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

NCT02653976 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 67

Last updated 2024-01-26

Study results available
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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.

Conditions

  • Peripheral T-Cell Lymphoma

Interventions

DRUG

SP-02L (darinaparsin for injection)

Darinaparsin 300 mg/m2 once daily for 5 consecutive days every 21 days

Sponsors & Collaborators

  • Solasia Pharma K.K.

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-03-25
Primary Completion
2020-10-11
Completion
2021-06-17

Countries

  • Hong Kong
  • Japan
  • South Korea
  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02653976 on ClinicalTrials.gov