Back to resultsA Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Primary Purpose
Peripheral T-Cell Lymphoma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
SP-02L (darinaparsin for injection)
Sponsored by
About this trial
This is an interventional treatment trial for Peripheral T-Cell Lymphoma
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
SP-02L (darinaparsin for injection)
Arm Description
Outcomes
Primary Outcome Measures
Tumor response
Secondary Outcome Measures
Progression-Free Survival
Overall Survival
Incidence of all adverse events including clinically significant changes in laboratory values and vital sign measurements
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02653976
Brief Title
A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Official Title
Asian Multinational Phase 2 Study of SP-02L (Darinaparsin for Injection) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
March 25, 2016 (Actual)
Primary Completion Date
October 11, 2020 (Actual)
Study Completion Date
June 17, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Solasia Pharma K.K.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral T-Cell Lymphoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
67 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SP-02L (darinaparsin for injection)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
SP-02L (darinaparsin for injection)
Intervention Description
Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days
Primary Outcome Measure Information:
Title
Tumor response
Time Frame
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 Measure Information:
Title
Progression-Free Survival
Time Frame
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.
Title
Overall Survival
Time Frame
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.
Title
Incidence of all adverse events including clinically significant changes in laboratory values and vital sign measurements
Time Frame
From the date of first dosing of study drug to the completion of all follow-up procedures. Duration is approximately 6 months.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
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
Facility Information:
City
Hong Kong
Country
Hong Kong
City
Nagoya
State/Province
Aichi
Country
Japan
City
Yoshida-gun
State/Province
Fukui
Country
Japan
City
Isehara
State/Province
Kanagawa
Country
Japan
City
Yokohama
State/Province
Kanagawa
Country
Japan
City
Sendai
State/Province
Miyagi
Country
Japan
City
Suita
State/Province
Osaka
Country
Japan
City
Chuo-ku
State/Province
Tokyo
Country
Japan
City
Koto-ku
State/Province
Tokyo
Country
Japan
City
Minato-ku
State/Province
Tokyo
Country
Japan
City
Fukuoka
Country
Japan
City
Gifu
Country
Japan
City
Okayama
Country
Japan
City
Goyang-si
State/Province
Gyeonggi-do
Country
Korea, Republic of
City
Hwasun-gun
State/Province
Jeollanam-do
Country
Korea, Republic of
City
Gangnam-gu
State/Province
Seoul
Country
Korea, Republic of
City
Nowon-gu
State/Province
Seoul
Country
Korea, Republic of
City
Seodaemun-gu
State/Province
Seoul
Country
Korea, Republic of
City
Songpa-gu
State/Province
Seoul
Country
Korea, Republic of
City
Beitou
State/Province
Taipei
Country
Taiwan
City
Zhongzheng
State/Province
Taipei
Country
Taiwan
City
Taichung
Country
Taiwan
City
Tainan
Country
Taiwan
City
Taoyuan
Country
Taiwan
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
We'll reach out to this number within 24 hrs