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Chronic myeloid leukaemia – Trials in Disease

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Ongoing Clinical Trials for Chronic Myeloid Leukaemia

Chronic myeloid leukaemia (CML) is a type of blood cancer affecting the bone marrow and blood cells. Currently, 24 clinical trials are investigating new treatments and treatment strategies for this condition across multiple European countries. These studies explore various medications including tyrosine kinase inhibitors and combination therapies, with particular focus on achieving deeper treatment responses and the possibility of treatment-free remission. (Also known as: Chronic Myelogenous Leukemia, CML)

Clinical trial locations

Long-Term Safety Study of Asciminib in Patients with Chronic Myelogenous Leukemia or Philadelphia Chromosome Positive Acute Lymphoblastic Leukemia

This study focuses on patients with chronic myeloid leukemia or Philadelphia chromosome-positive acute lymphoblastic leukemia who have previously participated in trials involving asciminib. The main purpose is to monitor the long-term safety of asciminib treatment.

Main inclusion criteria: Participants must have one of the specified blood cancers, be currently receiving asciminib treatment either alone or combined with other medications like imatinib, nilotinib, or dasatinib, have completed a previous Novartis-sponsored study, and have met the goals of that earlier study. Both male and female participants across all age groups are eligible, including children and vulnerable populations.

Main exclusion criteria: Patients without the specified types of leukemia, those not continuing from a related previous study, and those outside the designated age ranges cannot participate. Additionally, individuals not meeting the gender criteria or not classified as part of vulnerable populations where applicable are excluded.

Trial focus and what to expect: Participants will continue receiving the same treatment they had in their previous study. Regular monitoring will track any side effects and overall health benefits. The medication is taken orally as tablets or capsules. Throughout the study period, which extends until August 2030, participants will attend scheduled visits for health assessments and treatment adjustments as needed. The study does not involve comparing treatments to placebos but rather ensures ongoing access to medication while gathering safety data.

Investigational drug: Asciminib works by targeting specific proteins in cancer cells to help stop their growth and spread. It is administered as oral tablets.

Study for Adults with Chronic Myeloid Leukemia Using Asciminib Alone or with Nilotinib

This trial evaluates the effectiveness of asciminib, used either alone or in combination with nilotinib, in achieving deep molecular response in newly diagnosed chronic phase chronic myeloid leukemia patients who test positive for the BCR-ABL1 marker.

Main inclusion criteria: Participants must have confirmed BCR-ABL1+ Chronic Myeloid Leukemia in chronic phase, be at least 18 years old, and diagnosed within the last three months. Blood tests must show less than 15% blast cells, less than 30% combined blasts and promyelocytes, less than 20% basophils, adequate organ function, and proper levels of electrolytes. Effective contraception must be used throughout the study.

Main exclusion criteria: Patients without BCR-ABL1+ CML in early chronic phase, those outside the age range, and individuals unable to safely take the study medications are excluded. Participants from vulnerable populations not meeting study criteria cannot join.

Trial focus and what to expect: Participants will take either asciminib alone or in combination with nilotinib as oral tablets or capsules. Regular blood tests will measure BCR-ABL1 levels to determine treatment response. The primary goal is achieving major molecular response by Week 48, with additional assessments at 96 weeks. The study will continue monitoring participants for several years to evaluate long-term outcomes and the possibility of maintaining remission without ongoing treatment.

Investigational drugs: Asciminib blocks specific proteins causing cancer cells to grow, potentially leading to significant reduction in cancer cells. Nilotinib works similarly by inhibiting the activity of proteins involved in cancer cell growth.

Study of Asciminib treatment for patients with Chronic Myeloid Leukemia who have T315I mutation and cannot take or tolerate ponatinib

This study examines asciminib treatment for patients with chronic or accelerated phase CML who have the T315I mutation and either cannot take ponatinib or have not responded well to it.

Main inclusion criteria: Participants must be at least 18 years old with confirmed T315I mutation after at least one previous treatment. For chronic phase patients, specific blood criteria must be met including blast cell percentages and platelet counts. Previous asciminib treatment is not allowed, and participants must have evidence of BCR-ABL1 transcripts that can be measured.

Main exclusion criteria: Patients with severe allergic reactions to similar medications, pregnancy or breastfeeding, uncontrolled heart conditions, severe liver or kidney problems, active infections, other cancers requiring treatment, mental health conditions affecting study compliance, or medication interactions are excluded. Those with uncontrolled high blood pressure, stroke history, digestive problems affecting drug absorption, or HIV/hepatitis infections cannot participate.

Trial focus and what to expect: Participants will receive asciminib as oral tablets daily. Regular blood tests will monitor disease markers throughout the 12-month primary evaluation period. The study aims to assess treatment response at various timepoints, including 3, 6, 9, and 12 months, with long-term follow-up continuing at 18 and 24 months.

Investigational drug: Asciminib specifically targets the T315I mutation by binding to the ABL1 component of the BCR-ABL1 protein, making it effective even when other treatments fail due to resistance.

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

This trial compares the effectiveness of olverembatinib with bosutinib in achieving major molecular response over 24 weeks in chronic phase CML patients. A second phase focuses specifically on patients with the T315I mutation.

Main inclusion criteria: Participants must be at least 18 years old with adequate organ functions including proper kidney, liver, and blood cell counts. They must have a diagnosis of chronic phase CML according to specific guidelines, show evidence of BCR-ABL1 transcript during screening, and meet specific blood test requirements. Previous treatment with at least two approved tyrosine kinase inhibitors is required for Part A, while Part B requires previous treatment with at least one TKI, presence of T315I mutation, and no other effective treatments available.

Main exclusion criteria: Patients without chronic phase CML, those outside the specified age range, not treated with TKIs, or from vulnerable populations cannot participate.

Trial focus and what to expect: After eligibility confirmation and initial assessment, participants will be randomly assigned to receive either olverembatinib or bosutinib as oral tablets. Regular follow-up visits will monitor response and side effects. The main evaluation occurs at 24 weeks, with additional assessments at 48 and 96 weeks. The study continues until July 2028.

Investigational drugs: Olverembatinib is being tested for effectiveness in achieving major molecular response, particularly in patients with T315I mutation. Bosutinib serves as a comparison medication, blocking proteins that help cancer cells grow.

Study on Ponatinib for Treating Recurrent or Refractory Leukemias and Solid Tumors in Children

This pediatric study evaluates ponatinib’s safety and effectiveness in treating recurrent or refractory leukemias and solid tumors in children, divided into two phases to determine optimal dosing and efficacy.

Main inclusion criteria: Participants must have confirmed diagnosis of leukemias, lymphomas, or solid tumors that have not responded to standard treatments or where standard treatments are unsuitable. Age must be between 1 and 18 years. Participants need adequate physical ability measured by performance status scales, must have recovered from previous treatment side effects (except hair loss), and agree to pregnancy prevention measures. A parent or legal guardian must provide informed consent.

Main exclusion criteria: Patients with different cancer types than those being studied, adults, those unable to take oral medication, serious interfering health conditions, pregnant or breastfeeding patients, those in other trials simultaneously, recent major surgery patients, those with active infections requiring treatment, known medication allergies, and those who haven’t recovered from previous treatment side effects are excluded.

Trial focus and what to expect: Participants will take ponatinib orally once daily. Phase 1 aims to find the best dose for children, while Phase 2 evaluates effectiveness in specific leukemia types. Regular monitoring includes various tests to evaluate response and side effects. The study continues until 2025, allowing comprehensive data collection on long-term effects.

Investigational drug: Ponatinib is a tyrosine kinase inhibitor that blocks proteins helping cancer cells survive, taken orally once daily.

Study on Stopping Dasatinib in Patients with Chronic Myeloid Leukemia After a Previous Attempt to Stop Treatment

This study examines whether patients with chronic myeloid leukemia who previously tried to stop medication but needed to restart can maintain major molecular remission after a second treatment discontinuation attempt.

Main inclusion criteria: Participants must have chronic phase CML, have been treated with tyrosine kinase inhibitors for at least three years with dasatinib for the last two years, previously attempted TKI discontinuation unsuccessfully, achieved MR4 for at least one year, and been on treatment for at least one more year after the first discontinuation attempt failed. Age must be 18 or older, and participants must have specific BCR/ABL1 transcript types.

Main exclusion criteria: Patients not treated for at least three years with TKIs, those who haven’t used dasatinib for the last two years, those who haven’t achieved MR4 for at least one year, and vulnerable populations requiring special protection are excluded.

Trial focus and what to expect: The trial begins with eligibility confirmation. Eligible patients will stop dasatinib medication while undergoing regular monitoring through blood tests for 12 months to assess if major molecular remission can be maintained without medication. The study evaluates the proportion of patients maintaining remission at 6 and 12 months after stopping medication, continuing until December 2026.

Investigational drug: Dasatinib is a second-generation tyrosine kinase inhibitor that blocks the BCR-ABL protein responsible for uncontrolled cancer cell growth in CML, administered as oral tablets.

Study on the Dose and Safety of Asciminib in Children with Chronic Myeloid Leukemia

This pediatric study determines the appropriate dose and safety of asciminib in children with Philadelphia chromosome positive chronic myeloid leukemia in chronic phase who have been previously treated with tyrosine kinase inhibitors.

Main inclusion criteria: Participants must be male or female aged 1 to less than 18 years (pediatric group) or 14 to less than 18 years weighing at least 40 kg (adult formulation group). They must have confirmed Ph+ CML-CP diagnosis, previous treatment with at least one tyrosine kinase inhibitor with failure or intolerance to the most recent therapy, and have measurable BCR-ABL fusion gene. Specific blood test requirements must be met including blast percentages, platelet counts, and adequate organ function.

Main exclusion criteria: Patients without Ph+ CML-CP diagnosis, those not previously treated with TKIs, those outside the specified age range, those unable to take medication as required, those with interfering medical conditions or medications, pregnant or breastfeeding patients, and those unable to comply with study procedures are excluded.

Trial focus and what to expect: After informed consent and eligibility confirmation, participants will receive asciminib orally as film-coated tablets. The goal is achieving dosage providing similar exposure to the adult dose. Regular monitoring includes blood tests to measure drug processing and response. Safety assessments include growth and development monitoring. The study continues until June 2031.

Investigational drug: Asciminib is a tyrosine kinase inhibitor that specifically targets the ABL myristoyl pocket, providing a unique mechanism among similar medications. It is administered orally.

Study of Asciminib Treatment for Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase

This study evaluates asciminib treatment in combination with other BCR-ABL1 targeting medications for newly diagnosed chronic phase CML patients, aiming to achieve deep molecular response.

Main inclusion criteria: Participants must be at least 18 years old with confirmed chronic phase CML diagnosis showing Philadelphia chromosome or BCR-ABL1 positivity. ECOG performance status must be 2 or better, with adequate organ function including liver enzymes, lipase levels, and kidney function. Normal or corrected electrolyte levels are required, along with written informed consent and commitment to contraception use.

Main exclusion criteria: Prior CML treatment, known severe allergic reactions to similar medications, presence of BCR-ABL1 mutations, active infections, recent major surgery, significant heart problems, severe liver or kidney problems, pregnancy or breastfeeding, inability to swallow oral medications, participation in other trials, mental conditions affecting compliance, doctor-determined unsafe conditions, other recent cancers, and uncontrolled high blood pressure are exclusionary.

Trial focus and what to expect: After initial diagnosis confirmation and medical evaluation including blood and laboratory tests, participants begin oral asciminib treatment. Regular monitoring occurs throughout the study to assess molecular response at 12 months (primary goal of achieving MR4), with ongoing assessments of organ function and side effects. The study continues until 2027.

Investigational drug: Asciminib is an innovative ATP-competitive inhibitor that targets the BCR-ABL1 protein by blocking the myristoyl pocket, representing a new class of treatment for CML.

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

This study examines whether patients with chronic phase CML who have shown good response to tyrosine kinase inhibitors can maintain disease control with reduced medication doses over 12 months.

Main inclusion criteria: Participants must be at least 18 years old with chronic phase CML diagnosis, currently receiving TKI treatment (imatinib, bosutinib, dasatinib, nilotinib, or ponatinib), have maintained major molecular response for at least 6 continuous months, be physically and mentally capable of participation, provide written informed consent, and can be taking lower than standard doses or have previously switched TKIs due to side effects.

Main exclusion criteria: Age below 18 or above 65 years, not having CML, not achieving MMR, pregnancy or breastfeeding, poor compliance history, recent participation in other trials, significant heart/liver/kidney disease, active infections, mental conditions interfering with understanding, known medication allergies, recent major surgery, and investigator-determined unsuitable conditions are exclusionary.

Trial focus and what to expect: After initial assessment confirming eligibility and current good disease control, participants will have their TKI medication gradually reduced in dosage while continuing to take it orally. Response monitoring occurs for 12 months through regular blood tests checking BCR-ABL1 levels to ensure maintained major molecular response. The original dose may be restored if needed. The study extends until August 2025.

Investigational drugs: Tyrosine kinase inhibitors are oral medications that block proteins responsible for cancer cell growth, helping control the disease by preventing abnormal white blood cell multiplication.

Study of Pioglitazone and Avelumab Combined with Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia Patients with Complete Cytogenetic Response

This trial evaluates whether adding pioglitazone or avelumab to standard TKI therapy can help more chronic phase CML patients achieve deeper molecular response over 12 months.

Main inclusion criteria: Participants must be at least 18 years old with adequate liver function, acceptable blood bilirubin levels, and effective contraception use. For the avelumab group, adequate blood cell counts (neutrophils, platelets, hemoglobin) and kidney function are required. Women capable of pregnancy need negative pregnancy tests. Participants must have chronic phase CML with positive M BCR-ABL1 test, treatment with specific TKIs (imatinib, nilotinib, dasatinib, or bosutinib) for more than 2 years without recent medication or dose changes, complete cytogenetic response or BCR-ABL1 levels of 1% or less, detectable BCR-ABL1 levels above 0.0032%, and good physical performance status.

Main exclusion criteria: Age below 18 or above 65 years, known medication allergies, pregnancy or breastfeeding, severe kidney or liver problems, active infections, other cancers, heart problems including heart failure or recent heart attack, participation in other trials within 30 days, mental conditions interfering with procedures, uncontrolled diabetes, treatment non-compliance history, life expectancy less than 6 months, inability to provide consent, and recent substance abuse are exclusionary.

Trial focus and what to expect: After eligibility confirmation through medical records review and health checks including pregnancy testing, participants will receive either pioglitazone tablets or avelumab infusions while continuing their current leukemia medication. Regular monitoring through blood tests measures BCR-ABL1 levels throughout the 12-month primary period, with long-term follow-up continuing for up to 48 months until December 2028.

Investigational drugs: Imatinib, nilotinib, dasatinib, and bosutinib are tyrosine kinase inhibitors that block proteins signaling cancer cells to multiply, used in combination with pioglitazone or avelumab in this trial.

Summary

The 24 ongoing clinical trials for chronic myeloid leukaemia span across Europe, with particularly strong representation in France, Italy, Germany, and Spain. A notable concentration of studies focuses on asciminib, a newer targeted therapy appearing in multiple trials either as monotherapy or in combination with other treatments. This reflects growing interest in this medication’s potential for treating various patient populations, from newly diagnosed to those with resistant disease.

Several trials specifically address challenging patient populations, including those with the T315I mutation who have limited treatment options, and pediatric patients who historically have fewer treatment choices. The research landscape also shows significant interest in treatment-free remission, with multiple studies exploring whether patients can safely stop medication while maintaining disease control.

The trials demonstrate a shift toward personalized treatment approaches, comparing different medication strategies and investigating dose optimization. Many studies extend for several years, indicating commitment to understanding long-term outcomes and safety profiles. This comprehensive research approach aims to improve both treatment effectiveness and quality of life for patients with chronic myeloid leukaemia across all disease phases and patient populations.

Ongoing Clinical Trials on Chronic myeloid leukaemia

  • Long-Term Safety Study of Asciminib in Patients With Chronic Myelogenous Leukemia or Philadelphia Chromosome-Positive Acute Lymphoblastic Leukemia

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Austria Bulgaria Czechia Denmark France Germany +8

  • Study for Adults with Chronic Myeloid Leukemia Using Asciminib Alone or with Nilotinib

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy Spain

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

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Belgium France Germany Italy Poland Spain

  • Study on Stopping Dasatinib in Patients with Chronic Myeloid Leukemia After a Previous Attempt to Stop Treatment

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Denmark France The Netherlands

  • Asciminib in Pediatric Patients With Philadelphia Positive Chronic Myeloid Leukemia in Chronic Phase

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France Germany Italy The Netherlands Poland Spain

  • Study on Apixaban, Rivaroxaban, and Aspirin for Preventing Blood Clots in Patients with JAK2V617F-Positive Myeloproliferative Neoplasms

    Not yet recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study of ponatinib and azacitidine combination treatment in patients with accelerated phase or blast crisis chronic myelogenous leukemia

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

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

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    The Netherlands

  • Comparison of Nilotinib versus Imatinib treatment in newly diagnosed chronic myeloid leukemia patients to achieve treatment-free remission

    Not recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Italy The Netherlands

  • Study of Asciminib Treatment for Newly Diagnosed Patients with Chronic Myeloid Leukemia in Chronic Phase

    Not recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Germany

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