Phase 2 Study in Adult T-cell Leukemia/Lymphoma

JRCT ID: jRCT2071240011

Registered date:09/05/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Adult T-cell Leukemia/Lymphoma
• Date of first enrollment: 30/06/2024
• Target sample size: 20
• Study type: Interventional

Intervention(s)

This is a single-arm, open label, multicenter, uncontrolled study to evaluate the efficacy and safety of P1101 in Adult T-cell Leukemia/Lymphoma. The primary endpoint will be assessed 4, 8, 12, and 16 weeks after the first study treatment (Weeks 4, 8, 12, and 16).
The study consists of screening period, treatment period, and safety follow-up period. Subjects undergo the assessment and treatment with the study drug , regardless of whether they are hospitalized or outpatient.
The study drug should be administered subcutaneously every 2 weeks at an initial dose of 250 microgram (Day 1) and the dose will be increased to 500 microgram after Week 2.

Outcome(s)

• Primary Outcome: Response Proportion (RP)
• Secondary Outcome: Adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both
• Include criteria: Patients with a diagnosis of Adult T-cell Leukemia/Lymphoma
• Exclude criteria: Patients with previous use of IFN

Related Information

• Primary Sponsor: Shimoda Kazuya
• Secondary ID(s): Nil known