Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma

November 7, 2017 updated by: Mundipharma K.K.

Phase I portion:

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

25

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Okayama,, Japan, 700-8558
        • Okayama University Hospital
    • Aichi
      • Nagoya, Aichi, Japan, 460-0001
        • National Hospital Organization Nagoya Medical Center
    • Tokyo
      • Chuo, Tokyo, Japan, 104-0045
        • National Cancer Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Japanese patients at least 20 years of age.
  • 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 a chemotherapy agent or a high dose of a systemic adrenocorticosteroid within 21 days prior to initial administration of the study drug.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pralatrexate injection
Dietary Supplement: Vitamin B12, Folic Acid
Dietary supplement: Vitamin B12
Drug: Pralatrexate injection
Dietary supplement: Folic Acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Objective response rate (ORR) per independent central review committee
Time Frame: From screening period until first documented disease progression or treatment discontinuation from any cause, whichever came first. Duration is approximately 3 years.
The ORR is defined as the proportion of patients with complete response (CR) and partial response (PR). Response will be determined according to International Workshop Criteria (IWC). Assessments will be done at week 7 (end of Cycle 1), subsequently every 14 weeks (end of odd-numbered cycle).
From screening period until first documented disease progression or treatment discontinuation from any cause, whichever came first. Duration is approximately 3 years.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mundipharma K.K.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 1, 2014

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

September 1, 2017

Study Registration Dates

First Submitted

December 4, 2013

First Submitted That Met QC Criteria

December 11, 2013

First Posted (ESTIMATE)

December 17, 2013

Study Record Updates

Last Update Posted (ACTUAL)

November 9, 2017

Last Update Submitted That Met QC Criteria

November 7, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PDX-JP1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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