None listed
Conditions
Interventions
Drug : The treatment-free remission rate was investigated during follow-up for 3 years after discontinuation of P1101 (ropeginterferon alfa-2b) treatment. Patients with hematologic relapse (defined as
Sponsors
The Catholic University of Korea, Seoul St. Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects who meet all of the following criteria can participate in this clinical trial: 1) Those who have completed all procedures and visits (up to Visit 16) of the PV IIT clinical trial (Protocol no. IIT-KR-2020-001) 2) Those who have achieved CHR for at least two consecutive visits (around 24 weeks) as of the end visit (Visit 16) of the PV IIT clinical trial 3) Those who have received a detailed explanation of this clinical trial, voluntarily consented in writing to the subject consent form, and are capable of complying with the clinical trial requirements
Exclusion criteria
Exclusion criteria: Subjects cannot participate in this clinical trial if any of the following criteria apply (if they meet the dropout criteria specified in the PV IIT clinical trial). 1) Disease progression (progression to sMF or sAML) as assessed by the investigator 2) Failure to follow the investigator's instructions 3) Worsening of the underlying disease (major disease-related morbidity) in a situation where participation in the clinical trial (through dose adjustment to another treatment group) is no longer expected to provide sufficient medical care to the subject 4) Medical conditions unrelated to the underlying disease or the investigational product (i.e., the subject's condition has changed so that the investigator determines that further participation in the clinical trial is no longer possible for safety or ethical reasons) 5) When conducting the clinical trial is difficult due to an adverse event (AE) 6) When the investigator determines that the clinical trial should be discontinued 7) Pregnant or lactating women or women and men of childbearing potential who plan to become pregnant during this clinical trial or do not intend to use appropriate contraception
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the feasibility of maintaining treatment-free remission (TFR) in Polycythemia Vera patients with sustained complete hematologic response (as defined by two consecutive complete hematologic response) after discontinuing ropeginterferon, stratified by their molecular response at the time of discontinuation;To assess an association between moleular response (MR) and treatment-free remission (TFR) at the time point of discontinuation of ropeginterferon alfa-2b | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine the pattern of CHR and disease progression after discontinuation of ropeginterferon alfa-2b ;To assess the time to re-achieve complete hematologic response (CHR) after rechallenging ropeginterferon alfa-2b ;To confirm the absence of resistance to rechallenging ropeginterferon alfa-2b in subjects who experienced CHR loss;To identify clinical or genetic prognostic factors associated with CHR maintenance. | — |
Countries
Korea, Republic of
Contacts
Public ContactSung-Eun Lee
The Catholic University of Korea, Seoul St. Mary's Hospital
Outcome results
None listed