臨床研究等提出・公開システム

Date of registration	May. 09, 2024
Last modified on	May. 09, 2024
Trial ID	jRCT2071240011

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

Contact for Scientific Queries	Name	Shimoda Kazuya
	Affiliation	University of Miyazaki Hospital
	Address	5200, Kihara, Kiyotake-cho, Miyazaki, 889-1692, Japan
	Telephone	+81-985-85-1510
	E-mail	kshimoda@med.miyazaki-u.ac.jp
Contact for Public Queries	Name	Sato Mai
	Affiliation	PharmaEssentia Japan K.K.
	Address	1-3-13 Motoakasaka, Minato-ku, Tokyo, 107-0051, Japan
	Telephone	+81-3-6910-5103
	E-mail	mai_sato@pharmaessentia.com

Recruitment status	Recruiting

Anticipated date of first enrollment		June. 30, 2024
Target sample size		20
Study Type		Interventional
Study Design	allocation	single arm study
	masking	single blind
	control	uncontrolled control
	assignment	single assignment
	purpose	treatment purpose
Key inclusion & exclusion criteria	Inclusion Criteria	Patients with a diagnosis of Adult T-cell Leukemia/Lymphoma
	Exclusion Criteria	Patients with previous use of IFN
	Age Minimum	18age old over
	Age Maximum	No limit
	Gender	Both
Health Condition(s) or Problem(s) Studied		Adult T-cell Leukemia/Lymphoma
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.
Health Condition(s) Keyword		Myeloproliferative nemoplasms
Primary Outcome(s)		Response Proportion (RP)
Secondary Outcome(s)		Adverse events based on Common Terminology Criteria for Adverse Events (CTCAE) version 5.0

Primary Sponsor	PharmaEssentia Japan KK

Secondary Sponsor

Name of Certified Review Board	Saga University Hospital Institutional Review Board
Address	5-1-1 Nabeshima, Saga City, Saga 849-8501, Japan, Saga
Telephone	+81-952-34-3400
Approval Status	Approval
Date of approval	April. 01, 2024

Plan to share IPD	No

Secondary ID(s)	なし

Countries of Recruitment（Except Japan）	none