Essential ThrombocythemiaNCT06734637
Efficacy and Safety of Peginterferon in ET and PV.
A study testing Peginterferon α-2b injection in people with Essential Thrombocythemia and Polycythemia Vera, run by Zhenya Hong at 1 site in China.
Trial summary
This is a single-arm, single-center study aims to recruit 40 participants with Essential Thrombocythemia (ET) and Polycythemia Vera (PV). Eligible participants will receive a subcutaneous injection of Peginterferon α-2b 180 mcg once a week and follow-up，and efficacy and safety will be evaluated. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Thrombocythemia, Polycythemia Vera
- What is being tested?
- Peginterferon α-2b injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 Nov 2024to 20 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the 2016 WHO diagnostic criteria for ET (Essential Thrombocythemia) and PV (Polycythemia Vera)
- ET (Essential Thrombocythemia) major criteria:
- Platelet count > 450 * 10^9/L; (2) Bone marrow biopsy shows marked megakaryocytic proliferation with increased mature megakaryocyte volume and increased nuclear lobulation. There is no significant granulocytic proliferation, left shift, or erythroid proliferation, with grade 1 fibrosis observed in a few cases; (3) Does not meet the WHO diagnostic criteria for BCR-ABL1+ CML, PV, PMF, MDS, or other myeloproliferative neoplasms; (4) JAK2, CALR, or MPL mutation positive.
- Secondary criteria: (1) Presence of a clonal marker or absence of evidence for reactive thrombocytosis.
- The diagnosis of ET requires the fulfillment of all four main criteria, or the first three main criteria plus one secondary criterion.
- PV (Polycythemia Vera) main criteria: (1) Hemoglobin > 16.5 g/dL in males, > 16 g/dL in females, or Hematocrit > 49% in males, > 48% in females, or an increase in red cell volume of 25% or more above the normal value; (2) Bone marrow biopsy shows increased cellularity inappropriate for age, with marked erythroid, granulocytic, and megakaryocytic proliferation, and the presence of mature megakaryocytes of varying sizes and morphologies; (3) JAK2 V617F mutation positive or JAK2 exon 12 mutation positive.
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- Secondary criteria: Serum Epo (Erythropoietin) level below the lower limit of the normal range.
- The diagnosis of PV requires the fulfillment of three major criteria, or the first two main criteria plus one secondary criterion.
- For ET patients, the criteria for cytoreductive therapy must be met, as follows:
- For patients without a history of thrombosis: Age ≥ 60 years, regardless of the presence of cardiovascular risk (CVR) or JAK2V617 mutation; Any age with a platelet count > 1500 × 109/L. (2) For patients with a history of arterial thrombosis: Any age, regardless of the presence of CVR and JAK2V617 mutation; (3) For patients with a history of venous thrombosis: Any age, regardless of the presence of CVR and JAK2V617 mutation; 3.ECOG score ≤ 2. 4.Cardiac ejection fraction (EF) ≥ 60%. 5.The participant voluntarily signs the informed consent form.
Who cannot join
- Previous treatment with Peginterferon α-2b.
- ET patients who do not meet the criteria for cytoreductive therapy as per the 2016 Chinese Expert Consensus on Primary Thrombocythemia.
- Allergy to the active ingredient, α-interferon, or any excipients of this product.
- History of psychiatric illness, or allergy to interferon.
- Plasma total bilirubin greater than twice the normal value.
- Severe cardiac disease, liver insufficiency, chronic kidney disease, and neurological disorders (such as depression or mania).
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- History of other malignant tumors within the past three years.
- Autoimmune chronic hepatitis.
- Any condition deemed unsuitable for inclusion by the investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei
ZhenYa Hong, 13476158466, hongzhenya@126.com
About this study
Official title: A Single-arm, Single-center Study to Explore the Safety and Efficacy of Pegylated Interferon Alpha in Chinese Patients With ET (Essential Thrombocythemia) and PV (Polycythemia Vera).
This is a single-arm, single-center study aims to recruit 40 participants with Essential Thrombocythemia (ET) and Polycythemia Vera (PV). Eligible participants will receive a subcutaneous injection of Peginterferon α-2b 180 mcg once a week and follow-up，and efficacy and safety will be evaluated.
- Conditions
- Essential Thrombocythemia, Polycythemia Vera
- Being tested
- Peginterferon α-2b injection
- Keywords
- Essential thrombocythemia, Polycythemia vera, Peginterferon α-2b
- Medical subject headings
- Thrombocythemia, Essential, Polycythemia Vera
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peginterferon α-2b injectionDrug
Participants will receive Peginterferon α-2b 180 mcg once a week and follow-up. Dose adjustments will be made by the investigator based on the type and severity of adverse event (AE).
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon α-2b | Experimental | Not described Receives: Drug: Peginterferon α-2b injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hematologic remission rate
Measured: Week 12,24
Secondary outcomes (10)
Molecular remission rate
Measured: Week 24,48
Peripheral blood driver genes
Measured: Week 24,48
Bone marrow-driven genes
Measured: Week 24,48
The incidence of thrombosis
Measured: Week 24,48
Incidence of bleeding events
Measured: Week 24,48
The incidence of progression to myelofibrosis.
Measured: Week 24,48
The incidence of acute leukemia.
Measured: Week 24,48
Changes in the burden of driver gene mutations during maintenance therapy.
Measured: Week 24,48
Hematologic remission
Measured: Week 48
Spleen enlargement remission rate.
Measured: Week 24,48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2024
- Study start20 Nov 2024
- Primary completion20 Nov 2026 (estimated)
- Study completion20 Nov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential ThrombocythemiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhenya Hong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhenya Hong, Tongji Hospital
- Investigators
- ZhenYa Hong, Ph.D, Principal investigator, Tongji Medical College, Huazhong University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06734637
- Sponsor's protocol ID
- 2024S005
- Status last verified
- Dec 2024
- First submitted
- 11 Dec 2024
- Last updated
- 16 Dec 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Single-center Study to Explore the Safety and Efficacy of Pegylated Interferon Alpha in Chinese Patients With ET (Essential Thrombocythemia) and PV (Polycythemia Vera).
- ClinicalTrials.gov ID
- NCT06734637
- Acronym / sponsor ID
- 2024S005
- Conditions
- Essential Thrombocythemia, Polycythemia Vera
- Keywords
- Essential thrombocythemia, Polycythemia vera, Peginterferon α-2b
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Zhenya HongUniversity, hospital or other
- Study start
- 20 Nov 2024 (actual)
- Primary completion
- 20 Nov 2026 (estimated)
- Study completion
- 20 Nov 2027 (estimated)
- First posted
- 16 Dec 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a single-arm, single-center study aims to recruit 40 participants with Essential Thrombocythemia (ET) and Polycythemia Vera (PV). Eligible participants will receive a subcutaneous injection of Peginterferon α-2b 180 mcg once a week and follow-up，and efficacy and safety will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Peginterferon α-2b | Experimental | Drug: Peginterferon α-2b injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Meet the 2016 WHO diagnostic criteria for ET (Essential Thrombocythemia) and PV (Polycythemia Vera)
- Secondary criteria: (1) Presence of a clonal marker or absence of evidence for reactive thrombocytosis.
- The diagnosis of ET requires the fulfillment of all four main criteria, or the first three main criteria plus one secondary criterion.
- Secondary criteria: Serum Epo (Erythropoietin) level below the lower limit of the normal range.
- The diagnosis of PV requires the fulfillment of three major criteria, or the first two main criteria plus one secondary criterion.
Key exclusion criteria (9 listed)
- Previous treatment with Peginterferon α-2b.
- ET patients who do not meet the criteria for cytoreductive therapy as per the 2016 Chinese Expert Consensus on Primary Thrombocythemia.
- Allergy to the active ingredient, α-interferon, or any excipients of this product.
- History of psychiatric illness, or allergy to interferon.
- Plasma total bilirubin greater than twice the normal value.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peginterferon α-2b injectionParticipants will receive Peginterferon α-2b 180 mcg once a week and follow-up. Dose adjustments will be made by the investigator based on the type and severity of adverse event (AE). | Drug | Peginterferon α-2b |
Primary outcome
Hematologic remission rate
Time frame: Week 12,24
10 secondary outcomes
Molecular remission rate
Time frame: Week 24,48
Peripheral blood driver genes
Time frame: Week 24,48
Bone marrow-driven genes
Time frame: Week 24,48
The incidence of thrombosis
Time frame: Week 24,48
Incidence of bleeding events
Time frame: Week 24,48
The incidence of progression to myelofibrosis.
Time frame: Week 24,48
The incidence of acute leukemia.
Time frame: Week 24,48
Changes in the burden of driver gene mutations during maintenance therapy.
Time frame: Week 24,48
Hematologic remission
Time frame: Week 48
Spleen enlargement remission rate.
Time frame: Week 24,48
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ZhenYa Hong, Ph.D principal investigator
Tongji Medical College, Huazhong University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peginterferon α-2b injection in people with Essential Thrombocythemia and Polycythemia Vera, run by Zhenya Hong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ZhenYa Hong, Ph.D (13476158466, hongzhenya@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hematologic remission rate (time frame: Week 12,24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.