This clinical trial is focused on studying a type of blood cancer called Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ ALL). The study aims to compare two different treatment approaches for this disease. One approach involves using a combination of two medications, Ponatinib and Blinatumomab, which is a specific type of protein called a monoclonal antibody. The other approach uses traditional chemotherapy combined with another medication called Imatinib. The purpose of the study is to determine which treatment is more effective in improving the condition of patients with Ph+ ALL.
Participants in the study will receive either the combination of Ponatinib and Blinatumomab or the chemotherapy and Imatinib treatment. The study will begin with an induction phase, where Ponatinib is administered along with steroids, followed by Blinatumomab as a consolidation treatment. The alternative treatment involves a chemotherapy regimen combined with Imatinib. The study will monitor the participants over a period to assess the effectiveness of these treatments in terms of event-free survival, which includes factors like the absence of disease markers, survival rates, and any side effects or resistance to the treatment.
The trial will also explore additional aspects such as the ability of Blinatumomab to further reduce disease markers after Ponatinib treatment, the duration of complete remission, and overall survival rates at one and three years. The safety profile of the treatments will be evaluated, focusing on any significant side effects. Additionally, the study will compare the quality of life of patients receiving different treatments over time. This research aims to provide valuable insights into the most effective treatment strategy for adults with Ph+ ALL.
1joining the study
Upon joining the study, the patient is required to provide a signed written informed consent.
A negative pregnancy test is necessary for women of childbearing potential.
A bone marrow specimen from the primary diagnosis must be available.
2induction treatment
The induction treatment involves the administration of Ponatinib and steroids.
Ponatinib is taken orally in the form of Iclusig 15 mg film-coated tablets.
3consolidation treatment
Following the induction treatment, Blinatumomab is administered as a consolidation treatment.
Blinatumomab is given through infusion in the form of BLINCYTO 38.5 micrograms powder for concentrate and solution for infusion.
4control arm treatment
In the control arm, chemotherapy is combined with Imatinib.
Imatinib is taken orally in the form of Glivec 100 mg hard capsules.
5additional medications
Other medications may include Levetiracetam (oral), Methotrexate (intravenous), Idarubicin hydrochloride (intravenous), Prednisone (oral), Dexamethasone sodium phosphate (intravenous), Vincristine sulfate (intravenous), Melphalan hydrochloride (intravenous), Calcium levofolinate (intravenous), Cyclophosphamide (intravenous), Filgrastim (subcutaneous), Mercaptopurine (oral), Cytarabine (intravenous), and Methylprednisolone sodium succinate (intravenous).
6monitoring and follow-up
Throughout the trial, regular monitoring of health status and response to treatment is conducted.
The study aims to evaluate the efficacy of the treatments in terms of event-free survival, which includes factors such as non-achievement of minimal residual disease negativity, deaths, toxicity, and resistance.
Who Can Join the Study?
You must sign a written informed consent form, which is a document that explains the study and confirms your agreement to participate.
If you are a woman who can have children, you need to have a negative pregnancy test.
A sample of your bone marrow from the initial diagnosis must be available.
You must be a newly diagnosed adult with a specific type of leukemia called B-precursor Ph+ ALL.
Your ability to perform daily activities, measured by the WHO performance status, should be 2 or less. This means you should be able to take care of yourself with some help.
You must be 18 years or older, with no upper age limit.
Your kidney and liver functions need to be within certain limits:
AST (GOT), ALT (GPT), and AP should be less than 2 times the upper limit of normal.
Total bilirubin should be less than 1.5 times the upper limit of normal.
Creatinine clearance, which measures kidney function, should be 50 mL/min or higher.
Your pancreas function should be within certain limits:
Serum amylase and serum lipase should be less than or equal to 1.5 times the upper limit of normal.
Your heart function should be normal.
There should be no signs of leukemia in your central nervous system (CNS) at the start of a specific treatment called blinatumomab.
You must have a negative test for HIV, hepatitis B, and hepatitis C.
Who Cannot Join the Study?
Patients who do not have Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia cannot participate. This is a specific type of blood cancer.
Patients under the age of 18 cannot participate.
Patients who are unable to follow the study procedures or take the study medications as required cannot participate.
Patients with other serious health conditions that might interfere with the study cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible.
Patients who have allergies or reactions to the study medications cannot participate.
Ponatinib is a medication used in this trial as part of a chemo-free treatment strategy. It is given to patients with newly diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia (Ph+ALL) to help control the disease. Ponatinib works by targeting specific proteins in cancer cells, which can help stop their growth and spread.
Blinatumomab is a bispecific monoclonal antibody used in this trial as a consolidation treatment. After the initial treatment with Ponatinib, Blinatumomab is infused to help further reduce the number of cancer cells. It works by engaging the body’s immune system to attack and destroy the leukemia cells.
Imatinib is used in the control arm of the trial, combined with chemotherapy. It is a medication that targets specific proteins in cancer cells, similar to Ponatinib, and is used to help control the growth of leukemia cells in patients with Ph+ALL.
Adult Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia – This is a type of cancer that affects the blood and bone marrow, characterized by the presence of the Philadelphia chromosome. It primarily occurs in adults and involves the rapid production of immature white blood cells, known as lymphoblasts. These abnormal cells crowd out normal cells, leading to symptoms such as fatigue, frequent infections, and easy bruising or bleeding. The disease progresses quickly, requiring prompt medical attention. The presence of the Philadelphia chromosome is a result of a genetic abnormality that leads to the production of an abnormal protein promoting the growth of cancer cells. This form of leukemia is distinct due to its genetic marker, which influences treatment strategies.
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