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

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ClinicalTrials.gov Identifier: NCT05395507
Recruitment Status : Recruiting
First Posted : May 27, 2022
Last Update Posted : July 19, 2022
Sponsor:
Information provided by (Responsible Party):
Zhang Lei, Institute of Hematology & Blood Diseases Hospital

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.

Condition or disease Intervention/treatment Phase
Essential Thrombocytopenia Drug: Recombinant Interferon Alpha Drug: Pegylated interferon alfa-2b Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 194 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Prospective, Multicenter, Randomized Controlled Clinical Trial of Pegylated Interferon Alfa-2b Versus Interferon Alfa Therapy in the Treatment of Adult Essential Thrombocythemia
Actual Study Start Date : June 1, 2022
Estimated Primary Completion Date : March 31, 2025
Estimated Study Completion Date : June 30, 2025


Arm Intervention/treatment
Active Comparator: 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.
Drug: 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.

Experimental: 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.
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.




Primary Outcome Measures :
  1. Complete hematological remission (CHR) rates [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52 ]
    The CHR rates defined as European Leukemia Net will be compared between the two groups.


Secondary Outcome Measures :
  1. CHR rates at week 24 and 36 [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 24 and Week 36, respectively ]
    The CHR rates at week 24 and 36 will be compared between the two groups

  2. Time to CHR [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    The time of reaching CHR will be compared between the two groups

  3. The proportion of patients crossed to the contralateral group [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    The proportion of patients crossed to the contralateral group will be compared between the two groups

  4. The CHR rates after crossover [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    The CHR rates within 52 weeks after crossover

  5. Impact of therapy on driver mutations [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    To compare the proportion of subjects that display change on key biomarkers of the disease- JAK2V617F, CALR, MPL mutations.

  6. Impact of therapy on non-driver mutations [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    To compare the proportion of subjects that display change on key non-driver biomarkers of the disease-DNMT3A, ASXL1, TET2 or other mutations.

  7. Change of splenomegaly [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    To compare the proportion of subject with improvement and no progress rate of splenomegaly between the two groups.

  8. Change of bone marrow pathology [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    To compare the rate of patients with improvement and no progress rate of bone marrow pathology between the two groups

  9. The incidence of major thrombotic events [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    To compare the incidence of major thrombotic events between the two groups.

  10. The incidence of major bleeding events [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    To compare the incidence of major bleeding events between the two groups.

  11. The incidence of progressing to bone marrow fibrosis [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    The incidence of progressing to bone marrow fibrosis will be compared between the two groups

  12. The incidence of progressing to acute leukemia [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    The incidence of progressing to acute leukemia will be compared between the two groups

  13. Change in Myeloproliferative Neoplasm Symptom Assessment Form total symptom score [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    To compare the proportion of subjects that display change in Myeloproliferative Neoplasm Symptom Assessment Form total symptom score (0-100 scores, higher scores mean a worse outcome) between different treatment groups.

  14. Change of quality of life [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    Compare the rate of patients with improvement in quality of life between the two groups (assessed by EORTC quality of life scale QLQ-C30 V3.0 questionnaire).

  15. Change of microcirculation disturbance [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    The rate of patients with improvement in microcirculation disturbance (such as pruritus, headache, dizziness, chest tightness, erythematous limb pain and limb paresthesia) will be compared between the two groups

  16. Specific pre-defined toxicity [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    To compare incidence of specific pre-defined toxicity including fatigue, flu-like symptoms, dizziness, injection site necrosis, dyspnea, pain, depression, blurred Vision, insomnia, anorexia, weight Loss, weakness, pruritis, sweating, fever, decreased Libido, hot Flashes, flushing.


Other Outcome Measures:
  1. Changes of immune cell subgroups [ Time Frame: From the start of study treatment (Week 0) up to the end of Week 52. ]
    The proportion of T lymphocyte, B lymphocyte and dendritic cell subsets and the changes of gene expression profile of these cells will be analyzed before and after treatment.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05395507


Contacts
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Contact: Lei Zhang, MD 8602223909240 zhanglei1@ihcams.ac.cn

Locations
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China, Tianjin
Institute of Hematology & Blood Diseases Hospital Recruiting
Tianjin, Tianjin, China, 300020
Sponsors and Collaborators
Institute of Hematology & Blood Diseases Hospital
Investigators
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Principal Investigator: Lei Zhang, MD Institute of Hematology & Blood Diseases Hospital
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Responsible Party: Zhang Lei, Professor/Vice director of Thrombosis &Hemostasis Center, Institute of Hematology & Blood Diseases Hospital
ClinicalTrials.gov Identifier: NCT05395507    
Other Study ID Numbers: Peg-IFNα-ET-2022
First Posted: May 27, 2022    Key Record Dates
Last Update Posted: July 19, 2022
Last Verified: July 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Zhang Lei, Institute of Hematology & Blood Diseases Hospital:
Essential Thrombocytopenia
Interferon Alfa
Pegylated Interferon Alfa-2b
Efficacy
Safety
Additional relevant MeSH terms:
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Thrombocytopenia
Thrombocytosis
Thrombocythemia, Essential
Blood Platelet Disorders
Hematologic Diseases
Myeloproliferative Disorders
Bone Marrow Diseases
Blood Coagulation Disorders
Hemorrhagic Disorders
Interferons
Interferon-alpha
Interferon alpha-2
Peginterferon alfa-2b
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs