Comparing two types of interferon treatments for children and adolescents with essential thrombocythemia
A Prospective, Single-center Clinical Trial of Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in the Treatment of Childhood and Adolescent Essential Thrombocythemia
PHASE2 · Institute of Hematology & Blood Diseases Hospital, China · NCT04226950
This study is testing which of two interferon treatments works better and is safer for kids and teens with essential thrombocythemia.
Quick facts
| Phase | PHASE2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 19 Years |
| Sex | All |
| Sponsor | Institute of Hematology & Blood Diseases Hospital, China (other) |
| Locations | 1 site (Tianjin, Tianjin) |
| Trial ID | NCT04226950 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to compare the efficacy and safety of Pegylated Interferon Alfa-2b versus Interferon Alfa in treating childhood and adolescent patients diagnosed with essential thrombocythemia. The study will involve patients under 20 years old, who will be assigned to one of two treatment groups based on their guardians' or their own consent. The initial dosages will be adjusted according to laboratory results and patient tolerance, allowing for flexibility in treatment. The trial is designed as a prospective, open-label, nonrandomized, single-center study.
Who should consider this trial
Good fit: Ideal candidates for this study are children and adolescents under 20 years old diagnosed with essential thrombocythemia and meeting specific platelet count criteria.
Not a fit: Patients with known primary myelofibrosis, polycythemia vera, or those with life-threatening co-morbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective treatment option for children and adolescents suffering from essential thrombocythemia.
How similar studies have performed: While similar studies have explored interferon treatments, this specific comparison of Pegylated Interferon Alfa-2b and Interferon Alfa in a pediatric population is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * \<20 years old * Male or Female * Diagnosis of essential thrombocythemia according to the 2016 WHO criteria. * Platelet count ≥ 450 × 109 / L for more than 6 months（If the patient has JAK2 V617F, CALR or MPL gene mutation, the history may be less than 6 months） * Platelet count ≥ 1000 × 109 / L or other therapeutic indications at screening. * The guardians has provided written informed consent prior to enrollment Exclusion Criteria: * Known to meet the criteria for primary myelofibrosis or polycythemia vera by 2016 WHO criteria * Presence of any life-threatening co-morbidity * Secondary thrombocytosis * Familial thrombocytosis * Resistance, or intolerance, or any contraindications to interferon * Interferon is used in the past 1 month before enrollment * Patients with previous or present thrombosis or active bleeding * WBC\<4× 109 / L * HGB\<110g/L * Poor control of thyroid dysfunction * Patients with a prior malignancy within the last 3 years * 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 diagnosed as diabetes with poor control * 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
Where this trial is running
Tianjin, Tianjin
- Institute of Hematology & Blood Diseases Hospital — Tianjin, Tianjin, China (RECRUITING)
Study contacts
- Principal investigator: Lei Zhang, MD — Institute of Hematology & Blood Diseases Hospital, China
- Study coordinator: Rongfeng Fu, MD
- Email: furongfeng@ihcams.ac.cn
- Phone: +862223909009
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Essential Thrombocytopenia, Essential Thrombocythemia, Childhood, Interferon Alfa, Pegylated Interferon Alfa-2b, Adolescent