Active not recruitingPHASE2INTERVENTIONAL

Imatinib Mesylate or Dasatinib in Treating Patients With Previously Untreated Chronic Phase Chronic Myelogenous Leukemia

This research study is for people recently diagnosed with a specific type of blood cancer called chronic myeloid leukaemia (CML). Doctors want to compare two common medicines, imatinib and dasatinib, to see how well they work to control the cancer at different doses. Both medicines aim to stop cancer cells from growing by blocking certain proteins. The study will look at how much the cancer cells are reduced over time, how side effects compare between the different treatments, and how people's health generally improves. Participants will be randomly assigned to receive one of three treatment options: a standard dose of imatinib, a higher dose of imatinib, or dasatinib.

At a glance

Status

Active not recruiting

Phase

PHASE2

Sponsor

National Cancer Institute (NCI)

Enrolment target

406

Start

15 Aug 2004

Estimated completion

10 Mar 2027

Chronic Myeloid Leukemia, BCR-ABL1 Positive

Results

Results from this study

Posted July 2012

Results have been published for this study.

Primary outcome

Molecular Response Rate at 12 Months

Median value of baseline bcr-abl/bcr ratio from pretreatment was used as the baseline value for assessing each patient's molecular response. Molecular response criteria were: 1) not failed treatment on or before 12-month evaluation; 2) met criteria for hemalotogic response; 3) bcr-abl/bcr ration at 12-months must be 10,000 times smaller than the pretreatment ratio.

Full results on the registry

What is this study about?

This study is designed for individuals who have recently been diagnosed with a type of blood cancer called chronic myeloid leukaemia (CML) and who haven't yet started treatment. CML is a long-lasting cancer that affects blood cells, specifically white blood cells. The main goal of this research is to compare two common medicines: imatinib (also known by brand names like Gleevec) and dasatinib.

The researchers want to understand which of these medicines, and at what dose, is most effective at reducing the amount of cancer cells in the body. They will be looking at how well the cancer responds by tracking specific genetic markers in the blood. They will also compare the side effects of each treatment to help doctors better understand the best way to treat CML in the future. By joining this study, you could help improve treatment for people with CML.

Participants will be randomly assigned to one of three groups. One group will receive a standard dose of imatinib, another will receive a higher dose of imatinib, and the third group will receive dasatinib. This helps ensure the comparison is fair. The study will also look at how patients feel and how their cancer progresses over a period of up to five years, although the main comparisons will be made after 12 months of treatment.

Key takeaways

This study is for people recently diagnosed with a type of blood cancer called CML.
It compares two medicines, imatinib and dasatinib, to see which works best and with fewer side effects.
You will take medication daily for up to five years and have regular check-ups.
Participation is voluntary, and you can withdraw at any time.
The study aims to improve future CML treatments.

Who may be eligible?

To be considered for this study, you must have been recently diagnosed with chronic myeloid leukaemia (CML) and have received your diagnosis within the last six months. Your diagnosis must be confirmed by specific tests that show the presence of what's called the Philadelphia chromosome or related genetic changes.

You should not have received any previous treatment for CML, except for certain medications like hydroxyurea or anagrelide, which are sometimes used to manage blood counts initially. Your general health and ability to do daily activities, as assessed by your doctor, must be good. You also need to have healthy liver and kidney function, as shown by blood tests.

This study is for adults aged 18 years and older. Your doctor will perform checks, including a bone marrow test, to make sure you meet all the specific requirements before you can join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with CML in the last six months and not yet started treatment?
Do you have good general health, as assessed by your doctor?
Are your liver and kidney blood tests within healthy limits?
Have you not had any previous cancer treatment for CML, except for specific initial medications?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be randomly assigned to one of three treatment groups. You will take study medication, either imatinib or dasatinib, as a tablet every day, once or twice daily depending on your assigned group. Treatment will continue for up to five years, or until your cancer worsens, or if you experience side effects that make it difficult to continue.

You will have regular doctor's visits for check-ups, blood tests, and possibly bone marrow tests, especially in the first year, to see how you are responding to the treatment and to monitor for any side effects. This will involve frequent trips to the hospital or clinic. Your doctors will explain your specific schedule of visits and tests.

Potential risks and benefits

Participating in this study might offer you access to new ways of taking imatinib or dasatinib, which could be more effective in controlling your CML. The information gathered may also help future patients with CML. However, like all medications, imatinib and dasatinib can have side effects, which your study doctor will discuss with you. These can range from mild to severe. There is also the risk that the treatment may not work for you or that your condition could worsen. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (340)

Providence Saint Joseph Medical Center/Disney Family Cancer Center
Verified postcode
Burbank, United States
City of Hope Comprehensive Cancer Center
Verified postcode
Duarte, United States
Kaiser Permanente-Fremont
Verified postcode
Fremont, United States
USC / Norris Comprehensive Cancer Center
Verified postcode
Los Angeles, United States
Kaiser Permanente-Oakland
Verified postcode
Oakland, United States
Kaiser Permanente-Redwood City
Verified postcode
Redwood City, United States
Kaiser Permanente-Richmond
Verified postcode
Richmond, United States
Kaiser Permanente-Roseville
Verified postcode
Roseville, United States
Kaiser Permanente-South Sacramento
Verified postcode
Sacramento, United States
Kaiser Permanente Sacramento Medical Center
Verified postcode
Sacramento, United States
Kaiser Permanente-San Francisco
Verified postcode
San Francisco, United States
Kaiser Permanente-Santa Teresa-San Jose
Verified postcode
San Jose, United States

Common questions

What is CML?

CML stands for Chronic Myeloid Leukaemia, which is a type of blood cancer that starts in the bone marrow, the soft tissue inside your bones where blood cells are made.

What do the medicines imatinib and dasatinib do?

These medicines are designed to block certain signals in cancer cells that allow them to grow and multiply. By blocking these signals, they can help control the cancer.

Will I know which medicine I'm getting?

You will be randomly assigned to one of the three treatment groups, and your medical team will know which treatment you are receiving.

How long will the study last for me?

Your treatment in the study could last for up to five years, but the main comparisons between treatments will be looked at after 12 months.

Can I stop participating in the study if I want to?

Yes, you are free to leave the study at any time, for any reason, without it affecting your future medical care.