Asian Myeloproliferative Neoplasm (MPN) Registry

Primary Myelofibrosis Clinical Trial

Official title:

Asian Myeloproliferative Neoplasm (MPN) Registry - An Asian Myeloid Working Group (AMWG) Project.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05882773
• Other study ID #: AMWG002
• Status: Recruiting
• Start date: May 2023
• Est. completion date: December 2026

Study information

• Verified date: May 2023
• Source: The University of Hong Kong
• Contact: Harinder Gill, MD
• Phone: +852 22554542
• Email: gillhsh[@]hku.hk
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

This is a multinational, multicenter, prospective and retrospective, observational, cohort study of patients with myeloproliferative neoplasm.

Description:

This is a multinational, multicenter, prospective and retrospective, observational, cohort registry of patients with MPN. The registry mainly involves study centres in Asia including but not limited to Hong Kong, Singapore, Malaysia, Taiwan, Korea and Thailand. Clinicopathologic characteristics, cytogenetic characteristics, mutational characteristics, treatment characteristics, outcomes and survivals of Asian patients MPN diagnosed between 2010-2025 will be collected to establish clinical registry.

Data on the clinicopathologic characteristics, cytogenetics, mutational profile, prognostic scoring treatment characteristics, responses to treatment, outcome and survivals will be collected through routine clinic visits and/or reviewing medical records. Data will be collected at diagnosis, and approximately every 6 months thereafter (for prospective data) and at progression until death/study termination.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 2026
• Est. primary completion date: May 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age = 18 years old at the time of diagnosis of MPN.

2. Subject was diagnosed with one of the following disorders according to the 2017 WHO classification (for patients diagnosed before 2017, the bone marrow reports will be re-evaluated according to the 2017 WHO classification):

1. Polycythaemia vera

2. Essential thrombocythemia

3. Primary myelofibrosis, pre-fibrotic/early stage

4. Primary myelofibrosis, overt fibrotic stage

5. Post-polycythaemia vera myelofibrosis

6. Post-essential thrombocythaemia myelofibrosis

7. MPN-unclassifiable

3. All subjects need to provide informed consent.

Exclusion Criteria:

A subject will not be eligible if he/she meets any of the following criteria:

1. Subject was diagnosed with myelodysplastic syndrome, myelodysplastic syndrome/myeloproliferative neoplasm, or chronic myeloid leukaemia BCR-ABL1 positive, under the 2017 WHO classification

Related Conditions & MeSH terms

• Essential Thrombocythemia
• Myeloproliferative Disorders
• Myeloproliferative Neoplasm
• Neoplasms
• Polycythemia
• Polycythemia Vera
• Post-essential Thrombocythemia Myelofibrosis
• Post-polycythemia Vera Myelofibrosis
• Primary Myelofibrosis
• Primary Myelofibrosis, Fibrotic Stage
• Primary Myelofibrosis, Prefibrotic Stage
• Thrombocythemia, Essential
• Thrombocytosis

Locations

Country	Name	City	State
Hong Kong	Department of Medicine, Queen Mary Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Novartis

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to progression to secondary myelofibrosis (for PV and ET)	Measured in months, from date of diagnosis of MPN to date of documentation of secondary myelofibrosis (event), death (event) or latest follow-up (censor). Patient without an event will be censored at date last known to be progression-free	10 years
Primary	Progression-free survival (PFS)	Measured in months, from date of diagnosis of MPN to the date of the first MDS or AML or death due to any cause. Patient without an event will be censored at date last known to be progression-free and alive.	10 years
Primary	Overall survival (OS)	Measured in months from the date of diagnosis of MDS until the date of death due to any cause. Patient who is alive will be censored at the date last known alive	10 years