last verified
- Aug 2026
- First submitted
- 26 Aug 2019
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study in Patients With Hematological Malignancies to Evaluate Safety, Tolerability and Efficacy of Karonudib
- ClinicalTrials.gov ID
- NCT04077307
- Acronym / sponsor ID
- MAATEO / MAATEO
- Conditions
- Leukemia
- Keywords
- AML, ALL, MDS, Multiple myeloma, B cell lymphoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Thomas Helleday FoundationUniversity, hospital or other
- Study start
- 3 Dec 2019 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 4 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary Objective Part I
- To determine the safety and tolerability of Karonudib in escalating doses for the treatment of patients with advanced relapsed/refractory Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL) , Diffuse Large B-Cell Lymphoma, Multiple Myeloma (MM) and high-risk Myelodysplastic Syndrome (MDS)AML, ALL, DLBCL, Burkitt´s lymphoma, multiple myeloma and high-risk MDS Primary Objective Part II
- To determine the safety and tolerability of Karonudib in combination with standard of care treatment, Idarubicinother anti-cancer agents for the treatment of patients with advanced progressive, relapsed/refractory AML, and high-risk MDS
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- First part of the study - 3 different dose cohorts with escalating doses are planned. Extension part of the study - up to 50 patients with diagnosis of Relapsed, Refractory or Progressive AML and MDS to be enrolled and treated with RP2D.
| Arm | Type | Receives |
|---|---|---|
| Dose escalation | Experimental | Drug: KaronudibKaronudib is an oral inhibitor of MTH1 and will be supplied as an oral solution to be taken every other day. There are three planned dose cohorts. Patients will be given every second day dosing. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Written informed consent.
- Age 18-75 years (may be extended to older if deemed fit).
- The patient has received standard of care treatments and has refractory or relapsed or progressive disease with no suitable standard of care options available.
- For expansion cohort (Cohort V): Patients can only have received a maximum of 70% of anthracycline lifetime exposure to date of proposed dosing day.
- Cohorts I-IV: AML, ALL, DLBCL, Burkitt lymphoma, multiple myeloma or high-risk MDS, according to the WHO 2016 criteria.
Key exclusion criteria (23 listed)
- Age less than 18 years.
- Less than 4 weeks since stopping previous systemic chemotherapy treatment with the exception of stable dose Hydroxyurea, Trophosphamide, oral Cyclophosphamide, ImID or Thioguanine which needs to be stopped 10 x t1/2 prior to Karonudib administration.
- Less than 1 week since stopping palliative radiotherapy.
- Less than 2 weeks after surgery except access surgical procedures.
- Less than 6 months since a clinically significant cardiovascular event such as myocardial infarction, unstable angina, angioplasty, bypass surgery, stroke or TIA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KaronudibFirst part of the study - four different dose cohorts Extension part of the study - karonudib BID (twice a week) and Idarubicin days 1-3. | Drug | Dose escalation |
Primary outcome
Safety of Karonudib (TH1579)
Time frame: 28 days, first treatment cycle for the patient.
Grade and frequency of AE and SAE using the CTCAE version 5.0
Tolerability of Karonudib (TH1579)
Time frame: 28 days, first treatment cycle for the patient.
Grade and frequency of AE and SAE using the CTCAE version 5.0
1 secondary outcome
Preliminary signs of clinical efficacy of Karonudib.
Time frame: 28 days, first treatment cycle for the patient.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Stefan Deneberg, MD principal investigator
Karolinska University Hospital
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Karonudib in people with Leukemia, run by Thomas Helleday Foundation at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 19 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Serbia, Denmark, Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maria Klockare, BSc (+46706232505, maria.klockare@oxcia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of Karonudib (TH1579) (time frame: 28 days, first treatment cycle for the patient.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.