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Closed (no longer recruiting)Last updated: 30 January 2024

This Phase II trial is evaluating the safety and effectiveness of 3 oral drugs (Asciminib, Imatinib, Nilotinib) in patients that have been pre-treated for Chronic Myeloid Leukaemia (CML)A Phase 2, Multi-center, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response

Clinical summary

Summary

In this trial, patients will be randomised to receive either combination therapy with Asciminib (60 mg) and Imatinib (400 mg) once daily, or receive Imatinib (400mg once daily) or Nilotinib (300mg twice daily) alone.

Conditions

This trial is treating patients with Chronic Myeloid Leukaemia (CML).

Cancer

Blood Cancers Haematological

Age

People18+

Phase

II

More information

Trial Identifiers

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Trial sponsor

Novartis Pharmaceuticals

Scientific Title

A Phase 2, Multi-center, Open-label, Randomized Study of Oral Asciminib Added to Imatinib Versus Continued Imatinib Versus Switch to Nilotinib in Patients With CML-CP Who Have Been Previously Treated With Imatinib and Have Not Achieved Deep Molecular Response

Eligibility

Inclusion

  1. Male or female patients ≥ 18 years of age with a confirmed diagnosis of Chronic Myeloid Leukemia in chronic phase (CML-CP).
  2. Minimum of one year (12 calendar months) treatment with imatinib first line for CML-CP (patients have to be on imatinib 300mg or 400 mg QD at randomization

    For Korea only:

    (i)a minimum of one year (12 calendar months) of prior treatment with imatinib for patients with BCR-ABL levels > 0.1%, ≤ 1% IS at the time of randomization.

    (ii) a minimum of two years (24 calendar months) of prior treatment with imatinib for patients with BCR-ABL levels > 0.01%, ≤ 0.1% IS at the time of randomization.

  3. BCR-ABL1 levels > 0.01% IS (International Scale) and ≤ 1% IS at the time of randomization as confirmed with a central assessment at screening; patients must not have achieved deep molecular response (MR4 IS) confirmed by 2 consecutive tests at any time during prior imatinib treatment. An isolated, single test result with BCR-ABL1 levels < 0.01 % (MR4 IS) is allowed, however, it should not have been observed within the 9 months prior to randomization
  4. Patient must meet the following laboratory values before randomization:

    • Absolute Neutrophil Count ≥ 1.5 x 10E9/L
    • Platelets ≥ 75 x 10E9/L
    • Hemoglobin ≥ 9 g/dL
    • Serum creatinine < 1.5 mg/dL
    • Total bilirubin ≤ 1.5 x ULN (Upper Limit of Normal) except for patients with Gilbert's syndrome who may only be included with total bilirubin ≤ 3.0 x ULN
    • Aspartate transaminase (AST) ≤ 3.0 x ULN
    • Alanine transaminase (ALT) ≤ 3.0 x ULN
    • Alkaline phosphatase ≤ 2.5 x ULN
    • Serum lipase ≤ 1.5 x ULN
  5. Patients must have the following laboratory values ≥ Lower Limit of Normal or corrected to within normal limits with supplements prior to randomization: potassium increase of up to 6.0 mmol/L is acceptable if associated with creatinine clearance within normal limits ; calcium increase of up to 12.5 mg/dl or 3.1 mmol/L is acceptable if associated with creatinine clearance* within normal limits) ; magnesium increase up to 3.0 mg/dL or 1.23 mmol/L if associated with creatinine clearance within normal limits.

Exclusion

  1. Treatment failure according to European Leukemia Network (ELN) criteria 2013 during imatinib treatment.
  2. Known second chronic phase of CML after previous progression to Accelerated Phase (AP)/Blast Crisis (BC).
  3. Previous treatment with any tyrosine kinese inhibitors (TKIs) other than imatinib.
  4. History or current diagnosis of ECG abnormalities indicating significant risk or safety for subjects participating in the study such as:

    • History of myocardial infarction, angina pectoris, coronary artery bypass graft within 6 months prior to randomization
    • Concomitant clinically significant arrhythmias
    • Resting QTcF ≥ 450 msec (male) or ≥ 460 msec (female) prior to randomization
    • Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:

      • Risk factors for Torsades de Pointes
      • Concomitant medications with a "known" risk of Torsades de Pointes
      • inability to determine the QTcF interval
  5. Severe and/or uncontrolled concurrent medical disease that in the opinion of the investigator could cause unacceptable safety risks or compromise compliance with the protocol (e.g. uncontrolled diabetes, active or uncontrolled infection, uncontrolled clinically significant hyperlipidemia and high serum amylase)
  6. History of acute pancreatitis within 1 year prior to randomization or medical history of chronic pancreatitis; on-going acute liver disease or history of chronic liver disease
  7. History of other active malignancy within 3 years prior to randomization with the exception of basal cell skin cancer, indolent prostate cancer and carcinoma in situ treated curatively.

Other protocol defined inclusion/exclusion may apply.

Inclusion

  • You are currently receiving treatment for your cancer.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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