QMH-CML-001 = Cessation of TKI in CML [Hong Kong]

Study title

QMH-CML-001 = Cessation of Tyrosine Kinase Inhibitors in Patients With Chronic Phase Chronic Myelogenous Leukaemia

Scientific title

Cessation of Tyrosine Kinase Inhibitors in Patients With Chronic-phase Chronic Myelogenous Leukaemia Who Achieve Stable Deep Molecular Response (ClinicalTrials.gov NCT03131986)

Type of study

Treatment discontinuation trial

Current status

Unknown

What is the purpose of the study

International clinical trials have demonstrated that about 40-60% of CML patients who achieved deep molecular response on TKI manage to remain in sustained treatment-free remission after stopping treatment. Experience of discontinuing TKI treatment is lacking in Hong Kong.

The objective of this single-arm study is to collect local experience with TKI discontinuation in patients with CML in chronic phase who are treated with TKIs and remain in stable deep molecular response for at least two years. Patients who stop TKI treatment will be closely monitored and treatment outcomes will be reassessed.

Key inclusion criteria

This study includes male or female patients who:

– are at least 18 years old
– have been diagnosed with chronic myeloid leukemia in chronic phase
– have been treated with a tyrosine kinase inhibitor (TKI) in first line, or in second line due to intolerance of another first-line TKI
– have been on treatment with the same TKI for at least 3 years and had deep molecular response (MR4.5) for at least 2 years

Key exclusion criteria

Where can I find additional information

Study description in the US register ClinicalTrials.gov, a service of the U. S. National Institutes of Health

Study sponsor

The University of Hong Kong

Scientific lead / contact

Professor Yok-lam Kwong
The University of Hong Kong

Principal investigator

Contact: Yuk Man Cheung, MBBS(HK)

Study centers / principal investigators

Hong Kong

Yuk Man Cheung, MBBS(HK)
Queen Mary Hospital, Hong Kong