A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Study Overview
=================
Brief Summary
-----------------
This study is a phase 2 multinational, multicenter, single-arm, open-label, non-randomized study to evaluate the efficacy and safety of SP-02L monotherapy in relapsed or refractory patients with peripheral T-cell lymphoma.

Official Title
-----------------
Asian Multinational Phase 2 Study of SP-02L (Darinaparsin for Injection) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

Conditions
-----------------
Peripheral T-Cell Lymphoma

Intervention / Treatment
-----------------
* Drug: SP-02L (darinaparsin for injection)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a Japanese, Korean, Taiwanese, or Chinese ethnic background of each country/region Patients aged ≥20 years on the date of informed consent Patients with histologically confirmed diagnosis of one of the following: Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS) Angioimmunoblastic T-cell Lymphoma (AITL) Anaplastic large cell lymphoma (ALCL), (ALK-positive/negative) Relapsed or refractory patients with a treatment history of at least one regimen with antitumor agents for the above disease Have at least 1 measurable lesion Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 Patients with a life expectancy of at least 3 months as determined by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SP-02L (darinaparsin for injection)<br> | Drug: SP-02L (darinaparsin for injection)<br>* Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor response |  | Change from screening period in tumor response assessed at the end of every 3 cycles from the date of first dosing of study drug, and at the end of treatment visit. Duration is approximately 6 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-Free Survival |  | Change from screening period in tumor response assessed at the end of every 3 cycles from the date of first dosing of study drug, and every 3 months after the end of treatment visit until documented disease progression. Duration is approximately 1 year. | 
| Overall Survival |  | Survival follow-up from the date of first dosing of study drug until the date of death from any cause, assessed up to 2 years. | 
| Incidence of all adverse events including clinically significant changes in laboratory values and vital sign measurements |  | From the date of first dosing of study drug to the completion of all follow-up procedures. Duration is approximately 6 months. |