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

Solasia Pharma K.K.67 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Peripheral T-Cell Lymphoma

Interventions

SP-02L (darinaparsin for injection)DRUG

Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

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

Locations (24)

Unnamed facility

Hong Kong, Hong Kong

Unnamed facility

Nagoya, Aichi-ken, Japan

Unnamed facility

Yoshida-gun, Fukui, Japan

Outcomes

Primary Outcomes

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.

Time frame: 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 Outcomes

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.

Time frame: 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.

Data from ClinicalTrials.gov

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