A Prospective, Single-center Clinical Trial of Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in the Treatment of Childhood and Adolescent Essential Thrombocythemia
Sponsor study identifier
interventional
40
1 country
1
Study Start
January 10, 2020
Actual (reported)Primary Completion
October 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
November 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
November 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 10, 2019
Actual (reported)January 10, 2020
Actual (reported)January 13, 2020
Actual (reported)October 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
November 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Change in platelet count
Proportion of subjects with a continuous platelet count ≤600×109/L or decrease ≥50% (\<1000×109/L ) (at least 12 weeks) from baseline during treatment will be evaluated.
From the start of study treatment (Day 1) up to the end of month 12
The complete hematologic response rates
From the start of study treatment (Day 1) up to the end of month 12
Time to response in platelet count
From the start of study treatment (Day 1) up to the end of month 12
Impact of therapy on key biomarkers
From the start of study treatment (Day 1) up to the end of month 12
Incidence of major cardiovascular and thrombotic events
From the start of study treatment (Day 1) up to the end of month 12
Incidence of development of myelodysplastic disorders, myelofibrosis, or leukemic transformation.
From the start of study treatment (Day 1) up to the end of month 12
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).
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).
Institute of Hematology & Blood Diseases Hospital
Tianjin, Tianjin Municipality, 300020, China
Lei Zhang, MD
Institute of Hematology & Blood Diseases Hospital, China
Rongfeng Fu
Institute of Hematology & Blood Diseases Hospital, China
First Submitted
December 10, 2019
First Posted
January 13, 2020
Study Start
January 10, 2020
Actual (reported)Primary Completion
October 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
November 20, 2024
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
July 3, 2024
Record last verified: 2024-04
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Source: ClinicalTrials.gov.
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