Phase 2
N=65
A Phase 2 Study of SP-02L in Patients With Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)
Peripheral T-Cell Lymphoma
Bottom Line
View on ClinicalTrials.gov: NCT02653976 ↗Enrolled (actual)
65
Serious AEs
46.2%
Results posted
Jan 2024
Primary outcome: Primary: Tumor Response (Central Assessment) — 19.3; 45.6 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- SP-02L (darinaparsin for injection) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Solasia Pharma K.K.
- Primary completion
- Oct 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Tumor Response (Central Assessment) |
19.3; 45.6 | — |
| SECONDARY Tumor Response (Local Assessment) |
26.3; 54.4 | — |
| SECONDARY Progression-Free Survival |
3.3 | — |
| SECONDARY Overall Survival |
17.4 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
64; 45; 41; 19 | — |
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.
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
Data sourced from ClinicalTrials.gov (NCT02653976). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.