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

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

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.

Study Overview

• Status: Completed
• Conditions: Peripheral T-Cell Lymphoma
• Intervention / Treatment: Drug: SP-02L (darinaparsin for injection)

• Study Type: Interventional
• Enrollment (Actual): 67
• Phase: Phase 2

Contacts and Locations

Study Locations

• Hong Kong
  • Hong Kong, Hong Kong
• Japan
  • Fukuoka, Japan
  • Gifu, Japan
  • Okayama, Japan
  • Aichi
    • Nagoya, Aichi, Japan
  • Fukui
    • Yoshida-gun, Fukui, Japan
  • Kanagawa
    • Isehara, Kanagawa, Japan
    • Yokohama, Kanagawa, Japan
  • Miyagi
    • Sendai, Miyagi, Japan
  • Osaka
    • Suita, Osaka, Japan
  • Tokyo
    • Chuo-ku, Tokyo, Japan
    • Koto-ku, Tokyo, Japan
    • Minato-ku, Tokyo, Japan
• Korea, Republic of
  • Gyeonggi-do
    • Goyang-si, Gyeonggi-do, Korea, Republic of
  • Jeollanam-do
    • Hwasun-gun, Jeollanam-do, Korea, Republic of
  • Seoul
    • Gangnam-gu, Seoul, Korea, Republic of
    • Nowon-gu, Seoul, Korea, Republic of
    • Seodaemun-gu, Seoul, Korea, Republic of
    • Songpa-gu, Seoul, Korea, Republic of
• Taiwan
  • Taichung, Taiwan
  • Tainan, Taiwan
  • Taoyuan, Taiwan
  • Taipei
    • Beitou, Taipei, Taiwan
    • Zhongzheng, Taipei, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Response (Central Assessment)	Central assessments of tumor response were performed by the Efficacy and Safety review Committee according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on computed tomography (CT) and fluorodeoxyglucose-positron emission tomography (FDG-PET) findings. Overall Response Rate was defined as the percentage of participants who achieved Complete Response (CR, disappearance of all evidence of disease) or Partial Response (PR, regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or Stable Disease (SD) as their best response.	Central assessments of tumor response were performed every 3 cycles, and/or at the end of treatment visit, during 6-cycle treatment period. The best response was determined during 6-cycle treatment period. Maximum duration of assessments was 5.3 months.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tumor Response (Local Assessment)	Local assessments of tumor response were performed by individual site investigators according to the Revised Response Criteria for Malignant Lymphoma developed in 2007 based on CT and FDG-PET findings. Overall Response Rate was defined as the percentage of participants who achieved CR (disappearance of all evidence of disease) or PR (regression of measurable disease and no new sites) as their best response. Disease Control Rate is defined as the percentage of participants who achieved CR, PR or SD as their best response.	Local assessments of tumor response were performed at the end of every 3 cycles, and/or at the end of treatment visit. The best response was determined during the entire treatment period. Maximum duration of assessments was 42.4 months.
Progression-Free Survival	Progression-Free Survival was the duration of time from the first day of study drug administration to the date of Progressive Disease (PD) based on local assessment or the date of death from any cause, which occurs earlier. PD was defined using the Revised Response Criteria for Malignant Lymphoma developed in 2007, as any new lesion or increase by ≥ 50% of previously involved sites from nadir.	Tumor response was assessed at the end of every 3 cycles until documented PD. Maximum duration as of the cut-off date for data lock was 42.4 months.
Overall Survival	Overall Survival was the duration of time from the first day of study drug administration to the date of death from any cause.	Survival follow-up was performed for 2 years from the date of first dosing of study drug. Maximum duration was 24.9 months.
Number of Participants With Adverse Events (AEs)	AE was defined as any untoward medical occurrence in a participant administered the study drug. AE included clinically significant changes in laboratory values, vital signs, and electrocardiograms. Drug-related AE was defined as AE that there was at least a reasonable possibility to have the causal relationship to the study drug. The severity of AE was evaluated by the investigator according to Common Terminology Criteria for Adverse Events (Version 4.0) where Grade 1 (mild), Grade 2 (moderate), Grade 3 (severe or medically significant but not immediately life-threatening), Grade 4 (life-threatening consequences) and Grade 5 (death related to AE).	From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.

Collaborators and Investigators

• Sponsor: Solasia Pharma K.K.

Study record dates

Study Major Dates

• Study Start (Actual): March 25, 2016
• Primary Completion (Actual): October 11, 2020
• Study Completion (Actual): June 17, 2021

Study Registration Dates

• First Submitted: December 25, 2015
• First Submitted That Met QC Criteria: January 10, 2016
• First Posted (Estimated): January 13, 2016

Study Record Updates

• Last Update Posted (Actual): January 26, 2024
• Last Update Submitted That Met QC Criteria: May 15, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, T-Cell; Lymphoma, T-Cell, Peripheral
• Other Study ID Numbers: SP-02L02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO