Study of dose reduction strategy for tyrosine kinase inhibitors (imatinib, ponatinib, bosutinib, nilotinib, dasatinib) in patients with chronic myeloid leukemia

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What is this study about?

This study focuses on Chronic Myeloid Leukemia, a type of blood cancer that affects white blood cells. The research examines several medications known as tyrosine kinase inhibitors, which include imatinib, ponatinib, bosutinib, nilotinib, and dasatinib. These medications work by blocking specific proteins that contribute to cancer cell growth.

The purpose of this research is to evaluate how patients respond when their medication dose is reduced. The study will monitor patients who have shown a good response to their current treatment and investigate if maintaining disease control is possible with lower doses of these medications.

During the study, participants will continue taking their prescribed medication but at reduced doses. The treatment period will last for 12 months, during which doctors will regularly monitor the patient’s response to the adjusted medication doses. All medications will be taken by mouth. The maximum daily doses vary depending on the specific medication: imatinib (800 mg), ponatinib (45 mg), bosutinib (500 mg), nilotinib (400 mg), or dasatinib (140 mg).

1 Initial assessment

You have been diagnosed with chronic myeloid leukemia (CML) and are currently taking one of these medications: imatinib, ponatinib, bosutinib, nilotinib, or dasatinib

Your doctor has confirmed that you have maintained a major molecular response (MMR) for at least 6 months, which means your disease is well-controlled

2 Treatment phase begins

Your current medication (known as a tyrosine kinase inhibitor or TKI) will be gradually reduced in dosage

The medication continues to be taken orally as prescribed

Your current dose may already be lower than the standard dose – this is acceptable for the study

3 Monitoring period

Your response to the reduced medication dose will be monitored for 12 months

Regular tests will check if your major molecular response (MMR) remains stable

If needed, your original dose may be restored during this period

4 Study completion

The study will evaluate if the reduced dose was successful in maintaining disease control

The total study duration extends until August 2025

Your participation will help determine if lower doses of these medications can effectively control CML

Who Can Join the Study?

  • Must be 18 years or older
  • Diagnosed with chronic phase CML (chronic myeloid leukemia in its early, more manageable stage)
  • Currently receiving treatment with TKI medications (targeted therapy drugs) such as:
    • Imatinib
    • Bosutinib
    • Dasatinib
    • Nilotinib
    • Ponatinib
  • Must have achieved and maintained a major molecular response (MMR) (a significant reduction in cancer cells) for at least 6 continuous months when joining the study
  • Must be physically and mentally capable of participating in the study
  • Must provide written informed consent (formal agreement to participate)
  • Can be either male or female
  • Can be taking a lower than standard dose of TKI medication
  • Can have previously switched between different TKI medications due to side effects

Who Cannot Join the Study?

  • Age below 18 years or above 65 years
  • Not having chronic myeloid leukemia (a type of blood cancer)
  • Not achieving MMR (Major Molecular Response – a measure of treatment success in leukemia)
  • Pregnancy or breastfeeding
  • History of poor compliance with medical treatments
  • Participation in other clinical trials within the last 30 days
  • Presence of significant heart, liver, or kidney disease
  • Active or uncontrolled infections
  • Mental conditions that could interfere with understanding study requirements
  • Known allergies to study medications
  • Recent major surgery (within last 4 weeks)
  • Any condition that, in the investigator’s opinion, makes the patient unsuitable for the study

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Zuyderland Medisch Centrum Stichting Geleen The Netherlands
Frisius Heerenveen The Netherlands

Other Sites

Site Name City Country Status
Albert Schweitzer Ziekenhuis Dordrecht The Netherlands
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Catharina Ziekenhuis Stichting Eindhoven The Netherlands
Stichting Radboud University Medical Center Nijmegen The Netherlands
Reinier de Graaf Groep Delft The Netherlands
Ueqqqwuhaihy Mggnnni Cejqtvp Gszawiykm Groningen The Netherlands
Aqklqnilm Ubf Amsterdam The Netherlands

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
The Netherlands The Netherlands
Not recruiting
14.06.2022

Trial locations

Tyrosine kinase inhibitors (TKIs) are medications used to treat chronic myeloid leukemia. These drugs work by blocking specific proteins (tyrosine kinases) that are responsible for the growth of cancer cells. TKIs help control the disease by preventing the abnormal white blood cells from multiplying. This study looks at how these medications can be reduced in dosage while maintaining their effectiveness in treating leukemia.

Note: Since the source data doesn’t specify which particular TKIs are being used in this trial, I can only provide a general description of this class of medications. Common TKIs used in chronic myeloid leukemia treatment include imatinib, nilotinib, and dasatinib, but the specific ones used in this trial are not mentioned in the provided data.

Investigated diseases:

Chronic Myeloid Leukemia – A blood and bone marrow cancer that develops when the bone marrow makes too many white blood cells. The condition begins in a blood-forming cell of the bone marrow that produces too many abnormal white blood cells called granulocytes. These abnormal cells grow slowly but eventually crowd out healthy blood cells in the bone marrow. The disease typically progresses through three phases: chronic phase, accelerated phase, and blast phase. During the chronic phase, which can last several years, patients may have few or no symptoms as the disease develops gradually. The condition is characterized by the presence of an abnormal chromosome called the Philadelphia chromosome.

Trial ID:
2024-516511-24-00
Trial Phase:
Human Pharmacology (Phase I) – Other

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