NCT03150602

A Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy

A Multi-Center, Open-Labelled, Pralatrexate Study in Asian Patients With Peripheral T-cell Lymphoma After Prior Therapy

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 22 (estimated)
• Sponsor: Taiwan Mundipharma Pharmaceuticals Ltd. · Industry
• Sex: All
• Age: 20 Years
• Healthy volunteers: Not accepted

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

Conditions

• Peripheral T Cell Lymphoma
• Progression, Disease

Interventions

Type	Name	Description
DRUG	Pralatrexate	This is a single arm study. Pralatrexate will be administered via IV over 3-5 minutes into a IV line containing normal saline (0.9% sodium chloride, NaCl) with the initial dose of 30 mg/m2/week on days 1, 8, 15, 22, 29, and 36 for 6 weeks in a 7-week cycle. The scheduled date can be done within a window time of plus or minus 1 day. The pralatrexate dose may be reduced to 20 mg/m2/week or omit if a patient experiences adverse events. Pralatrexate administration can be up to 5 cycles or until subject meets withdrawal criteria.

Timeline

• Start date: 2016-08-30
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2017-05-12
• Last updated: 2017-05-12

Locations

1 site across 1 country: Taiwan