Status:
UNKNOWN
The Efficacy and Safety of Induction-Maintenance Protocol for Patients With Chronic Myelogenous Leukaemia
Lead Sponsor:
The University of Hong Kong
Conditions:
Chronic Myeloid Leukemia
Philadelphia Chromosome Positive CML
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this pilot study is to investigate whether some patients who were started on a 2G-TKI as first-line treatment can be safely switched to imatinib, a first-generation TKI, while maintaini...
Detailed Description
Imatinib, nilotinib and dasatinib are standard first-line options for newly diagnosed patients with chronic-phase chronic myeloid leukemia (CML). While nilotinib and dasatinib, also known as second-ge...
Eligibility Criteria
Inclusion
- Adult (aged 18 years or above) patients diagnosed with chronic-phase CML
- Must have received a 2G-TKI (nilotinib or dasatinib) as first-line therapy for at least 12 months (Note: Cytoreductive agents, namely hydroxyurea and anagrelide, prior to the use of TKI are allowed.)
- In sustained, good molecular response (i.e. molecular response (MR3) or below) for at least 6 months, as confirmed with at least 2 consecutive quantitative real time-polymerase chain reaction (RT-PCR) results
Exclusion
- Under 18 years old
- Adults under law protection or without ability to consent
- Previous or planned autologous/allogeneic haematopoietic stem cell transplantation
- Documented kinase domain mutation
- A change to the current TKI because of unsatisfactory response to a previous TKI (Note: patients are still considered eligible if the switch in TKI was due to intolerance or side effects)
- History of disease progression (accelerated or blast phase)
- Patients who can speak neither Chinese nor English
- Any molecular result during the preceding 6 months that is higher than MR3, i.e. BCR-ABL1/ABL1 ratio \>0.1% on IS ratio
Key Trial Info
Start Date :
August 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2021
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT03241199
Start Date
August 1 2017
End Date
January 1 2021
Last Update
August 8 2017
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The University of Hong Kong
Hong Kong, Hong Kong