A single-arm, open-label, multicenter study to assess molecular response of P1101 therapy in patients with polycythemia vera and elevated hematocrit

Not Applicable

Recruiting

• Conditions: Neoplasms

• Registration Number: KCT0006138
• Lead Sponsor: The Catholic University of Korea, Seoul St. Mary's Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 27 June 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 93

Inclusion Criteria

1.19 years or older
2.Diagnosis of Polycythemia Vera according to the WHO 2016 criteria with the mandatory presence of JAK2V617F mutation as the major disease criterion.
3.Hematocrit >45%
4.Patients who require cytoreduction treatment
5. Signed written informed consent

Exclusion Criteria

1.Any contraindication to the pegylated interferon, or any systemic exposure to a non-pegylated or pegylated interferon alpha
2.Documented autoimmune disease at screening or in the medical history
3.Clinically relevant pulmonary infiltrates, pneumonia, and pneumonitis at screening
4.Systemic infections, e.g. hepatitis B, hepatitis C, or HIV at screening
5.Known PV-related thromboembolic complications in the abdominal area (e.g. portal vein thrombosis, Budd-chiari syndrome) and/or splenectomy in the medical history
6.Any investigational drug less than 6 weeks prior to the first dose of study drug or not recovered from effects of prior administration of any investigational agent
7. History or presence of depression requiring treatment with antidepressant
8.Any risk of suicide at screening or previous suicide attempts
9.Any significant morbidity or abnormality which may interfere with the study participation
10.Pregnancy and breast-feeding females of reproductive potential and males not using effective means of contraception
11.History of active substance or alcohol abuse within the last year
12.Evidence of severe retinopathy (e.g. cytomegalovirus retinitis, macular degeneration) or clinically relevant ophthalmological disorder (due to diabetes mellitus or hypertension)
13.Thyroid dysfunction not adequately controlled
14.History of major organ transplantation
15.History of uncontrolled severe seizure disorder
16.Leukocytopenia at the time of screening
17.Thrombocytopenia at the time of screening
18.History of malignant disease, including solid tumours and hematological malignancies (except Stage 0 chronic lymphocytic leukemia, basal cell, squamous cell, and superficial melanoma) within the last 3 years
19.Subjects who was judged by the investigator as not suitable for participation in this clinical trial

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate association between P1101’s efficacy and association with molecular response (as assessed by reduction in JAK2 Val617Phe allele burden)

Secondary Outcome Measures

Name	Time	Method
- To estimate P1101’s efficacy. - To examine time to disease response, disease response duration. - To evaluate the safety of ropeginterferon alfa-2b