coiaward2010

MSIT = Malaysia Stop Tyrosine Kinase Inhibitor Trial

Study title

MSIT = Malaysia Stop Tyrosine Kinase Inhibitor Trial [Malaysia]

Scientific title

A Randomized Control Trial Comparing Peginterferon-α-2a Versus Observation After Stopping Tyrosine Kinase Inhibitor in Chronic Myeloid Leukemia With Deep Molecular Response for at Least Two Years (ClinicalTrials.gov NCT02381379)

Indication and most important inclusion criteria

To be considered for inclusion in this study patients must be 18 years or older and have been diagnosed with chronic phase (CP) chronic myeloid leukemai (CML). They have been treated with ongoing tyrosine kinase inhibitors (TKI) at any dose for at least 3 years.
Patients have achieved stable deep molecular response (MR4.5) on International Scale (IS) for at least 2 years. The last deep MR result must have been from within 3 months of enrollment.

Short description of intervention

This study compares two groups of CML patients in chronic phase with deep molecular response for at least 2 years. After stopping tyrosine kinase inhibitors, one group will use peginterferon-α-2a starting at 180µg weekly for one year whereas the other group will not use any active medication that might affect CML.
The study will compare the two groups with regard to relapse rate, time to re-attain deep molecular response after restarting TKIs in patients who relapse and time to regain deep molecular response after relapse after restarting whatever treatment.

Type of study

Treatment discontinuation trial
in a single country

Current status

Recruiting

Study sponsor

Ministry of Health, Malaysia

Scientific lead / contact

Jew Win Kuan, MRCP (UK)
Kian Meng Chang, FRCP, London

Principal investigator

Kian Meng Chang, FRCP, London
Ampang Hospital, Malaysia

Additional information

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

Study centers / principal investigators

Malaysia

Sultanah Aminah Hospital
Johor Bahru, Johor, Malaysia, 80100

Sultanah Bahiyah Hospital
Alor Setar, Kedah, Malaysia, 05460

Malacca General Hospital
Melaka, Melaka, Malaysia, 75400

Sarawak General Hospital
Kuching, Sarawak, Malaysia, 93586

Sibu Hospital
Sibu, Sarawak, Malaysia, 96000

Ampang Hospital
Ampang, Selangor, Malaysia, 68000

Miri Hospital
Miri Sarawak, Malaysia, 98000