臨床研究等提出・公開システム

Phase II clinical study of leucovorin in combination with pralatrexate in Japanese relapsed/refractory peripheral T-cell lymphoma patients

Study PDX-LV

No

MUNDIPHARMA K.K.

2-15-1 Kona minato-ku, Tokyo

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MUNDIPHARMA K.K.

2-15-1 Kona minato-ku, Tokyo

+81-3-6718-2370

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completed

Dec. 27, 2018

Interventional

open-label, single-group, multicenter, phase II clinical study

prevention purpose

2

- Patients with a histologically confirmed diagnosis of PTCL who have received at least one prior treatment and have relapsed/refractory disease
- Patients who have a measurable lesion confirmed by CT or PET-CT test
- Patients who are expected to survive for at least 3 months from study enrollment
- Patients with ECOG PS from 0 to 2
- Patients maintaine each internal organs function
- Patients who have given written informed consent prior to initiation of this study

- Patients who received any treatment of PTCL within 21 days prior to the initial administration of pralatrexate in this clinical study, or who have not completely recovered from the toxicities of such prior therapies with unstable medical conditions
- Patients who have stomatitis
- Patients with active CNS involvement or cerebral metastasis
- Patients who have NYHA classification III/IV congestive heart failure, poorly controlled arrhythmias or unstable angina pectoris
- Patients who have infectious disease requiring intravenous administration of antibacterial agent, fungicide, or antiviral drug
- Patients who tested positive for HBs antigen or HIV antibody. Or patients who tested positive for either HBs antibody or HBc antibody, and showed HBV DNA levels above the upper limit of quantification for the assay. Or patients who tested positive for HCV antibody, and showed HCV RNA levels above the upper limit of quantification for the assay
- Patients with hypersensitivity to pralatrexate, leucovorin, vitamin B12 or folic acid
- Pregnant women, lactating women, or women who may be pregnant

Both

Relapsed/Refractory peripheral T-cell lymphoma(r/r PTCL)

investigational material(s)
Generic name etc : Leucovorin tablet
INN of investigational material : Calcium Folinate
Therapeutic category code : 392 Antidotes
Dosage and Administration for Investigational material : Leucovorin 15-25 mg will be taken orally 3 times a day, beginning 24 hours after the initial administration of pralatrexate.

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

efficacy
The incidence of Grade 2 or higher stomatitis occurred in Cycle 1.

efficacy
Response rate to pralatrexate based on CT or PET/CT image evaluation.

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Nov. 07, 2018