RecruitingRare disease

Study on the Safety and Effects of Inobrodib, Betamethasone Sodium Phosphate, and Dimethyl Fumarate in Patients with Advanced Blood and Bone Marrow Cancers

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying certain types of blood cancers, specifically Acute Myeloid Leukemia (AML), higher-risk Myelodysplastic Syndrome (MDS), Multiple Myeloma (MM), and Non-Hodgkin Lymphoma (NHL). The trial will test the safety and effects of an experimental drug called CCS1477, both on its own and in combination with other treatments. The study aims to understand how this drug works in patients with these advanced blood cancers.

Participants in the study will receive CCS1477 in the form of a capsule taken by mouth. In some cases, it will be combined with other medications, such as Dexamethasone or Pomalidomide. The trial will monitor the safety and tolerability of these treatments, which means checking for any side effects and how well patients can handle the medication. The study will also look at how the drug is processed in the body and its potential effects on the cancer.

The trial will take place over several years, with regular check-ups and assessments to track the progress of the treatment. This includes looking at changes in the cancer through various tests and evaluations. The goal is to gather information on the drug's safety and its impact on the cancer, which could help in developing new treatment options for these serious conditions.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, you will be asked to provide written informed consent. This means you agree to participate after understanding the study's purpose and procedures.
You will undergo initial assessments to confirm eligibility, including a review of your medical history and current health status.
Step 2
Initial assessments
You will have a series of tests to assess your health. These may include blood tests, imaging studies, and other evaluations to establish a baseline for your condition.
These assessments help determine your suitability for the study and provide a starting point for measuring any changes during the trial.
Step 3
Medication administration
You will begin taking the study medication, CCS1477, which is administered orally. The dosage and frequency will be determined by the study protocol.
If you are part of a combination therapy group, you may also receive other medications such as dexamethasone or pomalidomide, also taken orally.
Step 4
Regular monitoring
Throughout the study, you will have regular visits to monitor your health and the effects of the medication. This includes checking vital signs, conducting laboratory tests, and possibly performing ECGs (a test that measures the electrical activity of the heart).
These visits help ensure your safety and assess the medication's impact on your condition.
Step 5
Ongoing assessments
You will undergo periodic assessments to evaluate the medication's effectiveness. This may involve imaging studies, blood tests, and other evaluations to measure changes in your condition.
These assessments help determine the study medication's impact on your health and its potential benefits.
Step 6
Completion of the study
At the end of the study, you will have a final assessment to evaluate your overall health and any changes that occurred during the trial.
You may be asked to provide feedback on your experience and any side effects you encountered.

Who can join the trial?

10 criteria

Provide written informed consent, which means you agree to participate after understanding the study details.
Women must use highly effective birth control if sexually active, not be breastfeeding, and have a negative pregnancy test if they can have children. Alternatively, they must show they cannot have children by being post-menopausal (no periods for 12 months and over 50 years old) or having had surgery to remove reproductive organs.
Be willing and able to participate in all required evaluations and procedures.
Be 18 years or older.
Have an ECOG performance status of 0 or 1, which means you are fully active or have some symptoms but can still do light work.
Have a confirmed diagnosis of certain blood or bone marrow cancers, such as Non-Hodgkin Lymphoma, Multiple Myeloma, Acute Myeloid Leukemia, or higher-risk Myelodysplastic Syndrome.
Have received standard therapy for your condition and not require urgent treatment to reduce high levels of cancer cells.
Have adequate blood function, meaning your blood cell counts meet specific levels, unless you have certain types of cancer where exceptions may apply.
Have adequate organ function at the start of the study.
Male participants must use barrier contraception (like condoms) during the study and for a period after, especially if their partner can have children and is not using effective contraception.

Who cannot join the trial?

10 criteria

Patients with other types of cancer not specified in the study.
Patients who are pregnant or breastfeeding.
Patients with severe heart problems.
Patients with uncontrolled infections.
Patients who have had another cancer treatment within the last 4 weeks.
Patients with known allergies to the study medication.
Patients with significant liver or kidney disease.
Patients who are unable to follow the study procedures.
Patients with a history of drug or alcohol abuse.
Patients who have participated in another clinical trial within the last 4 weeks.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Hospital Clinic De Barcelona
Verified
Barcelona, Spain
Hospital General Universitario Gregorio Maranon
Verified
Madrid, Spain
Hospital Universitario 12 De Octubre
Verified
Madrid, Spain

Trial locations

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Investigated drugs

CCS1477 is a new medication being tested to see if it is safe and effective for people with advanced blood or bone marrow cancers. This medication is being studied both on its own and in combination with other treatments. The goal is to understand how well it works and if it causes any side effects. By participating in this trial, patients will help researchers learn more about how this medication can be used to treat these types of cancers.

What is already known about the treatment

CCS1477 – CCS1477 is a medication currently being studied in clinical trials for its potential use in treating certain types of blood and bone marrow cancers, such as Acute Myeloid Leukemia, higher-risk Myelodysplastic Syndrome, Multiple Myeloma, and Non-Hodgkin Lymphoma. It is administered orally, meaning it is taken by mouth in the form of a pill. The main focus of current research is to determine its safety and how well it works when used alone or in combination with other treatments. At the molecular level, CCS1477 works by targeting specific proteins that are involved in the growth and survival of cancer cells, helping to stop their spread. It falls under the pharmacological classification of targeted cancer therapies, which are designed to specifically attack cancer cells while minimizing damage to normal cells.

Investigated diseases

Acute Myeloid Leukemia (AML)
Acute Myeloid Leukemia is a type of cancer that starts in the blood-forming cells of the bone marrow. It progresses rapidly, leading to the accumulation of immature white blood cells called myeloblasts. These cells crowd out normal blood cells, causing symptoms like fatigue, frequent infections, and easy bruising or bleeding. As the disease advances, it can spread to other parts of the body, including the lymph nodes, liver, and spleen. The rapid progression requires prompt medical attention to manage symptoms and complications.
Higher-risk Myelodysplastic Syndrome (MDS)
Higher-risk Myelodysplastic Syndrome is a group of disorders caused by poorly formed or dysfunctional blood cells. It progresses as the bone marrow fails to produce enough healthy blood cells, leading to anemia, infections, and bleeding issues. Over time, the condition can worsen, with an increased risk of transforming into acute myeloid leukemia. The disease affects the production of red blood cells, white blood cells, and platelets, causing various symptoms related to low blood counts. The progression is marked by increasing severity of symptoms and potential complications.
Multiple Myeloma (MM)
Multiple Myeloma is a cancer of plasma cells, a type of white blood cell found in the bone marrow. It progresses as these cancerous plasma cells accumulate in the bone marrow, leading to bone damage, kidney problems, and weakened immune function. The disease often causes bone pain, fractures, and high levels of calcium in the blood. As it advances, it can lead to anemia, increased risk of infections, and organ damage. The progression involves the spread of myeloma cells and worsening of symptoms over time.
Non-Hodgkin Lymphoma (NHL)
Non-Hodgkin Lymphoma is a cancer that originates in the lymphatic system, which is part of the body's immune system. It progresses as abnormal lymphocytes, a type of white blood cell, grow uncontrollably and form tumors in the lymph nodes and other tissues. The disease can cause swollen lymph nodes, fever, night sweats, and weight loss. As it advances, it may spread to other parts of the body, including the liver, spleen, and bone marrow. The progression varies depending on the specific type and aggressiveness of the lymphoma.