Ongoing Clinical Trials for Philadelphia Positive Acute Lymphocytic Leukaemia
Currently, there is 1 ongoing clinical trial for Philadelphia Positive Acute Lymphocytic Leukaemia (also known as Ph+ ALL, BCR-ABL1 positive ALL). This trial is being conducted across multiple European countries and compares two targeted medications combined with reduced-intensity chemotherapy for newly diagnosed patients.
Clinical trial locations
- Austria
- France
- Greece
- Italy
- Poland
- Spain
Study Comparing Ponatinib and Imatinib with Chemotherapy for Patients with Newly Diagnosed Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia
This clinical trial is comparing two treatment approaches for people who have just been diagnosed with this type of blood cancer. Both treatments use targeted medications combined with a less intensive form of chemotherapy than is typically used.
Who can join this trial?
The trial is looking for adults aged 18 years or older who have been newly diagnosed with Ph+ ALL or BCR-ABL1 positive ALL. Participants need to have a performance status of 2 or less, which means they should be able to carry out most daily activities without too much difficulty. They must also meet specific laboratory test requirements taken within 30 days before joining the study, including:
- Liver function tests showing bilirubin levels at 1.5 times or less the upper normal limit (unless they have Gilbert’s syndrome)
- Liver enzyme levels (ALT or AST) at 2.5 times or less the upper normal limit
- Kidney function showing creatinine at 1.5 times or less the upper normal limit and filtration ability of 30 mL/minute or more
- Lipase levels below 1.5 times the upper normal limit
Participants must have a normal heart rhythm on an electrocardiogram. Women of childbearing age need to agree to use highly effective birth control methods during the study or practice true abstinence. Men must also use effective barrier contraception during the study and for 120 days after their last dose, or practice true abstinence. All participants must be willing to provide written consent and attend scheduled visits.
Who cannot participate?
The trial excludes patients who have not been newly diagnosed with this specific type of leukemia, those who fall outside the required age range, and anyone who cannot receive the medications being tested (ponatinib or imatinib). People with other medical conditions that might interfere with the study treatments or results cannot join. Those unable to follow study procedures or attend required visits are also excluded, as are individuals from vulnerable populations who might be at higher risk.
What is the trial’s main goal?
The primary aim of this study is to determine which treatment approach is more effective as a first-line therapy. Participants are randomly assigned to receive either ponatinib or imatinib, both taken as tablets, combined with reduced-intensity chemotherapy. The trial follows a structured timeline:
- Upon joining, patients are randomly assigned to one of the two medication groups
- They begin taking their assigned medication as oral tablets according to their treatment plan
- During the induction phase, they receive the medication along with chemotherapy, aiming to achieve complete remission where no cancer cells are detectable
- Regular monitoring through blood tests and assessments tracks treatment effectiveness and side effects
- At the end of induction, doctors evaluate whether complete remission or minimal residual disease-negative complete remission has been achieved
- Treatment continues or is adjusted based on these results
- A follow-up period monitors long-term health and treatment effects
The researchers are particularly interested in seeing how well each treatment achieves a state where no cancer cells can be detected in the blood or bone marrow. They will also track how long remission lasts and the overall survival of participants.
Investigational drugs
Ponatinib is one of the medications being tested in this trial. It is a tyrosine kinase inhibitor that works by blocking specific proteins that promote cancer cell growth, particularly targeting the BCR-ABL protein. This protein is responsible for the uncontrolled multiplication of cancer cells in this type of leukemia. Ponatinib is taken orally as a tablet.
Imatinib is the comparison medication in this study. It is also a tyrosine kinase inhibitor that blocks the BCR-ABL protein and interferes with the signaling pathways that lead to cancer cell growth. Imatinib is a well-established treatment for various types of leukemia and is also taken orally as a tablet.
Both medications aim to stop the growth and spread of cancer cells by targeting the genetic abnormality that causes this disease. By comparing these two drugs, researchers hope to determine which provides better outcomes when combined with reduced-intensity chemotherapy.
Summary
Currently, one international clinical trial is recruiting patients with newly diagnosed Philadelphia Positive Acute Lymphocytic Leukaemia across six European countries: Austria, France, Greece, Italy, Poland, and Spain. This trial represents an important effort to find more effective first-line treatments for this aggressive blood cancer.
The study focuses on comparing two tyrosine kinase inhibitors, ponatinib and imatinib, both combined with reduced-intensity chemotherapy. This approach may offer patients an effective treatment option with potentially fewer side effects than traditional intensive chemotherapy regimens. The trial is designed to determine which of these two targeted medications produces better remission rates and longer-lasting results.
Patients interested in participating should discuss with their healthcare provider whether they meet the eligibility criteria and whether this trial might be appropriate for their situation.
