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

• Status: Completed
• Trial end date: 2021-06-17
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Solasia Pharma K.K.

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