Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in Adult Essential Thrombocythemia

NCT ID: NCT05395507

Last Updated: 2024-07-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 194 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2025-06-30

Brief Summary

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.

Detailed Description

This is a prospective, open-label, multicenter, randomized controlled clinical trial between Interferon Alfa and Pegylated Interferon Alfa-2b in adult essential thrombocythemia (≥18 years).

Patients will be randomly divided into the following two treatment groups: 1. 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. 2. 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.

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 or resistance occurs.

Conditions

Essential Thrombocytopenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Recombinant Interferon Alpha

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.

Group Type: ACTIVE_COMPARATOR

Recombinant Interferon Alpha

Intervention Type: DRUG

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

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.

Group Type: EXPERIMENTAL

Pegylated interferon alfa-2b

Intervention Type: DRUG

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.

Interventions

Recombinant Interferon Alpha

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.

Intervention Type: DRUG

Pegylated interferon alfa-2b

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• ≥18 years old.
• Male or Female.
• Diagnosis of essential thrombocythemia according to the 2016 World Health Organization criteria.
• Those who have not use interferon within 4 weeks before the first medication.
• Patients with indications for cytoreductive therapy.
• Men and women with reproductive potential, as well as all women with menopause less than 2 years, must agree to use acceptable contraceptive methods until 28 days after the last dose of study drug, and women must agree not to breastfeed during the study period.
• Voluntary written informed consent.

Exclusion Criteria

• Resistance, or intolerance, or any contraindications to interferon.
• Patients with active thrombosis or active bleeding.
• Neutrophil count < 1.0x10^9/L.
• Hemoglobin < 11g/dL for male, or < 10g/dL for female.
• 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 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institute of Hematology & Blood Diseases Hospital, China

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lei Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, China

Rongfeng Fu

Role: PRINCIPAL_INVESTIGATOR

Institute of Hematology & Blood Diseases Hospital, China

Rong Fu

Role: PRINCIPAL_INVESTIGATOR

Tianjin Medical University General Hospital

Locations

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Lei Zhang, MD

Role: CONTACT

zhanglei1@ihcams.ac.cn

8602223909240

Other Identifiers

IIT2022004

Identifier Type: -

Identifier Source: org_study_id