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

Primary Purpose

Peripheral T-cell Lymphoma

Status

Completed

Phase

Phase 1

Locations

Japan

Study Type

Interventional

Intervention

Pralatrexate injection

Vitamin B12

Folic Acid

About this trial

This is an interventional treatment trial for Peripheral T-cell Lymphoma

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

National Hospital Organization Nagoya Medical Center
National Cancer Center Hospital
Okayama University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pralatrexate injection

Arm Description

Dietary Supplement: Vitamin B12, Folic Acid

Outcomes

Primary Outcome Measures

Objective response rate (ORR) per independent central review committee

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).

Secondary Outcome Measures

Full Information

NCT ID

NCT02013362

First Posted

December 4, 2013

Last Updated

November 7, 2017

Sponsor

Mundipharma K.K.

1. Study Identification

Unique Protocol Identification Number

NCT02013362

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2017

Overall Recruitment Status

Completed

Study Start Date

March 2014 (Actual)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

September 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mundipharma K.K.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral T-cell Lymphoma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pralatrexate injection

Arm Type

Experimental

Arm Description

Dietary Supplement: Vitamin B12, Folic Acid

Intervention Type

Drug

Intervention Name(s)

Pralatrexate injection

Intervention Type

Dietary Supplement

Intervention Name(s)

Vitamin B12

Intervention Type

Dietary Supplement

Intervention Name(s)

Folic Acid

Primary Outcome Measure Information:

Title

Objective response rate (ORR) per independent central review committee

Description

Time Frame

From screening period until first documented disease progression or treatment discontinuation from any cause, whichever came first. Duration is approximately 3 years.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Kensei Tobinai, MD,PhD

Organizational Affiliation

National Cancer Center Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

National Hospital Organization Nagoya Medical Center

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

460-0001

Country

Japan

Facility Name

National Cancer Center Hospital

City

Chuo

State/Province

Tokyo

ZIP/Postal Code

104-0045

Country

Japan

Facility Name

Okayama University Hospital

City

Okayama,

ZIP/Postal Code

700-8558

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

28771889

Citation

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.

Results Reference

derived

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

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