Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
NCT ID: NCT02013362
Last Updated: 2017-11-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
25 participants
INTERVENTIONAL
2014-03-31
2017-09-30
Brief Summary
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To evaluate the safety and tolerability of pralatrexate with concurrent vitamin B12 and folic acid supplementation in Japanese patients with relapsed or refractory PTCL and to determine the recommended dosage. Also, to evaluate pharmacokinetics.
Phase II portion:
To evaluate the efficacy, safety, and pharmacokinetics of the recommended dosage regimen determined in the phase I portion. The primary efficacy endpoint shall be objective response rate (ORR).
Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Pralatrexate injection
Dietary Supplement: Vitamin B12, Folic Acid
Pralatrexate injection
Vitamin B12
Folic Acid
Interventions
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Pralatrexate injection
Vitamin B12
Folic Acid
Eligibility Criteria
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Inclusion Criteria
* Patients histologically diagnosed with peripheral T-cell lymphoma by pathological diagnosis of biopsied lesion.
* Relapsed or refractory patients with a treatment history of at least one regimen.
* Patients with an enlarged lymph node or extranodal mass lesion clearly measurable in two perpendicular directions and greater than 1.5 cm in maximum diameter on computed tomography performed.
* Patients expected to survive for at least 3 months.
* ECOG PS 0-2.
* Patients with adequate hemopoietic efficacy, liver and kidney function.
* Patients from whom written consent has been obtained prior to study initiation.
Exclusion Criteria
* Patients who received radiation therapy, phototherapy, or electron beam therapy within 21 days prior to initial administration of the study drug.
* Patients who received another study drug within 28 days prior to initial administration of the study drug.
* Patients who received antibody therapy within 100 days prior to initial administration of the study drug.
* Patients with a history of allogeneic hematopoietic stem cell transplantation. Or patients with a history of autologous hematopoietic stem cell transplantation within 100 days prior to initial administration of the study drug.
* Patients with cerebral metastasis or central nervous system lesion or a past history.
* Patients with active multiple primary cancer. Or patients with a history of a malignant neoplasm other than peripheral T-cell lymphoma within the past 5 years.
* Patients with severe cardiovascular disease.
* Patients positive for HBs antigen, HCV antibody or HIV antibody on immunological investigation. Or patients positive for either HBc antibody or HBs antibody, and showing DNA more than sensitivity in HBV-DNA assay.
* Patients positive for CMV antigen on immunological investigation.
* Patients with infectious disease requiring treatment consisting of intravenous administration of antibacterial agent, fungicide, or antiviral drug.
* Patients with interstitial pneumonia or pulmonary fibrosis, or patients judged to have insufficient pulmonary function.
20 Years
ALL
No
Sponsors
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Mundipharma K.K.
INDUSTRY
Responsible Party
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Principal Investigators
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Kensei Tobinai, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
National Cancer Center Hospital
Locations
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National Hospital Organization Nagoya Medical Center
Nagoya, Aichi-ken, Japan
National Cancer Center Hospital
Chūō, Tokyo, Japan
Okayama University Hospital
Okayama, , Japan
Countries
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References
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Maruyama D, Nagai H, Maeda Y, Nakane T, Shimoyama T, Nakazato T, Sakai R, Ishikawa T, Izutsu K, Ueda R, Tobinai K. Phase I/II study of pralatrexate in Japanese patients with relapsed or refractory peripheral T-cell lymphoma. Cancer Sci. 2017 Oct;108(10):2061-2068. doi: 10.1111/cas.13340. Epub 2017 Sep 4.
Other Identifiers
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PDX-JP1
Identifier Type: -
Identifier Source: org_study_id