ClinicalTrials.Veeva

Menu

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

S

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)

67 participants in 1 patient group

SP-02L (darinaparsin for injection)
Experimental group
Treatment:
Drug: SP-02L (darinaparsin for injection)

Trial documents
2

Trial contacts and locations

24

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems