Study on the Safety and Effects of Karonudib for Patients with Advanced Leukemia, Lymphoma, and Multiple Myeloma

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What is this study about?

This clinical trial is focused on studying certain types of blood cancers, known as hematological malignancies. These include Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Diffuse Large B-Cell Lymphoma, Multiple Myeloma (MM), and high-risk Myelodysplastic Syndrome (MDS). The treatment being tested is a medication called Karonudib, also known by its code name TH1579 or OXC-101. This medication is taken in the form of a tablet.

The purpose of the study is to determine how safe and tolerable Karonudib is when given in increasing doses to patients with advanced stages of these blood cancers, especially those who have not responded to previous treatments or whose disease has returned. Additionally, the study will explore the safety and tolerability of Karonudib when used in combination with other cancer-fighting drugs for patients with advanced, relapsed, or refractory AML and high-risk MDS.

Participants in the study will receive Karonudib orally, and the study will monitor their response to the treatment over time. The trial aims to gather information on how patients tolerate the medication and any side effects they may experience. The study is expected to continue until early 2026, providing valuable insights into the potential benefits and risks of Karonudib for treating these serious blood cancers.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes reviewing medical history and current health status.

Eligibility criteria include age between 18-75 years, previous standard treatments, and specific health conditions such as Acute Myeloid Leukemia (AML) or Multiple Myeloma.

2 consent and enrollment

Written informed consent is required to participate in the study.

Once consent is obtained, enrollment in the trial is confirmed.

3 treatment phase

The treatment involves taking Karonudib in tablet form orally.

Dosage is adjusted in escalating doses to determine safety and tolerability.

The treatment is administered over a specified period, with regular monitoring of health status.

4 monitoring and follow-up

Regular follow-up appointments are scheduled to monitor the effects of the treatment.

Health assessments include blood tests, imaging examinations, and evaluations of liver and kidney function.

5 completion of trial

Upon completion of the treatment phase, a final assessment is conducted.

The study aims to conclude by January 2026, with all data collected and analyzed.

Who Can Join the Study?

The patient must provide written informed consent, which means they agree to participate after understanding the study details.
The patient should be between 18 and 75 years old, but older patients may be included if they are considered fit.
The patient must have tried standard treatments and have a disease that has come back, not responded, or is getting worse, with no other standard treatment options available.
For a specific group in the study, patients can only have received up to 70% of a certain type of chemotherapy called anthracycline.
The patient must have certain types of blood cancers, such as Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Diffuse Large B-Cell Lymphoma, Burkitt lymphoma, Multiple Myeloma, or high-risk Myelodysplastic Syndromes (MDS), based on specific medical criteria.
The patient should have a life expectancy of at least 8 weeks, as assessed by the doctor.
The patient must have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 2, which is a scale used to assess how the disease affects their daily living abilities.
The patient must have a measurable disease, which means the disease can be measured by blood tests, bone marrow tests, or imaging scans.
The patient must have a normal left ventricular ejection fraction (LVEF), which is a measure of how well the heart pumps blood.
The patient must have adequate liver and kidney function, which includes specific levels of bilirubin, AST, ALT, and a calculated Glomerular Filtration Rate (GFR) of at least 30 ml/min.
The patient must have a platelet count of at least 10 x 10⁹/L, which can be supported by platelet transfusion if needed.
The patient must be able to take oral medication.
For females who can have children, a negative pregnancy test is required.

Who Cannot Join the Study?

Patients with other types of cancer that are not the focus of this study.
Patients who have not experienced a return or worsening of their blood cancer after treatment.
Patients who are not considered high-risk for their specific type of blood cancer.
Patients who are not adults, as the study is for adult participants only.
Patients who are part of a vulnerable population, meaning they may need special protection or care.
Patients who are not able to safely take the study medication or other treatments involved in the study.
Patients who are pregnant or breastfeeding, as the study may not be safe for them or their baby.
Patients who have a medical condition that could interfere with the study or make it unsafe for them to participate.
Patients who are currently participating in another clinical trial.
Patients who have had a recent major surgery or are recovering from a major illness.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Rigshospitalet	Copenhagen	Denmark
Karolinska Institutet	Stockholm	Sweden
Azfshd Uyqtkfrtsp Hwsheeud	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	08.05.2019
Sweden	Recruiting	08.05.2019

Trial locations

Investigated drugs:

Idarubicin Hydrochloride

Karonudib is being studied to see if it is safe and well-tolerated in patients with certain blood cancers. These include advanced forms of Acute Myeloid Leukemia (AML), Acute Lymphoblastic Leukemia (ALL), Diffuse Large B-Cell Lymphoma, and Multiple Myeloma (MM). The trial is also looking at how well Karonudib works when used with other cancer treatments for patients with advanced, relapsed, or difficult-to-treat AML and high-risk Myelodysplastic Syndromes (MDS).

Investigated diseases:

Haematological malignancy

Acute Myeloid Leukemia – A type of cancer that starts in the blood-forming cells of the bone marrow and progresses rapidly if not treated. It leads to the accumulation of abnormal white blood cells, which can interfere with the production of normal blood cells.

Acute Lymphoblastic Leukemia – A fast-growing cancer of the blood and bone marrow that affects white blood cells. It is characterized by the overproduction of immature lymphocytes, which can crowd out normal cells and impair the immune system.

Diffuse Large B-Cell Lymphoma – A common type of non-Hodgkin lymphoma that originates in the lymphatic system. It involves the rapid growth of large B-cells, which can form tumors in lymph nodes or other organs.

Multiple Myeloma – A cancer of plasma cells, which are a type of white blood cell found in the bone marrow. It causes abnormal plasma cells to multiply, leading to bone damage, anemia, and kidney problems.

Myelodysplastic Syndrome – A group of disorders caused by poorly formed or dysfunctional blood cells. It occurs when the bone marrow does not produce enough healthy blood cells, leading to symptoms like fatigue and increased risk of bleeding or infection.

Trial ID:

2024-513766-20-00

NCT ID:

NCT04077307

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on the Safety and Effects of Karonudib for Patients with Advanced Leukemia, Lymphoma, and Multiple Myeloma

What is this study about?

Who Can Join the Study?

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