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Study of Olverembatinib and Bosutinib for Patients with Chronic Phase Chronic Myeloid Leukemia

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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 a type of blood cancer called Chronic Myeloid Leukemia (CML), specifically in its chronic phase. The study is testing a new medication called Olverembatinib, also known by its code name HQP1351, to see how well it works compared to an existing treatment called Bosutinib. Both medications are taken as tablets by mouth. The purpose of the study is to compare the effectiveness of Olverembatinib with Bosutinib in achieving a significant reduction in cancer cells in the blood, known as a major molecular response, over a period of 24 weeks.

The study is divided into two parts. In the first part, participants will be randomly assigned to receive either Olverembatinib or Bosutinib to compare their effects. In the second part, the focus will be on patients with a specific genetic change in their cancer cells, known as the T315I mutation, to evaluate how well Olverembatinib works for them. The study will last for up to 48 weeks, with regular check-ups to monitor the response to the treatment and any side effects. Participants will be closely observed to ensure their safety and to gather information on how the treatments affect their health and quality of life.

This trial aims to provide valuable insights into the potential benefits of Olverembatinib for patients with chronic phase CML, especially those who have not responded well to other treatments. The findings could help improve treatment options for this type of leukemia, offering hope for better management of the disease.

The research process

The trial runs in 7 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, the patient will be informed about the trial's objectives and procedures. Written informed consent is required before any trial-related activities begin.
Step 2
Initial assessment
The patient will undergo an initial assessment to confirm eligibility. This includes checking organ function, blood tests, and ensuring the patient meets specific health criteria.
Step 3
Randomization and treatment assignment
The patient will be randomly assigned to receive either olverembatinib or bosutinib. This is an open-label study, meaning both the patient and the study team will know which medication is being administered.
Step 4
Medication administration
The patient will take the assigned medication orally. Olverembatinib and bosutinib are both administered in tablet form. The specific dosage and frequency will be determined by the study protocol.
Step 5
Regular monitoring
The patient will attend regular follow-up visits to monitor health status and response to treatment. This includes blood tests and other assessments to track progress and any side effects.
Step 6
Evaluation of response
The main goal is to evaluate the major molecular response (MMR) at 24 weeks. Additional assessments will occur at 48 and 96 weeks to measure the response and any changes in health status.
Step 7
Completion of study participation
The study is estimated to end by July 2028. Upon completion, the patient will undergo a final assessment to evaluate overall health and treatment outcomes.

Who can join the trial?

22 criteria

Must be **18 years old** or older.
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Must have **adequate organ functions**. This means:
- Kidneys working well, with a creatinine clearance of at least 30 mL/min. This is a measure of how well your kidneys are cleaning your blood.
- Total bilirubin, a substance made by the liver, should be less than 1.5 times the normal limit, unless you have Gilbert's syndrome, where it can be up to 3 times the normal limit.
- AST and ALT, which are liver enzymes, should be less than 3 times the normal limit.
- Serum amylase, an enzyme related to digestion, should be 1.5 times the normal limit or less.
- Alkaline phosphatase, another enzyme, should be 2.5 times the normal limit or less.
- Electrolyte levels, like potassium, calcium, and magnesium, should be normal or corrected to normal before starting the study medication.
- Must have a **diagnosis of Chronic Phase Chronic Myeloid Leukemia (CML-CP)** according to specific guidelines.
- Must show evidence of a specific genetic marker called **BCR::ABL1 transcript** during screening.
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  Must meet certain **blood test values** at the screening visit:
  - Less than 15% myeloblasts in the blood. Myeloblasts are immature blood cells.
  - Less than 30% combined myeloblasts and promyelocytes, another type of immature blood cell.
  - Less than 20% basophils, a type of white blood cell.
  - At least 50,000 platelets per mm³ of blood.
  - No evidence of leukemia cells outside the bone marrow, except for an enlarged liver or spleen.
  - For Part A of the study: Must have been treated with at least two approved **TKIs** (a type of cancer medication) like imatinib or dasatinib.
  - For Part B of the study: Must meet all three of these criteria:
    
    Previously treated with at least one approved TKI.
    Have a specific genetic change called **T315I mutation**.
    No other effective or tolerable treatments available.
    Must have experienced **failure or intolerance** to the most recent TKI therapy. This means:
    
    Failure could be not achieving certain treatment milestones or developing resistance.
    Intolerance could be severe side effects that don't improve with dose changes.
    Must have an **ECOG performance status** of 2 or less. This is a measure of how well you can perform daily activities.
    Must provide **written informed consent** before any screening procedures.

Who cannot join the trial?

4 criteria

Patients who do not have Chronic Phase Chronic Myeloid Leukemia cannot participate. This is a specific type of blood cancer.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not male or female cannot participate. This means the study is open to both men and women.
Patients who are part of a vulnerable population cannot participate. Vulnerable populations might include groups like children or pregnant women, but this study does not include them.

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Verified sites

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Responsive
Azienda Ospedaliera Ordine Mauriziano Di Torino
Turin, Italy
Responsive
Fundacion Para La Investigacion Biomedica Del Hospital Universitario La Paz
Madrid, Spain
Responsive
Grand Hopital De Charleroi
Charleroi, Belgium

Trial locations

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Investigated drugs

Olverembatinib
This medication is being studied for its effectiveness in treating patients with chronic phase chronic myeloid leukemia (CML-CP). It is being tested to see how well it helps achieve a major molecular response, which means a significant reduction in cancer cells, within 24 weeks. The study is also looking at how well it works in patients with a specific mutation known as T315I.
Bosutinib
This is another medication used in the study as a comparison to olverembatinib. It is already used to treat chronic myeloid leukemia and works by blocking certain proteins that help cancer cells grow. The trial aims to compare the effectiveness of bosutinib with olverembatinib in achieving a major molecular response in patients.

What is already known about the treatment

Olverembatinib
Olverembatinib is administered orally and is currently being studied in clinical trials for its effectiveness in treating chronic phase chronic myeloid leukemia. It is in the investigational stage, with ongoing research to determine its efficacy and safety. The main therapeutic indication is for patients with chronic myeloid leukemia, particularly those with the T315I mutation. Olverembatinib works by inhibiting specific proteins involved in cancer cell growth, thereby slowing down or stopping the progression of the disease. It is classified as a tyrosine kinase inhibitor, a type of targeted cancer therapy.
Bosutinib
Bosutinib is also administered orally and is an established medication used in the treatment of chronic myeloid leukemia. It is approved for use and well-documented in medical literature. The primary therapeutic indication is for patients with chronic myeloid leukemia who have not responded to other treatments. Bosutinib functions by blocking certain proteins that promote the growth of cancer cells, helping to control the disease. It belongs to the pharmacological class of tyrosine kinase inhibitors, which are designed to target specific pathways involved in cancer cell proliferation.

Investigated diseases

Chronic Phase Chronic Myeloid Leukemia – This is a type of cancer that affects the blood and bone marrow. It begins with an abnormal change in the bone marrow cells, leading to the production of too many white blood cells. In the chronic phase, the disease progresses slowly, and many people may not experience symptoms initially. Over time, the excess white blood cells can crowd out normal cells, leading to symptoms like fatigue, weight loss, and an enlarged spleen. The chronic phase can last for several years, during which the disease is generally more manageable. If untreated, it may progress to more aggressive phases.