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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02013362
Recruitment Status : Completed
First Posted : December 17, 2013
Last Update Posted : November 9, 2017
Sponsor:
Information provided by (Responsible Party):
Mundipharma K.K.

Study Description
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Brief Summary:

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).


Condition or disease Intervention/treatment Phase
Peripheral T-cell Lymphoma Drug: Pralatrexate injection Dietary Supplement: Vitamin B12 Dietary Supplement: Folic Acid Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Phase I/II Clinical Study of Pralatrexate in Japanese Patients With Relapsed or Refractory Peripheral T-cell Lymphoma
Actual Study Start Date : March 2014
Actual Primary Completion Date : December 2015
Actual Study Completion Date : September 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Folic Acid Lymphoma

Arms and Interventions
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Arm Intervention/treatment
Experimental: Pralatrexate injection
Dietary Supplement: Vitamin B12, Folic Acid
 Drug: Pralatrexate injection
Dietary Supplement: Vitamin B12
Dietary Supplement: Folic Acid


Outcome Measures
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Primary Outcome Measures :
  1. 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).


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02013362


Locations
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Japan
National Hospital Organization Nagoya Medical Center
Nagoya, Aichi, Japan, 460-0001
National Cancer Center Hospital
Chuo, Tokyo, Japan, 104-0045
Okayama University Hospital
Okayama,, Japan, 700-8558
Sponsors and Collaborators
Mundipharma K.K.
Investigators
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Principal Investigator: Kensei Tobinai, MD,PhD National Cancer Center Hospital
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Mundipharma K.K.
ClinicalTrials.gov Identifier: NCT02013362    
Other Study ID Numbers: PDX-JP1
First Posted: December 17, 2013    Key Record Dates
Last Update Posted: November 9, 2017
Last Verified: November 2017
Additional relevant MeSH terms:
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Lymphoma
Lymphoma, T-Cell
Lymphoma, T-Cell, Peripheral
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
 Lymphoma, Non-Hodgkin
Folic Acid
Vitamin B 12
Hydroxocobalamin
Vitamins
Micronutrients
Physiological Effects of Drugs
Hematinics
Vitamin B Complex