Malaysia Stop Tyrosine Kinase Inhibitor Trial

• Status: Active, not recruiting
• Trial end date: 2021-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ministry of Health, Malaysia
• Treatments: Peginterferon alfa-2a

Criteria

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