Ignite Creation Date:
2025-12-25 @ 4:03 AM
Ignite Modification Date:
2026-03-09 @ 4:04 AM
Study NCT ID:
NCT03150602
Status:
UNKNOWN
Last Update Posted:
2017-05-12
First Post:
2017-05-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy
Sponsor:
Taiwan Mundipharma Pharmaceuticals Ltd.
Organization:
Study Overview
Official Title:
A Multi-Center, Open-Labelled, Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy
Status:
UNKNOWN
Status Verified Date:
2017-05
Last Known Status:
RECRUITING
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 study is to evaluate the objective response rate to pralatrexate in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)
Detailed Description:
Peripheral T-cell lymphomas (PTCL) are a group of aggressive and diverse lymphoproliferative disorders. It is characterized by the presence of malignant mature T-cells or NK cells. There is as yet no consensus regarding standard frontline or relapsed/refractory therapy for PTCL.
A previous phase II study conducted in US showed durable responses of pralatrexate treatment in relapsed or refractory PTCL, irrespective of age, histological subtypes, amount of prior therapy, prior methotrexate, and prior autologous stem-cell transplant. This single-arm, multi-center study aims to evaluate the efficacy and safety of pralatrexate monotherapy in prior treatment failure PTCL patients who may undergo HSCT in case of CR or PR, or continue pralatrexate in case of CR, PR or SD.
Primary objective:
* To evaluate the objective response rate to pralatrexate in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)
Secondary objectives:
* To determine the safety of pralatrexate in Asian PTCL patients by,
* Incidence of adverse events (AEs) and serious adverse events (SAEs) emergent from the treatment
* To evaluate the efficacy of pralatrexate in Asian PTCL patients after prior treatment failure by,
* Overall survival (OS), progression-free-survival (PFS), complete response (CR) and partial response (PR) rate, and duration of CR and PR
* Treatment duration with pralatrexate in the patients without hematopoietic stem cell transplant (HSCT) who achieve CR or PR
* Percentage of patients who undergo HSCT
* 1-year OS, 1-year PFS, and 1-year relapse rate after HSCT
* 2-year OS, 2-year PFS, and 2-year relapse rate after HSCT
A previous phase II study conducted in US showed durable responses of pralatrexate treatment in relapsed or refractory PTCL, irrespective of age, histological subtypes, amount of prior therapy, prior methotrexate, and prior autologous stem-cell transplant. This single-arm, multi-center study aims to evaluate the efficacy and safety of pralatrexate monotherapy in prior treatment failure PTCL patients who may undergo HSCT in case of CR or PR, or continue pralatrexate in case of CR, PR or SD.
Primary objective:
* To evaluate the objective response rate to pralatrexate in Asian PTCL patients after prior treatment failure, as determined by independent imaging reviewer(s) using international workshop lymphoma response criteria (IWC)
Secondary objectives:
* To determine the safety of pralatrexate in Asian PTCL patients by,
* Incidence of adverse events (AEs) and serious adverse events (SAEs) emergent from the treatment
* To evaluate the efficacy of pralatrexate in Asian PTCL patients after prior treatment failure by,
* Overall survival (OS), progression-free-survival (PFS), complete response (CR) and partial response (PR) rate, and duration of CR and PR
* Treatment duration with pralatrexate in the patients without hematopoietic stem cell transplant (HSCT) who achieve CR or PR
* Percentage of patients who undergo HSCT
* 1-year OS, 1-year PFS, and 1-year relapse rate after HSCT
* 2-year OS, 2-year PFS, and 2-year relapse rate after HSCT
Study Oversight
Has Oversight DMC:
False
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?:
None
Is an FDA AA801 Violation?: