The Hong Kong CML Registry

Chronic Myeloid Leukemia Clinical Trial

Official title:

A Multi-centre Study of Epidemiology, Characteristics, Treatment and Outcome of Chronic Myeloid Leukaemia in Adults in Hong Kong

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03625583
• Other study ID #: QMH-CML-003
• Status: Recruiting
• Start date: April 1, 2018
• Est. completion date: September 30, 2023

Study information

• Verified date: August 2018
• Source: The University of Hong Kong
• Contact: Dr Carol Cheung, MBBS
• Phone: 852-22553456
• Email: drcarolcheung[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Chronic myeloid leukaemia (CML) is a malignant disorder of the haematopoietic system. It is characterized by the chromosomal translocation between chromosomes 9 and 22, resulting in the formation of the Philadelphia chromosome which contains the BCRABL1 fusion gene. The projected prevalence of CML is rising steadily, due to the significantly improved survival of CML patients and that the incidence rate increases with age. The efficacious yet costly tyrosine kinase inhibitors pose a significant financial burden to both patients and the health care system, while they carry their own side effects and long-term risks. This study aims to set up a local disease registry of CML to improve the knowledge concerning this disease, including epidemiology,characteristics and treatment outcome of CML in Hong Kong,as well as long-term safety and toxicities of therapeutic agents.

Description:

Chronic myeloid leukaemia (CML) is a malignant disorder of the haematopoietic system characterized by the presence of the Philadelphia chromosome arising from t(9;22)(q34;q 11).The annual incidence of CML is reported to be around 1-2 cases per 100,000 population.In Hong Kong, the age-standardised incidence rate of CML has remained static in recent years.

However, as the incidence of CML increases with age and Hong Kong has an ageing population, the crude incidence rate is expected to follow a rising trend. On the other hand, the prognosis of CML patients has improved significantly since the advent of tyrosine kinase inhibitors (TKis) more than two decades ago. With the efficacious TKis, CML has changed from a deadly cancer to a treatable chronic condition. It has been shown that life expectancy of CML patients is approaching that of the general population now.The prevalence of CML is expected to rise considerably in view of the increasing incidence in an ageing population and improved prognosis. The Hong Kong Cancer Registry only provides data on the incidence rates of cancers but it has yet to provide cancer prevalence data. A clinical registry is "an organized system that uses observational study methods to collect uniform data to evaluate specific outcomes". A disease registry specifically designed for CML would provide more accurate and comprehensive data and allow an in-depth study of the epidemiology and characteristics of CML in Hong Kong.

At present,there are three TKis approved for front-line treatment of newly diagnosed chronic-phase CML,viz.,imatinib, nilotinib and dasatinib.lmatinib is a first-generation TKI while nilotinib and dasatinib are second-generation TKis (2G-TKI) . Nilotinib and dasatinib demonstrate better in vitro efficacy and achieve molecular responses faster and deeper than imatinib,but these drugs not been proven superior to imatinib in conventional clinical endpoints including overall survival and progression-free survival.Besides, nilotinib and dasatinib are not without side effects and their long-term safety profiles are unclear. For example, nilotinib is associated with increased cardiovascular risk while dasatinib often leads to pleural effusion and less frequently,pulmonary hypertension.The safety of imatinib has been well established over the past 15 years and its side effects are generally considered tolerable. However, the generic formulation of imatinib has been recently introduced to public hospitals and substituted for branded imatinib in CML patients. There have been reports that patient switching to generic imatinib develop adverse drug reactions not experienced with branded imatinib. Other less commonly used therapeutic agents include bosutinib and ponatinib, which still play an important role in the management of CML. Therefore, it is important to determine the "real-world" clinical effectiveness of various drugs, and monitor their side effects and long-term toxicities in a population-based approach.

As physicians in Hong Kong are facing a growing patient population on long-term TKI,the demand on health care services and financial burden of drug costs will escalate accordingly. lt is pivotal for the investigators to understand the disease and patients in the locality better by systematic data collection, in order to improve quality of care, allow service planning and facilitate medical research and advances .

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2023
• Est. primary completion date: March 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Patients aged 18 years or above

2. Diagnosed with Philadelphia chromosome positive and/or BCR-ABLl positive chronic myeloid leukaemia in all phases

3. Managed in any of the participating centres in the period of 2007 to 2017

Exclusion Criteria:

1) Patients less than 18years of age

Related Conditions & MeSH terms

• Chronic Myeloid Leukemia
• Leukemia
• Leukemia, Myelogenous, Chronic, BCR-ABL Positive
• Leukemia, Myeloid

Locations

Country	Name	City	State
Hong Kong	The University of Hong Kong	Hong Kong

Sponsors (1)

Lead Sponsor	Collaborator
The University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Demographics	percentage of ethnic distribution	January 2007 to December 2017
Primary	Age	percentage of age distribution	January 2007 to December 2017
Primary	Etiology	percentage of etiology	January 2007 to December 2017
Primary	Clinical features	percentage of clinical features	January 2007 to December 2017
Primary	Sex	ratio of male to female patient	January 2007 to December 2017
Secondary	number of CML patients in Hong Kong	Estimated prevalence of CML in Hong Kong	up to 10 years
Secondary	number of newly diagnosis CML patient each year	Estimated incidence of CML in Hong Kong	up to 10 years
Secondary	Current treatment pattern of CML	Current treatment pattern of CML	up to 10 years
Secondary	record AE of each treatment	Safety data ofTKI	up to 10 years
Secondary	disease free and survival free	Treatment outcome of CML patients	up to 10 years
Secondary	disease free and survival free data in advanced phases (accelerated and blast phases)	Outcome of patients in advanced phases (accelerated and blast phases)	up to 10 years