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Long-Term Safety Study of Azacitidine for Patients with Blood Disorders Who Previously Participated in Azacitidine Clinical Trials

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What is this study about?

This clinical trial is focused on studying the long-term safety of a medication called azacitidine, which is used to treat certain blood disorders. Blood disorders can affect the way blood cells function, leading to various health issues. The study involves participants who have previously taken part in other clinical trials with azacitidine and have been receiving this treatment. The purpose of the study is to ensure that continuing the treatment is safe for these participants over a longer period.

Participants in this study will continue to take azacitidine in the form of a tablet. The study will monitor the safety of the treatment by observing any side effects that may occur. These side effects are known as adverse events, which are any unwanted effects that happen during the treatment. The study will also look at how long participants live after starting the treatment, which is referred to as survival. The study is designed to provide valuable information about the safety of azacitidine when used over an extended time.

The study is open-label, meaning that both the participants and the researchers know which treatment is being given. It is a single-arm study, which means all participants receive the same treatment without a comparison group. The study will continue until 2026, allowing researchers to gather comprehensive data on the long-term effects of azacitidine in treating blood disorders. Participants will take the medication orally, and the study will track their health and any changes that occur during the treatment period.

1 joining the study

Participation begins after previous involvement in a study with CC-486 (oral azacitidine).

Eligibility requires continued clinical benefit from CC-486 as determined by the investigator.

2 treatment phase

Receive azacitidine in tablet form, available in 100 mg, 150 mg, 200 mg, and 300 mg dosages.

The medication is taken orally. The specific dosage and frequency are determined by the healthcare provider based on individual needs.

3 monitoring and safety evaluation

Regular monitoring for any side effects or adverse events related to the treatment.

The focus is on the type, frequency, and severity of any side effects experienced.

4 follow-up phase

Participants may enter a follow-up phase if they were part of a previous study requiring survival monitoring.

Continued use of contraception is required for both men and women of childbearing potential during and after the study as specified.

5 study completion

The study is estimated to conclude by March 1, 2026.

The primary focus is on long-term safety and survival outcomes.

Who Can Join the Study?

  • Must have previously participated in a study with the medication called CC-486 and continue to meet the requirements of that original study.
  • Must still be benefiting from the treatment with CC-486, according to the doctor’s opinion.
  • If participating in the follow-up phase for survival, must have been in a previous CC-486 study where survival monitoring was necessary.
  • Both women who can have children and men who are sexually active with such women must use a reliable method of birth control after the last dose of CC-486 in the previous study, before starting this study, during the study, and for a certain time after finishing the treatment, as specified in the study guidelines.

Who Cannot Join the Study?

  • Participants who have not received CC-486 as a single treatment in previous related studies.
  • Participants who the study doctors do not believe will benefit from continuing treatment with CC-486.

Where you can join this trial?

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Other Sites

Site Name City Country Status
Hqneclmg Umijqswjia Ctpuhml Hdlofkck Helsinki Finland

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Finland Finland
Not recruiting
01.10.2023

Trial locations

Investigated drugs:

CC-486 (oral Azacitidine) is a medication being studied for its long-term safety in patients with blood disorders. It is used as a monotherapy, meaning it is given alone without combining it with other treatments. The trial aims to see if patients who have already been treated with CC-486 in previous studies can continue to benefit from it.

Investigated diseases:

Hematological Disorders – These are conditions that affect the blood, bone marrow, and lymphatic system. They can involve problems with blood cells, such as red blood cells, white blood cells, or platelets. Common symptoms may include fatigue, weakness, shortness of breath, and unusual bleeding or bruising. The progression of these disorders varies widely depending on the specific type and underlying cause. Some hematological disorders may lead to anemia, clotting issues, or immune system dysfunction. They can be chronic or acute, with some conditions developing slowly over time and others appearing suddenly.

Trial ID:
2023-503272-25-00
Protocol code:
CC-486-GEN-001
NCT ID:
NCT02494258
Trial Phase:
Therapeutic exploratory (Phase II)

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