Clinical trial · Interventional
A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea
A Phase 1 Study of SP-02L (Darinaparsin for Injection) in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL) in Korea
NCT01689220CI-TRIAL-00015537completedPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Korean patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Peripheral T-cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| SP-02L (darinaparsin for injection) | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- SP-02L
- interventionNames
- Drug: SP-02L (darinaparsin for injection)
Primary outcomes (1)
- measure
- Incidence of dose-limiting toxicity and adverse events
- timeFrame
- 12 or 16 weeks
Secondary outcomes (2)
- measure
- Tumor response (overall response)
- timeFrame
- 2 and 4 cycles
- measure
- Plasma concentration-time profile
- timeFrame
- 0, 0.5, 1, 2, 4, 8 hours post-dose on Day 1 and 5, and 0 hour on Day 2, 3, 4, 6, 8 and 15
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Korean patients aged ≥ 20 years of age at the day of obtaining the informed consent * Patients with histologically confirmed diagnosis of the following: * PTCL, not otherwise specified (PTCL-NOS) * Anaplastic Large Cell Lymphoma (ALCL ALK-positive/negative) * Angioimmunoblastic T-cell Lymphoma (AITL) * Have relapsed or refractory to at least one prior systemic chemotherapy for the above disease (currently requiring therapy) * Have at least 1 evaluable lesion * Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 * Life expectancy of at least 3 months
References
Publications (1)
- DERIVEDOgura M, Kim WS, Uchida T, Uike N, Suehiro Y, Ishizawa K, Nagai H, Nagahama F, Sonehara Y, Tobinai K. Phase I studies of darinaparsin in patients with relapsed or refractory peripheral T-cell lymphoma: a pooled analysis of two phase I studies conducted in Japan and Korea. Jpn J Clin Oncol. 2021 Feb 8;51(2):218-227. doi: 10.1093/jjco/hyaa177. PMID 33051668