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

Solasia Pharma

Status and phase: Completed; Phase 2

Conditions: Peripheral T-Cell Lymphoma

Treatments: Drug: SP-02L (darinaparsin for injection)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02653976

SP-02L02

Details and patient eligibility

About

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.

Enrollment: 67 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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67 participants in 1 patient group

SP-02L (darinaparsin for injection)

Experimental group

Treatment:

Drug: SP-02L (darinaparsin for injection)