A Prospective, Multicenter, Randomized Controlled Clinical Trial of Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in the Treatment of Adult Essential Thrombocythemia
Sponsor study identifier
interventional
194
1 country
1
Study Start
June 1, 2022
Actual (reported)Primary Completion
March 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
June 30, 2025
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 Adult patients (≥18 years) diagnosed as essential thrombocythemia treated with the Pegylated Interferon Alfa-2b vs. Interferon Alfa. Study Design: A prospective, open-label, multicenter, randomized controlled clinical trial.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
June 30, 2025
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.
May 10, 2022
Actual (reported)May 27, 2022
Actual (reported)June 1, 2022
Actual (reported)March 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
June 30, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Complete hematological remission (CHR) rates
The CHR rates defined as European Leukemia Net will be compared between the two groups.
From the start of study treatment (Week 0) up to the end of Week 52
CHR rates at week 24 and 36
From the start of study treatment (Week 0) up to the end of Week 24 and Week 36, respectively
Time to CHR
From the start of study treatment (Week 0) up to the end of Week 52.
The proportion of patients crossed to the contralateral group
From the start of study treatment (Week 0) up to the end of Week 52.
The CHR rates after crossover
From the start of study treatment (Week 0) up to the end of Week 52.
Impact of therapy on driver mutations
From the start of study treatment (Week 0) up to the end of Week 52.
Changes of immune cell subgroups
From the start of study treatment (Week 0) up to the end of Week 52.
Recombinant Interferon Alpha, with an initial dose of 300 wu three times a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available.
Pegylated Interferon Alfa-2b, with an initial dose of 135 ug at week 0 , and then 180 ug once a week from week 1 to week 52.
Recombinant Interferon Alpha, with an initial dose of 300 wu three times a week. Other interferons that have been listed can be used if Recombinant Interferon Alpha (300 wu) is not available.
Pegylated Interferon Alfa-2b, with an initial dose of 135 ug at week 0 , and then 180 ug once a week from week 1 to week 52.
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
Rong Fu
Tianjin Medical University General Hospital
First Submitted
May 10, 2022
First Posted
May 27, 2022
Study Start
June 1, 2022
Actual (reported)Primary Completion
March 31, 2025
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
June 30, 2025
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: 2023-11
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Source: ClinicalTrials.gov.
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