Follow-up Study on Chronic Myeloid Leukemia Patients Achieving Treatment-free Remission
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age20+
SponsorNational Taiwan University Hospital
About this trial
In recent years, the goal of stopping drug therapy, also known as treatment-free remission (TFR), is emerging as one of the management goals of chronic myeloid leukemia (CML) therapy. Because there is no available data on Asian patients with CML undergoing tyrosine kinase inhibitor discontinuation (TKI), the investigators plan to recruit chronic phase CML patients with deep treatment response and good medical compliance in Taiwan to evaluate the feasibility, safety and clinical consequences of TKI discontinuation.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
The participant should be an adult (age ⩾20 years) with CP-CML.
The BCR-ABL fusion should be in the form of either e13a2 or e14a2 (p210)
The participant should not have documented resistance to a 2nd-generation TKI (Nilotinib or Dasatinib)
The participant should have received ≥ 5 years of consecutive treatment with imatinib, or ≥ 4 years of consecutive treatment with a 2nd-generation TKI (Nilotinib or Dasatinib)
Disqualifiers
After evaluation, the participant is deemed to be ineligible by the investigator of this study.
The participant has no intention to be recruited into this study.
Trial population
Adults with CP-CML and are regularly followed up at National Taiwan University Hospital (NTUH) or at the branch hospitals of the NTUH healthcare system
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
The proportion of patients who were in major molecular response (MMR) without re-initiation of treatment
Real-time quantitative polymerase chain reaction (RT-qPCR) would be done to determined the transcript level of BCR-ABL fusion gene in peripheral blood samples
Time frame
at week 48 of tyrosine kinase inhibitor (TKI) discontinuationSecondary outcomes
1
The proportion of patients who were in MR4.5 (BCR-ABL transcript level ⩽0.0032% IS) and off treatment
Real-time quantitative polymerase chain reaction (RT-qPCR) would be done to determined the transcript level of BCR-ABL fusion gene in peripheral blood samples
Time frame
at week 48 of TKI discontinuation2
Treatment-free survival
Time frame
From the start of TKI discontinuation until the earliest occurrence of any of the following: loss of MMR, restart of TKI for any reason, progression to accelerated phase/blast phase, or death of any cause, assessed up to 60 months3
The proportion of patients who reachieved of MMR after TKI restart
Real-time quantitative polymerase chain reaction (RT-qPCR) would be done to determined the transcript level of BCR-ABL fusion gene in peripheral blood samples
Time frame
qPCR of BCR-ABL would be checked every four weeks until MR4 is re-established, and then every 12 weeks until study completion (week 240).4
The proportion of patients who reachieved of MR4.5 after TKI restart
Real-time quantitative polymerase chain reaction (RT-qPCR) would be done to determined the transcript level of BCR-ABL fusion gene in peripheral blood samples
Time frame
qPCR of BCR-ABL would be checked every four weeks until MR4 is re-established, and then every 12 weeks until study completion (week 240).Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov