A Phase 1 Study of SP-02L (Darinaparsin for Injection) in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
Phase 1
20 Years
N/A
20 Years
N/A
Open (Enrolling)
Both
Peripheral T-cell Lymphoma
Both
Peripheral T-cell Lymphoma
Trial Information
A Phase 1 Study of SP-02L (Darinaparsin for Injection) in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)
Inclusion Criteria:
- Japanese patients aged ≥ 20 years of age at the day of obtaining the informed consent
- Patients with histologically confirmed diagnosis of the following:
- Peripheral T-cell Lymphoma, not otherwise specified (PTCL-NOS)
- Anaplastic Large Cell Lymphoma (ALCL ALK-positive/negative)
- Angioimmunoblastic T-cell Lymphoma (AITL)
- Have relapsed or refractory to at least one prior systemic chemotherapy for the above
disease (currently requiring therapy)
- Have at least 1 evaluable lesion
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
- Life expectancy of at least 3 months
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
Incidence of dose-limiting toxicity and adverse events
Outcome Time Frame:
12 or 16 weeks
Safety Issue:
Yes
Authority:
Japan: Ministry of Health, Labor and Welfare
Study ID:
SP-02L01
NCT ID:
NCT01435863
Start Date:
September 2011
Completion Date:
December 2013
Related Keywords:
- Peripheral T-cell Lymphoma
- Lymphoma
- Lymphoma, T-Cell
- Lymphoma, T-Cell, Peripheral
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