Asian Myeloproliferative Neoplasm (MPN) Registry

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

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

Study Overview

• Status: Recruiting
• Conditions: Primary Myelofibrosis; Polycythemia Vera; Essential Thrombocythemia; Myeloproliferative Neoplasm; Post-polycythemia Vera Myelofibrosis; Post-essential Thrombocythemia Myelofibrosis; Primary Myelofibrosis, Prefibrotic Stage; Primary Myelofibrosis, Fibrotic Stage

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Harinder Gill, MD; Phone Number: +852 22554542; Email: gillhsh@hku.hk

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
    • Recruiting
    • Department of Medicine, Queen Mary Hospital
    • Contact: Harinder Gill, MD; Phone Number: +852 22554542; Email: gillhsh@hku.hk
    • Sub-Investigator: Yok-Lam Kwong, MD
    • Principal Investigator: Harinder Gill, MD
    • Sub-Investigator: Garret Leung, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Three study cohorts will be involved in the study. They are:

Prospective cohort - Subjects will be enrolled in the study at their diagnosis of MPN. All data will be collected on-study prospectively.

Partial prospective/retrospective cohort (partial-P/R) - Subjects will be enrolled in the study after they have been diagnosed of MPN for a period of time and still being followed up clinically (alive). Data from study enrollment forward will be collected prospectively at around 6-month intervals on-study. Data prior to study enrollment are the events of interest happened and will be collected retrospectively.

Retrospective cohort - Subjects enrolled in the study after they were diagnosed of MPN and died/lost to follow. All data will be collected retrospectively.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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

Collaborators and Investigators

• Sponsor: The University of Hong Kong
• Collaborators: Novartis
• Investigators: Principal Investigator: Harinder Gill, MD, The University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2023
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: May 21, 2023
• First Submitted That Met QC Criteria: May 21, 2023
• First Posted (Actual): May 31, 2023

Study Record Updates

• Last Update Posted (Actual): May 31, 2023
• Last Update Submitted That Met QC Criteria: May 21, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: Epidemiology; Outcome; Prognostic factors; Myeloproliferative neoplasm
• Additional Relevant MeSH Terms: Neoplasms by Site; Bone Marrow Diseases; Hematologic Diseases; Hemorrhagic Disorders; Blood Coagulation Disorders; Blood Platelet Disorders; Bone Marrow Neoplasms; Hematologic Neoplasms; Neoplasms; Primary Myelofibrosis; Thrombocytosis; Thrombocythemia, Essential; Myeloproliferative Disorders; Polycythemia Vera; Polycythemia
• Other Study ID Numbers: AMWG002

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No