A Phase 1 Study of SP-02L in Relapsed or Refractory Patients With Peripheral T-cell Lymphoma (PTCL)

Solasia Pharma

Status and phase: Completed; Phase 1

Conditions: Peripheral T-cell Lymphoma

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT01435863

SP-02L01

Details and patient eligibility

About

The purpose of this study is to evaluate the safety and tolerability of SP-02L monotherapy in Japanese patients with relapsed or refractory Peripheral T-cell Lymphoma (PTCL).

Enrollment: 17 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

SP-02L

Experimental group

Treatment:

Drug: SP-02L (darinaparsin for injection)

Drug: SP-02L (darinaparsin for injection)

Drug: SP-02L (darinaparsin for injection)