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

NCT05395507 | Unknown Phase 2

• 1 other identifier: IIT2022004
• Study Type: interventional
• Target: 194
• Locations: 1 country
• Sites: 1

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.

Conditions

Essential Thrombocytopenia

Keywords

Essential Thrombocytopenia; Interferon Alfa; Pegylated Interferon Alfa-2b; Efficacy; Safety

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (16)

• 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.

Other Outcomes (1)

• Changes of immune cell subgroups

  From the start of study treatment (Week 0) up to the end of Week 52.

Study Arms (2)

Recombinant Interferon Alpha

ACTIVE COMPARATOR

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.

Drug: Recombinant Interferon Alpha

Pegylated Interferon Alfa-2b

EXPERIMENTAL

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.

Drug: Pegylated interferon alfa-2b

Interventions

Recombinant Interferon Alpha 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.

Recombinant Interferon Alpha

Pegylated interferon alfa-2b 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.

Pegylated Interferon Alfa-2b

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

Study Sites (1)

Institute of Hematology & Blood Diseases Hospital

Tianjin, Tianjin Municipality, 300020, China

RECRUITING

MeSH Terms

Interventions

peginterferon alfa-2b

Study Officials

• Lei Zhang, MD

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

• Rongfeng Fu

  Institute of Hematology & Blood Diseases Hospital, China

  PRINCIPAL INVESTIGATOR

• Rong Fu

  Tianjin Medical University General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lei Zhang, MD

CONTACT

8602223909240; zhanglei1@ihcams.ac.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2022
• First Posted: May 27, 2022
• Study Start: June 1, 2022
• Primary Completion: March 31, 2025
• Study Completion: June 30, 2025
• Last Updated: July 3, 2024

Record last verified: 2023-11

Locations

CN (1)