Malaysia Stop Tyrosine Kinase Inhibitor Trial

To compare administration of peginterferon-α-2a for 1 year versus observation after stopping tyrosine kinase inhibitor (TKI) in chronic myeloid leukemia (CML) patients with deep MR ≥ 2 years.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

* The subject must be 18 years old or above
* The subject has CML in chronic phase during diagnosis
* The subject is treated with ongoing TKI at any dose for at least 3 years
* The subject has achieved stable deep molecular response (DMR) on International Scale (IS) for 2 years or more by any TKI
* Definition of deep molecular response (IS) ≥ 2 years

  * Deep molecular response = MR4 (IS 0.01%) or better
  * There must be at least 2 results (including the latest) of MR4.5 with an acceptable control gene copy number for the assay over the last two years
  * There must not be any result exceeding a major molecular response (MMR) (IS 0.1%) over the last two years
* The latest PCR result should be compelled with Intervention Start Date, which is within 4 weeks of Study Entry Date or 17 weeks of the latest PCR test.

Exclusion Criteria:

* The subject has previous history of any TKI failure as according to European LeukemiaNet 2009(17).
* The subject has previous history of successfully engrafted autologous or allogeneic haematopoeitic stem cell transplant and after transplant no disease relapse as defined by MSIT protocol
* The subject is planned for autologous or allogeneic stem cell transplantation
* The subject has previous history of interferon or peginterferon administration and achieved complete cytogenetic response with interferon or peginterferon
* The subject had undergone or on immune-modulatory treatments other than interferon or peginterferon
* The subject is undergoing treatment for other malignancies
* The subject has haemoglobin \<9g/dL and platelet count \<90x109/L for two successive readings of 1 month apart
* The subject has positive Hepatitis B surface Ag (HBsAg), Hepatitis C antibody (anti-HCV), or Human Immunodeficiency Virus 1 antibody (anti-HIV1)
* The subject has creatinine clearance of ≤50mL/min
* The subject has persistent alanine transaminase ≥2x upper normal limit for two successive readings of 1 month apart.
* Adults under law protection or without ability to consent
* The subject has previous history or on-going psychiatric illness

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