Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in Childhood and Adolescent Essential Thrombocythemia

• Status: Recruiting
• Trial end date: 2022-09-20
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Institute of Hematology & Blood Diseases Hospital
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2b

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 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