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

Phase 2

Completed

• Conditions: Peripheral T-Cell Lymphoma
• Interventions: Drug: SP-02L (darinaparsin for injection)

• Registration Number: NCT02653976
• Lead Sponsor: Solasia Pharma K.K.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-12-25
• Study First Submitted QC: 2016-01-10
• Study First Posted: 2016-01-13
• Study Start: 2016-03-25
• Primary Completion: 2020-10-11
• Study Completion: 2021-06-17
• Results First Submitted: 2022-07-01
• Status Verified: 2023-05
• Results First Submitted QC: 2023-05-15
• Last Update Submitted: 2023-05-15
• Results First Posted: 2024-01-26
• Last Update Posted: 2024-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
SP-02L (darinaparsin for injection)	SP-02L (darinaparsin for injection)	-

Primary Outcome Measures

Name	Time	Method
Tumor Response (Central Assessment)	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.	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.

Secondary Outcome Measures

Name	Time	Method
Tumor Response (Local Assessment)	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.	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.
Progression-Free Survival	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.	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.
Overall Survival	Survival follow-up was performed for 2 years from the date of first dosing of study drug. Maximum duration was 24.9 months.	Overall Survival was the duration of time from the first day of study drug administration to the date of death from any cause.
Number of Participants With Adverse Events (AEs)	From the date of first dosing of study drug to the completion of all follow-up procedures. Maximum duration was 42.4 months.	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).