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Imatinib Mesilate

Clinical trials investigating “Imatinib Mesilate” are studying how it performs in different patient groups, mainly people with gastrointestinal stromal tumors, chronic myeloid leukaemia, acute lymphoblastic leukemia, and acute ischemic stroke. The trials look at safety, effectiveness, and whether treatment can be continued, reduced, or stopped in selected patients.

Table of Contents

Trial overview

The trial data show that Imatinib Mesilate is being studied in different diseases, not just one condition.[1][2][3][4]

These studies include people with gastrointestinal stromal tumors, chronic myeloid leukaemia, newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia, and acute ischemic stroke.[1][2][3][4]

The trials are mainly Phase 2 and Phase 3 studies, with one low-intervention study, and the status is mostly authorised, while one stroke study is suspended.[1][2][3][4]

Studies in gastrointestinal stromal tumors

Two trials focus on gastrointestinal stromal tumor, a tumor that starts in the digestive tract wall.[1][3]

In one Phase 2 study, patients with locally advanced or metastatic disease that stayed controlled after at least 10 years of treatment are assigned to either maintenance or interruption of Imatinib Mesilate, and the study compares the 6-month progression-free rate between the two groups.[1]

In the Phase 3 adjuvant study, patients with intermediate-risk gastrointestinal stromal tumor and a high-risk Genomic Grade Index receive adjuvant Imatinib, which means treatment given after the main treatment to lower the chance of the disease coming back.[3]

This study measures metastatic relapse at 2 years using thoraco-abdominal and pelvic CT scans.[3]

Study in chronic myeloid leukaemia

The RODEO study includes people with chronic myeloid leukaemia, a long-term blood cancer that affects white blood cells.[2]

This low-intervention study looks at a patient-guided dose reduction strategy for tyrosine kinase inhibitors, and Imatinib Mesilate is one of the treatments listed in the study.[2]

The main result is the proportion of patients with treatment failure 12 months after the first dose reduction, with treatment failure defined as restarting the initial dose because of expected loss of MMR, which means major molecular response.[2]

Study in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia

One Phase 3 trial studies newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia, a blood cancer with a specific genetic change called the Philadelphia chromosome.[4]

The study compares olverembatinib plus chemotherapy with investigator’s choice of tyrosine kinase inhibitor plus chemotherapy, and Imatinib Mesilate is one of the listed treatment options in the chemotherapy backbone.[4]

The main endpoint is MRD-negative complete response at the end of induction, where MRD means minimal residual disease, or very small amounts of cancer left after treatment.[4]

Study in acute ischemic stroke

One Phase 3 trial studies acute ischemic stroke, which means a stroke caused by a blocked blood vessel in the brain.[5]

The trial is randomised, double-blind, placebo-controlled, and parallel-arm, which means patients are assigned by chance, neither the patient nor the study team knows the assignment, placebo is used for comparison, and groups are followed side by side.[5]

The study asked whether Imatinib, started within 8 hours of symptom onset and given for 6 days, improves function at 3 months as measured by the modified Rankin Scale, but the study status is suspended.[5]

Main outcomes being measured

The trials measure different outcomes depending on the disease being studied.[1][2][3][4][5]

  • Progression-free rate at 6 months in advanced gastrointestinal stromal tumor, which shows how many patients have no disease progression after randomization.[1]
  • Metastatic relapse at 2 years in intermediate-risk gastrointestinal stromal tumor with high genomic risk.[3]
  • Treatment failure at 12 months after dose reduction in chronic myeloid leukaemia, based on whether the original dose had to be restarted.[2]
  • MRD-negative complete response at the end of induction in newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia.[4]
  • Modified Rankin Scale score at 3 months in acute ischemic stroke, which measures how much the stroke affects daily function.[5]
Trial ID Phase Condition studied Status Enrollment
NCT05009927 Phase 2 Locally advanced or metastatic gastrointestinal stromal tumors Authorised 50
2024-516511-24-00 Low Intervention Chronic myeloid leukaemia Authorised 136
NCT02576080 Phase 3 Gastrointestinal stromal tumor Authorised 80
NCT06051409 Phase 3 Newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia Authorised 295
2023-506178-11-00 Phase 3 Acute ischemic stroke Suspended 680

FAQ

  • What is being studied in trials of Imatinib Mesilate? The trials study whether Imatinib Mesilate helps control disease, prevent relapse, or improve recovery in specific conditions. They also measure outcomes like progression-free survival, treatment failure, and functional recovery.
  • Who can take part in these trials? Each study has its own target group. The trials include patients with locally advanced or metastatic gastrointestinal stromal tumors, chronic myeloid leukaemia, intermediate-risk gastrointestinal stromal tumor with high genomic risk, newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia, and acute ischemic stroke.
  • What phases are the Imatinib Mesilate trials in? The studies include Phase 2 and Phase 3 trials, plus one low-intervention study. This means some trials are testing treatment effects in larger patient groups, while others are looking at how treatment changes work in real-world care.
  • What outcomes do the trials measure? The trials measure outcomes such as progression-free rate at 6 months, metastatic relapse at 2 years, treatment failure at 12 months, MRD-negative complete response at the end of induction, and change in modified Rankin Scale at 3 months. These outcomes help show whether the treatment is working.
  • Are these trials all testing the same treatment plan? No. Some trials study maintenance versus interruption of Imatinib Mesilate, some test adjuvant use after tumor treatment, and others compare Imatinib Mesilate with placebo or with other treatment choices. The trial design depends on the disease being studied.

Ongoing Clinical Trials on Imatinib Mesilate

  • Study of olverembatinib with chemotherapy versus standard therapy in adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia

    Recruiting

    1 1 1 1
    Investigated diseases:
    Investigated drugs:
    Bulgaria Czechia France Hungary Italy Romania +1

  • Study on the Effectiveness of Imatinib for Patients with Intermediate-Risk Gastrointestinal Stromal Tumor and High Genomic Grade Index

    Recruiting

    1 1 1 1
    Investigated drugs:
    France

  • Study on Continuing or Stopping Imatinib in Patients with Advanced or Metastatic Gastrointestinal Stromal Tumors After 10 Years of Treatment

    Recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    France

  • Study on Imatinib for Improving Recovery in Patients with Acute Ischemic Stroke

    Not yet recruiting

    1 1 1
    Investigated diseases:
    Investigated drugs:
    Sweden

  • 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

Glossary

  • Clinical trial: A research study in people that tests a treatment, compares treatment options, or checks how well a treatment works in a specific condition.
  • Phase 2: A trial stage that usually looks at whether a treatment seems to work and gathers more safety information in a smaller group.
  • Phase 3: A later trial stage that usually includes more people and compares treatment options to confirm how well a treatment works.
  • Interventional study: A study where researchers give a treatment or change care to see what happens.
  • Locally advanced disease: Cancer that has grown more than a small early tumor but has not clearly spread far from where it started.
  • Metastatic: Cancer that has spread to other parts of the body.
  • Gastrointestinal stromal tumor: A type of tumor that starts in the digestive tract wall.
  • Chronic myeloid leukaemia: A long-term blood cancer that affects white blood cells.
  • Philadelphia chromosome-positive: A cancer type with a specific genetic change called the Philadelphia chromosome.
  • Minimal residual disease (MRD): Very small amounts of cancer cells that can remain after treatment and are hard to detect.
  • Complete response (CR): A strong treatment response where signs of active disease are no longer seen by the study’s definition.
  • Modified Rankin Scale (mRS): A scale used to measure how much a stroke affects daily life and function.

References