Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in Childhood and Adolescent 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
Institute of Hematology & Blood Diseases Hospital, China
40 participants
Jan 10, 2020
INTERVENTIONAL
Conditions
Summary
Objectives: To compare the efficacy and safety in childhood and adolescent patients (\<20 years) diagnosed as essential thrombocythemia treated with the Pegylated Interferon Alfa-2b vs. Interferon Alfa. Study Design: A prospective, open-label, nonrandomized, single-center clinical trial
Eligibility
Inclusion Criteria6
- <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 Criteria20
- 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
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Interventions
Recombinant Interferon Alpha, with an initial dose of 300 wu twice a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available, and the specific dose will be determined by the researchers;
Pegylated Interferon Alfa-2b, with an initial dose of 135 ug once a week (body surface area \< 1.73 m2) or 180 ug once a week ( body surface area≥1.73 m2).
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT04226950