At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 67 enrolled
Drug / intervention
SP-02L (darinaparsin for injection)drug
Likely dose
Darinaparsin 300 mg/m² once daily for 5 consecutive days every 21 daysAI-extracted
Key inclusion· 7
- ✓Histologically confirmed PTCL-NOS, AITL, or ALCL (ALK-positive or -negative)
- ✓Relapsed or refractory disease with at least one prior systemic antitumor regimen
- ✓At least 1 measurable lesion
- ✓ECOG performance status 0–2
Key exclusion· 0
None specified.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Asian Multinational Phase 2 Study of SP-02L (Darinaparsin for Injection) in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
In Brief
A Phase 2 clinical trial evaluating SP-02L (darinaparsin for injection) for Peripheral T-Cell Lymphoma. Completed, enrolled 67 participants across 24 sites in 4 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPeripheral T-Cell Lymphoma
CountriesHong Kong, Japan, South Korea, Taiwan
Collaborators--
Timeline
Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedJan 2016
Enrollment StartMar 2016
Primary CompletionOct 2020
Study CompletionJun 2021
TodayJul 2026
First PostedJan 13, 2016
Enrollment StartMar 25, 2016
Primary CompletionOct 11, 2020
Study CompletionJun 17, 2021
TodayJul 2, 2026
Enrollment to primary: 4.5 yearsPosted 10.5 years ago
Interventions
SP-02L (darinaparsin for injection)drug
Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days