Essential ThrombocytopeniaPhase 2NCT05395507
Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in Adult Essential Thrombocythemia
A Phase 2 study testing Recombinant Interferon Alpha and Pegylated interferon alfa-2b in people with Essential Thrombocytopenia, run by Institute of Hematology & Blood Diseases Hospital, China at 1 site in China.
Trial summary
Objectives: To compare the efficacy and safety in Adult patients (≥18 years) diagnosed as essential thrombocythemia treated with the Pegylated Interferon Alfa-2b vs. Interferon Alfa. Study Design: A prospective, open-label, multicenter, randomized controlled clinical trial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Essential Thrombocytopenia
- What is being tested?
- Recombinant Interferon Alpha and Pegylated interferon alfa-2b
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 194 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2022to 30 Jun 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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
- ≥18 years old.
- Male or Female.
- Diagnosis of essential thrombocythemia according to the 2016 World Health Organization criteria.
- Those who have not use interferon within 4 weeks before the first medication.
- Patients with indications for cytoreductive therapy.
- Men and women with reproductive potential, as well as all women with menopause less than 2 years, must agree to use acceptable contraceptive methods until 28 days after the last dose of study drug, and women must agree not to breastfeed during the study period.
- Voluntary written informed consent.
Who cannot join
- Resistance, or intolerance, or any contraindications to interferon.
- Patients with active thrombosis or active bleeding.
- Neutrophil count < 1.0x10^9/L.
- Hemoglobin < 11g/dL for male, or < 10g/dL for female.
- Poor control of thyroid dysfunction.
- Patients with a prior malignancy within the last 3 years.
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- Patients with severe cardiac or pulmonary dysfunction.
- Severe renal damage (creatinine clearance < 30 ml / min).
- Severe liver dysfunction (ALT or AST > 2.5×ULN).
- Patients with hepatitis B virus, hepatitis C virus replication or HIV infection.
- Patients with a history of drug / alcohol abuse (within 2 years before the study).
- Patients that have participated in other experimental researches within one month before enrollment.
- History of psychiatric disorder.
- Any other circumstances that the investigator considers that the patient is not suitable to participate in the trial.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020
About this study
Official title: A Prospective, Multicenter, Randomized Controlled Clinical Trial of Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in the Treatment of Adult Essential Thrombocythemia
Objectives: To compare the efficacy and safety in Adult patients (≥18 years) diagnosed as essential thrombocythemia treated with the Pegylated Interferon Alfa-2b vs. Interferon Alfa. Study Design: A prospective, open-label, multicenter, randomized controlled clinical trial.
Read the detailed description
This is a prospective, open-label, multicenter, randomized controlled clinical trial between Interferon Alfa and Pegylated Interferon Alfa-2b in adult essential thrombocythemia (≥18 years).
Patients will be randomly divided into the following two treatment groups: 1. Recombinant Interferon Alpha, with an initial dose of 300 wu three times a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available. 2. Pegylated Interferon Alfa-2b, with an initial dose of 135 ug at week 0 , and then 180 ug once a week from week 1 to week 52.
The dosage will be adjusted according to the results of laboratory examinations and patient tolerance. The patient will be transferred to the other group if intolerance or resistance occurs.
- Conditions
- Essential Thrombocytopenia
- Being tested
- Recombinant Interferon Alpha, Pegylated interferon alfa-2b
- Keywords
- Essential Thrombocytopenia, Interferon Alfa, Pegylated Interferon Alfa-2b, Efficacy, Safety
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant Interferon AlphaDrug
Recombinant Interferon Alpha, with an initial dose of 300 wu three times a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available.
Pegylated interferon alfa-2bDrug
Pegylated Interferon Alfa-2b, with an initial dose of 135 ug at week 0 , and then 180 ug once a week from week 1 to week 52.
| Study group | Role | What they receive |
|---|---|---|
| Recombinant Interferon Alpha | Active comparator | Recombinant Interferon Alpha, with an initial dose of 300 wu three times a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available. Receives: Drug: Recombinant Interferon Alpha |
| Pegylated Interferon Alfa-2b | Experimental | Pegylated Interferon Alfa-2b, with an initial dose of 135 ug at week 0 , and then 180 ug once a week from week 1 to week 52. Receives: Drug: Pegylated interferon alfa-2b |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete hematological remission (CHR) rates
The CHR rates defined as European Leukemia Net will be compared between the two groups.
Measured: From the start of study treatment (Week 0) up to the end of Week 52
Secondary outcomes (16)
CHR rates at week 24 and 36
The CHR rates at week 24 and 36 will be compared between the two groups
Measured: From the start of study treatment (Week 0) up to the end of Week 24 and Week 36, respectively
Time to CHR
The time of reaching CHR will be compared between the two groups
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
The proportion of patients crossed to the contralateral group
The proportion of patients crossed to the contralateral group will be compared between the two groups
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
The CHR rates after crossover
The CHR rates within 52 weeks after crossover
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
Impact of therapy on driver mutations
To compare the proportion of subjects that display change on key biomarkers of the disease- JAK2V617F, CALR, MPL mutations.
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
Impact of therapy on non-driver mutations
To compare the proportion of subjects that display change on key non-driver biomarkers of the disease-DNMT3A, ASXL1, TET2 or other mutations.
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
Change of splenomegaly
To compare the proportion of subject with improvement and no progress rate of splenomegaly between the two groups.
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
Change of bone marrow pathology
To compare the rate of patients with improvement and no progress rate of bone marrow pathology between the two groups
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
The incidence of major thrombotic events
To compare the incidence of major thrombotic events between the two groups.
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
The incidence of major bleeding events
To compare the incidence of major bleeding events between the two groups.
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
The incidence of progressing to bone marrow fibrosis
The incidence of progressing to bone marrow fibrosis will be compared between the two groups
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
The incidence of progressing to acute leukemia
The incidence of progressing to acute leukemia will be compared between the two groups
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
Change in Myeloproliferative Neoplasm Symptom Assessment Form total symptom score
To compare the proportion of subjects that display change in Myeloproliferative Neoplasm Symptom Assessment Form total symptom score (0-100 scores, higher scores mean a worse outcome) between different treatment groups.
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
Change of quality of life
Compare the rate of patients with improvement in quality of life between the two groups (assessed by EORTC quality of life scale QLQ-C30 V3.0 questionnaire).
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
Change of microcirculation disturbance
The rate of patients with improvement in microcirculation disturbance (such as pruritus, headache, dizziness, chest tightness, erythematous limb pain and limb paresthesia) will be compared between the two groups
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
Specific pre-defined toxicity
To compare incidence of specific pre-defined toxicity including fatigue, flu-like symptoms, dizziness, injection site necrosis, dyspnea, pain, depression, blurred Vision, insomnia, anorexia, weight Loss, weakness, pruritis, sweating, fever, decreased Libido, hot Flashes, flushing.
Measured: From the start of study treatment (Week 0) up to the end of Week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2022
- Study start1 Jun 2022
- Primary completion31 Mar 2025 (estimated)
- Study completion30 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Essential ThrombocytopeniaStudies of the same condition, open and under way.
- More trials run by Institute of Hematology & Blood Diseases Hospital, ChinaThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 194 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Lei Zhang, MD, Principal investigator, Institute of Hematology & Blood Diseases Hospital, ChinaRongfeng Fu, Principal investigator, Institute of Hematology & Blood Diseases Hospital, ChinaRong Fu, Principal investigator, Tianjin Medical University General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05395507
- Sponsor's protocol ID
- IIT2022004
- Status last verified
- Nov 2023
- First submitted
- 10 May 2022
- Last updated
- 3 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multicenter, Randomized Controlled Clinical Trial of Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in the Treatment of Adult Essential Thrombocythemia
- ClinicalTrials.gov ID
- NCT05395507
- Acronym / sponsor ID
- IIT2022004
- Conditions
- Essential Thrombocytopenia
- Keywords
- Essential Thrombocytopenia, Interferon Alfa, Pegylated Interferon Alfa-2b, Efficacy, Safety
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 194 participants (estimated)
- Lead sponsor
- Institute of Hematology & Blood Diseases Hospital, ChinaUniversity, hospital or other
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 30 Jun 2025 (estimated)
- First posted
- 27 May 2022 (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.
Objectives: To compare the efficacy and safety in Adult patients (≥18 years) diagnosed as essential thrombocythemia treated with the Pegylated Interferon Alfa-2b vs. Interferon Alfa. Study Design: A prospective, open-label, multicenter, randomized controlled clinical trial.
Detailed description
This is a prospective, open-label, multicenter, randomized controlled clinical trial between Interferon Alfa and Pegylated Interferon Alfa-2b in adult essential thrombocythemia (≥18 years).
Patients will be randomly divided into the following two treatment groups: 1. Recombinant Interferon Alpha, with an initial dose of 300 wu three times a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available. 2. Pegylated Interferon Alfa-2b, with an initial dose of 135 ug at week 0 , and then 180 ug once a week from week 1 to week 52.
The dosage will be adjusted according to the results of laboratory examinations and patient tolerance. The patient will be transferred to the other group if intolerance or resistance occurs.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Recombinant Interferon Alpha | Active comparator | Drug: Recombinant Interferon AlphaRecombinant Interferon Alpha, with an initial dose of 300 wu three times a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available. |
| Pegylated Interferon Alfa-2b | Experimental | Drug: Pegylated interferon alfa-2bPegylated Interferon Alfa-2b, with an initial dose of 135 ug at week 0 , and then 180 ug once a week from week 1 to week 52. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- ≥18 years old.
- Male or Female.
- Diagnosis of essential thrombocythemia according to the 2016 World Health Organization criteria.
- Those who have not use interferon within 4 weeks before the first medication.
- Patients with indications for cytoreductive therapy.
Key exclusion criteria (14 listed)
- Resistance, or intolerance, or any contraindications to interferon.
- Patients with active thrombosis or active bleeding.
- Neutrophil count < 1.0x10^9/L.
- Hemoglobin < 11g/dL for male, or < 10g/dL for female.
- Poor control of thyroid dysfunction.
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 |
|---|---|---|
| Recombinant Interferon AlphaRecombinant Interferon Alpha, with an initial dose of 300 wu three times a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available. | Drug | Recombinant Interferon Alpha |
| Pegylated interferon alfa-2bPegylated Interferon Alfa-2b, with an initial dose of 135 ug at week 0 , and then 180 ug once a week from week 1 to week 52. | Drug | Pegylated Interferon Alfa-2b |
Primary outcome
Complete hematological remission (CHR) rates
Time frame: From the start of study treatment (Week 0) up to the end of Week 52
The CHR rates defined as European Leukemia Net will be compared between the two groups.
16 secondary outcomes
CHR rates at week 24 and 36
Time frame: From the start of study treatment (Week 0) up to the end of Week 24 and Week 36, respectively
Time to CHR
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
The proportion of patients crossed to the contralateral group
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
The CHR rates after crossover
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
Impact of therapy on driver mutations
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
Impact of therapy on non-driver mutations
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
Change of splenomegaly
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
Change of bone marrow pathology
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
The incidence of major thrombotic events
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
The incidence of major bleeding events
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
The incidence of progressing to bone marrow fibrosis
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
The incidence of progressing to acute leukemia
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
Change in Myeloproliferative Neoplasm Symptom Assessment Form total symptom score
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
Change of quality of life
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
Change of microcirculation disturbance
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
Specific pre-defined toxicity
Time frame: From the start of study treatment (Week 0) up to the end of Week 52.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2024.
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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. This study is not recruiting at the moment.
Lei Zhang, MD principal investigator
Institute of Hematology & Blood Diseases Hospital, China
Rongfeng Fu principal investigator
Institute of Hematology & Blood Diseases Hospital, China
Rong Fu principal investigator
Tianjin Medical University General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant Interferon Alpha and Pegylated interferon alfa-2b in people with Essential Thrombocytopenia, run by Institute of Hematology & Blood Diseases Hospital, China 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 7 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 3 Jul 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lei Zhang, MD (8602223909240, zhanglei1@ihcams.ac.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete hematological remission (CHR) rates (time frame: From the start of study treatment (Week 0) up to the end of Week 52). 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 3 Jul 2024.