Phase 2 Study in Adult T-cell Leukemia/Lymphoma

A Phase II, Single-Arm, Multicenter Study to Evaluate the Efficacy and Safety of Ropeginterferon alfa-2b (P1101) in Adult T-cell Leukemia/Lymphoma

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2071240011

Enrollment

Registered

2024-05-09

Start date

2024-06-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adult T-cell Leukemia/Lymphoma Myeloproliferative nemoplasms

Interventions

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 1

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with a diagnosis of Adult T-cell Leukemia/Lymphoma

Exclusion criteria

Exclusion criteria: Patients with previous use of IFN

Design outcomes

Primary

Measure	Time frame
Response Proportion (RP)	—

Secondary

Measure	Time frame
Adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0	—

Contacts

Public ContactMai Sato

PharmaEssentia Japan K.K.

mai_sato@pharmaessentia.com+81-3-6910-5103

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026