臨床研究等提出・公開システム

A Multi-Center, Phase 2, Open-label, Parallel Cohort Study of Efficacy and Safety of Duvelisib in Patients with Relapsed or Refractory Peripheral T-cell Lymphoma (PTCL)

A Study of Duvelisib in Patients with Relapsed or Refractory Peripheral T cell Lymphoma (PTCL)

Yakult Honsha Co., Ltd.(ICCC)

1-10-30, Kaigan, Minato-ku, Tokyo

clinical_development@yakult.co.jp

Yakult Honsha Co., Ltd.(ICCC)

1-10-30, Kaigan, Minato-ku, Tokyo

+81-3-6625-8913

clinical_development@yakult.co.jp

completed

Mar. 23, 2020

Interventional

Multi-center, parallel cohort, open-label study

treatment purpose

2

-Pathologically-confirmed PTCL, as defined by the World Health Organization. Slides must be submitted for central pathology review. Results of central pathology review are not required prior to initiation of treatment.
-Received at least 2 cycles of one standard regimen for newly diagnosed advanced PTCL, and one of the following:
(a) failed to achieve at least a partial response after 2 or more cycles of standard therapy;
(b) failed to achieve a complete response after completion of standard therapy; and/or
(c) persistent or progressive disease after an initial response
-For patients with CD30+ ALCL, failed or are ineligible or intolerant to brentuximab vedotin
-Measurable disease as defined by Lugano for PTCL, i.e., at least 1 measurable disease lesion > 1.5 cm in at least one dimension by conventional techniques (18FDG-PET-CT, CT with contrast, MRI)

-Primary leukemic PTCL subtypes (i.e., T-cell prolymphocytic leukemia, T-cell large granular lymphocytic leukemia, adult T-cell leukemia/lymphoma and aggressive NK-cell leukemia) or transformed mycosis fungoides
-Received prior treatment with a phosphoinositide-3-kinase (PI3K) inhibitor
-Known central nervous system involvement by PTCL
-Ongoing treatment with chronic immunosuppressants (e.g., cyclosporine) or systemic steroids > 20 mg of prednisone (or equivalent) once daily (QD)
-Ongoing treatment for systemic bacterial, fungal, or viral infection at Screening

Both

Peripheral T-cell Lymphoma

investigational material(s)
Generic name etc : IPI-145
INN of investigational material : Duvelisib
Therapeutic category code : 429 Other antitumor agents
Dosage and Administration for Investigational material : Duvelisib PO BID continuously

control material(s)
Generic name etc : -
INN of investigational material : -
Therapeutic category code :
Dosage and Administration for Investigational material : -

efficacy
-ORR

safety
efficacy
-DOR
-Safety parameters
-PFS
-DCR
-OS
-PK parameters

+81-86-235-7534

Jan. 21, 2020