Study of dasatinib treatment in children and adolescents with Philadelphia chromosome-positive leukemia who cannot take imatinib or for whom imatinib is not effective

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What is this study about?

This study focuses on treating children and adolescents with Chronic Myeloid Leukemia (CML) and Philadelphia chromosome-positive (Ph+) leukemias who either have newly diagnosed disease or have not responded well to treatment with imatinib. The study will test a medication called dasatinib (also known as Sprycel), which is available as both tablets and as a powder that can be made into a liquid for drinking.

The main purpose is to determine how well dasatinib works in young patients whose leukemia has either become resistant to imatinib treatment or who cannot tolerate imatinib’s side effects. The study will also look at how dasatinib works in patients who have just been diagnosed with CML. Resistance means the cancer continues to grow despite treatment, while intolerance means experiencing severe side effects that prevent continuing the medication.

During the study, participants will receive dasatinib treatment, and doctors will monitor how their disease responds to the medication. The study will track several important measures of treatment success, including how well the medication controls blood cell counts and whether it reduces or eliminates cancer cells that contain the Philadelphia chromosome, a specific genetic change found in these types of leukemia.

1 Initial evaluation and group assignment

You will be assigned to one of three groups (cohorts) based on your condition:

Cohort 1: Patients with chronic phase CML who cannot take imatinib

Cohort 2: Patients with Ph+ ALL or advanced phases of CML who cannot take imatinib

Cohort 3: Newly diagnosed patients with chronic phase CML

2 Medical examination

Your doctor will perform tests to check your blood cell counts

Your bone marrow will be examined to confirm diagnosis

Additional tests will check your liver and kidney function

3 Treatment initiation

You will receive dasatinib treatment

The medication comes as film-coated tablets or oral solution

You will take the medication by mouth as prescribed by your doctor

4 Regular monitoring

Your blood counts will be checked regularly

Bone marrow examinations will be performed to measure treatment response

Your doctor will monitor for any side effects

5 Response evaluation

Your doctor will measure how well the treatment is working by checking:

Blood cell counts returning to normal levels (Complete Hematologic Response)

Reduction in abnormal cells in bone marrow (Major Cytogenetic Response)

These evaluations will continue throughout the study period

6 Long-term follow-up

Your progress will be monitored for disease control

Regular check-ups will continue to ensure the treatment remains effective

The study will track your long-term health outcomes

Who Can Join the Study?

Patient must provide signed written informed consent
Age between 1 to 18 years (both males and females can participate)
Women who can become pregnant must use two methods of contraception during the study and for 1 month after the last dose
Patients must belong to one of these groups:
- Group 1: Patients with chronic phase CML who did not respond to or cannot tolerate Imatinib treatment
- Group 2: Patients with Ph+ ALL (a type of blood cancer) or advanced phase CML who did not respond to or cannot tolerate Imatinib treatment
- Group 3: Patients newly diagnosed with chronic phase CML
Patient must have a Lansky or Karnofsky score above 50 (scales that measure ability to perform daily activities)
Life expectancy must be at least 12 weeks
Patient must have recovered from side effects of previous treatments (except hair loss) to normal levels or mild symptoms
Blood tests must show adequate levels of:
- Sodium
- Bicarbonate
- Phosphate
- Calcium
- Liver function
- Kidney function

Who Cannot Join the Study?

Prior treatment with any BCR-ABL inhibitor other than imatinib (a medication used to treat certain types of blood cancer)
Known presence of the T315I mutation (a specific genetic change that makes the cancer resistant to certain treatments)
Active central nervous system involvement by leukemia
Significant heart problems, including:
- Uncontrolled or severe heart disease
- Heart attack within 6 months
- Unstable heart rhythm disorders
Severe liver problems (impaired liver function)
Severe kidney problems (impaired kidney function)
Active uncontrolled infections requiring treatment
Pregnancy or breastfeeding
Unable to take oral medications
Any serious medical condition that could interfere with study participation
Current participation in another clinical trial with investigational drugs
Known allergic reaction to the study medication or similar compounds

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name	City	Country	Status
Centre Hospitalier Lyon Sud	Pierre Benite	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	12.09.2008
Spain	Not recruiting	12.09.2008

Trial locations

Investigated drugs:

Dasatinib

Dasatinib is a medication used to treat certain types of blood cancers. It works by blocking specific proteins that cause cancer cells to grow and divide. This medication is specifically designed for patients whose cancer has become resistant to other treatments or who cannot tolerate them.

Imatinib is a cancer medication that was previously used in the treatment of these patients. It works similarly to dasatinib by targeting specific proteins in cancer cells. In this trial, dasatinib is being studied as an alternative treatment for patients who did not respond well to imatinib or couldn’t tolerate its side effects.

Investigated diseases:

Philadelphia chromosome positive

Chronic Myeloid Leukemia (CML) – A type of blood cancer that begins in the bone marrow and causes the body to produce too many white blood cells. The disease typically progresses through three phases: chronic phase, accelerated phase, and blast phase. In the chronic phase, patients may have mild symptoms or no symptoms at all. The disease develops when a genetic change occurs in blood stem cells, creating an abnormal gene called the Philadelphia chromosome.

Philadelphia Chromosome-positive Acute Lymphoblastic Leukemia (Ph+ ALL) – A fast-growing cancer of lymphoid blood cells characterized by the presence of an abnormal Philadelphia chromosome. The disease causes the bone marrow to produce too many immature lymphocytes (a type of white blood cell). These abnormal cells accumulate in the bone marrow, preventing the production of normal blood cells. The condition primarily affects blood and bone marrow.

Blast Phase CML (BP-CML) – An advanced phase of Chronic Myeloid Leukemia where immature blood cells (blasts) multiply rapidly in the bone marrow and blood. During this phase, more than 20% of the cells in the blood or bone marrow are blast cells. The condition results in decreased production of healthy blood cells.

Accelerated Phase CML (AP-CML) – A transitional phase of Chronic Myeloid Leukemia between the chronic and blast phases. During this phase, the number of immature blood cells increases in the bone marrow and blood. The disease shows signs of progression with an increase in blast cells, though not as high as in the blast phase.

Trial ID:

2024-510784-36-00

Protocol code:

CA180-226

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of dasatinib treatment in children and adolescents with Philadelphia chromosome-positive leukemia who cannot take imatinib or for whom imatinib is not effective

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?