Study of AZD2962 tablets alone and with other medications in patients with myelodysplastic syndromes and dysplastic chronic myelomonocytic leukemia

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What is this study about?

This study focuses on patients with Myelodysplastic Syndromes and Dysplastic Chronic Myelomonocytic Leukemia, which are blood disorders affecting the production of blood cells in the bone marrow. The study will test a new medication called AZD2962, which is taken as a film-coated tablet by mouth. This drug works by blocking a protein called IRAK4 that may play a role in these blood disorders.

The main purpose of this research is to understand how safe the medication is and how well patients can tolerate it. The study will evaluate AZD2962 both when given alone and when combined with other treatments. Researchers will also determine the most effective dose of the medication that can be safely given to patients.

During the study, participants will take the medication and undergo regular check-ups to monitor their health. Doctors will track how patients respond to the treatment by examining their blood and bone marrow samples. The study will also measure how long the medication stays in the body and how it affects the blood disorder over time.

1 Initial assessment

Your eligibility for the study will be evaluated based on specific medical criteria.

A bone marrow assessment or biopsy will be required before starting the treatment.

Laboratory tests will check your blood cell counts and organ function, including liver and kidney tests.

2 Treatment initiation

You will receive AZD2962 in the form of film-coated tablets that you will take by mouth.

The medication is designed to treat blood disorders including myelodysplastic syndromes or chronic myelomonocytic leukemia.

Your doctor will determine the appropriate dose for your condition.

3 Monitoring period

Regular medical examinations will track your health status.

Blood tests will be performed to monitor your response to treatment.

Heart monitoring through ECG (electrical heart activity recording) will be conducted.

Any side effects or reactions will be documented and assessed.

4 Response assessment

Your response to the treatment will be evaluated through regular medical check-ups.

Blood tests will track changes in your condition.

The effectiveness of the treatment will be measured by examining how your disease responds.

5 Long-term follow-up

Your health status will continue to be monitored throughout the study period.

The study is expected to continue until February 2028.

Regular assessments will track your long-term response to the treatment.

Who Can Join the Study?

Must be at least 18 years old when signing the consent form
Must have either:
– Relapsed/refractory MDS (a bone marrow disorder where blood cells don’t develop properly) or
– Relapsed/refractory dysplastic CMML (a blood cell disorder), with less than 20% abnormal cells in blood or bone marrow
– Must have received at least one previous treatment
Must have an ECOG performance status of 2 or better (able to perform most daily activities with some limitations)
Must have symptoms that require treatment and can be measured to assess if therapy is working
Must be willing to provide a bone marrow sample before starting treatment
Must meet specific blood test requirements:
– White blood cell count must be 10.0 x 109/L or less for MDS patients, or less than 13.0 x 109/L for CMML patients
– Liver function tests (ALT and AST) must be no more than 3 times the normal limit
– Bilirubin level must be no more than 1.5 times the normal limit (3 times if you have Gilbert’s Syndrome)
– Kidney function must show creatinine clearance of 60 mL/min or better

Who Cannot Join the Study?

Age below 18 years or above 65 years
Pregnant or breastfeeding women
History of severe allergic reactions to medications
Active infections or ongoing serious illness
Participation in other clinical trials within the past 30 days
Severe heart, liver, or kidney problems
Previous treatment with similar medications in the past 6 months
Mental conditions that could affect the ability to provide informed consent
Abnormal blood test results that suggest poor organ function
History of other types of cancer in the past 5 years
Unable to follow study procedures or attend regular visits
Taking medications that could interact with the study drug
Uncontrolled high blood pressure or diabetes
Bone marrow transplant in the past 2 years
Life expectancy less than 3 months

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Hospital Universitario Y Politecnico La Fe	Valencia	Spain
Hospital Universitario De Salamanca	Salamanca	Spain
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country	Status
MD Anderson Cancer Center	Madrid	Spain
Hkcqmsks Vhwu deodqlun	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Spain	Not yet recruiting	18.12.2025

Trial locations

AZD2962 is an IRAK4 inhibitor medication being studied for treating blood-related cancers (hematologic neoplasms). This medication works by blocking a specific protein called IRAK4, which plays a role in cell signaling pathways that can contribute to cancer growth. The medication is being tested both on its own (monotherapy) and in combination with other cancer treatments to evaluate how safe it is and how well it works in patients with blood cancers.

Investigated diseases:

Haematological malignancy

Dysplastic chronic myelomonocytic leukemia – A blood cell disorder that affects bone marrow function and blood cell production. The condition causes abnormal white blood cells called monocytes to build up in the blood and bone marrow. It combines features of two blood disorders: myelodysplastic syndrome and myeloproliferative disorder. The disease typically develops slowly over time, leading to decreased production of normal blood cells.

Myelodysplastic syndromes – A group of blood disorders where the bone marrow doesn’t produce enough healthy blood cells. In this condition, immature blood cells fail to develop normally and die in the bone marrow or blood. This leads to low levels of one or more types of blood cells. The condition causes the bone marrow to make blood cells that are both defective and poorly formed.

Trial ID:

2025-520786-44-00

Protocol code:

D7770C00001

Trial Phase:

Phase I and Phase II (Integrated) – First administration to humans

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Study of AZD2962 tablets alone and with other medications in patients with myelodysplastic syndromes and dysplastic chronic myelomonocytic leukemia

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?