This study focuses on older adults with a newly diagnosed type of cancer called B-cell precursor Acute Lymphoblastic Leukemia. Specifically, the study looks at patients who are Philadelphia-negative, which means their cancer cells do not have a specific genetic marker. The purpose of the study is to compare a new treatment approach to the current standard of care to see how well it works and how safe it is.
Participants may receive different combinations of medications. One group will receive blinatumomab alternating with low-intensity chemotherapy, which is a type of treatment that uses drugs to kill cancer cells. The other group will receive the standard of care, which includes medications such as rituximab, cytarabine, dexamethasone, vincristine sulfate, cyclophosphamide, methotrexate sodium, mercaptopurine, prednisone, idarubicin, asparaginase, and doxorubicin. Other substances mentioned in the study include pegaspargase, crisantaspase, and prednisolone.
The study will monitor how long patients live and how long they stay without the cancer returning. Researchers will also look at the minimal residual disease, which refers to the small number of cancer cells that remain in the body after treatment. Additionally, the study will track how the treatments affect the patients’ quality of life, including levels of pain, tiredness, and physical function.
Who Can Join the Study?
You must give informed consent, which means you or your legal representative agrees to take part in the study after understanding all the details, before any study steps begin.
You must be 55 years of age or older.
You may be between 40 and 54 years of age if you have certain comorbidities, which are other medical conditions present at the same time as your leukemia, such as:
A history of severe pancreatitis (inflammation of the pancreas).
Diabetes mellitus that has caused damage to organs like the eyes, kidneys, or nerves.
Severe liver disease, such as cirrhosis (permanent scarring of the liver) with high pressure in the veins or a history of bleeding in the food pipe, accompanied by very high liver enzyme levels.
A body mass index (BMI) of 40 or higher combined with metabolic issues.
Other serious health conditions that make standard intensive chemotherapy too difficult to handle.
You must have a new diagnosis of Philadelphia-negative B-cell precursor acute lymphoblastic leukemia (ALL), which is a specific type of cancer found in the white blood cells.
Your ECOG performance status must be 2 or lower, which is a scale used to measure how well you can perform daily activities; a higher score may be allowed if it is caused by your leukemia.
Your kidney function must be adequate, measured by how well your kidneys filter waste from your blood.
Your liver function must be adequate, specifically looking at your total bilirubin levels, unless you have a specific harmless condition called Gilbert’s Disease or the cancer has spread to the liver.
Your heart function must be adequate, meaning your heart must pump blood effectively (measured by left ventricular ejection fraction) and you must not have uncontrolled or recent heart disease, such as a myocardial infarction (heart attack) or stroke within the last 3 months.
Who Cannot Join the Study?
You cannot participate if you have active CNS leukemia, which means cancer cells are currently present in your central nervous system (the brain and spinal cord), as confirmed by a lumbar puncture (a procedure where a needle is used to collect fluid from the spinal canal).
You cannot participate if you have had another type of malignancy (cancer) within the last 3 years, unless it was a specific type of skin, cervical, breast, or prostate cancer that was fully treated and is no longer active.
You cannot participate if you have CNS pathology, which refers to any medical conditions or damage affecting the brain or spinal cord, such as epilepsy (seizures), paresis (muscle weakness), aphasia (difficulty speaking or understanding language), stroke, dementia (memory loss and mental decline), or Parkinson’s disease.
You cannot participate if you have a psychiatric condition (mental health disorder) that would prevent you from taking high doses of corticosteroids (strong anti-inflammatory medicines).
You cannot participate if you currently have or have a history of autoimmune disease (a condition where the immune system mistakenly attacks the body) that could affect the brain or spinal cord.
You cannot participate if you have a known infection with HIV (the virus that causes AIDS).
You cannot participate if you have an active or chronic infection of Hepatitis B or Hepatitis C (viruses that cause liver inflammation).
You cannot participate if you show any signs or symptoms of an acute infection (a sudden, severe infection) or an uncontrolled chronic infection (a long-term infection that is not being managed).
You cannot participate if you have already received cancer chemotherapy (drugs used to kill cancer cells) for this specific leukemia, unless it was IT chemotherapy (medicine injected directly into the spinal fluid) or specific preparation medicine.
You cannot participate if you are currently taking part in another study testing a new drug or medical device, or if you finished a different study less than 30 days ago.
Blinatumomab is a type of immunotherapy that helps the body’s own immune system find and destroy specific cancer cells.
Mercaptopurine is a chemotherapy medication used to prevent the growth of cancer cells.
Rituximab is a targeted therapy that attaches to certain proteins on the surface of cancer cells to help the immune system identify and attack them.
Cytarabine is a chemotherapy drug used to treat various types of blood cancers by preventing cancer cells from making new DNA.
Methotrexate is a chemotherapy medication that interferes with the growth of cancer cells by blocking certain nutrients they need to multiply.
Cyclophosphamide is a chemotherapy drug used to kill rapidly dividing cancer cells.
Dexamethasone is a steroid medication used to reduce inflammation and sometimes to help kill certain types of cancer cells.
Idarubicin is a chemotherapy medication used to treat leukemia by interfering with the DNA of cancer cells.
Prednisone is a steroid medication used to reduce swelling and inflammation in the body.
Pegaspargase is a therapy used to treat certain leukemias by depriving cancer cells of a specific nutrient they need to survive.
Doxorubicin is a chemotherapy drug used to treat several types of cancer, including leukemia, by damaging the DNA of cancer cells.
Vincristine is a chemotherapy medication that stops cancer cells from dividing properly.
Asparaginase is a therapy used to treat leukemia by reducing the amount of a specific amino acid that cancer cells require to grow.
Crisantaspase is a type of enzyme therapy used to treat certain blood cancers by targeting the nutrients cancer cells need to survive.
B-cell precursor Acute Lymphoblastic Leukemia – This is a type of cancer that affects the white blood cells, specifically the immature cells known as precursors. These abnormal cells accumulate in the bone marrow and blood, interfering with the production of normal blood cells. The disease can progress by spreading from the bone marrow to other parts of the body, such as the lymph nodes, spleen, or liver. It is characterized by the rapid multiplication of these cancerous cells.
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