Ignite Creation Date:
2024-05-06 @ 6:38 PM
Last Modification Date:
2024-10-26 @ 2:51 PM
Study NCT ID:
NCT05731245
Status:
RECRUITING
Last Update Posted:
2023-02-16
First Post:
2023-02-07
Brief Title:
Ropeginterferon Alfa 2b for Early MyelofibrosisDIPSS LowIntermediate-1 Risk Myelofibrosis
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Efficacy and Safety of Ropeginterferon Alfa-2b for Pre-fibrotic Primary Myelofibrosis and DIPSS LowIntermediate-1 Risk Myelofibrosis
Status:
RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-centre phase 2 open-label prospective study designed to assess the efficacy and safety of ropeg patients with pre-fibrotic primary myelofibrosis or DIPSS lowintermediate-1 risk myelofibrosis after 24 months of treatment
Detailed Description:
This is a multi-centre phase 2 open-label prospective study designed to assess the efficacy and safety of ropeg patients with pre-fibrotic primary myelofibrosis or DIPSS lowintermediate-1 risk myelofibrosis after 24 months of treatment In patients achieving any molecular response at 24 months treatment with ropeg will be continued until disease progression
After obtaining a written informed consent screening evaluations will be performed Eligibility will be determined based on the inclusion and exclusion criteria in section 6 of this protocol Subject visits will be scheduled regularly after recruitment for efficacy evaluations and safety assessments A safety follow-up will be scheduled 28 days after end-of-treatment visit Efficacy evaluations safety assessments and sample collection will be performed according to the schedule laid in section 2 in this protocol
Efficacy will be evaluated using laboratory assessment of haematological parameters physical examination for liver and spleen size assessment quantitative assessment of JAK2V617F CALR MPL and other driver mutations bone marrow examination and symptom burden assessment by MPN-SAF-TSS Quantitative assessment of JAK2V617F CALR MPL and other driver mutations will be performed using real-time quantitative PCR or ddPCR at the laboratory at the Department of Medicine the University of Hong Kong National Taiwan University Hospital and Chang Gung Memorial Hospital Chiayi
Safety evaluations will be performed using symptoms physical examination laboratory studies Chest X-rays ophthalmic assessment ECOG performance status and CTCAE version 50
After obtaining a written informed consent screening evaluations will be performed Eligibility will be determined based on the inclusion and exclusion criteria in section 6 of this protocol Subject visits will be scheduled regularly after recruitment for efficacy evaluations and safety assessments A safety follow-up will be scheduled 28 days after end-of-treatment visit Efficacy evaluations safety assessments and sample collection will be performed according to the schedule laid in section 2 in this protocol
Efficacy will be evaluated using laboratory assessment of haematological parameters physical examination for liver and spleen size assessment quantitative assessment of JAK2V617F CALR MPL and other driver mutations bone marrow examination and symptom burden assessment by MPN-SAF-TSS Quantitative assessment of JAK2V617F CALR MPL and other driver mutations will be performed using real-time quantitative PCR or ddPCR at the laboratory at the Department of Medicine the University of Hong Kong National Taiwan University Hospital and Chang Gung Memorial Hospital Chiayi
Safety evaluations will be performed using symptoms physical examination laboratory studies Chest X-rays ophthalmic assessment ECOG performance status and CTCAE version 50
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None