Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in the Treatment of Childhood Essential Thrombocythemia

  • STATUS
    Recruiting
  • participants needed
    40
  • sponsor
    Institute of Hematology & Blood Diseases Hospital
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Updated on 16 February 2024
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platelet count
interferon
essential thrombocythemia
thrombocytosis
interferon alfa
peginterferon alfa-2b
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Summary

Objectives: To compare the efficacy and safety in children (<18 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

Description

This is a prospective, open-label, nonrandomized, single-center clinical trial between Interferon Alfa and Pegylated Interferon Alfa-2b in childhood essential thrombocythemia (<18 years).

Patients will be divided into the following two treatment groups: 1. 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; 2. 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 area1.73 m2).

The current drug therapies and possible risks of Pegylated Interferon Alfa-2b and Interferon Alfa in the treatment of childhood essential thrombocythemia will be fully introduced to the guardians of the children by the researchers. Then the children will be divided into one of the two groups according to the guardians' will.

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 occurs.

Details
Condition Essential Thrombocytopenia
Age 17years or below
Treatment Recombinant Interferon Alpha, Pegylated interferon alfa-2b
Clinical Study IdentifierNCT04226950
SponsorInstitute of Hematology & Blood Diseases Hospital
Last Modified on16 February 2024

Eligibility

 Yes No Not Sure

Inclusion Criteria

<18 years old
Male or Female
Diagnosis of essential thrombocythemia according to the 2016 WHO criteria
Platelet count 450 109 / L for more than 6 monthsIf 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 > 2.5ULN)
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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